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1. Electrokinetically Enhanced Flow and Dewatering Characteristics of Black Coal-water Suspensions in Pipes

Author: Chemeca 93 (21st : 1993 : Melbourne, Vic.), Rozakeas, PK, Snow, RJ, and Jones, CU
Published: 1993

2. Costs of Supply of Coalbed Methane to Potential Central Queensland Demand Centres

Author: Chemeca 92 (20th : 1992 : Canberra, A.C.T.) and Jones, CU
Published: 1992

3. The Potential for Coal Slurry Transportation and Beneficiation Operations in Electricity Generation

Author: Engineering Conference (1983 : Newcastle, N.S.W.), Rigby, GR, Jones, CU, and Mainwaring, DE
Published: 1983

4. Modelling of Coal Hydroliquefaction in a Bubble-column Reactor

Author: Chemeca 82 (10th : 1982 : Sydney, N.S.W.), Agnew, JB, Jones, CU, and Rangaiah, GP
Published: 1982

5. Electrodewatering and its effect on rheology of a Queensland coal-water slurry

Author: CHEMECA 89 (17th : 1989 : Gold Coast, Qld.), Patil, DD, Snow, RJ, Bhattacharya, SN, and Jones, CU
Published: 1989

6. Production of charged pions, kaons and protons at large transverse momenta in pp and Pb–Pb collisions at √sNN = 2.76 TeV

Author: Piano, Stefano, Lea, Ramona, Camerini, Paolo, Luparello, Grazia, Margagliotti, Giacomo, Rui, Rinaldo, Abelev bt, B., Adam ak, J., Adamová cb, D., Aggarwal cf, M. M., Aglieri Rinella ah, G., Agnello cm, M., Agostinelli z, A., Agrawal ar, N., Ahammed dw, Z., Ahmad r, N., Ahmad Masoodi r, A., Ahmed o, I., Ahn bm, S. U., Ahn bm, S. A., Aimo cm, I., Aiola eb, S., Ajaz o, M., Akindinov bc, A., Aleksandrov cs, D., Alessandro dd, B., Alexandre cu, D., Alici cx, A., L, Alkin c, A., Alme ai, J., Alt am, T., Altini ae, V., Altinpinar q, S., Altsybeev dv, I., Alves Garcia Prado dl, C., Andrei bw, C., Andronic cp, A., Anguelov cl, V., Anielski ay, J., Anticˇic ́ cq, T., Antinori da, F., Antonioli cx, P., Aphecetche df, L., Appelshäuser aw, H., Arbor bp, N., Arcelli z, S., Armesto p, N., Arnaldi dd, R., Aronsson eb, T., Arsene u, I. C., Arslandok aw, M., Augustinus ah, A., Averbeck cp, R., Awes cc, T. C., Azmi r, M. D., Bach am, M., Badalà cz, A., Baek an, Y. W., Bagnasco dd, S., Bailhache aw, R., Bairathi cj, V., Bala ci, R., Baldisseri n, A., Baltasar Dos Santos Pedrosa ah, F., Bán bd, J., Baral bf, R. C., Barbera aa, R., Barile ae, F., Barnaföldi ea, G. G., Barnby cu, L. S., Barret bo, V., Bartke di, J., Basile z, M., Bastid bo, N., Basu dw, S., Bathen ay, B., Batigne df, G., Batyunya bk, B., Batzing u, P. C., Baumann aw, C., Bearden by, I. G., Beck aw, H., Bedda cm, C., Behera ar, N. K., Belikov az, I., Bellini z, F., Bellwied dn, R., Belmont Moreno bi, E., Bencedi ea, G., Beole y, S., Berceanu bw, I., Bercuci bw, A., Berdnikov cd, Y., 1, Berenyi ea, D., Berger ck, M. E., Bertens bb, R. A., Berzano y, D., Betev ah, L., Bhasin ci, A., Bhati cf, A. K., Bhattacharjee ao, B., Bhom ds, J., Bianchi y, L., Bianchi bq, N., Bianchin bb, C., Bielcˇík ak, J., Bielcˇíková cb, J., Bilandzic by, A., Bjelogrlic bb, S., Blanco j, F., Blau cs, D., Blume aw, C., Bock cl, F., Bogdanov bu, A., Bøggild by, H., Bogolyubsky de, M., Böhmer ck, F. V., Boldizsár ea, L., Bombara al, M., Book aw, J., Borel n, H., Borissov dz, A., Bornschein am, J., Bossú bj, F., Botje bz, M., Botta y, E., Böttger av, S., Braun Munzinger cp, P., Bregant dl, M., Breitner av, T., Broker aw, T. A., Browning cn, T. A., Broz aj, M., Bruna dd, E., Bruno ae, G. E., Budnikov cr, D., Buesching aw, H., Bufalino dd, S., Buncic ah, P., Busch cl, O., Buthelezi bj, Z., Caffarri ab, D., Cai g, X., Caines eb, H., Caliva bb, A., Calvo Villar cv, E., Canoa Roman ah, V., Carena ah, F., Carena ah, W., Carminati ah, F., Casanova Díaz bq, A., Castillo Castellanos n, J., Casula w, E. A. R., Catanescu bw, V., Cavicchioli ah, C., Ceballos Sanchez i, C., Cepila ak, J., Cerello dd, P., Chang do, B., Chapeland ah, S., Charvet n, J. L., Chattopadhyay dw, S., Chattopadhyay ct, S., Cherney ce, M., Cheshkov du, C., Cheynis du, B., Chibante Barroso ah, V., Chinellato dn, D. D., Chochula ah, P., Chojnacki by, M., Choudhury dw, S., Christakoglou bz, P., Christensen by, C. H., Christiansen af, P., Chujo ds, T., Chung co, S. U., Cicalo cy, C., Cifarelli l, L., Z, Cindolo cx, F., Cleymans ch, J., Colamaria ae, F., Colella ae, D., Collu w, A., Colocci z, M., Conesa Balbastre bp, G., Conesa del Valle au, Z., Connors eb, M. E., Contin x, G., Contreras k, J. G., Cormier cc, T. M., Corrales Morales y, Y., Cortese ad, P., Cortés Maldonado b, I., Cosentino bs, M. R., Costa ah, F., Crochet bo, P., Cruz Albino k, R., Cuautle bh, E., Cunqueiro bq, L., Dainese da, A., Dang g, R., Danu bg, A., Das ct, D., Das au, I., Das ct, K., Das d, S., Dash dm, A., Dash ar, S., De dw, S., Delagrange df, H., 2, Deloff bv, A., Dénes ea, E., D’Erasmo ae, G., de Barros dl, G. O. V., De Caro l, A., de Cataldo cw, G., de Cuveland am, J., De Falco w, A., De Gruttola ac, D., De Marco dd, N., De Pasquale ac, S., de Rooij bb, R., Diaz Corchero j, M. A., Dietel ay, T., Divià ah, R., Di Bari ae, D., Di Liberto db, S., Di Mauro ah, A., Di Nezza bq, P., Djuvsland q, Ø., Dobrin bb, A., Dobrowolski bv, T., Domenicis Gimenez dl, D., Dönigus aw, B., Dordic u, O., Dørheim ck, S., Dubey dw, A. K., Dubla bb, A., Ducroux du, L., Dupieux bo, P., Dutta Majumdar ct, A. K., Ehlers eb, R. J., Elia cw, D., Engel av, H., Erazmus ah, B., Erdal ai, H. A., Eschweiler am, D., Espagnon au, B., Estienne df, M., Esumi ds, S., Evans cu, D., Evdokimov de, S., Eyyubova u, G., Fabris da, D., Faivre bp, J., Falchieri z, D., Fantoni bq, A., Fasel cl, M., Fehlker q, D., Feldkamp ay, L., Felea bg, D., Feliciello dd, A., Feofilov dv, G., Ferencei cb, J., Fernández Téllez b, A., Ferreiro p, E. G., Ferretti y, A., Festanti ab, A., Figiel di, J., Figueredo dl, M. A. S., Filchagin cr, S., Finogeev ba, D., Fionda ae, F. M., Fiore ae, E. M., Floratos cg, E., Floris ah, M., Foertsch bj, S., Foka cp, P., Fokin cs, S., Fragiacomo dc, E., Francescon ab, A., Frankenfeld cp, U., Fuchs ah, U., Furget bp, C., Fusco Girard ac, M., Gaardhøje by, J. J., Gagliardi y, M., Gago cv, A. M., Gallio y, M., Gangadharan s, D. R., Ganoti cg, P., Garabatos cp, C., Garcia Solis m, E., Gargiulo ah, C., Garishvili bt, I., Gerhard am, J., Germain df, M., Gheata ah, A., Gheata bg, M., Ghidini ae, B., Ghosh dw, P., Ghosh d, S. K., Gianotti bq, P., Giubellino ah, P., Gladysz Dziadus di, E., Glässel cl, P., Gomez k, R., González Zamora j, P., Gorbunov am, S., Görlich di, L., Gotovac dh, S., Graczykowski dy, L. K., Grajcarek cl, R., Grelli bb, A., Grigoras ah, A., Grigoras ah, C., Grigoriev bu, V., Grigoryan a, A., Grigoryan bk, S., Grinyov c, B., Grion dc, N., Grosse Oetringhaus ah, J. F., Grossiord du, J. Y., Grosso ah, R., Guber ba, F., Guernane bp, R., Guerzoni z, B., Guilbaud du, M., Gulbrandsen by, K., Gulkanyan a, H., Gunji dr, T., Gupta ci, A., Gupta ci, R., Khan o, K. H., Haake ay, R., Haaland q, Ø., Hadjidakis au, C., Haiduc bg, M., Hamagaki dr, H., Hamar ea, G., Hanratty cu, L. D., Hansen by, A., Harris eb, J. W., Hartmann am, H., Harton m, A., Hatzifotiadou cx, D., Hayashi dr, S., Heckel aw, S. T., Heide ay, M., Helstrup ai, H., Herghelegiu bw, A., Herrera Corral k, G., Hess ag, B. A., Hetland ai, K. F., Hicks eb, B., Hippolyte az, B., Hladky be, J., Hristov ah, P., Huang q, M., Humanic s, T. J., Hutter am, D., Hwang t, D. S., Ilkaev cr, R., Ilkiv bv, I., Inaba ds, M., Incani w, E., Innocenti y, G. M., Ionita ah, C., Ippolitov cs, M., Irfan r, M., Ivanov cp, M., Ivanov cd, V., Ivanytskyi c, O., Jachołkowski aa, A., Jacobs bs, P. M., Jahnke dl, C., Jang bm, H. J., Janik dy, M. A., Jayarathna dn, P. H. S. Y., Jena ar, S., Jimenez Bustamante bh, R. T., Jones cu, P. G., Jung an, H., Jusko cu, A., Kalcher am, S., Kalinak bd, P., Kalweit ah, A., Kamin aw, J., Kang ec, J. H., Kaplin bu, V., Kar dw, S., Karasu Uysal bn, A., Karavichev ba, O., Karavicheva ba, T., Karpechev ba, E., Kebschull av, U., Keidel ed, R., Ketzer ck, B., Khan r, M. M., 3, Khan ct, P., Khan dw, S. A., Khanzadeev cd, A., Kharlov de, Y., Kileng ai, B., Kim ec, B., Kim bm, D. W., Kim do, D. J., Kim an, J. S., Kim an, M., Kim ec, M., Kim t, S., Kim ec, T., Kirsch am, S., Kisel am, I., Kiselev bc, S., Kisiel dy, A., Kiss ea, G., Klay f, J. L., Klein cl, J., Klein Bösing ay, C., Kluge ah, A., Knichel cp, M. L., Knospe dj, A. G., Kobdaj ah, C., Kofarago ah, M., Köhler cp, M. K., Kollegger am, T., Kolojvari dv, A., Kondratiev dv, V., Kondratyeva bu, N., Konevskikh ba, A., Kovalenko dv, V., Kowalski ah, M., Kox bp, S., Koyithatta Meethaleveedu ar, G., Kral do, J., Králik bd, I., Kramer aw, F., Kravcˇáková al, A., Krelina ak, M., Kretz am, M., Krivda cu, M., Krizek cb, F., Krus ak, M., Kryshen cd, E., Krzewicki cp, M., Kucˇera cb, V., Kucheriaev cs, Y., Kugathasan ah, T., Kuhn az, C., Kuijer bz, P. G., Kulakov aw, I., Kumar ar, J., Kurashvili bv, P., Kurepin ba, A., Kurepin ba, A. B., Kuryakin cr, A., Kushpil cb, S., Kushpil cb, V., Kweon cl, M. J., Kwon ec, Y., Ladron de Guevara bh, P., Lagana Fernandes dl, C., Lakomov au, I., Langoy dx, R., Lara av, C., Lardeux df, A., Lattuca y, A., La Pointe dd, S. L., La Rocca aa, P., Leardini cl, L., Lee cu, G. R., Legrand ah, I., Lehnert aw, J., Lemmon ca, R. C., Lenhardt cp, M., Lenti cw, V., Leogrande bb, E., Leoncino y, M., León Monzón dk, I., Lévai ea, P., Li g, S., Lien dx, J., Lietava cu, R., Lindal u, S., Lindenstruth am, V., Lippmann cp, C., Lisa s, M. A., Ljunggren af, H. M., Lodato bb, D. F., Loenne q, P. I., Loggins dz, V. R., Loginov bu, V., Lohner cl, D., Loizides bs, C., Lopez bo, X., López Torres i, E., Lu cl, X. G., Luettig aw, P., Lunardon ab, M., Luo g, J., Luzzi ah, C., Ma eb, R., Maevskaya ba, A., Mager ah, M., Mahapatra bf, D. P., Maire cl, A., Malaev cd, M., Maldonado Cervantes bh, I., Malinina bk, L., 4, Mal’Kevich bc, D., Malzacher cp, P., Mamonov cr, A., Manceau dd, L., Manko cs, V., Manso bo, F., Manzari ah, V., Marchisone y, M., Mareš be, J., Margotti cx, A., Marín cp, A., Markert ah, C., Marquard aw, M., Martashvili dq, I., Martin cp, N. A., Martinengo ah, P., Martínez b, M. I., Martínez García df, G., Martin Blanco df, J., Martynov c, Y., Mas df, A., Masciocchi cp, S., Masera y, M., Masoni cy, A., Massacrier df, L., Mastroserio ae, A., Matyja di, A., Mayer di, C., Mazer dq, J., Mazumder as, R., Mazzoni db, M. A., Meddi v, F., Menchaca Rocha bi, A., Meninno ac, E., Mercado Pérez cl, J., Meres aj, M., Miake ds, Y., Mikhaylov bc, K., Milano ah, L., Milosevic u, J., 5, Mischke bb, A., Mishra as, A. N., Mis ́kowiec cp, D., Mitu bg, C. M., Mlynarz dz, J., Mohanty dw, B., Molnar az, L., Montaño Zetina k, L., Montes j, E., Morando ab, M., Moreira De Godoy dl, D. A., Moretto ab, S., Morreale do, A., Morsch ah, A., Muccifora bq, V., Mudnic dh, E., Muhuri dw, S., Mukherjee dw, M., Müller ah, H., Munhoz dl, M. G., Murray ch, S., Musa ah, L., Musinsky bd, J., Nandi ar, B. K., Nania cx, R., Nappi cw, E., Nattrass dq, C., Nayak dw, T. K., Nazarenko cr, S., Nedosekin bc, A., Nicassio cp, M., Niculescu bg, M., Nielsen by, B. S., Nikolaev cs, S., Nikulin cs, S., Nikulin cd, V., Nilsen ce, B. S., Noferini l, F., Nomokonov bk, P., Nooren bb, G., Nyanin cs, A., Nystrand q, J., Oeschler cl, H., Oh eb, S., Oh bl, S. K., An, 6, Okatan bn, A., Olah ea, L., Oleniacz dy, J., Oliveira Da Silva dl, A. C., Onderwaater cp, J., Oppedisano dd, C., Ortiz Velasquez af, A., Oskarsson af, A., Otwinowski cp, J., Oyama cl, K., Pachmayer cl, Y., Pachr ak, M., Pagano ac, P., Paic ́ bh, G., Painke am, F., Pajares p, C., Pal dw, S. K., Palmeri cz, A., Pant ar, D., Papikyan a, V., Pappalardo cz, G. S., Park cp, W. J., Passfeld ay, A., Patalakha de, D. I., Paticchio cw, V., Paul ct, B., Pawlak dy, T., Peitzmann bb, T., Pereira Da Costa n, H., Pereira De Oliveira Filho dl, E., Peresunko cs, D., Pérez Lara bz, C. E., Peryt dy, W., Pesci cx, A., Pestov e, Y., Petrácˇek ak, V., Petran ak, M., Petris bw, M., Petrovici bw, M., Petta aa, C., Pikna aj, M., Pillot df, P., Pinazza ah, O., Pinsky dn, L., Piyarathna dn, D. B., Płoskon ́ bs, M., Planinic cq, M., Pluta dy, J., Pochybova ea, S., Podesta Lerma dk, P. L. M., Poghosyan ah, M. G., Pohjoisaho ap, E. H. O., Polichtchouk de, B., Poljak cq, N., Pop bw, A., Porteboeuf Houssais bo, S., Porter bs, J., Pospisil ak, V., Potukuchi ci, B., Prasad d, S. K., Preghenella cx, R., Prino dd, F., Pruneau dz, C. A., Pshenichnov ba, I., Puddu w, G., Punin cr, V., Putschke dz, J., Qvigstad u, H., Rachevski dc, A., Raha d, S., Rak do, J., Rakotozafindrabe n, A., Ramello ad, L., Raniwala cj, R., Raniwala cj, S., Räsänen ap, S. S., Rascanu aw, B. T., Rathee cf, D., Rauf o, A. W., Razazi w, V., Read dq, K. F., Real bp, J. S., Redlich bv, K., 7, Reed eb, R. J., Rehman q, A., Reichelt aw, P., Reicher bb, M., Reidt cl, F., Renfordt aw, R., Reolon bq, A. R., Reshetin ba, A., Rettig am, F., Revol ah, J. P., Reygers cl, K., Riabov cd, V., Ricci br, R. A., Richert af, T., Richter u, M., Riedler ah, P., Riegler ah, W., Riggi aa, F., Rivetti dd, A., Rocco bb, E., Rodríguez Cahuantzi b, M., Rodriguez Manso bz, A., Røed u, K., Rogochaya bk, E., Rohni ci, S., Rohr am, D., Röhrich q, D., Romita dp, R., Ronchetti bq, F., Ronflette df, L., Rosnet bo, P., Rossegger ah, S., Rossi ah, A., Roukoutakis cg, F., Roy as, A., Roy az, C., Roy ct, P., Rubio Montero j, A. J., Russo y, R., Ryabinkin cs, E., Ryabov cd, Y., Rybicki di, A., Sadovsky de, S., Šafarˇík ah, K., Sahlmuller aw, B., Sahoo as, R., Sahu bf, P. K., Saini dw, J., Salgado p, C. A., Salzwedel s, J., Sambyal ci, S., Samsonov cd, V., Sanchez Castro az, X., Sánchez Rodríguez dk, F. J., Šándor bd, L., Sandoval bi, A., Sano ds, M., Santagati aa, G., Sarkar dw, D., Scapparone cx, E., Scarlassara ab, F., Scharenberg cn, R. P., Schiaua bw, C., Schicker cl, R., Schmidt cp, C., Schmidt ag, H. R., Schuchmann aw, S., Schukraft ah, J., Schulc ak, M., Schuster eb, T., Schutz ah, Y., Schwarz cp, K., Schweda cp, K., Scioli z, G., Scomparin dd, E., Scott cu, P. A., Scott dq, R., Segato ab, G., Seger ce, J. E., Selyuzhenkov cp, I., Seo co, J., Serradilla j, E., Sevcenco bg, A., Shabetai df, A., Shabratova bk, G., Shahoyan ah, R., Shangaraev de, A., Sharma dq, N., Sharma ci, S., Shigaki aq, K., Shtejer y, K., Sibiriak cs, Y., Siddhanta cy, S., Siemiarczuk bv, T., Silvermyr cc, D., Silvestre bp, C., Simatovic dt, G., Singaraju dw, R., Singh ci, R., Singha bx, S., Singhal dw, V., Sinha dw, B. C., Sinha ct, T., Sitar aj, B., Sitta ad, M., Skaali u, T. B., Skjerdal q, K., Smakal ak, R., Smirnov eb, N., Snellings bb, R. J. M., Søgaard af, C., Soltz bt, R., Song co, J., Song ec, M., Soramel ab, F., Sorensen dq, S., Spacek ak, M., Sputowska di, I., Spyropoulou Stassinaki cg, M., Srivastava cn, B. K., Stachel cl, J., Stan bg, I., Stefanek bv, G., Steinpreis s, M., Stenlund af, E., Steyn bj, G., Stiller cl, J. H., Stocco df, D., Stolpovskiy de, M., Strmen aj, P., Suaide dl, A. A. P., Subieta Vasquez y, M. A., Sugitate aq, T., Suire au, C., Suleymanov o, M., Sultanov bc, R., Šumbera cb, M., Susa cq, T., Symons bs, T. J. M., Szanto de Toledo dl, A., Szarka aj, I., Szczepankiewicz ah, A., Szymanski dy, M., Takahashi dm, J., Tangaro ae, M. A., Tapia Takaki au, J. D., 8, Tarantola Peloni aw, A., Tarazona Martinez ah, A., Tarzila bw, M. G., Tauro ah, A., Tejeda Muñoz b, G., Telesca ah, A., Terrevoli w, C., Ter Minasyan bu, A., Thäder cp, J., Thomas bb, D., Tieulent du, R., Timmins dn, A. R., Toia da, A., Torii dr, H., Trubnikov c, V., Trzaska do, W. H., Tsuji dr, T., Tumkin cr, A., Turrisi da, R., Tveter u, T. S., Ulery aw, J., Ullaland q, K., Uras du, A., Usai w, G. L., Vajzer cb, M., Vala bk, M., Valencia Palomo au, L., Vallero y, S., Vande Vyvre ah, P., Vannucci br, L., Van Der Maarel bb, J., Van Hoorne ah, J. W., van Leeuwen bb, M., Vargas b, A., Varma ar, R., Vasileiou cg, M., Vasiliev cs, A., Vechernin dv, V., Veldhoen bb, M., Velure q, A., Venaruzzo x, M., Vercellin y, E., Vergara Limón b, S., Vernet h, R., Verweij dz, M., Vickovic dh, L., Viesti ab, G., Viinikainen do, J., Vilakazi bj, Z., Villalobos Baillie cu, O., Vinogradov cs, A., Vinogradov dv, L., Vinogradov cr, Y., Virgili ac, T., Viyogi dw, Y. P., Vodopyanov bk, A., Völkl cl, M. A., Voloshin bc, K., Voloshin dz, S. A., Volpe ah, G., von Haller ah, B., Vorobyev dv, I., Vranic cp, D., Vrláková al, J., Vulpescu bo, B., Vyushin cr, A., Wagner q, B., Wagner cp, J., Wagner ak, V., Wang g, M., Wang cl, Y., Watanabe ds, D., Weber dn, M., Wessels ay, J. P., Westerhoff ay, U., Wiechula ag, J., Wikne u, J., Wilde ay, M., Wilk bv, G., Wilkinson cl, J., Williams cx, M. C. S., Windelband cl, B., Winn cl, M., Xiang g, C., Yaldo dz, C. G., Yamaguchi dr, Y., Yang bb, H., Yang g, P., Yang q, S., Yano aq, S., Yasnopolskiy cs, S., Yi co, J., Yin g, Z., Yoo co, I. K., Yushmanov cs, I., Zaccolo by, V., Zach ak, C., Zaman o, A., Zampolli cx, C., Zaporozhets bk, S., Zarochentsev dv, A., Závada be, P., Zaviyalov cr, N., Zbroszczyk dy, H., Zgura bg, I. S., Zhalov cd, M., Zhang g, F., Zhang g, H., Zhang bo, X., Bs, G, Zhangg, Y., Zhaou, C., Zhoug, D., Zhoug, F., Zhoubb, Y., Zhug, H., Zhudf, J., G, Zhug, J., Zhug, X., Zichichil, A., Zimmermann cl, A., Zimmermann ay, M. B., Zinovjev c, G., Zoccarato du, Y., Zynovyev c, M., Zyzak aw, M., Piano, Stefano, Lea, Ramona, Camerini, Paolo, Luparello, Grazia, Margagliotti, Giacomo, Rui, Rinaldo, B., Abelev bt, J., Adam ak, D., Adamová cb, M. M., Aggarwal cf, G., Aglieri Rinella ah, M., Agnello cm, Dd, A., Agostinelli z, N., Agrawal ar, Z., Ahammed dw, N., Ahmad r, A., Ahmad Masoodi r, I., Ahmed o, S. U., Ahn bm, S. A., Ahn bm, I., Aimo cm, S., Aiola eb, M., Ajaz o, A., Akindinov bc, D., Aleksandrov c, B., Alessandro dd, D., Alexandre cu, A., Alici cx, L, A., Alkin c, J., Alme ai, T., Alt am, V., Altini ae, S., Altinpinar q, I., Altsybeev dv, C., Alves Garcia Prado dl, C., Andrei bw, A., Andronic cp, V., Anguelov cl, J., Anielski ay, T., Anticˇic ́ cq, F., Antinori da, P., Antonioli cx, L., Aphecetche df, H., Appelshäuser aw, N., Arbor bp, S., Arcelli z, N., Armesto p, R., Arnaldi dd, T., Aronsson eb, I. C., Arsene u, Cp, M., Arslandok aw, A., Augustinus ah, R., Averbeck cp, T. C., Awes cc, M. D., Azmi r, Ch, M., Bach am, A., Badalà cz, Y. W., Baek an, Bo, S., Bagnasco dd, R., Bailhache aw, V., Bairathi cj, R., Bala ci, A., Baldisseri n, F., Baltasar Dos Santos Pedrosa ah, J., Bán bd, R. C., Baral bf, R., Barbera aa, F., Barile ae, G. G., Barnaföldi ea, L. S., Barnby cu, V., Barret bo, J., Bartke di, M., Basile z, N., Bastid bo, S., Basu dw, B., Bathen ay, G., Batigne df, B., Batyunya bk, P. C., Batzing u, C., Baumann aw, I. G., Bearden by, H., Beck aw, C., Bedda cm, N. K., Behera ar, I., Belikov az, F., Bellini z, R., Bellwied dn, E., Belmont Moreno bi, G., Bencedi ea, S., Beole y, I., Berceanu bw, A., Bercuci bw, Y., Berdnikov cd, D., Berenyi ea, M. E., Berger ck, R. A., Bertens bb, D., Berzano y, L., Betev ah, A., Bhasin ci, A. K., Bhati cf, B., Bhattacharjee ao, J., Bhom d, L., Bianchi y, N., Bianchi bq, C., Bianchin bb, J., Bielcˇík ak, J., Bielcˇíková cb, A., Bilandzic by, S., Bjelogrlic bb, F., Blanco j, D., Blau c, C., Blume aw, F., Bock cl, Bs, A., Bogdanov bu, H., Bøggild by, M., Bogolyubsky de, F. V., Böhmer ck, L., Boldizsár ea, M., Bombara al, J., Book aw, H., Borel n, A., Borissov dz, Co, J., Bornschein am, F., Bossú bj, M., Botje bz, E., Botta y, S., Böttger av, P., Braun Munzinger cp, M., Bregant dl, T., Breitner av, T. A., Broker aw, T. A., Browning cn, M., Broz aj, Ak, E., Bruna dd, G. E., Bruno ae, D., Budnikov cr, H., Buesching aw, S., Bufalino dd, P., Buncic ah, O., Busch cl, Z., Buthelezi bj, D., Caffarri ab, X., Cai g, H., Caines eb, A., Caliva bb, E., Calvo Villar cv, V., Canoa Roman ah, F., Carena ah, W., Carena ah, F., Carminati ah, A., Casanova Díaz bq, J., Castillo Castellanos n, E. A. R., Casula w, V., Catanescu bw, C., Cavicchioli ah, C., Ceballos Sanchez i, J., Cepila ak, P., Cerello dd, B., Chang do, S., Chapeland ah, J. L., Charvet n, S., Chattopadhyay dw, S., Chattopadhyay ct, M., Cherney ce, C., Cheshkov du, B., Cheynis du, V., Chibante Barroso ah, D. D., Chinellato dn, Dm, P., Chochula ah, M., Chojnacki by, S., Choudhury dw, P., Christakoglou bz, C. H., Christensen by, P., Christiansen af, T., Chujo d, S. U., Chung co, C., Cicalo cy, L., Cifarelli l, Z, F., Cindolo cx, J., Cleymans ch, F., Colamaria ae, D., Colella ae, A., Collu w, M., Colocci z, G., Conesa Balbastre bp, Z., Conesa del Valle au, Ah, M. E., Connors eb, Contin x, G., J. G., Contreras k, T. M., Cormier cc, Dz, Y., Corrales Morales y, P., Cortese ad, I., Cortés Maldonado b, M. R., Cosentino b, Dl, F., Costa ah, P., Crochet bo, R., Cruz Albino k, E., Cuautle bh, L., Cunqueiro bq, A., Dainese da, R., Dang g, A., Danu bg, D., Das ct, I., Das au, K., Das ct, S., Das d, A., Dash dm, S., Dash ar, S., De dw, H., Delagrange df, A., Deloff bv, E., Dénes ea, G., D’Erasmo ae, G. O. V., de Barros dl, A., De Caro l, Ac, G., de Cataldo cw, J., de Cuveland am, A., De Falco w, D., De Gruttola ac, N., De Marco dd, S., De Pasquale ac, R., de Rooij bb, M. A., Diaz Corchero j, T., Dietel ay, R., Divià ah, D., Di Bari ae, S., Di Liberto db, A., Di Mauro ah, P., Di Nezza bq, Ø., Djuvsland q, A., Dobrin bb, T., Dobrowolski bv, D., Domenicis Gimenez dl, B., Dönigus aw, O., Dordic u, S., Dørheim ck, A. K., Dubey dw, A., Dubla bb, L., Ducroux du, P., Dupieux bo, A. K., Dutta Majumdar ct, R. J., Ehlers eb, D., Elia cw, H., Engel av, B., Erazmus ah, Df, H. A., Erdal ai, D., Eschweiler am, B., Espagnon au, M., Estienne df, S., Esumi d, D., Evans cu, S., Evdokimov de, G., Eyyubova u, D., Fabris da, J., Faivre bp, D., Falchieri z, A., Fantoni bq, M., Fasel cl, D., Fehlker q, L., Feldkamp ay, D., Felea bg, A., Feliciello dd, G., Feofilov dv, J., Ferencei cb, A., Fernández Téllez b, E. G., Ferreiro p, A., Ferretti y, A., Festanti ab, J., Figiel di, M. A. S., Figueredo dl, Dp, S., Filchagin cr, D., Finogeev ba, F. M., Fionda ae, E. M., Fiore ae, E., Floratos cg, M., Floris ah, S., Foertsch bj, P., Foka cp, S., Fokin c, E., Fragiacomo dc, A., Francescon ab, U., Frankenfeld cp, U., Fuchs ah, C., Furget bp, M., Fusco Girard ac, J. J., Gaardhøje by, M., Gagliardi y, A. M., Gago cv, M., Gallio y, D. R., Gangadharan, P., Ganoti cg, Cc, C., Garabatos cp, E., Garcia Solis m, C., Gargiulo ah, I., Garishvili bt, J., Gerhard am, M., Germain df, A., Gheata ah, M., Gheata bg, B., Ghidini ae, P., Ghosh dw, S. K., Ghosh d, P., Gianotti bq, P., Giubellino ah, E., Gladysz Dziadus di, P., Glässel cl, R., Gomez k, P., González Zamora j, S., Gorbunov am, L., Görlich di, S., Gotovac dh, L. K., Graczykowski dy, R., Grajcarek cl, A., Grelli bb, A., Grigoras ah, C., Grigoras ah, V., Grigoriev bu, A., Grigoryan a, S., Grigoryan bk, B., Grinyov c, N., Grion dc, J. F., Grosse Oetringhaus ah, J. Y., Grossiord du, R., Grosso ah, F., Guber ba, R., Guernane bp, B., Guerzoni z, M., Guilbaud du, K., Gulbrandsen by, H., Gulkanyan a, T., Gunji dr, A., Gupta ci, R., Gupta ci, K. H., Khan o, R., Haake ay, Ø., Haaland q, C., Hadjidakis au, M., Haiduc bg, H., Hamagaki dr, G., Hamar ea, L. D., Hanratty cu, A., Hansen by, J. W., Harris eb, H., Hartmann am, A., Harton m, D., Hatzifotiadou cx, S., Hayashi dr, S. T., Heckel aw, M., Heide ay, H., Helstrup ai, A., Herghelegiu bw, G., Herrera Corral k, B. A., Hess ag, K. F., Hetland ai, B., Hicks eb, B., Hippolyte az, J., Hladky be, P., Hristov ah, M., Huang q, T. J., Humanic, D., Hutter am, D. S., Hwang t, R., Ilkaev cr, I., Ilkiv bv, M., Inaba d, E., Incani w, G. M., Innocenti y, C., Ionita ah, M., Ippolitov c, M., Irfan r, M., Ivanov cp, V., Ivanov cd, O., Ivanytskyi c, A., Jachołkowski aa, P. M., Jacobs b, C., Jahnke dl, H. J., Jang bm, M. A., Janik dy, P. H. S. Y., Jayarathna dn, S., Jena ar, Dn, R. T., Jimenez Bustamante bh, P. G., Jones cu, H., Jung an, A., Jusko cu, S., Kalcher am, P., Kalinak bd, A., Kalweit ah, J., Kamin aw, J. H., Kang ec, V., Kaplin bu, S., Kar dw, A., Karasu Uysal bn, O., Karavichev ba, T., Karavicheva ba, E., Karpechev ba, U., Kebschull av, R., Keidel ed, B., Ketzer ck, M. M., Khan r, P., Khan ct, S. A., Khan dw, A., Khanzadeev cd, Y., Kharlov de, B., Kileng ai, B., Kim ec, D. W., Kim bm, An, D. J., Kim do, J. S., Kim an, M., Kim an, M., Kim ec, S., Kim t, T., Kim ec, S., Kirsch am, I., Kisel am, S., Kiselev bc, A., Kisiel dy, G., Kiss ea, J. L., Klay f, J., Klein cl, C., Klein Bösing ay, A., Kluge ah, M. L., Knichel cp, A. G., Knospe dj, C., Kobdaj ah, Dg, M., Kofarago ah, M. K., Köhler cp, T., Kollegger am, A., Kolojvari dv, V., Kondratiev dv, N., Kondratyeva bu, A., Konevskikh ba, V., Kovalenko dv, M., Kowalski ah, Di, S., Kox bp, G., Koyithatta Meethaleveedu ar, J., Kral do, I., Králik bd, F., Kramer aw, A., Kravcˇáková al, M., Krelina ak, M., Kretz am, M., Krivda cu, Bd, F., Krizek cb, Ap, M., Krus ak, E., Kryshen cd, M., Krzewicki cp, V., Kucˇera cb, Y., Kucheriaev c, T., Kugathasan ah, C., Kuhn az, P. G., Kuijer bz, I., Kulakov aw, J., Kumar ar, P., Kurashvili bv, A., Kurepin ba, A. B., Kurepin ba, A., Kuryakin cr, S., Kushpil cb, V., Kushpil cb, M. J., Kweon cl, At, Y., Kwon ec, P., Ladron de Guevara bh, C., Lagana Fernandes dl, I., Lakomov au, R., Langoy dx, C., Lara av, A., Lardeux df, A., Lattuca y, S. L., La Pointe dd, Bb, P., La Rocca aa, L., Leardini cl, G. R., Lee cu, I., Legrand ah, J., Lehnert aw, R. C., Lemmon ca, M., Lenhardt cp, V., Lenti cw, E., Leogrande bb, M., Leoncino y, I., León Monzón dk, P., Lévai ea, S., Li g, J., Lien dx, R., Lietava cu, S., Lindal u, V., Lindenstruth am, C., Lippmann cp, M. A., Lisa, H. M., Ljunggren af, D. F., Lodato bb, P. I., Loenne q, V. R., Loggins dz, V., Loginov bu, D., Lohner cl, C., Loizides b, X., Lopez bo, E., López Torres i, X. G., Lu cl, P., Luettig aw, M., Lunardon ab, J., Luo g, C., Luzzi ah, R., Ma eb, A., Maevskaya ba, M., Mager ah, D. P., Mahapatra bf, A., Maire cl, Az, M., Malaev cd, I., Maldonado Cervantes bh, L., Malinina bk, D., Mal’Kevich bc, P., Malzacher cp, A., Mamonov cr, L., Manceau dd, V., Manko c, F., Manso bo, V., Manzari ah, Cw, M., Marchisone y, J., Mareš be, A., Margotti cx, A., Marín cp, C., Markert ah, Dj, M., Marquard aw, I., Martashvili dq, N. A., Martin cp, P., Martinengo ah, M. I., Martínez b, G., Martínez García df, J., Martin Blanco df, Y., Martynov c, A., Mas df, S., Masciocchi cp, M., Masera y, A., Masoni cy, L., Massacrier df, A., Mastroserio ae, A., Matyja di, C., Mayer di, J., Mazer dq, R., Mazumder a, M. A., Mazzoni db, F., Meddi v, A., Menchaca Rocha bi, E., Meninno ac, J., Mercado Pérez cl, M., Meres aj, Y., Miake d, K., Mikhaylov bc, Bk, L., Milano ah, J., Milosevic u, A., Mischke bb, A. N., Mishra a, D., Mis ́kowiec cp, C. M., Mitu bg, J., Mlynarz dz, B., Mohanty dw, Bx, L., Molnar az, L., Montaño Zetina k, E., Montes j, M., Morando ab, D. A., Moreira De Godoy dl, S., Moretto ab, A., Morreale do, A., Morsch ah, V., Muccifora bq, E., Mudnic dh, S., Muhuri dw, M., Mukherjee dw, H., Müller ah, M. G., Munhoz dl, S., Murray ch, L., Musa ah, J., Musinsky bd, B. K., Nandi ar, R., Nania cx, E., Nappi cw, C., Nattrass dq, T. K., Nayak dw, S., Nazarenko cr, A., Nedosekin bc, M., Nicassio cp, M., Niculescu bg, B. S., Nielsen by, S., Nikolaev c, S., Nikulin c, V., Nikulin cd, B. S., Nilsen ce, F., Noferini l, Cx, P., Nomokonov bk, G., Nooren bb, A., Nyanin c, J., Nystrand q, H., Oeschler cl, Ax, S., Oh eb, S. K., Oh bl, An, 6, A., Okatan bn, L., Olah ea, J., Oleniacz dy, A. C., Oliveira Da Silva dl, J., Onderwaater cp, C., Oppedisano dd, A., Ortiz Velasquez af, A., Oskarsson af, J., Otwinowski cp, K., Oyama cl, Y., Pachmayer cl, M., Pachr ak, P., Pagano ac, G., Paic ́ bh, F., Painke am, C., Pajares p, S. K., Pal dw, A., Palmeri cz, D., Pant ar, V., Papikyan a, G. S., Pappalardo cz, W. J., Park cp, A., Passfeld ay, D. I., Patalakha de, V., Paticchio cw, B., Paul ct, T., Pawlak dy, T., Peitzmann bb, H., Pereira Da Costa n, E., Pereira De Oliveira Filho dl, D., Peresunko c, C. E., Pérez Lara bz, W., Peryt dy, A., Pesci cx, Y., Pestov e, V., Petrácˇek ak, M., Petran ak, M., Petris bw, M., Petrovici bw, C., Petta aa, M., Pikna aj, P., Pillot df, O., Pinazza ah, L., Pinsky dn, D. B., Piyarathna dn, M., Płoskon ́ b, M., Planinic cq, Dt, J., Pluta dy, S., Pochybova ea, P. L. M., Podesta Lerma dk, M. G., Poghosyan ah, Ce, E. H. O., Pohjoisaho ap, B., Polichtchouk de, N., Poljak cq, A., Pop bw, S., Porteboeuf Houssais bo, J., Porter b, V., Pospisil ak, B., Potukuchi ci, S. K., Prasad d, R., Preghenella cx, F., Prino dd, C. A., Pruneau dz, I., Pshenichnov ba, G., Puddu w, V., Punin cr, J., Putschke dz, H., Qvigstad u, A., Rachevski dc, S., Raha d, J., Rak do, A., Rakotozafindrabe n, L., Ramello ad, R., Raniwala cj, S., Raniwala cj, S. S., Räsänen ap, B. T., Rascanu aw, D., Rathee cf, A. W., Rauf o, V., Razazi w, K. F., Read dq, J. S., Real bp, K., Redlich bv, R. J., Reed eb, A., Rehman q, P., Reichelt aw, M., Reicher bb, F., Reidt cl, R., Renfordt aw, A. R., Reolon bq, A., Reshetin ba, F., Rettig am, J. P., Revol ah, K., Reygers cl, V., Riabov cd, R. A., Ricci br, T., Richert af, M., Richter u, P., Riedler ah, W., Riegler ah, F., Riggi aa, A., Rivetti dd, E., Rocco bb, M., Rodríguez Cahuantzi b, A., Rodriguez Manso bz, K., Røed u, E., Rogochaya bk, S., Rohni ci, D., Rohr am, D., Röhrich q, R., Romita dp, Ca, F., Ronchetti bq, L., Ronflette df, P., Rosnet bo, S., Rossegger ah, A., Rossi ah, F., Roukoutakis cg, A., Roy a, C., Roy az, P., Roy ct, A. J., Rubio Montero j, R., Russo y, E., Ryabinkin c, Y., Ryabov cd, A., Rybicki di, S., Sadovsky de, K., Šafarˇík ah, B., Sahlmuller aw, R., Sahoo a, P. K., Sahu bf, J., Saini dw, C. A., Salgado p, J., Salzwedel, S., Sambyal ci, V., Samsonov cd, X., Sanchez Castro az, Bh, F. J., Sánchez Rodríguez dk, L., Šándor bd, A., Sandoval bi, M., Sano d, G., Santagati aa, D., Sarkar dw, E., Scapparone cx, F., Scarlassara ab, R. P., Scharenberg cn, C., Schiaua bw, R., Schicker cl, C., Schmidt cp, H. R., Schmidt ag, S., Schuchmann aw, J., Schukraft ah, M., Schulc ak, T., Schuster eb, Y., Schutz ah, K., Schwarz cp, K., Schweda cp, G., Scioli z, E., Scomparin dd, P. A., Scott cu, R., Scott dq, G., Segato ab, J. E., Seger ce, I., Selyuzhenkov cp, J., Seo co, E., Serradilla j, Bi, A., Sevcenco bg, A., Shabetai df, G., Shabratova bk, R., Shahoyan ah, A., Shangaraev de, N., Sharma dq, Bf, S., Sharma ci, K., Shigaki aq, K., Shtejer y, Y., Sibiriak c, S., Siddhanta cy, T., Siemiarczuk bv, D., Silvermyr cc, C., Silvestre bp, G., Simatovic dt, R., Singaraju dw, R., Singh ci, S., Singha bx, Dw, V., Singhal dw, B. C., Sinha dw, T., Sinha ct, B., Sitar aj, M., Sitta ad, T. B., Skaali u, K., Skjerdal q, R., Smakal ak, N., Smirnov eb, R. J. M., Snellings bb, C., Søgaard af, R., Soltz bt, J., Song co, M., Song ec, F., Soramel ab, S., Sorensen dq, M., Spacek ak, I., Sputowska di, M., Spyropoulou Stassinaki cg, B. K., Srivastava cn, J., Stachel cl, I., Stan bg, G., Stefanek bv, M., Steinpreis, E., Stenlund af, G., Steyn bj, J. H., Stiller cl, D., Stocco df, M., Stolpovskiy de, P., Strmen aj, A. A. P., Suaide dl, M. A., Subieta Vasquez y, T., Sugitate aq, C., Suire au, M., Suleymanov o, R., Sultanov bc, M., Šumbera cb, T., Susa cq, T. J. M., Symons b, A., Szanto de Toledo dl, I., Szarka aj, A., Szczepankiewicz ah, M., Szymanski dy, J., Takahashi dm, M. A., Tangaro ae, J. D., Tapia Takaki au, A., Tarantola Peloni aw, A., Tarazona Martinez ah, M. G., Tarzila bw, A., Tauro ah, G., Tejeda Muñoz b, A., Telesca ah, C., Terrevoli w, A., Ter Minasyan bu, J., Thäder cp, D., Thomas bb, R., Tieulent du, A. R., Timmins dn, A., Toia da, Aw, H., Torii dr, V., Trubnikov c, W. H., Trzaska do, T., Tsuji dr, A., Tumkin cr, R., Turrisi da, T. S., Tveter u, J., Ulery aw, K., Ullaland q, A., Uras du, G. L., Usai w, M., Vajzer cb, M., Vala bk, L., Valencia Palomo au, S., Vallero y, Cl, P., Vande Vyvre ah, L., Vannucci br, J., Van Der Maarel bb, J. W., Van Hoorne ah, M., van Leeuwen bb, A., Vargas b, R., Varma ar, M., Vasileiou cg, A., Vasiliev c, V., Vechernin dv, M., Veldhoen bb, A., Velure q, M., Venaruzzo x, E., Vercellin y, S., Vergara Limón b, R., Vernet h, M., Verweij dz, L., Vickovic dh, G., Viesti ab, J., Viinikainen do, Z., Vilakazi bj, O., Villalobos Baillie cu, A., Vinogradov c, L., Vinogradov dv, Y., Vinogradov cr, T., Virgili ac, Y. P., Viyogi dw, A., Vodopyanov bk, M. A., Völkl cl, K., Voloshin bc, S. A., Voloshin dz, G., Volpe ah, B., von Haller ah, I., Vorobyev dv, D., Vranic cp, J., Vrláková al, B., Vulpescu bo, A., Vyushin cr, B., Wagner q, J., Wagner cp, V., Wagner ak, M., Wang g, Y., Wang cl, D., Watanabe d, M., Weber dn, J. P., Wessels ay, U., Westerhoff ay, J., Wiechula ag, J., Wikne u, M., Wilde ay, G., Wilk bv, J., Wilkinson cl, M. C. S., Williams cx, B., Windelband cl, M., Winn cl, C., Xiang g, C. G., Yaldo dz, Y., Yamaguchi dr, H., Yang bb, P., Yang g, S., Yang q, S., Yano aq, S., Yasnopolskiy c, J., Yi co, Z., Yin g, I. K., Yoo co, I., Yushmanov c, Zaccolo by, V., C., Zach ak, A., Zaman o, C., Zampolli cx, S., Zaporozhets bk, A., Zarochentsev dv, P., Závada be, N., Zaviyalov cr, H., Zbroszczyk dy, I. S., Zgura bg, M., Zhalov cd, F., Zhang g, H., Zhang g, X., Zhang bo, G, B, Y., Zhangg, C., Zhaou, D., Zhoug, F., Zhoug, Y., Zhoubb, H., Zhug, J., Zhudf, G, J., Zhug, X., Zhug, A., Zichichil, A., Zimmermann cl, M. B., Zimmermann ay, G., Zinovjev c, Y., Zoccarato du, M., Zynovyev c, and M., Zyzak aw
Subjects: Particle ratios, ALICE, High pT, Nuclear modification factor, Identified particle production, Particle ratio, LHC, Baryon anomaly
Abstract: Transverse momentum spectra of π±, K± and p(p ̄) up to pT = 20 GeV/c at mid-rapidity in pp, peripheral (60–80%) and central (0–5%) Pb–Pb collisions at √sNN = 2.76 TeV have been measured using the ALICE detector at the Large Hadron Collider. The proton-to-pion and the kaon-to-pion ratios both show a distinct peak at pT ≈ 3 GeV/c in central Pb–Pb collisions. Below the peak, pT < 3 GeV/c, both ratios are in good agreement with hydrodynamical calculations, suggesting that the peak itself is dominantly the result of radial flow rather than anomalous hadronization processes. For pT > 10 GeV/c particle ratios in pp and Pb–Pb collisions are in agreement and the nuclear modification factors for π±, K± and p(p ̄) indicate that, within the systematic and statistical uncertainties, the suppression is the same. This suggests that the chemical composition of leading particles from jets in the medium is similar to that of vacuum jets.
Published: 2014

7. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial [corrected] [published erratum appears in J PHYSIOTHER 2010;56(4):221].

Author: Jones CU, Sangthong B, and Pachirat O
Abstract: Question: Can adding an inspiratory load enhance the antihypertensive effects of slow breathing training performed at home? Design: Randomised trial with concealed allocation. Participants: Thirty patients with essential hypertension Stage I or II. Intervention: Experimental groups performed slow deep breathing at home, either unloaded or breathing against a load of 20 cmH2O using a threshold-loaded breathing device. Participants trained for 30 min, twice daily for 8 weeks. A control group continued with normal activities. Outcome measures: Resting blood pressure and heart rate were measured at home and in the laboratory before and after the training period. Results: Compared to the control group, systolic and diastolic blood pressure decreased significantly with unloaded breathing by means of 7.0 mmHg (95% CI 5.5 to 8.5) and 13.5 mmHg (95% CI 11.3 to 15.7), respectively (laboratory measures). With loaded breathing, the reductions were greater at 18.8 mmHg (95% CI 16.1 to 21.5) and 8.6 mmHg (95% CI 6.8 to 10.4), respectively. The improvement in systolic blood pressure was 5.3 mmHg (95% CI 1.0 to 9.6) greater than with unloaded breathing. Heart rate declined by 8 beats/min (95% CI 6.5 to 10.3) with unloaded breathing, and 9 beats/min (95% CI 5.6 to 12.2) with loaded breathing. Very similar measures of blood pressure and heart rate were obtained by the patients at home. Conclusion: Home-based training with a simple device is well tolerated by patients and produces clinically valuable reductions in blood pressure. Adding an inspiratory load of 20 cmH2O enhanced the decrease in systolic blood pressure. Trial registration: NCT007919689. [ABSTRACT FROM AUTHOR]
Published: 2010
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8. Conical-PEP is safe, reduces lung hyperinflation and contributes to improved exercise endurance in patients with COPD: a randomised cross-over trial.

Author: Padkao T, Boonsawat W, and Jones CU
Abstract: Question: Does a new positive expiratory pressure device (conical-PEP) decrease lung hyperinflation during exercise in patients with chronic obstructive pulmonary disease compared to normal breathing? Does it increase the duration of exercise? Design: A randomised, cross-over trial with concealed allocation. Participants: Thirteen patients with moderate to severe chronic obstructive pulmonary disease (mean FEV1 61% predicted). Intervention: The experimental intervention was conical-PEP breathing with a positive expiratory pressure of 4-20 cmH2O during 30% of 1 RM alternate knee extension exercise at 70% age-predicted HRmax to fatigue. The control intervention was normal breathing. Outcome measures: Total lung capacity (inspiratory capacity and slow vital capacity), breathlessness, and leg discomfort were measured pre and post exercise. Cardiorespiratory function was measured pre and during the last 30 s of exercise. Duration of exercise was recorded. Results: After the experimental intervention, inspiratory capacity increased 200 ml (95% CI 0 to 400) and slow vital capacity increased 200 ml (95% CI 0 to 400) more than the control intervention. Participants exercised for 107 s (95% CI -23 to 238) more during the experimental intervention than the control intervention. Conical-PEP breathing during exercise resulted in 6.1 fewer breaths/min (95% CI 1.4 to 10.8) than normal breathing; it did not have any adverse effects on CO2 retention or oxygen saturation. Conclusion: The novel conical-PEP device decreases lung hyperinflation, is safe to use, and tends to increase the duration of exercise. [ABSTRACT FROM AUTHOR]
Published: 2010
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9. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.

Author: Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, and Ang KK
Published: 2006

10. External Validation of a Digital Pathology-based Multimodal Artificial Intelligence Architecture in the NRG/RTOG 9902 Phase 3 Trial.

Author: Ross AE, Zhang J, Huang HC, Yamashita R, Keim-Malpass J, Simko JP, DeVries S, Morgan TM, Souhami L, Dobelbower MC, McGinnis LS, Jones CU, Dess RT, Zeitzer KL, Choi K, Hartford AC, Michalski JM, Raben A, Gomella LG, Sartor AO, Rosenthal SA, Sandler HM, Spratt DE, Pugh SL, Mohamad O, Esteva A, Chen E, Schaeffer EM, Tran PT, and Feng FY
Subjects: Aged, Humans, Male, Middle Aged, Prognosis, Risk Assessment methods, Clinical Trials, Phase III as Topic, Randomized Controlled Trials as Topic, Artificial Intelligence, Prostatic Neoplasms pathology, Prostatic Neoplasms therapy
Abstract: Background: Accurate risk stratification is critical to guide management decisions in localized prostate cancer (PCa). Previously, we had developed and validated a multimodal artificial intelligence (MMAI) model generated from digital histopathology and clinical features. Here, we externally validate this model on men with high-risk or locally advanced PCa treated and followed as part of a phase 3 randomized control trial., Objective: To externally validate the MMAI model on men with high-risk or locally advanced PCa treated and followed as part of a phase 3 randomized control trial., Design, Setting, and Participants: Our validation cohort included 318 localized high-risk PCa patients from NRG/RTOG 9902 with available histopathology (337 [85%] of the 397 patients enrolled into the trial had available slides, of which 19 [5.6%] failed due to poor image quality)., Outcome Measurements and Statistical Analysis: Two previously locked prognostic MMAI models were validated for their intended endpoint: distant metastasis (DM) and PCa-specific mortality (PCSM). Individual clinical factors and the number of National Comprehensive Cancer Network (NCCN) high-risk features served as comparators. Subdistribution hazard ratio (sHR) was reported per standard deviation increase of the score with corresponding 95% confidence interval (CI) using Fine-Gray or Cox proportional hazards models., Results and Limitations: The DM and PCSM MMAI algorithms were significantly and independently associated with the risk of DM (sHR [95% CI] = 2.33 [1.60-3.38], p < 0.001) and PCSM, respectively (sHR [95% CI] = 3.54 [2.38-5.28], p < 0.001) when compared against other prognostic clinical factors and NCCN high-risk features. The lower 75% of patients by DM MMAI had estimated 5- and 10-yr DM rates of 4% and 7%, and the highest quartile had average 5- and 10-yr DM rates of 19% and 32%, respectively (p < 0.001). Similar results were observed for the PCSM MMAI algorithm., Conclusions: We externally validated the prognostic ability of MMAI models previously developed among men with localized high-risk disease. MMAI prognostic models further risk stratify beyond the clinical and pathological variables for DM and PCSM in a population of men already at a high risk for disease progression. This study provides evidence for consistent validation of our deep learning MMAI models to improve prognostication and enable more informed decision-making for patient care., Patient Summary: This paper presents a novel approach using images from pathology slides along with clinical variables to validate artificial intelligence (computer-generated) prognostic models. When implemented, clinicians can offer a more personalized and tailored prognostic discussion for men with localized prostate cancer., (Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
Published: 2024
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11. Corrigendum to "Androgen Deprivation and Radiotherapy with or Without Docetaxel for Localized High-risk Prostat Cancer: Long-term Follow-up from the Randomized NRG Oncology RTOG 0521 Trial" [Eur. Eurol. 84(2) (2023) 156-163].

Author: Sartor O, Karrison TG, Sandler HM, Gomella LG, Amin M, Purdy J, Michalski JM, Garzotto MG, Pervez N, Balogh AG, Rodrigues GB, Souhami L, Neil Reaume M, Williams SG, Hannan R, Jones CU, Horwitz EM, Rodgers JP, Feng FY, and Rosenthal SA
Abstract: Background: Intensification of therapy may improve outcomes for patients with high-risk localized prostate cancer., Objective: To provide long-term follow-up data from phase III RTOG 0521, which compared a combination of androgen deprivation therapy (ADT) + external beam radiation therapy (EBRT) + docetaxel with ADT + EBRT., Design, Setting, and Participants: High-risk localized prostate cancer patients (>50% of patients had Gleason 9-10 disease) were prospectively randomized to 2 yr of ADT + EBRT or ADT + EBRT + six cycles of docetaxel. A total of 612 patients were accrued, and 563 were eligible and included in the modified intent-to-treat analysis., Outcome Measurements and Statistical Analysis: The primary endpoint was overall survival (OS). Analyses with Cox proportional hazards were performed as prespecified in the protocol; however, there was evidence of nonproportional hazards. Thus, a post hoc analysis was performed using the restricted mean survival time (RMST). The secondary endpoints included biochemical failure, distant metastasis (DM) as detected by conventional imaging, and disease-free survival (DFS)., Results and Limitations: After 10.4 yr of median follow-up among survivors, the hazard ratio (HR) for OS was 0.89 (90% confidence interval [CI] 0.70-1.14; one-sided log-rank p = 0.22). Survival at 10 yr was 64% for ADT + EBRT and 69% for ADT + EBRT + docetaxel. The RMST at 12 yr was 0.45 yr and not statistically significant (one-sided p = 0.053). No differences were detected in the incidence of DFS (HR = 0.92, 95% CI 0.73-1.14), DM (HR = 0.84, 95% CI 0.73-1.14), or prostate-specific antigen recurrence risk (HR = 0.97, 95% CI 0.74-1.29). Two patients had grade 5 toxicity in the chemotherapy arm and zero patients in the control arm., Conclusions: After a median follow-up of 10.4 yr among surviving patients, no significant differences are observed in clinical outcomes between the experimental and control arms. These data suggest that docetaxel should not be used for high-risk localized prostate cancer. Additional research may be warranted using novel predictive biomarkers., Patient Summary: No significant differences in survival were noted after long-term follow-up for high-risk localized prostate cancer patients in a large prospective trial where patients were treated with androgen deprivation therapy + radiation to the prostate ± docetaxel., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
Published: 2024
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12. Effects of Androgen Deprivation Therapy on Prostate Cancer Outcomes According to Competing Event Risk: Secondary Analysis of a Phase 3 Randomised Trial.

Author: Mell LK, Pugh SL, Jones CU, Nelson TJ, Zakeri K, Rose BS, Zeitzer KL, Gore EM, Bahary JP, Souhami L, Michalski JM, Hartford AC, Mishra MV, Roach M 3rd, Parliament MB, Choi KN, Pisansky TM, Husain SM, Malone SC, Horwitz EM, and Feng F
Subjects: Humans, Male, Clinical Trials, Phase III as Topic, Follow-Up Studies, Prostate-Specific Antigen, Randomized Controlled Trials as Topic, Androgen Antagonists therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms pathology
Abstract: Background: Previous studies indicate that the benefit of short-term androgen deprivation therapy (ADT) with radiotherapy (RT) for prostate cancer depends on competing risks., Objective: To determine whether a quantitative method to stratify patients by risk for competing events (omega score) could identify subgroups that selectively benefit from ADT., Design, Setting, and Participants: An ancillary analysis of NRG/RTOG 9408 phase 3 trial (NCT00002597) involving 1945 prostate cancer patients was conducted., Intervention: Short-term ADT., Outcome Measurements and Statistical Analysis: We applied generalised competing event regression models incorporating age, performance status, comorbidity, T category, Gleason score (GS), and prostate-specific antigen (PSA), to stratify patients according to relative hazards for primary cancer-related events (distant metastasis or prostate cancer death) versus competing noncancer mortality. We tested interactions between ADT and subgroups defined by standard risk criteria versus relative risk (RR) using the omega score., Results and Limitations: T2b, higher GS, and higher PSA were associated with an increased RR for cancer-related versus competing mortality events (a higher omega score); increased age and comorbidity were associated with a decreased omega score. Of 996 patients with low-risk/favourable intermediate-risk (FIR) disease, 286 (28.7%) had a high omega score (≥0.314). Of 768 patients with unfavourable intermediate-risk disease, 175 (22.8%) had a low omega score. The overall discordance in risk classification was 26.1%. Both standard criteria and omega score identified significant interactions for the effect of ADT on cancer-related events and late mortality in low- versus high-risk subgroups. Within the low-risk/FIR subgroup, a higher omega score identified patients in whom ADT significantly reduced cancer events and improved event-free survival. Limitations are the need for external/prospective validation and lower RT doses than contemporary standards., Conclusions: Stratification based on competing event risk is useful for identifying prostate cancer patients who selectively benefit from ADT., Patient Summary: We analysed the effectiveness of androgen deprivation therapy (ADT) for localised prostate cancer among patients, defined by the relative risk (RR) for cancer versus noncancer events. Among patients with traditional low-risk/favourable intermediate-risk disease, those with a higher RR benefitted from short-term ADT., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
Published: 2024
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13. Surrogate endpoints in clinical trials of p16-positive squamous cell carcinoma of the oropharynx: an individual patient data meta-analysis.

Author: Gharzai LA, Morris E, Suresh K, Nguyen-Tân PF, Rosenthal DI, Gillison ML, Harari PM, Garden AS, Koyfman S, Caudell JJ, Jones CU, Mitchell DL, Krempl G, Ridge JA, Gensheimer MF, Bonner JA, Filion E, Dunlap NE, Stokes WA, Le QT, Torres-Saavedra P, Mierzwa M, and Schipper MJ
Subjects: Male, Humans, Female, Adolescent, Adult, Middle Aged, Motivation, Biomarkers, Oropharyngeal Neoplasms therapy, Carcinoma, Squamous Cell therapy
Abstract: Background: The increased incidence of human papillomavirus (HPV)-related cancers has motivated efforts to optimise treatment for these patients with excellent prognosis. Validation of surrogates for overall survival could expedite the investigation of new therapies. We sought to evaluate candidate intermediate clinical endpoints in trials assessing definitive treatment of p16-positive oropharyngeal cancer with chemotherapy or radiotherapy., Methods: We did a retrospective review of five multicentre, randomised trials (NRG/RTOG 9003, 0129, 0234, 0522, and 1016) that tested radiotherapy with or without chemotherapy in patients (aged ≥18 years) with p16-positive localised head or neck squamous-cell carcinomas. Eight intermediate clinical endpoints were considered as potential surrogates for overall survival: freedom from local progression, freedom from regional progression, freedom from distant metastasis, freedom from locoregional progression, freedom from any progression, locoregional progression-free survival, progression-free survival, and distant metastasis-free survival. We used a two-stage meta-analytical framework, which requires high correlation between the intermediate clinical endpoint and overall survival at the patient level (condition 1), and high correlation between the treatment effect on the intermediate clinical endpoint and the treatment effect on overall survival (condition 2). For both, an r 2 greater than 0·7 was used as criteria for clinically relevant surrogacy., Findings: We analysed 1373 patients with oropharyngeal cancer from May 9, 2020, to Nov 22, 2023. 1231 (90%) of patients were men, 142 (10%) were women, and 1207 (88%) were White, with a median age of 57 years (IQR 51-62). Median follow-up was 4·2 years (3·1-5·1). For the first condition, correlating the intermediate clinical endpoints with overall survival at the individual and trial level, the three composite endpoints of locoregional progression-free survival (Kendall's τ 0·91 and r 2 0·72), distant metastasis-free survival (Kendall's τ 0·93 and r 2 0·83), and progression-free survival (Kendall's τ 0·88 and r 2 0·70) were highly correlated with overall survival at the patient level and at the trial-group level. For the second condition, correlating treatment effects of the intermediate clinical endpoints and overall survival, the composite endpoints of locoregional progression-free survival (r 2 0·88), distant metastasis-free survival (r 2 0·96), and progression-free survival (r 2 0·92) remained strong surrogates. Treatment effects on the remaining intermediate clinical endpoints were less strongly correlated with overall survival., Interpretation: We identified locoregional progression-free survival, distant metastasis-free survival, and progression-free survival as surrogates for overall survival in p16-positive oropharyngeal cancers treated with chemotherapy or radiotherapy, which could serve as clinical trial endpoints., Funding: NRG Oncology Operations, NRG Oncology SDMC, the National Cancer Institute, Eli Lilly, Aventis, and the University of Michigan., Competing Interests: Declaration of interests LAG reports grant funding from the PROTEUS Consortium. JAB reports royalties or licenses from Bristol Myers Squibb, Eli Lilly, and Merck Serono; consulting fees from Cel-Sci, Merck Serano, and ICON; payment for lectures or presentations from Bristol Myers Squibb, Eli Lilly, Merck Serano, and Cel-Sci; and support for attending meetings or travel from Bristol Myers Squibb, Eli Lilly, and Merck Serono. MLG reports research funding from Genocea Biosciences, Bristol Myers Squibb, Genentech, Kura, Cullinan Labs, Agenus, LaRoche, NRG Oncology, and the University of Cincinnati; consulting fees from iTeos Therapeutics, Istari Oncology, LLX Solutions, OncLive Intellisphere, Seagen, Sensei Biotherapeutics, Kura Oncology, Coherus Biosciences, Mirati Therapeutics, BioNtech AG, Sensei Biotherapeutics, Caladrius Biosciences, Bristol Myers Squibb, Bicara Therapeutics, Bayer Healthcare Pharmaceutics, Genocea Biosciences, Shattuck Labs, EMD Serono, Debiopharm, Merck & Co, Ipsen Biopharmaceuticals, Gilead Sciences, Nektar Therapeutics, Eisai Medical Research, Roche, Roche Diagnostics, NewLink Genetics, Aspyrian Therapeutics, Amgen, TRM Oncology, AstraZeneca Pharmaceuticals, Celgene, and Exelixis; payment from OncLive and Roche; and support for meetings or travel for presentations from the American Association for Cancer Research, the American Society of Clinical Oncology, and the Society for Immunotherapy of Cancer. SK reports research funding from Merck, Bristol Myers Squibb, Castle Biosciences, and Regeneron; consulting fees from Merck, Bristol Myers Squibb, Regeneron, and Galera Therapeutics; and honorarium from Varian Medical Systems. Q-TL reports a leadership role as RTOG Group Chair for NRG Oncology and support from RTOG Foundation for attending meetings and travel. MM reports clinical trial drug support from Bristol Myers Squbb, and grant funding from the PROTEUS Consortium and Livestrong Foundation, advistory board of Adaptimmune. DLM reports a grant from the National Cancer Institute (3R01CA262388-02S1 NCI Diversity Supplement Award). EM reports a University of Michigan M-Cubed Grant (P30CA046592). JAR reports non-financial interests National Comprehensive Cancer Network Thyroid Cancer Panel and American Thyroid Association Guidelines Task Force. DIR reports payments from Merck to the Scientific Advisory Board for presentations. MJS reports consulting fees from Innovative Analytics. WAS reports a research grant from Georgia Research Alliance. PT-S reports NRG Oncology SDMC Grant from the National Cancer Institute (NCI). All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
Published: 2024
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14. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non-Human Papillomavirus Head and Neck Carcinoma: A Phase 2 Randomized Clinical Trial.

Author: Wong SJ, Torres-Saavedra PA, Saba NF, Shenouda G, Bumpous JM, Wallace RE, Chung CH, El-Naggar AK, Gwede CK, Burtness B, Tennant PA, Dunlap NE, Redman R, Stokes WA, Rudra S, Mell LK, Sacco AG, Spencer SA, Nabell L, Yao M, Cury FL, Mitchell DL, Jones CU, Firat S, Contessa JN, Galloway T, Currey A, Harris J, Curran WJ Jr, and Le QT
Subjects: Humans, Male, Female, Cisplatin adverse effects, Lapatinib, Progression-Free Survival, Antineoplastic Combined Chemotherapy Protocols adverse effects, Head and Neck Neoplasms drug therapy, Carcinoma drug therapy
Abstract: Importance: Patients with locally advanced non-human papillomavirus (HPV) head and neck cancer (HNC) carry an unfavorable prognosis. Chemoradiotherapy (CRT) with cisplatin or anti-epidermal growth factor receptor (EGFR) antibody improves overall survival (OS) of patients with stage III to IV HNC, and preclinical data suggest that a small-molecule tyrosine kinase inhibitor dual EGFR and ERBB2 (formerly HER2 or HER2/neu) inhibitor may be more effective than anti-EGFR antibody therapy in HNC., Objective: To examine whether adding lapatinib, a dual EGFR and HER2 inhibitor, to radiation plus cisplatin for frontline therapy of stage III to IV non-HPV HNC improves progression-free survival (PFS)., Design, Setting, and Participants: This multicenter, phase 2, double-blind, placebo-controlled randomized clinical trial enrolled 142 patients with stage III to IV carcinoma of the oropharynx (p16 negative), larynx, and hypopharynx with a Zubrod performance status of 0 to 1 who met predefined blood chemistry criteria from October 18, 2012, to April 18, 2017 (median follow-up, 4.1 years). Data analysis was performed from December 1, 2020, to December 4, 2020., Intervention: Patients were randomized (1:1) to 70 Gy (6 weeks) plus 2 cycles of cisplatin (every 3 weeks) plus either 1500 mg per day of lapatinib (CRT plus lapatinib) or placebo (CRT plus placebo)., Main Outcomes and Measures: The primary end point was PFS, with 69 events required. Progression-free survival rates between arms for all randomized patients were compared by 1-sided log-rank test. Secondary end points included OS., Results: Of the 142 patients enrolled, 127 (median [IQR] age, 58 [53-63] years; 98 [77.2%] male) were randomized; 63 to CRT plus lapatinib and 64 to CRT plus placebo. Final analysis did not suggest improvement in PFS (hazard ratio, 0.91; 95% CI, 0.56-1.46; P = .34) or OS (hazard ratio, 1.06; 95% CI, 0.61-1.86; P = .58) with the addition of lapatinib. There were no significant differences in grade 3 to 4 acute adverse event rates (83.3% [95% CI, 73.9%-92.8%] with CRT plus lapatinib vs 79.7% [95% CI, 69.4%-89.9%] with CRT plus placebo; P = .64) or late adverse event rates (44.4% [95% CI, 30.2%-57.8%] with CRT plus lapatinib vs 40.8% [95% CI, 27.1%-54.6%] with CRT plus placebo; P = .84)., Conclusion and Relevance: In this randomized clinical trial, dual EGFR-ERBB2 inhibition with lapatinib did not appear to enhance the benefit of CRT. Although the results of this trial indicate that accrual to a non-HPV HNC-specific trial is feasible, new strategies must be investigated to improve the outcome for this population with a poor prognosis., Trial Registration: ClinicalTrials.gov Identifier: NCT01711658.
Published: 2023
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15. Final Report of NRG Oncology RTOG 0022: A Phase 1/2 Study of Conformal and Intensity Modulated Radiation for Oropharyngeal Cancer.

Author: Garden AS, Harris J, Eisbruch A, Chao KSC, Morrison WH, Harari PM, Swanson TA, Jones CU, Yom SS, Spencer SA, Scrimger R, Shenouda G, Shukla M, Lau HY, Mierzwa M, Torres-Saavedra P, and Le QT
Subjects: Humans, Radiotherapy, Intensity-Modulated adverse effects, Oropharyngeal Neoplasms radiotherapy
Published: 2023
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16. Androgen Deprivation and Radiotherapy with or Without Docetaxel for Localized High-risk Prostate Cancer: Long-term Follow-up from the Randomized NRG Oncology RTOG 0521 Trial.

Author: Sartor O, Karrison TG, Sandler HM, Gomella LG, Amin MB, Purdy J, Michalski JM, Garzotto MG, Pervez N, Balogh AG, Rodrigues GB, Souhami L, Reaume MN, Williams SG, Hannan R, Jones CU, Horwitz EM, Rodgers JP, Feng FY, and Rosenthal SA
Subjects: Male, Humans, Docetaxel therapeutic use, Androgens therapeutic use, Follow-Up Studies, Prospective Studies, Androgen Antagonists adverse effects, Prostatic Neoplasms drug therapy, Prostatic Neoplasms radiotherapy
Abstract: Background: Intensification of therapy may improve outcomes for patients with high-risk localized prostate cancer., Objective: To provide long-term follow-up data from phase III RTOG 0521, which compared a combination of androgen deprivation therapy (ADT) + external beam radiation therapy (EBRT) + docetaxel with ADT + EBRT., Design, Setting, and Participants: High-risk localized prostate cancer patients (>50% of patients had Gleason 9-10 disease) were prospectively randomized to 2 yr of ADT + EBRT or ADT + EBRT + six cycles of docetaxel. A total of 612 patients were accrued, and 563 were eligible and included in the modified intent-to-treat analysis., Outcome Measurements and Statistical Analysis: The primary endpoint was overall survival (OS). Analyses with Cox proportional hazards were performed as prespecified in the protocol; however, there was evidence of nonproportional hazards. Thus, a post hoc analysis was performed using the restricted mean survival time (RMST). The secondary endpoints included biochemical failure, distant metastasis (DM) as detected by conventional imaging, and disease-free survival (DFS)., Results and Limitations: After 10.4 yr of median follow-up among survivors, the hazard ratio (HR) for OS was 0.89 (90% confidence interval [CI] 0.70-1.14; one-sided log-rank p = 0.22). Survival at 10 yr was 64% for ADT + EBRT and 69% for ADT + EBRT + docetaxel. The RMST at 12 yr was 0.45 yr and not statistically significant (one-sided p = 0.053). No differences were detected in the incidence of DFS (HR = 0.92, 95% CI 0.73-1.14), DM (HR = 0.84, 95% CI 0.73-1.14), or prostate-specific antigen recurrence risk (HR = 0.97, 95% CI 0.74-1.29). Two patients had grade 5 toxicity in the chemotherapy arm and zero patients in the control arm., Conclusions: After a median follow-up of 10.4 yr among surviving patients, no significant differences are observed in clinical outcomes between the experimental and control arms. These data suggest that docetaxel should not be used for high-risk localized prostate cancer. Additional research may be warranted using novel predictive biomarkers., Patient Summary: No significant differences in survival were noted after long-term follow-up for high-risk localized prostate cancer patients in a large prospective trial where patients were treated with androgen deprivation therapy + radiation to the prostate ± docetaxel., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
Published: 2023
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17. Local Failure Events in Prostate Cancer Treated with Radiotherapy: A Pooled Analysis of 18 Randomized Trials from the Meta-analysis of Randomized Trials in Cancer of the Prostate Consortium (LEVIATHAN).

Author: Ma TM, Chu FI, Sandler H, Feng FY, Efstathiou JA, Jones CU, Roach M 3rd, Rosenthal SA, Pisansky T, Michalski JM, Bolla M, de Reijke TM, Maingon P, Neven A, Denham J, Steigler A, Joseph D, Nabid A, Souhami L, Carrier N, Incrocci L, Heemsbergen W, Pos FJ, Sydes MR, Dearnaley DP, Tree AC, Syndikus I, Hall E, Cruickshank C, Malone S, Roy S, Sun Y, Zaorsky NG, Nickols NG, Reiter RE, Rettig MB, Steinberg ML, Reddy VK, Xiang M, Romero T, Spratt DE, and Kishan AU
Subjects: Humans, Male, Proportional Hazards Models, Prostate-Specific Antigen, Randomized Controlled Trials as Topic, Retrospective Studies, Neoplasm Recurrence, Local pathology, Prostatic Neoplasms pathology
Abstract: Context: The prognostic importance of local failure after definitive radiotherapy (RT) in National Comprehensive Cancer Network intermediate- and high-risk prostate cancer (PCa) patients remains unclear., Objective: To evaluate the prognostic impact of local failure and the kinetics of distant metastasis following RT., Evidence Acquisition: A pooled analysis was performed on individual patient data of 12 533 PCa (6288 high-risk and 6245 intermediate-risk) patients enrolled in 18 randomized trials (conducted between 1985 and 2015) within the Meta-analysis of Randomized Trials in Cancer of the Prostate Consortium. Multivariable Cox proportional hazard (PH) models were developed to evaluate the relationship between overall survival (OS), PCa-specific survival (PCSS), distant metastasis-free survival (DMFS), and local failure as a time-dependent covariate. Markov PH models were developed to evaluate the impact of specific transition states., Evidence Synthesis: The median follow-up was 11 yr. There were 795 (13%) local failure events and 1288 (21%) distant metastases for high-risk patients and 449 (7.2%) and 451 (7.2%) for intermediate-risk patients, respectively. For both groups, 81% of distant metastases developed from a clinically relapse-free state (cRF state). Local failure was significantly associated with OS (hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.06-1.30), PCSS (HR 2.02, 95% CI 1.75-2.33), and DMFS (HR 1.94, 95% CI 1.75-2.15, p < 0.01 for all) in high-risk patients. Local failure was also significantly associated with DMFS (HR 1.57, 95% CI 1.36-1.81) but not with OS in intermediate-risk patients. Patients without local failure had a significantly lower HR of transitioning to a PCa-specific death state than those who had local failure (HR 0.32, 95% CI 0.21-0.50, p < 0.001). At later time points, more distant metastases emerged after a local failure event for both groups., Conclusions: Local failure is an independent prognosticator of OS, PCSS, and DMFS in high-risk and of DMFS in intermediate-risk PCa. Distant metastasis predominantly developed from the cRF state, underscoring the importance of addressing occult microscopic disease. However a "second wave" of distant metastases occurs subsequent to local failure events, and optimization of local control may reduce the risk of distant metastasis., Patient Summary: Among men receiving definitive radiation therapy for high- and intermediate-risk prostate cancer, about 10% experience local recurrence, and they are at significantly increased risks of further disease progression. About 80% of patients who develop distant metastasis do not have a detectable local recurrence preceding it., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)
Published: 2022
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18. Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial.

Author: Jones CU, Pugh SL, Sandler HM, Chetner MP, Amin MB, Bruner DW, Zietman AL, Den RB, Leibenhaut MH, Longo JM, Bahary JP, Rosenthal SA, Souhami L, Michalski JM, Hartford AC, Amin PP, Roach M 3rd, Yee D, Efstathiou JA, Rodgers JP, Feng FY, and Shipley WU
Subjects: Androgens, Follow-Up Studies, Humans, Male, Prostate-Specific Antigen, Androgen Antagonists therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms radiotherapy
Abstract: Purpose: For men with localized prostate cancer, NRG Oncology/Radiation Therapy Oncology Group (RTOG) 9408 demonstrated that adding short-term androgen deprivation therapy (ADT) to radiation therapy (RT) improved the primary endpoint of overall survival (OS) and improved disease-specific mortality (DSM), biochemical failure (BF), local progression, and freedom from distant metastases (DM). This study was performed to determine whether the short-term ADT continued to improve OS, DSM, BF, and freedom from DM with longer follow-up., Methods and Materials: From 1994 to 2001, NRG/RTOG 9408 randomized 2028 men from 212 North American institutions with T1b-T2b, N0 prostate adenocarcinoma and prostate-specific antigen (PSA) ≤20ng/mL to RT alone or RT plus short-term ADT. Patients were stratified by PSA, tumor grade, and surgical versus clinical nodal staging. ADT was flutamide with either goserelin or leuprolide for 4 months. Prostate RT (66.6 Gy) was started after 2 months. OS was calculated at the date of death from any cause or at last follow-up. Secondary endpoints were DSM, BF, local progression, and DM. Acute and late toxic effects were assessed using RTOG toxicity scales., Results: Median follow-up in surviving patients was 14.8 years (range, 0.16-21.98). The 10-year and 18-year OS was 56% and 23%, respectively, with RT alone versus 63% and 23% with combined therapy (HR 0.94; 95% confidence interval [CI], 0.85-1.05; P = .94). The hazards were not proportional (P = .003). Estimated restricted mean survival time at 18 years was 11.8 years (95% CI, 11.4-12.1) with combined therapy versus 11.3 years with RT alone (95% CI, 10.9-11.6; P = .05). The 10-year and 18-year DSM was 7% and 14%, respectively, with RT alone versus 3% and 8% with combined therapy (HR 0.56; 95% CI, 0.41-0.75; P < .01). DM and BF favored combined therapy at 18 years. Rates of late grade ≥3 hepatic, gastrointestinal, and genitourinary toxicity were ≤1%, 3%, and 8%, respectively, with combined therapy versus ≤1%, 2%, and 5% with RT alone., Conclusions: Further follow-up demonstrates that OS converges at approximately 15 years, by which point the administration of 4 months of ADT had conferred an estimated additional 6 months of life., (Copyright © 2021 Elsevier Inc. All rights reserved.)
Published: 2022
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19. Comparison of Response to Definitive Radiotherapy for Localized Prostate Cancer in Black and White Men: A Meta-analysis.

Author: Ma TM, Romero T, Nickols NG, Rettig MB, Garraway IP, Roach M 3rd, Michalski JM, Pisansky TM, Lee WR, Jones CU, Rosenthal SA, Wang C, Hartman H, Nguyen PL, Feng FY, Boutros PC, Saigal C, Chamie K, Jackson WC, Morgan TM, Mehra R, Salami SS, Vince R, Schaeffer EM, Mahal BA, Dess RT, Steinberg ML, Elashoff D, Sandler HM, Spratt DE, and Kishan AU
Subjects: Black People, Humans, Male, Prostatic Neoplasms ethnology, Randomized Controlled Trials as Topic, Treatment Outcome, White People, Prostatic Neoplasms radiotherapy
Abstract: Importance: Black men have a 2-fold increased risk of dying from prostate cancer compared with White men. However, race-specific differences in response to initial treatment remain unknown., Objective: To compare overall and treatment-specific outcomes of Black and White men with localized prostate cancer receiving definitive radiotherapy (RT)., Data Sources: A systematic search was performed of relevant published randomized clinical trials conducted by the NRG Oncology/Radiation Therapy Oncology Group between January 1, 1990, and December 31, 2010. This meta-analysis was performed from July 1, 2019, to July 1, 2021., Study Selection: Randomized clinical trials of definitive RT for patients with localized prostate cancer comprising a substantial number of Black men (self-identified race) enrolled that reported on treatment-specific and overall outcomes., Data Extraction and Synthesis: Individual patient data were obtained from 7 NRG Oncology/Radiation Therapy Oncology Group randomized clinical trials evaluating definitive RT with or without short- or long-term androgen deprivation therapy. Unadjusted Fine-Gray competing risk models, with death as a competing risk, were developed to evaluate the cumulative incidences of end points. Cox proportional hazards models were used to evaluate differences in all-cause mortality and the composite outcome of distant metastasis (DM) or death. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed., Main Outcomes and Measures: Subdistribution hazard ratios (sHRs) of biochemical recurrence (BCR), DM, and prostate cancer-specific mortality (PCSM)., Results: A total of 8814 patients (1630 [18.5%] Black and 7184 [81.5%] White) were included; mean (SD) age was 69.1 (6.8) years. Median follow-up was 10.6 (IQR, 8.0-17.8) years for surviving patients. At enrollment, Black men were more likely to have high-risk disease features. However, even without adjustment, Black men were less likely to experience BCR (sHR, 0.88; 95% CI, 0.58-0.91), DM (sHR, 0.72; 95% CI, 0.58-0.91), or PCSM (sHR, 0.72; 95% CI, 0.54-0.97). No significant differences in all-cause mortality were identified (HR, 0.99; 95% CI, 0.92-1.07). Upon adjustment, Black race remained significantly associated with improved BCR (adjusted sHR, 0.79; 95% CI, 0.72-0.88; P < .001), DM (adjusted sHR, 0.69; 95% CI, 0.55-0.87; P = .002), and PCSM (adjusted sHR, 0.68; 95% CI, 0.50-0.93; P = .01)., Conclusions and Relevance: The findings of this meta-analysis suggest that Black men enrolled in randomized clinical trials present with more aggressive disease but have better BCR, DM, and PCSM with definitive RT compared with White men, suggesting that other determinants of outcome, such as access to care, are important factors of achieving racial equity.
Published: 2021
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20. The impact of age on outcome in phase III NRG Oncology/RTOG trials of radiotherapy (XRT) +/- systemic therapy in locally advanced head and neck cancer.

Author: Kish JA, Zhang Q, Langer CJ, Nguyen-Tân PF, Rosenthal DI, Weber RS, List MA, Wong SJ, Garden AS, Hu K, Trotti AM, Bonner JA, Jones CU, Yom SS, Thorstad W, Schultz CJ, Ridge JA, Shenouda G, Harris J, and Le QT
Subjects: Aged, Humans, Prognosis, Proportional Hazards Models, Retrospective Studies, Chemoradiotherapy, Head and Neck Neoplasms radiotherapy
Abstract: Purpose: To examine the role age plays in the treatment and prognosis of locally advanced head and neck cancer (LAHNC) treated definitively with radiation alone or combined modality therapy., Methods: A retrospective analysis was performed of three NRG/RTOG trials examining either radiation alone or combined radiation and systemic therapy for LAHNC. The effect of age (≥70 yrs.) on cause-specific survival (CSS), overall survival (OS), and toxicity was evaluated., Results: A total of 2688 patients were analyzed, of whom 309 patients (11.5%) were ≥ 70. For all studies combined, the hazard ratio (HR) for CSS for patients age ≥ 70 vs. those <70 was 1.33 (95%CI: 1.14-1.55, p < 0.001). For OS, the HR for patients age ≥ 70 vs. those <70 for all studies combined was 1.55 (95% CI 1.35-1.77, p < 0.001). After adjustment for all covariates, age ≥ 70 was associated with worse OS regardless of adjustment for smoking and p16 status. The survival difference was more pronounced in those receiving combined radiation and systemic therapy. Hematologic and renal toxicities were increased in combined modality trials in patients ≥70 years old., Conclusions: Patients age ≥ 70 with LAHNC were underrepresented in these clinical trials. Their CSS and OS proved inferior to patients <70 years old., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
Published: 2021
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21. Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002).

Author: Yom SS, Torres-Saavedra P, Caudell JJ, Waldron JN, Gillison ML, Xia P, Truong MT, Kong C, Jordan R, Subramaniam RM, Yao M, Chung CH, Geiger JL, Chan JW, O'Sullivan B, Blakaj DM, Mell LK, Thorstad WL, Jones CU, Banerjee RN, Lominska C, and Le QT
Subjects: Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Male, Middle Aged, Oropharyngeal Neoplasms pathology, Oropharyngeal Neoplasms therapy, Oropharyngeal Neoplasms virology, Papillomaviridae isolation & purification, Papillomavirus Infections virology, Prognosis, Radiotherapy Dosage, Squamous Cell Carcinoma of Head and Neck pathology, Squamous Cell Carcinoma of Head and Neck therapy, Squamous Cell Carcinoma of Head and Neck virology, Survival Rate, Chemoradiotherapy mortality, Oropharyngeal Neoplasms radiotherapy, Papillomavirus Infections complications, Radiotherapy, Intensity-Modulated mortality, Squamous Cell Carcinoma of Head and Neck radiotherapy
Abstract: Purpose: Reducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus-associated oropharyngeal squamous cell carcinoma (OPSCC). Whether reduced-dose radiation produces disease control and QOL equivalent to standard chemoradiation is not proven., Patients and Methods: In this randomized, phase II trial, patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC (7th edition staging) with ≤ 10 pack-years of smoking received 60 Gy of intensity-modulated radiation therapy (IMRT) over 6 weeks with concurrent weekly cisplatin (C) or 60 Gy IMRT over 5 weeks. To be considered for a phase III study, an arm had to achieve a 2-year progression-free survival (PFS) rate superior to a historical control rate of 85% and a 1-year mean composite score ≥ 60 on the MD Anderson Dysphagia Inventory (MDADI)., Results: Three hundred six patients were randomly assigned and eligible. Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS ≤ 85% ( P = .04). For IMRT, 2-year PFS was 87.6% ( P = .23). One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively. Two-year overall survival rates were 96.7% for IMRT + C and 97.3% for IMRT. Acute adverse events (AEs) were defined as those occurring within 180 days from the end of treatment. There were more grade 3-4 acute AEs for IMRT + C (79.6% v 52.4%; P < .001). Rates of grade 3-4 late AEs were 21.3% and 18.1% ( P = .56)., Conclusion: The IMRT + C arm met both prespecified end points justifying advancement to a phase III study. Higher rates of grade ≥ 3 acute AEs were reported in the IMRT + C arm.
Published: 2021
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22. Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer.

Author: Mell LK, Shen H, Nguyen-Tân PF, Rosenthal DI, Zakeri K, Vitzthum LK, Frank SJ, Schiff PB, Trotti AM 3rd, Bonner JA, Jones CU, Yom SS, Thorstad WL, Wong SJ, Shenouda G, Ridge JA, Zhang QE, and Le QT
Subjects: Adult, Aged, Aged, 80 and over, Case-Control Studies, Female, Follow-Up Studies, Head and Neck Neoplasms pathology, Head and Neck Neoplasms therapy, Humans, Male, Middle Aged, Neoplasm Recurrence, Local pathology, Neoplasm Recurrence, Local therapy, Prognosis, Survival Rate, Chemoradiotherapy mortality, Head and Neck Neoplasms mortality, Neoplasm Recurrence, Local mortality, Nomograms
Abstract: Purpose: Previous studies indicate that the benefit of therapy depends on patients' risk for cancer recurrence relative to noncancer mortality (ω ratio). We sought to test the hypothesis that patients with head and neck cancer (HNC) with a higher ω ratio selectively benefit from intensive therapy., Experimental Design: We analyzed 2,688 patients with stage III-IVB HNC undergoing primary radiotherapy (RT) with or without systemic therapy on three phase III trials (RTOG 9003, RTOG 0129, and RTOG 0522). We used generalized competing event regression to stratify patients according to ω ratio and compared the effectiveness of intensive therapy as a function of predicted ω ratio (i.e., ω score). Intensive therapy was defined as treatment on an experimental arm with altered fractionation and/or multiagent concurrent systemic therapy. A nomogram was developed to predict patients' ω score on the basis of tumor, demographic, and health factors. Analysis was by intention to treat., Results: Decreasing age, improved performance status, higher body mass index, node-positive status, P16-negative status, and oral cavity primary predicted a higher ω ratio. Patients with ω score ≥0.80 were more likely to benefit from intensive treatment [5-year overall survival (OS), 70.0% vs. 56.6%; HR of 0.73, 95% confidence interval (CI): 0.57-0.94; P = 0.016] than those with ω score <0.80 (5-year OS, 46.7% vs. 45.3%; HR of 1.02, 95% CI: 0.92-1.14; P = 0.69; P = 0.019 for interaction). In contrast, the effectiveness of intensive therapy did not depend on risk of progression., Conclusions: Patients with HNC with a higher ω score selectively benefit from intensive treatment. A nomogram was developed to help select patients for intensive therapy., (©2019 American Association for Cancer Research.)
Published: 2019
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23. Gleason pattern 5 is associated with an increased risk for metastasis following androgen deprivation therapy and radiation: An analysis of RTOG 9202 and 9902.

Author: Hamstra DA, Pugh SL, Lepor H, Rosenthal SA, Pienta KJ, Gomella L, Peters C, D'Souza DP, Zeitzer KL, Jones CU, Hall WA, Horwitz E, Pisansky TM, Souhami L, Hartford AC, Dominello M, Feng F, and Sandler HM
Subjects: Aged, Follow-Up Studies, Humans, Male, Multivariate Analysis, Neoplasm Grading, Neoplasm Metastasis, Neoplasm Staging, Prostate pathology, Prostate-Specific Antigen, Prostatic Neoplasms radiotherapy, Risk, Survival Analysis, Androgen Antagonists therapeutic use, Prostatic Neoplasms pathology, Prostatic Neoplasms therapy
Abstract: Background/purpose: Stratification of Gleason score (GS) into three categories (2-6, 7, and 8-10) may not fully utilize its prognostic discrimination, with Gleason pattern 5 (GP5) previously identified as an independent adverse factor., Materials/methods: Patients treated on RTOG 9202 (n = 1292) or RTOG 9902 (n = 378) were pooled and assessed for association of GS and GP5 on biochemical failure (BF), local failure (LF), distant metastasis (DM), and overall survival (OS). Fine and Gray's regression and cumulative incidence methods were used for univariate and multivariate analyses., Results: With median follow-up of 9.4 years, patients with GS 8-10 with GP5 had worse outcome than GS 4 + 4 for DM on both RTOG9202 (p = 0.038) and RTOG9902 (p < 0.001) with a trend toward worse OS (p = 0.059 and p = 0.089, respectively), but without differences in BF or LF. At 10-years DM was higher by 11% (RTOG 9202) and 18% (RTOG 9902) with GP5 compared to GS 4 + 4. On multivariate analysis restricted to long-term androgen deprivation therapy the presence of GP5 substantially increased distant metastasis (HR = 0.43, 95%CI: 0.24-0.76, p = 0.0039) with a trend toward worse OS (HR:0.74, 95% CI:0.54-1.0, p = 0.052) without association with LF (HR:0.55, 95%CI:0.28-1.09, p = 0.085) or BF (HR:1.15, 95%CI:0.84-1.59, p = 0.39). We did not observed substantial differences between Gleason 3 + 5, 5 + 3, or Gleason 9-10., Conclusions: These results validate GP5 as an independent prognostic factor which is strongest for DM. As a result GP5 should be considered when stratifying patients with GS 8 and may be a patient population in which to evaluate newly approved systemic therapies or additional local treatments., (Copyright © 2019 Elsevier B.V. All rights reserved.)
Published: 2019
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24. Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion.

Author: Adelstein DJ, Ismaila N, Ku JA, Burtness B, Swiecicki PL, Mell L, Beitler JJ, Gross N, Jones CU, Kaufman M, Le QT, Semrad TJ, Siu LL, and Ridge JA
Subjects: Humans, Oropharyngeal Neoplasms therapy
Abstract: Purpose: An ASCO provisional clinical opinion offers timely clinical direction to ASCO's membership after publication or presentation of potentially practice-changing data from major studies. This provisional clinical opinion addresses the role of treatment deintensification in the management of p16+ oropharyngeal cancer (OPC)., Clinical Context: For patients with p16+ OPC, current treatment approaches are well established. In the good-prognosis subset of nonsmoking p16+ patients with early-stage disease, these treatments have been highly successful, albeit with significant associated acute and late toxicity. Deintensification of surgical, radiation, and medical treatment in an effort to reduce toxicity while preserving high survival rates is an appropriate therapeutic objective currently being explored in patients who are experiencing the best treatment results. However, careful delineation of this good-risk subset is essential. While the current eighth edition of the American Joint Committee on Cancer staging system is prognostically robust, it should not be interpreted as reason to alter therapeutic decisions or justify treatment deintensification. The development of transoral surgical techniques and the adoption of intensity-modulated radiation therapy planning have been transformative in disease management and suggest potentially beneficial approaches. Recent advances in systemic treatments have been notable. The optimal integration and modification of these modalities to ameliorate toxicity has not been defined and remains an important focus of current investigation., Provisional Clinical Opinion: The hypothesis that de-escalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards. Treatment deintensification for these patients should only be undertaken in a clinical trial. Additional information is available at www.asco.org/head-neck-cancer-guidelines .
Published: 2019
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25. ACR Appropriateness Criteria ® Neck Mass-Adenopathy.

Author: Aulino JM, Kirsch CFE, Burns J, Busse PM, Chakraborty S, Choudhri AF, Conley DB, Jones CU, Lee RK, Luttrull MD, Moritani T, Policeni B, Ryan ME, Shah LM, Sharma A, Shih RY, Subramaniam RM, Symko SC, and Bykowski J
Subjects: Contrast Media, Diagnosis, Differential, Evidence-Based Medicine, Humans, Societies, Medical, United States, Head and Neck Neoplasms diagnostic imaging, Lymphadenopathy diagnostic imaging
Abstract: A palpable neck mass may be the result of neoplastic, congenital, or inflammatory disease. Older age suggests neoplasia, and a congenital etiology is more prevalent in the pediatric population. The imaging approach is based on the patient age, mass location, and clinical pulsatility. Underlying human papillomavirus-related malignancy should be considered in all age groups. Although the imaging appearance of some processes in the head and neck overlap, choosing the appropriate imaging examination may allow a specific diagnosis, or a limited differential diagnosis. Tissue sampling is indicated to confirm suspected malignancy. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment., (Copyright © 2019 American College of Radiology. Published by Elsevier Inc. All rights reserved.)
Published: 2019
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26. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial.

Author: Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, and Le QT
Subjects: Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Cetuximab administration & dosage, Cetuximab adverse effects, Chemoradiotherapy adverse effects, Chemoradiotherapy methods, Cisplatin administration & dosage, Cisplatin adverse effects, Drug Administration Schedule, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Oropharyngeal Neoplasms virology, Papillomavirus Infections complications, Radiotherapy, Intensity-Modulated adverse effects, Radiotherapy, Intensity-Modulated methods, Squamous Cell Carcinoma of Head and Neck virology, Treatment Outcome, Antineoplastic Agents therapeutic use, Cetuximab therapeutic use, Cisplatin therapeutic use, Oropharyngeal Neoplasms therapy, Squamous Cell Carcinoma of Head and Neck therapy
Abstract: Background: Patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma have high survival when treated with radiotherapy plus cisplatin. Whether replacement of cisplatin with cetuximab-an antibody against the epidermal growth factor receptor-can preserve high survival and reduce treatment toxicity is unknown. We investigated whether cetuximab would maintain a high proportion of patient survival and reduce acute and late toxicity., Methods: RTOG 1016 was a randomised, multicentre, non-inferiority trial at 182 health-care centres in the USA and Canada. Eligibility criteria included histologically confirmed HPV-positive oropharyngeal carcinoma; American Joint Committee on Cancer 7th edition clinical categories T1-T2, N2a-N3 M0 or T3-T4, N0-N3 M0; Zubrod performance status 0 or 1; age at least 18 years; and adequate bone marrow, hepatic, and renal function. We randomly assigned patients (1:1) to receive either radiotherapy plus cetuximab or radiotherapy plus cisplatin. Randomisation was balanced by using randomly permuted blocks, and patients were stratified by T category (T1-T2 vs T3-T4), N category (N0-N2a vs N2b-N3), Zubrod performance status (0 vs 1), and tobacco smoking history (≤10 pack-years vs >10 pack-years). Patients were assigned to receive either intravenous cetuximab at a loading dose of 400 mg/m 2 5-7 days before radiotherapy initiation, followed by cetuximab 250 mg/m 2 weekly for seven doses (total 2150 mg/m 2 ), or cisplatin 100 mg/m 2 on days 1 and 22 of radiotherapy (total 200 mg/m 2 ). All patients received accelerated intensity-modulated radiotherapy delivered at 70 Gy in 35 fractions over 6 weeks at six fractions per week (with two fractions given on one day, at least 6 h apart). The primary endpoint was overall survival, defined as time from randomisation to death from any cause, with non-inferiority margin 1·45. Primary analysis was based on the modified intention-to-treat approach, whereby all patients meeting eligibility criteria are included. This study is registered with ClinicalTrials.gov, number NCT01302834., Findings: Between June 9, 2011, and July 31, 2014, 987 patients were enrolled, of whom 849 were randomly assigned to receive radiotherapy plus cetuximab (n=425) or radiotherapy plus cisplatin (n=424). 399 patients assigned to receive cetuximab and 406 patients assigned to receive cisplatin were subsequently eligible. After median follow-up duration of 4·5 years, radiotherapy plus cetuximab did not meet the non-inferiority criteria for overall survival (hazard ratio [HR] 1·45, one-sided 95% upper CI 1·94; p=0·5056 for non-inferiority; one-sided log-rank p=0·0163). Estimated 5-year overall survival was 77·9% (95% CI 73·4-82·5) in the cetuximab group versus 84·6% (80·6-88·6) in the cisplatin group. Progression-free survival was significantly lower in the cetuximab group compared with the cisplatin group (HR 1·72, 95% CI 1·29-2·29; p=0·0002; 5-year progression-free survival 67·3%, 95% CI 62·4-72·2 vs 78·4%, 73·8-83·0), and locoregional failure was significantly higher in the cetuximab group compared with the cisplatin group (HR 2·05, 95% CI 1·35-3·10; 5-year proportions 17·3%, 95% CI 13·7-21·4 vs 9·9%, 6·9-13·6). Proportions of acute moderate to severe toxicity (77·4%, 95% CI 73·0-81·5 vs 81·7%, 77·5-85·3; p=0·1586) and late moderate to severe toxicity (16·5%, 95% CI 12·9-20·7 vs 20·4%, 16·4-24·8; p=0·1904) were similar between the cetuximab and cisplatin groups., Interpretation: For patients with HPV-positive oropharyngeal carcinoma, radiotherapy plus cetuximab showed inferior overall survival and progression-free survival compared with radiotherapy plus cisplatin. Radiotherapy plus cisplatin is the standard of care for eligible patients with HPV-positive oropharyngeal carcinoma., Funding: National Cancer Institute USA, Eli Lilly, and The Oral Cancer Foundation., (Copyright © 2019 Elsevier Ltd. All rights reserved.)
Published: 2019
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27. In Regard to Bossi et al.

Author: Fakhry C, Nguyen-Tân PF, Lambert L, Rosenthal DI, Weber RS, Gillison ML, Trotti AM 3rd, Barrett WL, Thorstad WL, Jones CU, Yom SS, Wong SJ, Ridge JA, Rao SSD, Bonner JA, Vigneault E, Raben D, Kudrimoti MR, Harris J, and Le QT
Subjects: Humans, Nomograms, Oropharyngeal Neoplasms
Published: 2018
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28. Sequence of hormonal therapy and radiotherapy field size in unfavourable, localised prostate cancer (NRG/RTOG 9413): long-term results of a randomised, phase 3 trial.

Author: Roach M, Moughan J, Lawton CAF, Dicker AP, Zeitzer KL, Gore EM, Kwok Y, Seider MJ, Hsu IC, Hartford AC, Horwitz EM, Yamoah K, Jones CU, Michalski JM, Lee WR, Pisansky TM, Rabinovitch R, Rotman M, Pryzant RM, Kim HE, Thomas CR Jr, Shipley WU, and Sandler HM
Subjects: Adenocarcinoma mortality, Adenocarcinoma pathology, Antineoplastic Combined Chemotherapy Protocols adverse effects, Canada, Chemoradiotherapy adverse effects, Chemoradiotherapy mortality, Drug Administration Schedule, Flutamide adverse effects, Goserelin adverse effects, Humans, Kallikreins blood, Leuprolide adverse effects, Male, Neoplasm Grading, Neoplasm Staging, Progression-Free Survival, Prostate-Specific Antigen blood, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Time Factors, United States, Adenocarcinoma therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Chemoradiotherapy methods, Dose Fractionation, Radiation, Flutamide administration & dosage, Goserelin administration & dosage, Leuprolide administration & dosage, Prostatic Neoplasms therapy
Abstract: Background: The NRG/RTOG 9413 study showed that whole pelvic radiotherapy (WPRT) plus neoadjuvant hormonal therapy (NHT) improved progression-free survival in patients with intermediate-risk or high-risk localised prostate cancer compared with prostate only radiotherapy (PORT) plus NHT, WPRT plus adjuvant hormonal therapy (AHT), and PORT plus AHT. We provide a long-term update after 10 years of follow-up of the primary endpoint (progression-free survival) and report on the late toxicities of treatment., Methods: The trial was designed as a 2 × 2 factorial study with hormonal sequencing as one stratification factor and radiation field as the other factor and tested whether NHT improved progression-free survival versus AHT, and NHT plus WPRT versus NHT plus PORT. Eligible patients had histologically confirmed, clinically localised adenocarcinoma of the prostate, an estimated risk of lymph node involvement of more than 15% and a Karnofsky performance status of more than 70, with no age limitations. Patients were randomly assigned (1:1:1:1) by permuted block randomisation to receive either NHT 2 months before and during WPRT followed by a prostate boost to 70 Gy (NHT plus WPRT group), NHT 2 months before and during PORT to 70 Gy (NHT plus PORT group), WPRT followed by 4 months of AHT (WPRT plus AHT group), or PORT followed by 4 months of AHT (PORT plus AHT group). Hormonal therapy was combined androgen suppression, consisting of goserelin acetate 3·6 mg once a month subcutaneously or leuprolide acetate 7·5 mg once a month intramuscularly, and flutamide 250 mg twice a day orally for 4 months. Randomisation was stratified by T stage, Gleason Score, and prostate-specific antigen concentration. NHT was given 2 months before radiotherapy and was continued until radiotherapy completion; AHT was given at the completion of radiotherapy for 4 months. The primary endpoint progression-free survival was analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00769548. The trial has been terminated to additional follow-up collection and this is the final analysis for this trial., Findings: Between April 1, 1995, and June 1, 1999, 1322 patients were enrolled from 53 centres and randomly assigned to the four treatment groups. With a median follow-up of 8·8 years (IQR 5·07-13·84) for all patients and 14·8 years (7·18-17·4) for living patients (n=346), progression-free survival across all timepoints continued to differ significantly across the four treatment groups (p=0·002). The 10-year estimates of progression-free survival were 28·4% (95% CI 23·3-33·6) in the NHT plus WPRT group, 23·5% (18·7-28·3) in the NHT plus PORT group, 19·4% (14·9-24·0) in the WPRT plus AHT group, and 30·2% (25·0-35·4) in the PORT plus AHT group. Bladder toxicity was the most common grade 3 or worse late toxicity, affecting 18 (6%) of 316 patients in the NHT plus WPRT group, 17 (5%) of 313 in the NHT plus PORT group, 22 (7%) of 317 in the WPRT plus AHT group, and 14 (4%) of 315 in the PORT plus AHT group. Late grade 3 or worse gastrointestinal adverse events occurred in 22 (7%) of 316 patients in the NHT plus WPRT group, five (2%) of 313 in the NHT plus PORT group, ten (3%) of 317 in the WPRT plus AHT group, and seven (2%) of 315 in the PORT plus AHT group., Interpretation: In this cohort of patients with intermediate-risk and high-risk localised prostate cancer, NHT plus WPRT improved progression-free survival compared with NHT plus PORT and WPRT plus AHT at long-term follow-up albeit increased risk of grade 3 or worse intestinal toxicity. Interactions between radiotherapy and hormonal therapy suggests that WPRT should be avoided without NHT., Funding: National Cancer Institute., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
Published: 2018
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29. NRG oncology RTOG 9006: a phase III randomized trial of hyperfractionated radiotherapy (RT) and BCNU versus standard RT and BCNU for malignant glioma patients.

Author: Ali AN, Zhang P, Yung WKA, Chen Y, Movsas B, Urtasun RC, Jones CU, Choi KN, Michalski JM, Fischbach AJ, Markoe AM, Schultz CJ, Penas-Prado M, Garg MK, Hartford AC, Kim HE, Won M, and Curran WJ Jr
Subjects: Adolescent, Adult, Aged, Aged, 80 and over, Combined Modality Therapy, Female, Humans, Male, Middle Aged, Survival Analysis, Treatment Outcome, Young Adult, Antineoplastic Agents, Alkylating therapeutic use, Brain Neoplasms drug therapy, Brain Neoplasms radiotherapy, Carmustine therapeutic use, Dose Fractionation, Radiation, Glioma drug therapy, Glioma radiotherapy
Abstract: From 1990 to 1994, patients with newly diagnosed malignant gliomas were enrolled and randomized between hyperfractionated radiation (HFX) of 72.0 Gy in 60 fractions given twice daily and 60.0 Gy in 30 fractions given once daily. All patients received 80 mg/m 2 of 1,3 bis(2 chloroethyl)-1 nitrosourea on days 1-3 q8 weeks for 1 year. Patients were stratified by age, KPS, and histology. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS) and toxicity. Out of the 712 patients accrued, 694 (97.5%) were analyzable cases (350 HFX, 344 standard arm). There was no significant difference between the arms on overall acute or late treatment-related toxicity. No statistically significant effect for HFX, as compared to standard therapy, was found on either OS, with a median survival time (MST) of 11.3 versus 13.1 months (p = 0.20) or PFS, with a median PFS time of 5.7 versus 6.9 months (p = 0.18). The treatment effect on OS remained insignificant based on the multivariate analysis (hazard ratio 1.16; p = 0.0682). When OS was analyzed by histology subgroup there was also no significant difference between the two arms for patients with glioblastoma multiforme (MST: 10.3 vs. 11.2 months; p = 0.34), anaplastic astrocytoma (MST: 69.8 vs. 50.0 months; p = 0.91) or anaplastic oligodendroglioma (MST: 92.1 vs. 66.5 months; p = 0.33). Though this trial provided many invaluable secondary analyses, there was no trend or indication of a benefit to HFX radiation to 72.0 Gy in any subset of malignant glioma patients.
Published: 2018
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30. Development and Validation of Nomograms Predictive of Overall and Progression-Free Survival in Patients With Oropharyngeal Cancer.

Author: Fakhry C, Zhang Q, Nguyen-Tân PF, Rosenthal DI, Weber RS, Lambert L, Trotti AM 3rd, Barrett WL, Thorstad WL, Jones CU, Yom SS, Wong SJ, Ridge JA, Rao SSD, Bonner JA, Vigneault E, Raben D, Kudrimoti MR, Harris J, Le QT, and Gillison ML
Subjects: Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell diagnosis, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell radiotherapy, Chemoradiotherapy, Cohort Studies, Disease-Free Survival, Female, Head and Neck Neoplasms diagnosis, Head and Neck Neoplasms drug therapy, Head and Neck Neoplasms radiotherapy, Humans, Male, Middle Aged, Organoplatinum Compounds administration & dosage, Oropharyngeal Neoplasms diagnosis, Oropharyngeal Neoplasms drug therapy, Oropharyngeal Neoplasms radiotherapy, Predictive Value of Tests, Prognosis, Proportional Hazards Models, Randomized Controlled Trials as Topic, Squamous Cell Carcinoma of Head and Neck, Survival Rate, Carcinoma, Squamous Cell mortality, Head and Neck Neoplasms mortality, Nomograms, Oropharyngeal Neoplasms mortality
Abstract: Purpose Treatment of oropharyngeal squamous cell carcinoma (OPSCC) is evolving toward risk-based modification of therapeutic intensity, which requires patient-specific estimates of overall survival (OS) and progression-free survival (PFS). Methods To develop and validate nomograms for OS and PFS, we used a derivation cohort of 493 patients with OPSCC with known p16 tumor status (surrogate of human papillomavirus) and cigarette smoking history (pack-years) randomly assigned to clinical trials using platinum-based chemoradiotherapy (NRG Oncology Radiation Therapy Oncology Group [RTOG] 0129 and 0522). Nomograms were created from Cox models and internally validated by use of bootstrap and cross-validation. Model discrimination was measured by calibration plots and the concordance index. Nomograms were externally validated in a cohort of 153 patients with OPSCC randomly assigned to a third trial, NRG Oncology RTOG 9003. Results Both models included age, Zubrod performance status, pack-years, education, p16 status, and T and N stage; the OS model also included anemia and age × pack-years interaction; and the PFS model also included marital status, weight loss, and p16 × Zubrod interaction. Predictions correlated well with observed 2-year and 5-year outcomes. The uncorrected concordance index was 0.76 (95% CI, 0.72 to 0.80) for OS and 0.70 (95% CI, 0.66 to 0.74) for PFS, and bias-corrected indices were similar. In the validation set, OS and PFS models were well calibrated, and OS and PFS were significantly different across tertiles of nomogram scores (log-rank P = .003;< .001). Conclusion The validated nomograms provided useful prediction of OS and PFS for patients with OPSCC treated with primary radiation-based therapy.
Published: 2017
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31. Serum testosterone changes in patients treated with radiation therapy alone for prostate cancer on NRG oncology RTOG 9408.

Author: Nichols RC, Hu C, Bahary JP, Zeitzer KL, Souhami L, Leibenhaut MH, Rotman M, Gore EM, Balogh AG, McGowan D, Michalski J, Raben A, Rudoler S, Jones CU, and Sandler H
Abstract: Objectives: We reviewed testosterone changes for patients who were treated with radiation therapy (RT) alone on NRG oncology RTOG 9408., Methods and Materials: Patients (T1b-T2b, prostate-specific antigen <20 ng/mL) were randomized between RT alone and RT plus 4 months of androgen ablation. Serum testosterone (ST) levels were investigated at enrollment, RT completion, and the first follow-up 3 months after RT. The Wilcoxon signed rank test was used to compare pre- and post-treatment ST levels in patients who were randomized to the RT-alone arm., Results: Of 2028 patients enrolled, 992 patients were randomized to receive RT alone and 917 (92.4%) had baseline ST values available and completed RT. Of these 917 patients, immediate and 3-month post-RT testosterone levels were available for 447 and 373 patients, respectively. Excluding 2 patients who received hormonal therapy off protocol after RT, 447 and 371 patients, respectively, were analyzed. For all patients, the median change in ST values at completion of RT and at 3-month follow-up were -30.0 ng/dL (p5-p95; -270.0 to 162.0; P < .001) and -34.0 ng/dL (p5-p95, -228.0 to 160.0; P < .01), respectively., Conclusion: RT for prostate cancer was associated with a median 9.2% decline in ST at completion of RT and a median 9.3% decline 3 months after RT. These changes were statistically significant.
Published: 2017
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32. Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.

Author: Truong MT, Zhang Q, Rosenthal DI, List M, Axelrod R, Sherman E, Weber R, Nguyen-Tân PF, El-Naggar A, Konski A, Galvin J, Schwartz D, Trotti A, Silverman C, Singh A, Godette K, Bonner JA, Jones CU, Garden AS, Shenouda G, Matthiesen C, Le QT, and Bruner D
Subjects: Antineoplastic Agents administration & dosage, Cetuximab administration & dosage, Chemoradiotherapy statistics & numerical data, Cisplatin administration & dosage, Dose Fractionation, Radiation, Female, Head and Neck Neoplasms psychology, Humans, Longitudinal Studies, Male, Middle Aged, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local psychology, Prevalence, Risk Factors, Survival Rate, Treatment Outcome, United States epidemiology, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Chemoradiotherapy mortality, Chemoradiotherapy psychology, Head and Neck Neoplasms mortality, Head and Neck Neoplasms therapy, Neoplasm Recurrence, Local prevention & control, Quality of Life psychology
Abstract: Purpose: To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year., Methods and Materials: Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years. The pretreatment QOL/PS scores were correlated with outcome and p16 status in patients with oropharyngeal cancer (OPC)., Results: Of 818 analyzable patients, the 1-year change from baseline score for FACT-HN total was -0.41 (CIS arm) and -5.11 (CET/CIS arm) (P=.016), representing a 3.2% between-arm change of the FACT-HN total score. The mean EQ-5D index and PSS-HN scores were not significantly different between arms. The p16-positive OPC patients had significantly higher baseline and 1-year scores for PSS-HN, FACT-HN total, physical and functional subscales, and 2-years for the EQ-5D index compared with p16-negative OPC patients. Higher pretreatment PSS-HN diet, PSS-HN eating, FACT-HN, and EQ-5D index scores were associated with better overall survival (OS) and progression-free (PFS) survival on multivariate analysis. Higher baseline FACT-HN total, functional, physical subscale, and EQ-5D index scores were associated with improved OS and PFS in p16-positive OPC patients but not in p16-negative and non-OPC patients., Conclusion: There was no clinically meaningful difference in QOL/PS between arms. The p16-positive OPC patients had significantly higher QOL/PS than did p16-negative patients. Pretreatment QOL/PS is a significant independent predictor of outcome in locally advanced HNC., (Copyright © 2016 Elsevier Inc. All rights reserved.)
Published: 2017
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33. Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129.

Author: Xiao C, Zhang Q, Nguyen-Tân PF, List M, Weber RS, Ang KK, Rosenthal D, Filion EJ, Kim H, Silverman C, Raben A, Galloway T, Fortin A, Gore E, Winquist E, Jones CU, Robinson W, Raben D, Le QT, and Bruner D
Subjects: Adult, Aged, Aged, 80 and over, Antineoplastic Agents administration & dosage, Chemoradiotherapy statistics & numerical data, Cisplatin administration & dosage, Dose Fractionation, Radiation, Female, Head and Neck Neoplasms psychology, Humans, Longitudinal Studies, Male, Middle Aged, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local psychology, Prevalence, Risk Factors, Survival Rate, Treatment Outcome, United States epidemiology, Chemoradiotherapy mortality, Chemoradiotherapy psychology, Head and Neck Neoplasms mortality, Head and Neck Neoplasms therapy, Neoplasm Recurrence, Local prevention & control, Quality of Life psychology
Abstract: Purpose/objective(s): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival., Methods and Materials: Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment., Results: The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001)., Conclusions: The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival., (Copyright © 2016 Elsevier Inc. All rights reserved.)
Published: 2017
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34. ACR appropriateness criteria ® nasal cavity and paranasal sinus cancers.

Author: Siddiqui F, Smith RV, Yom SS, Beitler JJ, Busse PM, Cooper JS, Hanna EY, Jones CU, Koyfman SA, Quon H, Ridge JA, Saba NF, Worden F, Yao M, and Salama JK
Subjects: Combined Modality Therapy methods, Evidence-Based Medicine, Female, Humans, Male, Nose Neoplasms mortality, Nose Neoplasms pathology, Paranasal Sinus Neoplasms mortality, Paranasal Sinus Neoplasms pathology, Prognosis, Risk Assessment, Societies, Medical, Survival Analysis, Treatment Outcome, Chemoradiotherapy, Adjuvant methods, Nasal Cavity pathology, Nasal Surgical Procedures methods, Nose Neoplasms therapy, Paranasal Sinus Neoplasms therapy, Practice Guidelines as Topic
Abstract: The American College of Radiology (ACR) Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Here, we present the Appropriateness Criteria for cancers arising in the nasal cavity and paranasal sinuses (maxillary, sphenoid, and ethmoid sinuses). This includes clinical presentation, prognostic factors, principles of management, and treatment outcomes. Controversies regarding management of cervical lymph nodes are discussed. Rare and unusual nasal cavity cancers, such as esthesioneuroblastoma and sinonasal undifferentiated carcinomas, are included. © 2016 American College of Radiology. Head Neck, 2016 © 2016 Wiley Periodicals, Inc. Head Neck 39: 407-418, 2017., (© 2016 Wiley Periodicals, Inc.)
Published: 2017
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35. Acute and late urinary toxicity following radiation in men with an intact prostate gland or after a radical prostatectomy: A secondary analysis of RTOG 94-08 and 96-01.

Author: Mak RH, Hunt D, Efstathiou JA, Heney NM, Jones CU, Lukka HR, Bahary JP, Patel M, Balogh A, Nabid A, Leibenhaut MH, Hamstra DA, Roof KS, Jeffrey Lee R, Gore EM, Sandler HM, and Shipley WU
Subjects: Acute Disease, Aged, Aged, 80 and over, Follow-Up Studies, Humans, Male, Middle Aged, Prostate radiation effects, Prostatectomy, Prostatic Neoplasms surgery, Severity of Illness Index, Time Factors, Urethra radiation effects, Prostatic Neoplasms radiotherapy, Radiation Injuries etiology, Radiotherapy adverse effects, Urologic Diseases etiology
Abstract: Introduction: To estimate the contribution of the prostate gland and prostatic urethral inflammation to urinary symptoms after radiation therapy for prostate cancer, we performed a secondary analysis of urinary toxicity after primary radiation to an intact prostate vs. postprostatectomy radiation to the prostatic fossa in protocols RTOG 94-08 and 96-01, respectively., Materials and Methods: Patients randomized to the radiation-alone arms (without hormone therapy) of the 2 trials were evaluated, including 104 men receiving primary prostate radiation to 68.4Gy on RTOG 94-08 and 371 men receiving 64.8Gy to the prostatic fossa on RTOG 96-01. Acute and late urinary toxicity were scored prospectively by RTOG scales. Chi-square test/logistic regression and cumulative incidence approach/Fine-Gray regression model were used for analyses of acute and late toxicity, respectively., Results: Grade≥2 acute urinary toxicity was significantly higher after primary prostatic radiation compared with postprostatectomy radiation (30.8% vs. 14.0%; P<0.001), but acute grade≥3 toxicity did not differ (3.8% vs. 2.7%; P = 0.54). After adjusting for age, primary radiation resulted in significantly higher grade≥2 acute urinary toxicity (odds ratio = 3.72; 95% CI: 1.65-8.37; P = 0.02). With median follow-up of 7.1 years, late urinary toxicity was not significantly different with primary vs. postprostatectomy radiation (5-year grade≥2: 16.7% vs. 18.3%; P = 0.65; grade≥3: 6.0% vs. 3.3%; P = 0.24)., Conclusions: Primary radiation to an intact prostate resulted in higher grade≥2 acute urinary toxicity than radiation to the prostatic fossa, with no difference in late urinary toxicity. Thus, a proportion of acute urinary toxicity in men with an intact prostate may be attributable to inflammation of the prostatic gland or urethra., (Copyright © 2016 Elsevier Inc. All rights reserved.)
Published: 2016
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36. ACR Appropriateness Criteria(®) Locoregional therapy for resectable oropharyngeal squamous cell carcinomas.

Author: Beitler JJ, Quon H, Jones CU, Salama JK, Busse PM, Cooper JS, Koyfman SA, Ridge JA, Saba NF, Siddiqui F, Smith RV, Worden F, Yao M, and Yom SS
Subjects: Aged, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell virology, Chemoradiotherapy methods, Combined Modality Therapy, Delphi Technique, Disease-Free Survival, Female, Head and Neck Neoplasms pathology, Head and Neck Neoplasms virology, Humans, Male, Middle Aged, Neck Dissection methods, Neoplasm Invasiveness pathology, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local pathology, Neoplasm Recurrence, Local therapy, Neoplasm Staging, Oropharyngeal Neoplasms pathology, Oropharyngeal Neoplasms virology, Oropharynx surgery, Papillomavirus Infections epidemiology, Pharyngectomy methods, Prognosis, Risk Assessment, Societies, Medical, Squamous Cell Carcinoma of Head and Neck, Survival Analysis, Carcinoma, Squamous Cell mortality, Carcinoma, Squamous Cell therapy, Head and Neck Neoplasms mortality, Head and Neck Neoplasms therapy, Oropharyngeal Neoplasms mortality, Oropharyngeal Neoplasms therapy, Papillomavirus Infections diagnosis, Practice Guidelines as Topic
Abstract: Background: There are no level I studies to guide treatment for resectable oropharyngeal squamous cell carcinoma (SCC). Treatment toxicities influence management recommendations. Ongoing investigations are examining deintensified treatments for human papillomavirus (HPV)-associated oropharyngeal SCC., Methods: The Appropriateness Criteria panel, using modified Delphi methodology, produced a literature summary, an assessment of treatment recommendations, and cases to illustrate their use., Results: A multidisciplinary team produces optimum results. Based on HPV status, smoking history, and staging, patients are divided into groups at low, intermediate, and high-risk of death. In the future, treatment recommendations may be influenced by HPV status, which has changed the epidemiology of oropharyngeal SCC., Conclusion: T1 to T2N0M0 resectable oropharyngeal SCC can be treated with surgery or radiation without chemotherapy. Patients with T1-2N1-2aM0 disease can receive radiation, chemoradiation, or transoral surgery with neck dissection and appropriate adjuvant therapy. Patients with T1-2N2b-3M0 disease should receive chemoradiation or transoral surgery with neck dissection and appropriate adjuvant therapy. Concurrent chemoradiation is preferred for T3 to T4 disease. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1299-1309, 2016., (© 2016 Wiley Periodicals, Inc.)
Published: 2016
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37. Correlation Between the Severity of Cetuximab-Induced Skin Rash and Clinical Outcome for Head and Neck Cancer Patients: The RTOG Experience.

Author: Bar-Ad V, Zhang QE, Harari PM, Axelrod R, Rosenthal DI, Trotti A, Jones CU, Garden AS, Song G, Foote RL, Raben D, Shenouda G, Spencer SA, Harris J, and Le QT
Subjects: Adult, Aged, Antineoplastic Agents therapeutic use, Carcinoma, Squamous Cell pathology, Causality, Chemoradiotherapy, Comorbidity, Disease-Free Survival, Female, Head and Neck Neoplasms mortality, Head and Neck Neoplasms pathology, Head and Neck Neoplasms therapy, Humans, Incidence, Male, Middle Aged, Prognosis, Radiodermatitis pathology, Radiotherapy Dosage, Reproducibility of Results, Risk Factors, Sensitivity and Specificity, Severity of Illness Index, Squamous Cell Carcinoma of Head and Neck, Statistics as Topic, Survival Rate, Treatment Outcome, Carcinoma, Squamous Cell mortality, Carcinoma, Squamous Cell therapy, Cetuximab therapeutic use, Drug Eruptions mortality, Head and Neck Neoplasms drug therapy, Radiodermatitis mortality
Abstract: Purpose: To evaluate the severity of cetuximab-induced skin rash and its correlation with clinical outcome and late skin toxicity in patients with head and neck squamous cell carcinoma treated with chemoradiation therapy and cetuximab., Methods and Materials: Analysis included patients who received loading dose and ≥1 cetuximab dose concurrent with definitive chemoradiation therapy (70 Gy + cisplatin) or postoperative chemoradiation therapy (60-66 Gy + docetaxel or cisplatin)., Results: Six hundred two patients were analyzed; 383 (63.6%) developed grade 2 to 4 cetuximab rash. Patients manifesting grade 2 to 4 rash had younger age (P<.001), fewer pack-years smoking history (P<.001), were more likely to be males (P=.04), and had p16-negative (P=.04) oropharyngeal tumors (P=.003). In univariate analysis, grade 2 to 4 rash was associated with better overall survival (hazard ratio [HR] 0.58, P<.001) and progression-free survival (HR 0.75, P=.02), and reduced distant metastasis rate (HR 0.61, P=.03), but not local-regional failure (HR 0.79, P=.16) relative to grade 0 to 1 rash. In multivariable analysis, HRs for overall survival, progression-free survival, distant metastasis, and local-regional failure were, respectively, 0.68 (P=.008), 0.85 (P=.21), 0.64 (P=.06), and 0.89 (P=.48). Grade ≥2 rash was associated with improved survival in p16-negative patients (HR 0.28 [95% confidence interval 0.11-0.74]) but not in p16-positive patients (HR 1.10 [0.42-2.89]) (P=.05 for interaction). Twenty-five percent of patients with grade 2 to 4 acute in-field radiation dermatitis experienced grade 2 to 4 late skin fibrosis, versus 14% of patients with grade 0 to 1 acute in-field radiation dermatitis (P=.002)., Conclusion: Grade 2 to 4 cetuximab rash was associated with better survival, possibly due to reduction of distant metastasis. This observation was noted mainly in p16-negative patients. Grade 2 to 4 acute in-field radiation dermatitis was associated with higher rate of late grade 2 to 4 skin fibrosis., (Copyright © 2016 Elsevier Inc. All rights reserved.)
Published: 2016
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38. ACR Appropriateness criteria® for nasopharyngeal carcinoma.

Author: Saba NF, Salama JK, Beitler JJ, Busse PM, Cooper JS, Jones CU, Koyfman S, Quon H, Ridge JA, Siddiqui F, Worden F, Yao M, and Yom SS
Subjects: Carcinoma diagnostic imaging, Carcinoma mortality, Carcinoma pathology, Chemoradiotherapy, Adjuvant, Combined Modality Therapy, Disease-Free Survival, Early Detection of Cancer methods, Evidence-Based Medicine, Female, Humans, Male, Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms diagnostic imaging, Nasopharyngeal Neoplasms mortality, Nasopharyngeal Neoplasms pathology, Neoplasm Invasiveness pathology, Prognosis, Societies, Medical, Survival Analysis, United States, Carcinoma therapy, Nasopharyngeal Neoplasms therapy, Nasopharynx surgery, Practice Guidelines as Topic, Quality of Life
Abstract: Background: Nasopharyngeal carcinoma (NPC) presents mostly with locally advanced disease and is treated with multimodal therapy; however, consensus is lacking for different clinical scenarios., Methods: The American College of Radiology (ACR) Appropriateness Criteria® are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment., Results: The ACR Expert Panel on Radiation Oncology - Head and Neck Cancer developed consensus recommendations for guiding management of nasopharyngeal carcinoma., Conclusion: Multidisciplinary evaluation is essential to guiding the optimal use of surgery, radiation, and systemic therapy in this disease. © 2015 Wiley Periodicals, Inc. Head Neck 38: 979-986, 2016., (© 2016 Wiley Periodicals, Inc.)
Published: 2016
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39. Cardiovascular Mortality Following Short-term Androgen Deprivation in Clinically Localized Prostate Cancer: An Analysis of RTOG 94-08.

Author: Voog JC, Paulus R, Shipley WU, Smith MR, McGowan DG, Jones CU, Bahary JP, Zeitzer KL, Souhami L, Leibenhaut MH, Rotman M, Husain SM, Gore E, Raben A, Chafe S, Sandler HM, and Efstathiou JA
Subjects: Aged, Antineoplastic Agents, Hormonal adverse effects, Flutamide adverse effects, Follow-Up Studies, Goserelin adverse effects, Humans, Incidence, Leuprolide adverse effects, Male, Middle Aged, Proportional Hazards Models, Prostatic Neoplasms pathology, Prostatic Neoplasms radiotherapy, Retrospective Studies, Survival Rate, Time Factors, Antineoplastic Agents, Hormonal administration & dosage, Cardiovascular Diseases mortality, Flutamide administration & dosage, Goserelin administration & dosage, Leuprolide administration & dosage, Prostatic Neoplasms drug therapy
Abstract: Background: Androgen deprivation therapy (ADT) is associated with coronary heart disease and diabetes in men with prostate cancer (PCa); however, controversy exists regarding ADT and cardiovascular mortality (CVM) with limited data for lower risk disease., Objective: We conducted a hypothesis-generating retrospective analysis to evaluate the relationship between short-course ADT and CVM in patients with clinically localized PCa enrolled in a phase III trial., Design, Setting, and Participants: A total of 1979 men with clinically localized (T1b-2b, prostate-specific antigen [PSA] <20 ng/ml) PCa enrolled in Radiation Therapy Oncology Group (RTOG) 94-08 from 1994 to 2001. Patients were randomized to radiation therapy (RT) with or without short-course ADT (4 mo of gonadotropin-releasing hormone (GnRH) agonist therapy and antiandrogen). Median follow-up was 9.1 yr for survivors., Outcome Measurements and Statistical Analysis: The Cox proportional hazards model assessed overall survival. The Fine-Gray proportional hazards model assessed disease-specific survival (DSS) and CVM. Covariates included age, race, weight, baseline cardiovascular disease, baseline diabetes, baseline hypertension, Gleason score, T stage, and PSA., Results and Limitations: Short-course ADT improved overall survival and DSS and was not associated with an increased risk of CVM. Overall, 191 cardiovascular-related deaths were observed. At 10 yr, 83 patients (cumulative incidence rate: 10%) receiving RT and ADT versus 95 patients (cumulative incidence rate: 11%) receiving RT alone experienced CVM. The treatment arm was not associated with increased CVM (unadjusted hazard ratio: 1.07; confidence interval, 0.81-1.42; p=0.62). Increased CVM was not observed in patients at low risk of PCa death or at high risk of cardiac-related death., Conclusions: Data from patients enrolled in RTOG 94-08 support the hypothesis that ADT does not increase CVM risk in men with clinically localized PCa treated with short-course GnRH agonist therapy. These data support ADT use in settings with proven survival benefit., Patient Summary: We investigated the controversial relationship between hormone therapy and cardiovascular mortality in men with prostate cancer (PCa) treated with radiation in a large randomized trial. Our data suggest that hormone therapy does not increase the risk of cardiovascular death in patients with clinically localized PCa and support the use of such therapy in settings with proven survival benefit., (Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
Published: 2016
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40. ACR Appropriateness Criteria(®) Aggressive Nonmelanomatous Skin Cancer of the Head and Neck.

Author: Koyfman SA, Cooper JS, Beitler JJ, Busse PM, Jones CU, McDonald MW, Quon H, Ridge JA, Saba NF, Salama JK, Siddiqui F, Smith RV, Worden F, Yao M, and Yom SS
Subjects: Antineoplastic Agents therapeutic use, Carcinoma, Basal Cell pathology, Carcinoma, Basal Cell therapy, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell therapy, Humans, Immunocompromised Host, Radiotherapy Dosage, Radiotherapy, Adjuvant, Head and Neck Neoplasms pathology, Head and Neck Neoplasms therapy, Skin Neoplasms pathology, Skin Neoplasms therapy
Abstract: Background: Aggressive nonmelanomatous skin cancer (NMSC) of the head and neck presents an increasingly common therapeutic challenge for which prospective clinical trials are lacking., Methods: The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment., Results: The American College of Radiology Expert Panel on Radiation Oncology - Head and Neck Cancer developed consensus recommendations for guiding management of aggressive NMSC., Conclusion: Multidisciplinary assessment is vital to guiding the ideal use of surgery, radiation, and systemic therapy in this disease., (Copyright © 2015 Wiley Periodicals, Inc.)
Published: 2016
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41. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902.

Author: Rosenthal SA, Hunt D, Sartor AO, Pienta KJ, Gomella L, Grignon D, Rajan R, Kerlin KJ, Jones CU, Dobelbower M, Shipley WU, Zeitzer K, Hamstra DA, Donavanik V, Rotman M, Hartford AC, Michalski J, Seider M, Kim H, Kuban DA, Moughan J, and Sandler H
Subjects: Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Hormonal adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Chemotherapy, Adjuvant adverse effects, Chemotherapy, Adjuvant methods, Combined Modality Therapy methods, Disease Progression, Early Termination of Clinical Trials, Estramustine therapeutic use, Etoposide therapeutic use, Humans, Male, Middle Aged, Neoplasm Grading, Paclitaxel therapeutic use, Prostate-Specific Antigen blood, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Time Factors, Androgen Antagonists therapeutic use, Antineoplastic Agents, Hormonal therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms radiotherapy
Abstract: Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS)., Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20-100 ng/mL and Gleason score [GS] ≥ 7 or clinical stage ≥ T2 and GS ≥ 8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05., Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P=.81), biochemical failure (58% vs 54%; P=.82), local progression (11% vs 7%; P=.09), distant metastases (16% vs 14%; P=.42), or disease-free survival (22% vs 26%; P=.61)., Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for the feasibility of clinical trial accrual and tolerability using CT for PCa., (Copyright © 2015 Elsevier Inc. All rights reserved.)
Published: 2015
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42. Importance of Local Control in Early-Stage Prostate Cancer: Outcomes of Patients With Positive Post-Radiation Therapy Biopsy Results Treated in RTOG 9408.

Author: Krauss DJ, Hu C, Bahary JP, Souhami L, Gore EM, Chafe SM, Leibenhaut MH, Narayan S, Torres-Roca J, Michalski J, Zeitzer KL, Donavanik V, Sandler H, McGowan DG, Jones CU, and Shipley WU
Subjects: Adenocarcinoma blood, Adenocarcinoma drug therapy, Adenocarcinoma mortality, Aged, Aged, 80 and over, Biopsy methods, Combined Modality Therapy, Disease-Free Survival, Flutamide therapeutic use, Gonadotropin-Releasing Hormone agonists, Humans, Male, Middle Aged, Neoplasm Grading, Neoplasm Recurrence, Local blood, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local pathology, Neoplasm Staging, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms drug therapy, Prostatic Neoplasms mortality, Treatment Outcome, Adenocarcinoma pathology, Adenocarcinoma radiotherapy, Androgen Antagonists therapeutic use, Prostate pathology, Prostatic Neoplasms pathology, Prostatic Neoplasms radiotherapy
Abstract: Purpose: The purpose of this study was to assess the association between positive post-radiation therapy (RT) biopsy results and subsequent clinical outcomes in males with localized prostate cancer., Methods and Materials: Radiation Therapy Oncology Group study 94-08 analyzed 1979 males with prostate cancer, stage T1b-T2b and prostate-specific antigen concentrations of ≤ 20 ng/dL, to investigate whether 4 months of total androgen suppression (TAS) added to RT improved survival compared to RT alone. Patients randomized to receive TAS received flutamide with luteinizing hormone releasing hormone (LHRH) agonist. According to protocol, patients without evidence of clinical recurrence or initiation of additional endocrine therapy underwent repeat prostate biopsy 2 years after RT completion. Statistical analysis was performed to evaluate the impact of positive post-RT biopsy results on clinical outcomes., Results: A total of 831 patients underwent post-RT biopsy, 398 were treated with RT alone and 433 with RT plus TAS. Patients with positive post-RT biopsy results had higher rates of biochemical failure (hazard ratio [HR] = 1.7; 95% confidence interval [CI] = 1.3-2.1) and distant metastasis (HR = 2.4; 95% CI = 1.3-4.4) and inferior disease-specific survival (HR = 3.8; 95% CI = 1.9-7.5). Positive biopsy results remained predictive of such outcomes after correction for potential confounders such as Gleason score, tumor stage, and TAS administration. Prior TAS therapy did not prevent elevated risk of adverse outcome in the setting of post-RT positive biopsy results. Patients with Gleason score ≥ 7 with a positive biopsy result additionally had inferior overall survival compared to those with a negative biopsy result (HR = 1.56; 95% CI = 1.04-2.35)., Conclusions: Positive post-RT biopsy is associated with increased rates of distant metastases and inferior disease-specific survival in patients treated with definitive RT and was associated with inferior overall survival in patients with high-grade tumors., (Copyright © 2015 Elsevier Inc. All rights reserved.)
Published: 2015
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43. Metabolic tumor volume as a prognostic imaging-based biomarker for head-and-neck cancer: pilot results from Radiation Therapy Oncology Group protocol 0522.

Author: Schwartz DL, Harris J, Yao M, Rosenthal DI, Opanowski A, Levering A, Ang KK, Trotti AM, Garden AS, Jones CU, Harari P, Foote R, Holland J, Zhang Q, and Le QT
Subjects: Adult, Aged, Blood Glucose analysis, Chemoradiotherapy methods, Confidence Intervals, Disease-Free Survival, Female, Follow-Up Studies, Head and Neck Neoplasms metabolism, Head and Neck Neoplasms pathology, Humans, Hypopharyngeal Neoplasms diagnostic imaging, Hypopharyngeal Neoplasms metabolism, Hypopharyngeal Neoplasms pathology, Hypopharyngeal Neoplasms therapy, Laryngeal Neoplasms diagnostic imaging, Laryngeal Neoplasms metabolism, Laryngeal Neoplasms pathology, Laryngeal Neoplasms therapy, Lymphatic Metastasis, Male, Middle Aged, Neoplasm Staging, Oropharyngeal Neoplasms pathology, Phenotype, Positron-Emission Tomography instrumentation, Prognosis, Tomography, X-Ray Computed instrumentation, Tomography, X-Ray Computed methods, Fluorodeoxyglucose F18 pharmacokinetics, Head and Neck Neoplasms diagnostic imaging, Head and Neck Neoplasms therapy, Positron-Emission Tomography methods, Radiopharmaceuticals pharmacokinetics
Abstract: Purpose: To evaluate candidate fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) imaging biomarkers for head-and-neck chemoradiotherapy outcomes in the cooperative group trial setting., Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0522 patients consenting to a secondary FDG-PET/CT substudy were serially imaged at baseline and 8 weeks after radiation. Maximum standardized uptake value (SUVmax), SUV peak (mean SUV within a 1-cm sphere centered on SUVmax), and metabolic tumor volume (MTV) using 40% of SUVmax as threshold were obtained from primary tumor and involved nodes., Results: Of 940 patients entered onto RTOG 0522, 74 were analyzable for this substudy. Neither high baseline SUVmax nor SUVpeak from primary or nodal disease were associated with poor treatment outcomes. However, primary tumor MTV above the cohort median was associated with worse local-regional control (hazard ratio 4.01, 95% confidence interval 1.28-12.52, P=.02) and progression-free survival (hazard ratio 2.34, 95% confidence interval 1.02-5.37, P=.05). Although MTV and T stage seemed to correlate (mean MTV 6.4, 13.2, and 26.8 for T2, T3, and T4 tumors, respectively), MTV remained a strong independent prognostic factor for progression-free survival in bivariate analysis that included T stage. Primary MTV remained prognostic in p16-associated oropharyngeal cancer cases, although sample size was limited., Conclusion: High baseline primary tumor MTV was associated with worse treatment outcomes in this limited patient subset of RTOG 0522. Additional confirmatory work will be required to validate primary tumor MTV as a prognostic imaging biomarker for patient stratification in future trials., (Copyright © 2015 Elsevier Inc. All rights reserved.)
Published: 2015
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44. Slow breathing training reduces resting blood pressure and the pressure responses to exercise.

Author: Jones CU, Sangthong B, Pachirat O, and Jones DA
Subjects: Adult, Aged, Blood Pressure Determination methods, Female, Heart Rate physiology, Humans, Male, Middle Aged, Blood Pressure physiology, Breathing Exercises methods, Exercise physiology, Hand Strength physiology
Abstract: Slow breathing training reduces resting blood pressure, probably by modifying central autonomic control, but evidence for this is lacking. The pressor response to static handgrip exercise is a measure of autonomic control and the aim of this study was to determine whether slow breathing training modulates the pressor responses to exercise of untrained muscles. Twenty hypertensive patients trained for 8 weeks, 10 with unloaded slow breathing (Unloaded) and 10 breathing against an inspiratory load of 20 cm H(2)O (Loaded). Ten subjects were untrained controls. Subjects performed a 2 min handgrip pressor test (30 % MVC) pre- and post-training, and blood pressure and heart rate (HR) were measured before the contraction, at the end and following 2 min recovery. Resting systolic (sBP) and HR were reduced as a result of training, as reported previously. After training there was both a smaller pressor response to hand grip exercise and a more rapid recovery of sBP and HR compared to pre-training. There were no changes in the Controls and no differences between the Unloaded and Loaded groups. Combining the two training groups, the sBP response to handgrip exercise after training was reduced by 10 mm Hg (95 % CI: -7, -13) and HR by 5 bpm (95 % CI: -4, -6), all p<0.05. These results are consistent with slow breathing training modifying central mechanisms regulating cardiovascular function.
Published: 2015
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45. Acute hemodynamic responses to 30° head-down postural drainage in stable, ventilated trauma patients: a randomized crossover trial.

Author: Hongrattana G, Reungjui P, and Jones CU
Subjects: Acute Disease, Adult, Cross-Over Studies, Female, Heart Rate physiology, Hemodynamics physiology, Humans, Male, Oxygen metabolism, Wounds and Injuries physiopathology, Drainage, Postural methods, Head-Down Tilt, Respiration, Artificial, Wounds and Injuries therapy
Abstract: Objective: To determine whether 30° head-down tilt (HDT) used for secretion clearance is safe for acute trauma patients., Background: There are concerns that HDT may lead to cardiac irregularities in intubated patients in the ICU., Methods: Eleven mechanically ventilated trauma patients (25-42 yrs) without cardiovascular problems received two interventions, one supine HDT for 10 min and a control in the horizontal supine position (HS), in a crossover design., Results: Compared to baseline there were statistically significant (p < 0.05) increases in SBP (6.3 mm Hg; 95% CI 2.5, 12.7) and CVP (7.3 cm H2O; 5.7, 10.0) during 10 min HDT although these were not of clinical concern. Heart rate and oxygen saturation were unchanged. No episodes of arrhythmia or hypoxemia were observed. All values returned close to baseline during 10 min horizontal recovery. There were no significant changes during the control HS intervention., Conclusion: 30° HDT entails minimal risk for trauma patients who have no underlying cardiovascular disease., (Copyright © 2014 Elsevier Inc. All rights reserved.)
Published: 2014
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46. Randomized trial of hyperfractionation versus conventional fractionation in T2 squamous cell carcinoma of the vocal cord (RTOG 9512).

Author: Trotti A 3rd, Zhang Q, Bentzen SM, Emami B, Hammond ME, Jones CU, Morrison WH, Sagar SM, Ridge JA, Fu KK, and Ang KK
Subjects: Adult, Aged, Aged, 80 and over, Carcinoma, Squamous Cell mortality, Carcinoma, Squamous Cell pathology, Disease-Free Survival, Dose Fractionation, Radiation, Female, Humans, Laryngeal Neoplasms mortality, Laryngeal Neoplasms pathology, Male, Middle Aged, Neoplasm Staging, Radiation Injuries pathology, Carcinoma, Squamous Cell radiotherapy, Laryngeal Neoplasms radiotherapy, Vocal Cords
Abstract: Purpose: To compare hyperfractionation versus standard fractionation for T2N0 vocal cord carcinoma in a randomized controlled trial., Methods and Materials: Patients with T2 vocal cord cancer were stratified by substage (T2a vs T2b) and randomly assigned to receive either hyperfractionation (HFX) to 79.2 Gy in 66 fractions of 1.2 Gy given twice a day, or standard fractionation (SFX) to 70 Gy in 35 fractions given once a day. The trial was designed to detect a 55% reduction in the local failure hazard rate with 80% statistical power., Results: Between April 1996 and July 2003, a total of 250 patients were enrolled. Of 239 patients analyzable for outcomes, 94% were male, 83% had a Karnofsky performance status of 90-100, and 62% had T2a tumor. Median follow-up for all surviving patients was 7.9 years (range, 0.6-13.1 years). The 5-year local control (LC) rate was 8 points higher but not statistically significant (P=.14 for HFX [78%] vs SFX [70%]), corresponding to a 30% hazard rate reduction. The 5-year disease-free survival (DFS) was 49% versus 40% (P=.13) and overall survival (OS) was 72% versus 63% (P=.29). HFX was associated with higher rates of acute skin, mucosal, and laryngeal toxicity. Grade 3-4 late effects were similar with a 5-year cumulative incidence of 8.5% (3.4%-13.6%) after SFX and 8.5% (3.4%-13.5%) after HFX., Conclusions: The 5-year local control was modestly higher with HFX compared to SFX for T2 glottic carcinoma, but the difference was not statistically significant. These results are consistent with prior studies of hyperfractionation showing a benefit in local control. Substaging by T2a versus T2b carries prognostic value for DFS and OS. For cost and convenience reasons other altered fractionation schedules have been adopted in routine practice., (Copyright © 2014 Elsevier Inc. All rights reserved.)
Published: 2014
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47. Final results of local-regional control and late toxicity of RTOG 9003: a randomized trial of altered fractionation radiation for locally advanced head and neck cancer.

Author: Beitler JJ, Zhang Q, Fu KK, Trotti A, Spencer SA, Jones CU, Garden AS, Shenouda G, Harris J, and Ang KK
Subjects: Carcinoma, Squamous Cell mortality, Carcinoma, Squamous Cell pathology, Cause of Death, Confidence Intervals, Enteral Nutrition statistics & numerical data, Head and Neck Neoplasms mortality, Head and Neck Neoplasms pathology, Humans, Hypopharyngeal Neoplasms pathology, Hypopharyngeal Neoplasms radiotherapy, Laryngeal Neoplasms pathology, Laryngeal Neoplasms radiotherapy, Mouth Neoplasms pathology, Mouth Neoplasms radiotherapy, Oropharyngeal Neoplasms pathology, Oropharyngeal Neoplasms radiotherapy, Radiation Injuries pathology, Squamous Cell Carcinoma of Head and Neck, Time Factors, Tongue Neoplasms pathology, Tongue Neoplasms radiotherapy, Treatment Failure, Carcinoma, Squamous Cell radiotherapy, Dose Fractionation, Radiation, Head and Neck Neoplasms radiotherapy
Abstract: Purpose: To test whether altered radiation fractionation schemes (hyperfractionation [HFX], accelerated fractionation, continuous [AFX-C], and accelerated fractionation with split [AFX-S]) improved local-regional control (LRC) rates for patients with squamous cell cancers (SCC) of the head and neck when compared with standard fractionation (SFX) of 70 Gy., Methods and Materials: Patients with stage III or IV (or stage II base of tongue) SCC (n=1076) were randomized to 4 treatment arms: (1) SFX, 70 Gy/35 daily fractions/7 weeks; (2) HFX, 81.6 Gy/68 twice-daily fractions/7 weeks; (3) AFX-S, 67.2 Gy/42 fractions/6 weeks with a 2-week rest after 38.4 Gy; and (4) AFX-C, 72 Gy/42 fractions/6 weeks. The 3 experimental arms were to be compared with SFX., Results: With patients censored for LRC at 5 years, only the comparison of HFX with SFX was significantly different: HFX, hazard ratio (HR) 0.79 (95% confidence interval 0.62-1.00), P=.05; AFX-C, 0.82 (95% confidence interval 0.65-1.05), P=.11. With patients censored at 5 years, HFX improved overall survival (HR 0.81, P=.05). Prevalence of any grade 3, 4, or 5 toxicity at 5 years; any feeding tube use after 180 days; or feeding tube use at 1 year did not differ significantly when the experimental arms were compared with SFX. When 7-week treatments were compared with 6-week treatments, accelerated fractionation appeared to increase grade 3, 4 or 5 toxicity at 5 years (P=.06). When the worst toxicity per patient was considered by treatment only, the AFX-C arm seemed to trend worse than the SFX arm when grade 0-2 was compared with grade 3-5 toxicity (P=.09)., Conclusions: At 5 years, only HFX improved LRC and overall survival for patients with locally advanced SCC without increasing late toxicity., (Published by Elsevier Inc.)
Published: 2014
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48. Breathing exercise using a new breathing device increases airway secretion clearance in mechanically ventilated patients.

Author: Jones CU, Kluayhomthong S, Chaisuksant S, and Khrisanapant W
Subjects: Adolescent, Adult, Aged, Cross-Over Studies, Double-Blind Method, Equipment Design, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Respiration Disorders metabolism, Respiration Disorders physiopathology, Treatment Outcome, Young Adult, Breathing Exercises instrumentation, Respiration, Respiration Disorders therapy, Respiration, Artificial methods, Sputum metabolism
Abstract: Objectives: To evaluate the efficacy and safety of a new device (BreatheMAX) that humidifies and oscillates inspired air to increase secretion clearance in mechanically ventilated patients., Background: Poor secretion clearance is a serious problem for intubated patients leading to lung complications and delayed weaning., Methods: Double blinded crossover; fifteen patients, median age 60 years, range 16-75. Interventions consisted of spontaneous deep breathing with (treatment) and without (sham) humidification and oscillation of inspired air. Airway secretions were aspirated for 3 h before and after each intervention and wet weight and viscosity determined., Results: The sham intervention caused no change in secretion clearance (95% CI: -1.8, 1.8 g) but after treatment secretions increased by 4.0 g (95% CI: 1.3, 6.7; p < 0.05). Viscosity decreased 30% after treatment and was unchanged after sham. Changes in cardiopulmonary function were not clinically significant and the patients reported only mild perceptions of breathlessness., Conclusions: Breathing exercise with a device that includes vibration and humidification of inspired air is effective for increasing secretion clearance with patients dependent on mechanical ventilation and was without any adverse effects., (Copyright © 2013 Elsevier Inc. All rights reserved.)
Published: 2013
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49. Radiotherapy and short-term androgen deprivation for localized prostate cancer.

Author: Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, and Shipley WU
Subjects: Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Combined Modality Therapy, Erectile Dysfunction etiology, Flutamide administration & dosage, Flutamide adverse effects, Follow-Up Studies, Gonadotropin-Releasing Hormone agonists, Gonadotropin-Releasing Hormone therapeutic use, Goserelin administration & dosage, Goserelin adverse effects, Humans, Leuprolide administration & dosage, Leuprolide adverse effects, Male, Middle Aged, Multivariate Analysis, Prostate pathology, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Radiotherapy adverse effects, Radiotherapy Dosage, Risk, Survival Rate, Androgen Antagonists therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prostatic Neoplasms drug therapy, Prostatic Neoplasms radiotherapy
Abstract: Background: It is not known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma., Methods: From 1994 through 2001, we randomly assigned 1979 eligible patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a prostate-specific antigen (PSA) level of 20 ng per milliliter or less to radiotherapy alone (992 patients) or radiotherapy with 4 months of total androgen suppression starting 2 months before radiotherapy (radiotherapy plus short-term ADT, 987 patients). The primary end point was overall survival. Secondary end points included disease-specific mortality, distant metastases, biochemical failure (an increasing level of PSA), and the rate of positive findings on repeat prostate biopsy at 2 years., Results: The median follow-up period was 9.1 years. The 10-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving radiotherapy alone (hazard ratio for death with radiotherapy alone, 1.17; P=0.03). The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8% to 4% (hazard ratio for radiotherapy alone, 1.87; P=0.001). Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT. Acute and late radiation-induced toxic effects were similar in the two groups. The incidence of grade 3 or higher hormone-related toxic effects was less than 5%. Reanalysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients, with no significant reductions among low-risk patients., Conclusions: Among patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less, the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival. According to post hoc risk analysis, the benefit was mainly seen in intermediate-risk, but not low-risk, men. (Funded by the National Cancer Institute; RTOG 94-08 ClinicalTrials.gov number, NCT00002597.).
Published: 2011
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50. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22).

Author: Eisbruch A, Harris J, Garden AS, Chao CK, Straube W, Harari PM, Sanguineti G, Jones CU, Bosch WR, and Ang KK
Subjects: Adult, Aged, Aged, 80 and over, Carcinoma, Squamous Cell pathology, Dose Fractionation, Radiation, Female, Humans, Male, Middle Aged, Neoplasms, Second Primary, Oropharyngeal Neoplasms pathology, Quality Control, Radiation Injuries pathology, Radiotherapy, Intensity-Modulated standards, Tumor Burden, Carcinoma, Squamous Cell radiotherapy, Oropharyngeal Neoplasms radiotherapy, Radiotherapy, Intensity-Modulated methods
Abstract: Purpose: To assess the results of a multi-institutional study of intensity-modulated radiation therapy (IMRT) for early oropharyngeal cancer., Patients and Methods: Patients with oropharyngeal carcinoma Stage T1-2, N0-1, M0 requiring treatment of the bilateral neck were eligible. Chemotherapy was not permitted. Prescribed planning target volumes (PTVs) doses to primary tumor and involved nodes was 66 Gy at 2.2 Gy/fraction over 6 weeks. Subclinical PTVs received simultaneously 54-60 Gy at 1.8-2.0 Gy/fraction. Participating institutions were preapproved for IMRT, and quality assurance review was performed by the Image-Guided Therapy Center., Results: 69 patients were accrued from 14 institutions. At median follow-up for surviving patients (2.8 years), the 2-year estimated local-regional failure (LRF) rate was 9%. 2/4 patients (50%) with major underdose deviations had LRF compared with 3/49 (6%) without such deviations (p = 0.04). All cases of LRF, metastasis, or second primary cancer occurred among patients who were current/former smokers, and none among patients who never smoked. Maximal late toxicities Grade >or=2 were skin 12%, mucosa 24%, salivary 67%, esophagus 19%, osteoradionecrosis 6%. Longer follow-up revealed reduced late toxicity in all categories. Xerostomia Grade >or=2 was observed in 55% of patients at 6 months but reduced to 25% and 16% at 12 and 24 months, respectively. In contrast, salivary output did not recover over time., Conclusions: Moderately accelerated hypofractionatd IMRT without chemotherapy for early oropharyngeal cancer is feasible, achieving high tumor control rates and reduced salivary toxicity compared with similar patients in previous Radiation Therapy Oncology Group studies. Major target underdose deviations were associated with higher LRF rate.
Published: 2010
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