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2. Health care setting and severity, symptom burden, and complications in patients with Philadelphia-negative myeloproliferative neoplasms (MPN): a comparison between university hospitals, community hospitals, and office-based physicians

Author

Kaifie, A., Isfort, S., Gattermann, N., Hollburg, W., Klausmann, M., Wolf, D., Maintz, C., Hänel, M., Goekkurt, E., Göthert, J. R., Platzbecker, U., Geer, T., Parmentier, S., Jost, E., Serve, H., Ehninger, G., Berdel, W. E., Brümmendorf, T. H., Koschmieder, Steffen, and for the Study Alliance Leukemia (SAL)

Published
2016
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4. Correction:High-risk additional chromosomal abnormalities at low blast counts herald death by CML (Leukemia, (2020), 34, 8, (2074-2086), 10.1038/s41375-020-0826-9)

Author

Hehlmann, Rüdiger, Voskanyan, Astghik, Lauseker, Michael, Pfirrmann, Markus, Kalmanti, Lida, Rinaldetti, Sebastien, Kohlbrenner, Katharina, Haferlach, Claudia, Schlegelberger, Brigitte, Fabarius, Alice, Seifarth, Wolfgang, Spieß, Birgit, Wuchter, Patrick, Krause, Stefan, Kolb, Hans Jochem, Neubauer, Andreas, Hossfeld, Dieter K., Nerl, Christoph, Gratwohl, Alois, Baerlocher, Gabriela M., Burchert, Andreas, Brümmendorf, Tim H., Hasford, Jörg, Hochhaus, Andreas, Saußele, Susanne, Baccarani, Michele, von Weikersthal, L. Fischer, Hahn, M., Schlimok, G., Reichert, D., Janssen, J., Martens, U., Majunke, P., Reichert, Peter, Neben, K., Korsten, S., Scholz, Ch, Oldenkott, B., Heßling, J., Kingreen, D., Sperling, C., Schelenz, C., Blau, I., Urmersbach, A., Ludwig, W., Le Coutre, P., Arnold, R., de Wit, M., Pezzutto, A., Schäfer, E., Schroers, R., Lochter, A., Behringer, D., Ko, Y., Weidenhöfer, S., Verbeek, W., Brossart, P., Trenn, G., Pommerien, W., Krauter, J., Doering, G., Munzinger, H., Diekmann, C., Hertenstein, B., Stier, S., Möller-Faßbender, F., Hänel, M., Zöller, T., Lamberti, C., Koch, B., Henzel, A., Wagner, S., Schmalenbach, A., Hoffknecht, M., Ehninger, G., Kiani, A., Illmer, T., Aul, C., Flaßhove, M., Henneke, F., Simon, M., Müller, L., Becker, H., Janz, R., Eckart, M. J., Fuchs, R., Schlegel, F., Wattad, M., Rudolph, R., Beelen, D. W., Lindemann, A., Linck, D., Wassman, Jäger, E., Al-Batran, S., Reiber, T., Waller, C. F., Hoeffkes, H., Schulz, L., Tajrobehkar, K., Mittermüller, J., Pralle, H., Runde, V., Hoyer, A., Tessen, H., Trümper, L., Schmidt, C., Sieber, M., Eschenburg, H., Depenbusch, R., Rösel, S., Lindemann, H. W., Wolf, H., Spohn, C., Moeller, R., Hossfeld, D., Zander, A., Schafhausen, P., Köster, H., Hollburg, W., Schmitz, N., Dürk, H., Hemeier, M., Grote-Metke, A., Weischer, H., Bechtel, B., Balleisen, L., Sosada, M., Ho, A., Petersen, V., Dengler, J., Bildat, S., Hahn, L., Dietzfelbinger, H., Gröschel, W., Bartholomäus, A., Freier, W., Sievers, B., Pfreundschuh, I. M., Herrmann, T., Fauser, A., Menzel, J., Kemmerling, M., Hansen, R., Link, H., Schatz, M., Bentz, M., Prümmer, O., Kneba, M., Heymanns, J., Schmitz, S., Scheid, C., Lollert, A., Neise, M., Planker, M., Stauch, M., Schröder, M., Kempf, B., Vehling-Kaiser, U., Kremers, S., Köchling, G., Hartmann, F., Neuhaus, T., Fetscher, S., Kämpfe, D., Heil, G., Uppenkamp, M., Goldmann, B., Huber, T. Fischer, Hieber, U., Plöger, C., Griesshammer, M., Lange, C., Göttler, B., Lunscken, C., Schiel, X., Scheidegger, C., Stötzer, O., Hitz, H., Schick, H., Völkl, S., Spiekermann, K., Berdel, W., Hebart, H., Ladda, E., Schmidt, P., Burkhardt, U., Hentschke, S., Falge, C., Reschke, D., Köhne, C. A., Müller-Naendrup, C., Sauer, M., Frühauf, S., Ranft, K., Dencausse, Y., Sandritter, B., Baake, G., Hofknecht, M., Dengler, R., Edinger, M., Schenk, M., Wehmeier, A., Weidelich, H. P., Pihusch, R., Stahlhut, K., Baldus, M., Matzdorff, A., Geer, T., Schanz, S., Käfer, G., Gassmann, W., Priebe-Richter, C., Demandt, M., Springer, G., Fiechtner, H., Denzlinger, C., Schleicher, J., Assman, D., Gaeckler, R., Adam, G., Waladkhani, A., Rendenbach, B., Forstbauer, H., Kanz, L., Jacki, S., Stegelmann, F., Kalhori, N., Nusch, A., Langer, W., Müller, F., Brettner, S., Uebelmesser, B., Kamp, T., Schadeck-Gressel, C., Josten, K., Klein, O., Schwerdtfeger, R., Baurmann, H., Strotkötter, H., Fett, W., Raghavachar, A., Maintz, C., Goebler, M. C., Schlag, R., Elsel, W., Wernli, M., Heim, D., Wuillemin, W., Hess, U., Gmür, J., and Mayer, J.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020
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5. Selected Abstract Zoledronic acid therapy versus control in patients with Multiple Myeloma in stage I (Durie & Salmon): Results of a phase III study of the “Deutsche Studiengruppe Multiples Myelom (DSMM)” and “Ostdeutsche Studiengruppe Haematologie und Onkologie (OSHO)”: V347

Author

Sezer, O., Jakob, C., Aldaoud, A., Schwarzer, A., Maintz, C., Kropff, M., Blumenstengel, K., Mittermüller, J., Aulitzky, W., Wolf, H., Duerk, H., Cordes, H., Beck, C., Einsele, H., Schmidt, K., Friedrichs, U., Haus, U., and Freund, M.

Published
2010

9. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Gligorov, J, Ataseven, B, Verrill, M, de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Lauer, S, Shing, M, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, Van Thuan, T, Gligorov J., Ataseven B., Verrill M., de Laurentiis M., Jung K. H., Azim H. A., Al-Sakaff N., Lauer S., Shing M., Pivot X., Koroveshi D., Bouzid K., Casalnuovo M., Cascallar D., Korbenfeld E. P., Bastick P., Beith J., Colosimo M., Friedlander M., Ganju V., Green M., Patterson K., Redfern A., Richardson G., Ceric T., Gordana K., Beato C. A., Ferrari M., Hegg R., Helena V., Ismael G. F., Lessa A. E., Mano M., Morelle A., Nogueira J. A., Timcheva K., Tomova A., Tsakova M., Zlatareva-Petrova A., Asselah J., Assi H., Brezden-Masley C., Chia S., Freedman O., Harb M., Joy A. A., Kulkarni S., Prady C., Gaete A. A. A., Matamala L., Torres R., Yanez E., Franco S., Urrego M., Gugic D., Vrbanec D., Melichar B., Prausova J., Vyzula R., Pilarte R. G., Leon M. I., Munoz R., Ramos G., Azeem H. A., Aziz A. A., El Zawahry H., Osegueda F. R., Alexandre J., Artignan X., Barletta H., Beguier E., Berdah J. -F., Marty C. B., Bollet M., Bourgeois H., Bressac C., Burki F., Campone M., Coeffic D., Cojocarasu O. Z., Dagada C., Dalenc F., Del Piano F., Desauw C., Desmoulins I., Dohollou N., Egreteau J., Ferrero J. -M., Foa C., Garidi R., Gasnault L., Guardiola E., Hamizi S., Jarcau R., Jacquin J. -P., Jaubert D., Jolimoy G., Mineur H. L., Largillier R., Leduc B., Martin P., Melis A., Monge J., Moullet I., Mousseau M., Nguyen S., Orfeuvre H., Petit T., Priou F., Bach I. S., Simon H., Stefani L., Uwer L., Youssef A., Aktas B., von der Assen A., Augustin D., Balser C., Bauer L. -E., Bechtner C., Beyer G., Brucker C., Buckner U., Busch S., Christensen B., Deryal M., Farrokh A., Faust E., Friedrichs K., Graf H., Griesshammer M., Grischke E. -M., Hanle C., Heider A., Henschen S., Hesse T., Jackisch C., Kisro J., Kohler A., Kuemmel S., Lampe D., Lantzsch T., Latos K., Lex B., Liedtke C., Luedders D., Maintz C., Muller V., Overkamp F., Park-Simon T. -W., Paul M., Prechtl A., Ringsdorf U., Runnebaum I., Ruth S., Salat C., Scheffen I., Schilling J., Schmatloch S., Schmidt M., Schneeweiss A., Schrader I., Seipelt G., Simon E., Stefek A., Stickeler E., Thill M., Tio J., Tuczek A., Warm M., Weigel M., Wischnik A., Wojcinski S., Ziegler-Lohr K., Aravantinos G., Ardavanis A., Fountzilas G., Gogas H., Kakolyris S., Mavroudis D., Papadimitriou C., Papandreou C., Papazisis K., Castro H., Hernandez-Monroy C. E., Ngan R., Yeo W., Bittner N., Boer K., Csejtei A., Horvath Z., Kocsis J., Mangel L. C., Mezei K., Nagy Z., Szanto J., Atmakusuma D., Fadjari H., Kurnianda D., Prayogo N., Tanggo E. H., Coate L., Hennessy B., Kelly C., Martin M., Nasim S., O'Connor M., Aieta M., Allegrini G., Amadori D., Bidoli P., Biti G., Bordonaro R., Bottini A., Carterni G., Cavanna L., Cazzaniga M., Cognetti F., Contu A., Cruciani G., Donadio M., Falcone A., Farci D., Forcignano R. C., Frassoldati A., Gaion F., Gamucci T., Giotta F., Livi L., Lorusso V., Maiello E., Marchetti P., Mariani G., Mion M., Moscetti L., Musolino A., Pazzola A., Pedrazzoli P., Pigi A., de Placido S., Caremoli E. R., Santoro A., Tienghi A., Ahn J. -S., Lee K. S., Lee S. H., Seo J. H., Sohn J. -H., Cesas A., Juozaityte E., Cheah N. L. C., Chong F. L. T., Devi B. C. R., Phua V., Teoh D., Ching L. W., Yusof M., Corona J., Dominguez A., Mendoza R. L. G., Hernandez C. A., Ramiro A. J., Santos J. M., Espinosa P. M., Villarreal Garza C. M., Errihani H., Bakker S., van den Berkmortel F., Blaisse R. J. B., Huinink D. T. B., van den Bosch J., Braun J. J., Dercksen M. W., Droogendijk H., Erdkamp F., Haringhuizen A., de Jongh F. E., Kok T. C., Los M., Madretsma S., Terwogt J. M. M., van der Padt A., van Rossum-Schornagel Q. C., Smilde T. J., de Valk B., van der Velden A., van Warmerdam L., van de Wouw A. J., North R., Kersten C., Mjaaland I., Wist E., Aziz Z., Masood N., Rashid K., Shah M., Alcedo J. C., Aleman D., Neciosup S., Reategui R., Valdiviezo N., Vera L., Fernando G., Roque F., Strebel H. M., Krzemieniecki K., Litwiniuk M., Mruk A., Pienkowski T., Sawrycki P., Slomian G., Tomczak P., Afonso N., Cardoso F., Damasceno M., Nave M., Badulescu F., Ciule L., Curescu S., Eniu A., Filip D., Grecea D., Jinga D. -C., Lungulescu D., Oprean C. M., Stanculeanu D. L., Turdean M., Dvornichenko V., Emelyanov S., Lichinitser M., Manikhas A., Sakaeva D., Shirinkin V., Stroyakovskiy D., Abulkhair O., Zekri J., Filipovic S., Kovcin V., Nedovic J., Pesic J., Vasovic S., Ng R., Bystricky B., Leskova J., Mardiak J., Misurova E., Wagnerova M., Takac I., Demetriou G. S., Dreosti L., Govender P., Jordaan J. P., Veersamy P., Romero J. L. A., Lopez N. B., Arias C. C., Chacon J., Aramburo A. F., Morales L. A. F., Garcia M., Estevez L. G., Garcia-Palomo Perez A., Garcia Saenz J. A., Garcia Sanchis L., Cubells L. G., Cortijo L. G., Santiago S. G., De Aranguiz B. H. F., Manas J. J. I., Gallego P. J., Cussac A. L., Ferrandiz C. L., Garrido M. L., Alvarez P. L., Vega J. M. L., Del Prado P. M., Janez N. M., Murillo S. M., Rosales A. M., Jaso L. M., Fernandez I. P., Martorell A. P., Carrion R. P., Simon S. P., Alcibar A. P., Lorenzo J. P., Garcia V. Q., Asensio T. R. Y. C., Maicas M. D. T., Villanueva Silva M. J., Killander F., Svensson J. H., Fehr M., Hauser N., Muller A., Pagani O., Passmann-Kegel H., Popescu R., Rabaglio M., Rauch D., Schlatter C., Zaman K., Chang T. -W., Huang C. -S., Wang H. -C., Yu J. -C., Bandidwattanawong C., Maneechavakajorn J., Seetalarom K., Dejthevaporn T. S., Somwangprasert A., Vongsaisuwon M., Akbulut H., Altundag K., Arican A., Bozcuk H., Eralp Y., Idris M., Isikdogan A., Senol C. H., Sevinc A., Uygun K., Yucel E., Yucel I., Yumuk F., Shparyk Y., Voitko N., Jaloudi M., Adams J., Agrawal R., Ahmed S., Alhasso A., Allerton R., Anwar S., Archer C., Ashford R., Barraclough L., Bertelli G., Bishop J., Branson T., Butt M., Chakrabarti A., Chakraborti P., Churn M., Crowley C., Davis R., Dhadda A., Eldeeb H., Fraser J., Hall J., Hickish T., Hogg M., Howe T., Joffe J., Kelleher M., Kelly S., Kendall A., Kristeleit H., Lumsden G., Macmillan C., MacPherson I., Malik Z., Mithal N., Neal A., Panwar U., Proctor A., Proctor S. J., Raj S., Rehman S., Sandri I., Scatchard K., Sherwin E., Sims E., Singer J., Smith S., Tahir S., Taylor W., Tsalic M., Wardley A., Waters S., Wheatley D., Wright K., Yuille F., Alonso I., Artagaveytia N., Rodriguez R., Arbona E., Garcia Y., Lion L., Marcano D., Van Thuan T., Gligorov, J, Ataseven, B, Verrill, M, de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Lauer, S, Shing, M, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, 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H., Azim H. A., Al-Sakaff N., Lauer S., Shing M., Pivot X., Koroveshi D., Bouzid K., Casalnuovo M., Cascallar D., Korbenfeld E. P., Bastick P., Beith J., Colosimo M., Friedlander M., Ganju V., Green M., Patterson K., Redfern A., Richardson G., Ceric T., Gordana K., Beato C. A., Ferrari M., Hegg R., Helena V., Ismael G. F., Lessa A. E., Mano M., Morelle A., Nogueira J. A., Timcheva K., Tomova A., Tsakova M., Zlatareva-Petrova A., Asselah J., Assi H., Brezden-Masley C., Chia S., Freedman O., Harb M., Joy A. A., Kulkarni S., Prady C., Gaete A. A. A., Matamala L., Torres R., Yanez E., Franco S., Urrego M., Gugic D., Vrbanec D., Melichar B., Prausova J., Vyzula R., Pilarte R. G., Leon M. I., Munoz R., Ramos G., Azeem H. A., Aziz A. A., El Zawahry H., Osegueda F. R., Alexandre J., Artignan X., Barletta H., Beguier E., Berdah J. -F., Marty C. B., Bollet M., Bourgeois H., Bressac C., Burki F., Campone M., Coeffic D., Cojocarasu O. 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L., Turdean M., Dvornichenko V., Emelyanov S., Lichinitser M., Manikhas A., Sakaeva D., Shirinkin V., Stroyakovskiy D., Abulkhair O., Zekri J., Filipovic S., Kovcin V., Nedovic J., Pesic J., Vasovic S., Ng R., Bystricky B., Leskova J., Mardiak J., Misurova E., Wagnerova M., Takac I., Demetriou G. S., Dreosti L., Govender P., Jordaan J. P., Veersamy P., Romero J. L. A., Lopez N. B., Arias C. C., Chacon J., Aramburo A. F., Morales L. A. F., Garcia M., Estevez L. G., Garcia-Palomo Perez A., Garcia Saenz J. A., Garcia Sanchis L., Cubells L. G., Cortijo L. G., Santiago S. G., De Aranguiz B. H. F., Manas J. J. I., Gallego P. J., Cussac A. L., Ferrandiz C. L., Garrido M. L., Alvarez P. L., Vega J. M. L., Del Prado P. M., Janez N. M., Murillo S. M., Rosales A. M., Jaso L. M., Fernandez I. P., Martorell A. P., Carrion R. P., Simon S. P., Alcibar A. P., Lorenzo J. P., Garcia V. Q., Asensio T. R. Y. C., Maicas M. D. T., Villanueva Silva M. J., Killander F., Svensson J. H., Fehr M., Hauser N., Muller A., Pagani O., Passmann-Kegel H., Popescu R., Rabaglio M., Rauch D., Schlatter C., Zaman K., Chang T. -W., Huang C. -S., Wang H. -C., Yu J. -C., Bandidwattanawong C., Maneechavakajorn J., Seetalarom K., Dejthevaporn T. S., Somwangprasert A., Vongsaisuwon M., Akbulut H., Altundag K., Arican A., Bozcuk H., Eralp Y., Idris M., Isikdogan A., Senol C. H., Sevinc A., Uygun K., Yucel E., Yucel I., Yumuk F., Shparyk Y., Voitko N., Jaloudi M., Adams J., Agrawal R., Ahmed S., Alhasso A., Allerton R., Anwar S., Archer C., Ashford R., Barraclough L., Bertelli G., Bishop J., Branson T., Butt M., Chakrabarti A., Chakraborti P., Churn M., Crowley C., Davis R., Dhadda A., Eldeeb H., Fraser J., Hall J., Hickish T., Hogg M., Howe T., Joffe J., Kelleher M., Kelly S., Kendall A., Kristeleit H., Lumsden G., Macmillan C., MacPherson I., Malik Z., Mithal N., Neal A., Panwar U., Proctor A., Proctor S. J., Raj S., Rehman S., Sandri I., Scatchard K., Sherwin E., Sims E., Singer J., Smith S., Tahir S., Taylor W., Tsalic M., Wardley A., Waters S., Wheatley D., Wright K., Yuille F., Alonso I., Artagaveytia N., Rodriguez R., Arbona E., Garcia Y., Lion L., Marcano D., and Van Thuan T.

Abstract

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Published
2017

10. Patients with metastatic non-small cell lung cancer and PD-L1 expression in Germany. Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)

Author

Sebastian, M, additional, Eberhardt, WEE, additional, Losem, C, additional, Bernhardt, C, additional, Maintz, C, additional, Marschner, N, additional, Jaenicke, M, additional, Fleitz, A, additional, Spring, L, additional, Sahlmann, J, additional, Karatas, A, additional, Hipper, A, additional, Weichert, W, additional, Hoffknecht, P, additional, Grah, C, additional, Rittmeyer, A, additional, Griesinger, F, additional, and Thomas, M, additional

Published
2020
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11. Impact of prophylactic systemic antibiotics (SA) on outcome of patients (pts) with RAS-wildtype (RAS-wt) metastatic colorectal carcinoma (mCRC) treated with cetuximab-based first-line therapy. Subgroup analysis of the german non-interventional study ERBITAG

Author

Sahm, S.W., primary, Zahn, M.-O., additional, Maintz, C., additional, Goehler, T., additional, Janssen, J., additional, Hering-Schubert, C., additional, Rubanov, O., additional, Zander, I., additional, Stenzel, K.G., additional, and Overkamp, F., additional

Published
2019
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12. Patients with metastatic non-small cell lung cancer and PD-L1 expression in Germany: Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)

Author

Sebastian, M., primary, Eberhardt, W.E.E., additional, Losem, C., additional, Bernhardt, C., additional, Maintz, C., additional, Marschner, N.W., additional, Jänicke, M., additional, Fleitz, A., additional, Spring, L., additional, Sahlmann, J., additional, Karatas, A., additional, Hipper, A., additional, Weichert, W., additional, Hoffknecht, P., additional, Grah, C., additional, Rittmeyer, A., additional, Griesinger, F., additional, and Thomas, M., additional

Published
2019
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13. Abstract P6-21-11: Final results from IMPROVE: A randomized, controlled, open-label, cross-over phase IV study to determine the patients' preference for either combined endocrine therapy (exemestane plus everolimus) or immunochemotherapy (capecitabine plus bevacizumab) as first line treatment for advanced HR+/HER2- breast cancer

Author

Kurbacher, CM, primary, Söling, U, additional, Hahn, A, additional, Chiabudini, M, additional, Maintz, C, additional, Rieger, L, additional, Falkenstein, J, additional, Runkel, E, additional, Potthoff, K, additional, and Decker, T, additional

Published
2019
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17. Clonal Evolution and Blast Crisis Correlate with Enhanced Proteolytic Activity of Separase in BCR-ABL b3a2 Fusion Type CML under Imatinib Therapy

Author

Haaß, Wiltrud, Kleiner, Helga, Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung, Morgner, A., Herbst, R., Matek, W., Lamberti, C., Zöller, T., Koch, B., Marth, T., Henzel, A., Wagner, S., Woska, E., German CML Study Group, Neumann, F., Hoffknecht, M. M., Illmer, T., Wolf, T., Ehninger, G., Kiani, A., Platzbecker, U., Aul, C., Badrakhan, C. D., Giagounidis, A., Wernli, M., Flaßhove, M., Henneke, F., Moritz, T., Simon, M., Müller, L. L., Janz, R., Eckart, M., Häcker, B., Rech, D., Mackensen, A., Bargetzi, M., Krause, S. W., Staib, P., Schlegel, F., Wätzig, K., Rudolph, R., Wattad, M., Baur, F. K., Heit, W., Beelen, D. W., Hüttmann, A., Fischer von Weikersthal, L., Novotny, J., Trenschel, R., Lindemann, A., Linck, D., Jäger, E., Al-Batran, Salah-Eddin, Ottmann, O. G., Serve, H., Reiber, T., Semsek, D., Gro, V., Waller, C., Kühnemund, A., Hoeffkes, H. G., Lambertz, H., Schulz, L., Tajrobehkar, K., Mittermüller, J., Rummel, M. J., Burchardt, A., Pralle, H., Müller, S., Runde, V., Klei, M., Westheider, J., Hoyer, A., Tessen, H. W., Hesse, A., Trümper, L., Binder, C., Schmidt, C. A., Hirt, C., Hahn, M., Sieber, M., Eschenburg, H., Wilhelm, S., Depenbusch, R., Rösel, S., Eimermacher, H., Spohn, C., Moeller, R., Schmitz, N., Nickelsen, M., Schlimok, G., Engel, E., Haatanen, T., Hollburg, W., Platz, D., Köster, H., Bokemeyer, C., Schafhausen, P., Grote-Metke, A., Bechtel, B., Hemeier, M., Reichert, D., Sosada, M., Ganser, A., Schlegelberger, B., Ho, A. D., Rohlfing, S., Dengler, J., Petersen, V., Porowski, P., Hahn, L., Dietzfelbinger, H., Weiß, Christel, Janssen, J., Gröschel, W., Bartholomäus, A., Pfreundschuh, M., Kemmerling, M., Hansen, R., Reeb, M., Link, H., Mahlmann, S., Mezger, J., Schatz, M., Furkert, J., Schmier, M., Gatter, J., Neumann, S., Heymanns, J., Steinmetz, H. T., Schmitz, S., Scheid, C., Planker, M., Frieling, T., Lollert, A., Mandel, T., Neise, M., Schröder, M., Greif, D., Kempf, B., März, W., Kremers, S., Müller, L., Hartmann, F., Heil, G., Goldmann, B., Majunke, P. J., Heinkele, P., Gregor, M., Theobald, M., Fischer, T., Thomas, S., Hensel, M., Plöger, C., Schuster, D., Brust, J., Hieber, U., Paliege, R., Hehlmann, R., Neubauer, A., Burchert, A., Graeven, U., Lange, C., Schmidt, G., Völkl, S., Schmidt, B., Hitz, H., Spiekermann, K., Reichert, P., Hiddemann, W., Haferlach, T., Haferlach, C., Schnittger, S., Stötzer, O., Scheidegger, C., Fischer, C., Berdel, W. E., Koppele, A., Hebart, H., Fuss, H., Snaga, A., Schmidt, P., Hoffmann, R., Reschke, D., Zirpel, I., Sauer, M., Lenk, G., Theilmann, L., Sandritter, B., Neben, K., Schenk, M., Dengler, R., Herr, W., Krause, S., Braun, B., Günther, E., Wacker, A., Pihusch, R., Baldus, M., Matzdorff, A., Staiger, H. J., Pollmeier, G., Grimminger, W., Geer, T., Schanz, S., Jür, C., Gassmann, W., Seitz, K., Kaesberger, J., Mück, R., Heim, D., Illerhaus, G., Denzlinger, C., Fiechtner, H., Springer, G., Hoffmann, D., Jacki, S. H., Kanz, L., Bross-Bach, U., Döhner, H., Stegelmann, F., Haferlach, Claudia, Gratwohl, A., Kalhori, N., Langer, W., Nusch, A., Wei, J., Kamp, T., Schadeck-Gressel, C., Schwerdtfeger, R., Josten, K. M., Klein, O., Fett, W., Tichelli, A., Strotkötter, H., Maintz, C., Groschek, M., Schlag, R., Elsel, W., Schüler, F., Dölken, G., Lindemann, H. W., Wolf, H. H., Schmoll, H. J., Korsten, S., Braumann, D., Hoelzer, P., Kleeberg, U., Hossfeld, D., Lange, E., Schubert, J., Weischer, H., Dürk, H. A., Kirchner, H. H., Bu, E C., Henesser, D., Sievers, B., Freier, W., Kaiser, U., Peest, D., Römer, E., Hermann, T., Fauser, A., Valverde, M. L., Menzel, J., Kemper, J., le Coutre, P., Hochhaus, A., La Rosée, P., Bentz, M., Prümmer, O., Kneba, M., Strack, U., Schoch, R., Severin, K., Stauch, M., Arnold, R., Karbach, U., Vehling-Kaiser, U., Köchling, G., Wei, U., Middeke, H., Neuhaus, T., Martin, H., Fetscher, S., Schmielau, J., Kämpfe, D., Ludwig, W. D., Uppenkamp, M., Wei, B., Thum, P., Wuillemin, W., Hofmann, W. K., Griesshammer, M., Tischler, H. J., Becker, M., Hanfstein, B., Müller, M., Ratei, R., Saußele, S., Lunscken, C., Kolb, H. J., Lutz, L., Hentrich, M., Nerl, C., Wendtner, C., Ladda, E., Gnad, M., Teutsch, C., Suna, H., Schmidt, E., Koschmieder, S., Falge, C., Wandt, H., Wilhelm, M., Köhne, C. H., Schweiger, C., Müller-Naendrup, C., Frühauf, S., Ludwig, F., Ranft, K., Dencausse, Y., Baake, G., Ritter, P. R., Kloke, O., Göttler, B., Schick, H. D., Schlegelberger, Brigitte, Urmersbach, A., Weidenhöfer, S., Weidinger, P., Wacker, D., Wehmeyer, J., Kreuser, E. D., Schlenska-Lange, A., Edinger, R., Andreesen, R., Wehmeier, A., Stahlhut, K., Blau, I., Käfer, G., Cerny, T., Hess, U., Priebe-Richter, C., Stange-Budumlu, O., Demandt, M., Freunek, G., Heidemann, E., Schleicher, J., Mergenthaler, H. G., Ihle, H., Boewer, C., Zeller, C., Laubenstein, H. P., Rendenbach, B., Clemens, M., Waladkhani, A. R., Forstbauer, H., Müller, F., Brettner, S., Raghavachar, A., Sperling, C., Kunzmann, V., Goebeler, M. E., Gmür, J., Schelenz, C., Koschuth, A., Kingreen, D., Heßling, J., Derwahl, K. M., Oldenkott, B., Müller, Martin C., Englisch, H. J., Thiel, E., Burmeister, T., Notter, M., de Wit, M., Rothaug, W., Büschel, G., Beyer, J., Dahmen, E., Hehlmann, Rüdiger, Biaggi, C., Lämmle, B., Friess, D., Baerlocher, G., Oppliger Leibundgut, E., Tobler, A., Just, M., Schäfer, E., Behringer, D., Brandt, M., Hofmann, Wolf-Karsten, Schmiegel, W., Vaupel, H. A., Verbeek, W., Ko, Y. D., Sauerbruch, T., Hahn-Ast, C., Janzen, V., Schmidt-Wolf, Ingo G. H., Trenn, G., Fabarius, Alice, van der Linde, M., Pommerien, W., Fritz, L., Krauter, J., Lordick, F., Fritsch, G., Pflüger, K. H., Diekmann, C., Kullmer, J., Doering, G., Seifarth, Wolfgang, Munzinger, H., Hertenstein, B., Peyn, A., Mayer, J., Zácková, D., Kujickova, J., Stier, S., Wejda, B., Möller-Faßbender, F., and Hänel, M.

Subjects
Adult, Aged, 80 and over, Chromosome Aberrations, Adolescent, Fusion Proteins, bcr-abl, Antineoplastic Agents, Chromosome Breakage, Middle Aged, Clonal Evolution, Young Adult, hemic and lymphatic diseases, Cell Line, Tumor, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Proteolysis, Imatinib Mesylate, Humans, Blast Crisis, Separase, Research Article, Aged
Abstract

PLoS ONE 10(6), e0129648 (2015). doi:10.1371/journal.pone.0129648, Published by PLoS, Lawrence, Kan.

Published
2015
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19. 119 UPDATE ON THE MULTICENTER MDS BIOREGISTRY PROJECT OF THE “KREBSHILFE-VERBUNDFORSCHUNGSPROJEKT MDS” OF THE GERMAN MDS STUDY GROUP

Author

Schemenau, I., primary, Strupp, C., additional, Wulfert, M., additional, Schroeder, T., additional, Xicoy, B., additional, Nusch, A., additional, Langer, W., additional, Kalhori, N., additional, Haase, D., additional, Brümmendorf, T., additional, Schütte, J., additional, Ganser, A., additional, Parmentier, S., additional, Schulte, K., additional, Plewe, D., additional, Losem, C., additional, Biekmann, E., additional, Hoffmann, W., additional, Hahn, L., additional, Neise, M., additional, Lollert, A., additional, Maintz, C., additional, Hinske, C., additional, Weißinger, F., additional, Heudobler, D., additional, Rodermann, E., additional, Culmann, H., additional, Kretschmar, T., additional, Steinmetz, T., additional, Giagounidis, A., additional, Meckenstock, G., additional, Runde, V., additional, Haas, R., additional, Germing, U., additional, Hofmann, W.K., additional, and Gattermann, N., additional

Published
2015
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22. Joint meeting of the Association of British Neurologists and the Norwegian Neurological Association on the coastal steamer Hurtigruten, 6-9 May 2001

Author

Bindoff, L, Hilton-Jones, D, Loseth, S, Torbergsen, T, Brautaset, N., Stalberg, E, Chinnery, P., Dearlove, A, Johnson, M., Walls, T., Gibson, G., Fawcett, P., Jamieson, S, Fulthorpe, J., Cullen, M, Hudgson, P, Bushby, K., Brathen, G, Sand, T, Michler, R, Brodtkorb, E, Helde, G, Bovim, G, Zeman, A, Stone, J, Porteous, M, Barron, L, Warner, J, Donaghy, M, Vedeler, C, Hallin, R., Bekkelund, S., Pierre-Jerome, C, Newsom-Davis, J, McConville, J, Kennett, R, Anslow, P, Hoch, W, Vincent, A, Orstavik, K, Schmidt, R, Jorum, E, Chmelz, S., Weidner, C, Hilliges, M, Torebjork, E, Nyland, H, Skeidsvold, H, Thorsen, E, Thrush, D, Miller, D., Russell, D, Bracewell, R., Wing, A., Nilsen, K., Kristiansen, T, Garseth, M, Stovner, L., Westgaard, R, Ford, H, Denton, S, Bo, L, Trapp, B., Mork, S, Midgard, R, Ebers, G, Kampmann, M, Parratt, J., Wilson, S, Donnan, P, O'riordan, J, Swingler, S, Harbo, H., Celius, E., Dai, K, Vartdal, F, Vandvik, B, Spurkland, A, Brex, P., Ciccarelli, O, O'Riordan, J., Sailer, M, Thompson, A., Warlow, C., Thomassen, L, Waje-Andreassen, U, Maintz, C, Al, S, Ronning, O., Lossius, M, Roste, L, Tauboll, E, Krogenas, A, Isojarvi, J, Gjerstad, L, Dietrichs, E, Stevens, D, Smith, D., Vlies, M, Bartolo, R, and Leach, J.

Subjects
Genetics, Psychiatry and Mental health, Inclusion body myopathy, Proceedings, Chromosome (genetic algorithm), business.industry, Medicine, Surgery, Neurology (clinical), business, Early respiratory failure
Published
2001

23. Bleeding, thrombosis, and anticoagulation in myeloproliferative neoplasms (MPN): analysis from the German SAL-MPN-registry.

Author

Kaifie, A., Kirschner, M., Wolf, D., Maintz, C., Hänel, M., Gattermann, N., Gökkurt, E., Platzbecker, U., Hollburg, W., Göthert, J. R., Parmentier, S., Lang, F., Hansen, R., Isfort, S., Schmitt, K., Jost, E., Serve, H., Ehninger, G., Berdel, W. E., and Brümmendorf, T. H.

Abstract

Background: Patients with Ph-negative myeloproliferative neoplasms (MPN), such as polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), are at increased risk for thrombosis/thromboembolism and major bleeding. Due to the morbidity and mortality of these events, antiplatelet and/or anticoagulant agents are commonly employed as primary and/or secondary prophylaxis. On the other hand, disease-related bleeding complications (i.e., from esophageal varices) are common in patients with MPN. This analysis was performed to define the frequency of such events, identify risk factors, and assess antiplatelet/anticoagulant therapy in a cohort of patients with MPN. Methods: The MPN registry of the Study Alliance Leukemia is a non-interventional prospective study including adult patients with an MPN according to WHO criteria (2008). For statistical analysis, descriptive methods and tests for significant differences as well as contingency tables were used to identify the odds of potential risk factors for vascular events. Results: MPN subgroups significantly differed in sex distribution, age at diagnosis, blood counts, LDH levels, JAK2V617F positivity, and spleen size (length). While most thromboembolic events occurred around the time of MPN diagnosis, one third of these events occurred after that date. Splanchnic vein thrombosis was most frequent in post-PV-MF and MPN-U patients. The chance of developing a thromboembolic event was significantly elevated if patients suffered from post-PV-MF (OR 3.43; 95 % CI = 1.39–8.48) and splenomegaly (OR 1.76; 95 % CI = 1.15–2.71). Significant odds for major bleeding were previous thromboembolic events (OR = 2.71; 95 % CI = 1.36–5.40), splenomegaly (OR = 2.22; 95 % CI 1.01–4.89), and the administration of heparin (OR = 5.64; 95 % CI = 1.84–17.34). Major bleeding episodes were significantly less frequent in ET patients compared to other MPN subgroups. Conclusions: Together, this report on an unselected “real-world” cohort of German MPN patients reveals important data on the prevalence, diagnosis, and treatment of thromboembolic and major bleeding complications of MPN. [ABSTRACT FROM AUTHOR]

Published
2016
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25. Oral idarubicin, dexamethasone and vincristine (VID) in the treatment of multiple myeloma.

Author

Glasmacher, A., Haferlach, T., Gorschlüter, M., Mezger, J., Maintz, C., Clemens, M. R., Ko, Y., Hahn, C., Übelacker, R., Kleinschmidt, R., and Gieseler, F.

Subjects
DRUG efficacy, DRUG toxicity, ANTHRACYCLINES, ANTINEOPLASTIC agents, VINCRISTINE, MULTIPLE myeloma treatment
Abstract

In order to replace the central venous line necessary for continuous infusion of vincristine and doxorubicin with high-dose dexamethasone (VAD) and to avoid hospitalization, we evaluated the efficacy and toxicity of oral idarubicin, vincristine and dexamethasone (VID) inpatients with multiple myeloma. Vincristine (1.6 mg/m², max 2 mg) was given as a bolus injection on day 1. Idarubicin was given in capsules 10 mg/m²/day for days 1-4 with an intraindividual dose escalation, 40 mg dexamethasone were given on days 1-4, 9-12, 17-20. Treatment cycles were repeated every 28 days. At this interim analysis, 53 patients have been entered into the ongoing trial; 46 patients are evaluable for toxicity. The median age was 60 years (interquartile range, 52-65). 46% were primary or secondary refractory, 20% had previously been treated with VAD and 30% had previously untreated disease, 4% had two or more relapses. Four patients died within 2 months from entry and were considered as early deaths (8.7%). 45% of the 42 patients evaluable for efficacy achieved a partial remission and 26% a minor remission. The median reduction of the M-component was 43% (interquartile range, 25-64%). VID is an effective and convenient alternative to VAD even in relapsed or refractory patients. [ABSTRACT FROM AUTHOR]

Published
1997

27. Oral idarubicin, dexamethasone and vincristine (VID) in the treatment of multiple myeloma

Author

Glasmacher A, Haferlach T, Gorschlüter M, Mezger J, Maintz C, Clemens MR, Ko Y, Hahn C, Ubelacker R, Kleinschmidt R, and Frank Gieseler

Subjects
Male, Administration, Oral, Middle Aged, Dexamethasone, Drug Administration Schedule, Immunoglobulin A, Immunoglobulin Isotypes, Survival Rate, Vincristine, Immunoglobulin G, Antineoplastic Combined Chemotherapy Protocols, Humans, Female, Immunoglobulin Light Chains, Idarubicin, Multiple Myeloma, Aged, Neoplasm Staging
Abstract

In order to replace the central venous line necessary for continuous infusion of vincristine and doxorubicin with high-dose dexamethasone (VAD) and to avoid hospitalization, we evaluated the efficacy and toxicity of oral idarubicin, vincristine and dexamethasone (VID) in patients with multiple myeloma. Vincristine (1.6 mg/m2, max 2 mg) was given as a bolus injection on day 1. Idarubicin was given in capsules 10 mg/m2/day for days 1-4 with an intraindividual dose escalation, 40 mg dexamethasone were given on days 1-4, 9-12, 17-20. Treatment cycles were repeated every 28 days. At this interim analysis, 53 patients have been entered into the ongoing trial; 46 patients are evaluable for toxicity. The median age was 60 years (interquartile range, 52-65). 46% were primary or secondary refractory, 20% had previously been treated with VAD and 30% had previously untreated disease, 4% had two or more relapses. Four patients died within 2 months from entry and were considered as early deaths (8.7%). 45% of the 42 patients evaluable for efficacy achieved a partial remission and 26% a minor remission. The median reduction of the M-component was 43% (interquartile range, 25-64%). VID is an effective and convenient alternative to VAD even in relapsed or refractory patients.

28. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Jose Chacon, Katja Ziegler-Löhr, Kamran Rashid, Stanley Madretsma, Hortense Laharie Mineur, Soo Hyeon Lee, Bohuslav Melichar, Jasna Pesic, Julia Hall, Jörg Schilling, Paola Morales Espinosa, Wendy Taylor, Francesco Cognetti, Doris Augustin, Ines Sandri, Laura Murillo Jaso, Alejandro Juarez Ramiro, Nora Artagaveytia, Rocio Reategui, Nataliia Voitko, Teresa Gamucci, Lisa H Barraclough, Jérôme Alexandre, Mohammed Butt, Frank Priou, A.J. van de Wouw, Cristina Marinela Oprean, Isabel Alonso, Suzana Vasovic, Fernando Roque, Marc Thill, Viktoria Dvornichenko, K. Bouzid, Idris Yucel, Andrea Stefek, Jose Manuel Lopez Vega, Daniil Stroyakovskiy, R. Chiara Forcignanò, Mohammed Harb, Andrzej Mruk, Jana Prausová, Lydia Dreosti, Prabir Chakraborti, Armando Santoro, Lee Wei Ching, Anna Tuczek, Jane Beith, Larisa Ciule, Hakan Bozcuk, Antonino Musolino, Hartmut Kristeleit, Clare Crowley, T.C. Kok, Dhurata Koroveshi, Natasha Mithal, Laura Garcia Sanchis, Stephan Henschen, Carmen Cañabate Arias, A. Contu, Antoaneta Tomova, Alper Sevinc, Helga Droogendijk, Gustavo Fernando Ismael, Konstantinos Papazisis, Laurent Gasnault, Sandra Bakker, Judit Kocsis, Bernd Christensen, Stephen Kelly, Rosana Jarcau, Christian Jackisch, George Fountzilas, Cyril Foa, Annebeth W. Haringhuizen, Silvia Neciosup, Juan Matos Santos, Finlander Rosales Osegueda, Robinson Rodriguez, Marcus Schmidt, Bart de Valk, Kathryn Wright, A.S. Dhadda, Elizabeth Sherwin, Sabino De Placido, Luigi Cavanna, Joelle Egreteau, Shazza Rehman, Giacomo Allegrini, Doerte Luedders, Poovandren Govender, Hugues Barletta, Iztok Takač, Yuraima Garcia, Michael Green, Geneviève Jolimoy, Marcela Urrego, Chanyoot Bandidwattanawong, Vito Lorusso, Annette van der Velden, Rene Muñoz, Djumhana Atmakusuma, Christos Papandreou, Craig Macmillan, Hassan Errihani, Iris Schrader, Isabelle Desmoulins, Jean-Marc Ferrero, Mohamed Idris, B. Ataseven, Andre Farrokh, Isabelle Moullet, Iain R. Macpherson, N. Al-Sakaff, Stephen Chia, Blanca Hernando Fernandez De Aranguiz, Lorena Lion, Alexandros Ardavanis, Ani Zlatareva-Petrova, Ernesto Pablo Korbenfeld, Hugo Castro, Mirta Garcia, Heike Passmann-Kegel, Lionel Uwer, Gary Richardson, Marion Paul, Georgia Demetriou, Andreas Köhler, V. Kovcin, Eliot Sims, Gerasimos Aravantinos, Adriana Dominguez, Daniel Rauch, Greta Beyer, Laurence J. C. van Warmerdam, Roberto Bordonaro, Raymond Ng, David Coeffic, Rostislav Vyzula, Bernard Leduc, Jozef Mardiak, Andrea Pigi, Ingo Runnebaum, Jose Angel Garcia Saenz, Areewan Somwangprasert, Cristina Llorca Ferrandiz, Coskun Hasan Senol, Martin Griesshammer, Friedrich Overkamp, Suzanne Nguyen, Maria Turdean, Udaiveer Panwar, Zsuzsanna Nagy, Francesco Giotta, Andreas Schneeweiss, Teresa Ramon y Cajal Asensio, Jae Hong Seo, Joohyuk Sohn, Jean-Philippe Jacquin, Daniela Grecea, Jasmina Nedovic, Arrate Plazaola Alcibar, Tadeusz Pienkowski, Jetske M. Meerum Terwogt, Elmar Stickeler, Hazem I. Assi, Vadim Shirinkin, Grzegorz Slomian, Etela Mišurová, Roberto Hegg, K. Friedrichs, Corinne Dagada, Jean-François Berdah, Fulden Yumuk, Alexandru Eniu, Amit Chakrabarti, Mathias Fehr, Christoph Salat, Dan Lungulescu, Heinrik Martin Strebel, Antonio Llombart Cussac, Rémy Largillier, Stefan Curescu, Albert von der Assen, Emmanuel Guardiola, Andras Csejtei, Tamas Hickish, Krzysztof Krzemieniecki, Yaroslav Shparyk, Ramon Perez Carrion, Michela Donadio, Purificacion Martinez del Prado, Sandra Franco, J.J. Braun, Michael Friedlander, Suhail Anwar, Thierry Petit, Sarah Smith, Rafael Gutierrez Pilarte, Laia Garrigos Cubells, Frans L. G. Erdkamp, Jedzada Maneechavakajorn, Mastura Yusof, Jocelyn Adams, Diana Cascallar, Luis Antonio Fernandez Morales, Max S. Mano, Simon Waters, Carlos Beato, Philippe Martin, Martin Hogg, Isabelle Sillet Bach, Monica Casalnuovo, Klara Mezei, Alexey Manikhas, Margarida Damasceno, Sergey Emelyanov, Gabriella Mariani, Kecman Gordana, Gianfilippo Bertelli, Ignacio Pelaez Fernandez, Damir Vrbanec, Maria Wagnerova, Johannes Petrus Jordaan, Marina Cazzaniga, Mustafa Deryal, Ruth Davis, Abdurrahman Isikdogan, Sanjay Raj, José Juan Illarramendi Mañas, Vinod Ganju, Maria Dolores Torregrosa Maicas, Glenda Ramos, Nugroho Prayogo, H. Orfeuvre, Filipovic S, Joke Tio, Andrew Redfern, M. Shing, Eduardo Yanez, Khalil Zaman, Jin-Seok Ahn, Dino Amadori, Bahriye Aktas, Miriam O'Connor, Uta Ringsdorf, Christophe Desauw, J. Gligorov, Jorge Corona, Michele De Laurentiis, Arthur Wischnik, Paolo Pedrazzoli, Katalin Boér, Caroline Archer, Anne Kendall, Ori Freedman, Maya Tsakova, Dana Lucia Stanculeanu, Kevin Patterson, Cathy Kelly, Nellie Lay Chin Cheah, X. Artignan, Anil A. Joy, Steffi Busch, Monica Nave, Bryan Hennessy, Lorenzo Livi, X. Pivot, R.J.B. Blaisse, Adolfo Murias Rosales, Juan Carlos Alcedo, Dalila Marcano, Emmanuel Beguier, Andreas Müller, László Csaba Mangel, Christina Schlatter, Fernando Gaion, Tjoung-Won Park-Simon, Sebastian Wojcinski, Ute Bückner, Florinel Badulescu, Cynthia Mayte Villarreal Garza, Rozenn Allerton, Mikhail Lichinitser, Damir Gugić, Manuela Rabaglio, Jens Kisro, Iris Scheffen, Vincent Phua, Marc A. Bollet, Giampaolo Biti, M. Verrill, Adrien Melis, Andrew M Wardley, Ali Arican, Hamdy A. Azim, Lelia-Eveline Bauer, Tsai-Wang Chang, Nik Hauser, René Lazaro González Mendoza, Dominique Jaubert, Samreen Ahmed, Mazhar Shah, János Szántó, Kunibert Latos, Xavier Pivot, Helen Gogas, Elona Juozaityte, Luca Moscetti, Helene Simon, Giacomo Carterni, Dan-Corneliu Jinga, Olivia Pagani, Elena Rota Caremoli, Esther Arbona, Cornelia Liedtke, Stylianos Kakolyris, Abdulla Alhasso, Omalkhair Abulkhair, Jose Ponce Lorenzo, Julian Singer, Tony Branson, Claudia Hänle, Ingvild Mjaaland, Chiun-Sheng Huang, Heri Fadjari, Jonathan Joffe, Laetitia Stefani, Dieter Lampe, Franck Burki, S. Lauer, Sabine Schmatloch, Gracieux Fernando, Dina Sakaeva, Christina Balser, Michael Martin, Nora Bittner, Andrea Heider, Antonio Frassoldati, Serafin Morales Murillo, Hakan Akbulut, Saad Tahir, Tilmann Lantzsch, Christine Brezden-Masley, Vanessa Helena, Tran Van Thuan, F.E. de Jongh, Roger K.C. Ngan, Elke Faust, Hugues Bourgeois, Flora Li Tze Chong, Nehal Masood, Keun Seok Lee, J. Bishop, Mathias Warm, Dimitris Mavroudis, Petrosian Veersamy, Judith Fraser, Andres Garcia-Palomo Perez, Heiko Graf, Vanesa Quiroga Garcia, Jyh-Cherng Yu, Maria Jose Villanueva Silva, Elke Simon, Diana Aleman, Kazim Uygun, Cosima Brucker, Michael Weigel, Volkmar Müller, Djohan Kurnianda, Duncan Wheatley, Amr Abdel Aziz, Benno Lex, Laura G. Estévez, Darren Teoh, María Isabel León, Noemia Afonso, Frances Yuille, Amelia Tienghi, Gernot Seipelt, Jose Alberto Nogueira, Dumitru Filip, Zafar Malik, Fatima Cardoso, Giorgio Cruciani, Winnie Yeo, Luis Vera, Santiago Gonzalez Santiago, Richard North, M.W. Dercksen, Zsolt Horváth, Noelia Martinez Jañez, Marta Mion, Marcela Ferrari, Natalia Valdiviezo, Oana Zveltlana Cojocarasu, Alessandra Morelle, Medy Tsalic, Sonia Pernas Simon, Christoph Maintz, Daniele Farci, Alvaro Edson Lessa, Jeremy Monge, Joseph Gligorov, Anthony Neal, Norberto Batista Lopez, Piotr Tomczak, Yesim Eralp, Kasan Seetalarom, Thitiya (Sirisinha) Dejthevaporn, Jamal Zekri, Steven John Proctor, Saira Nasim, Muireann Kelleher, Eftal Yucel, Quirine Clementine van Rossum-Schornagel, Linda Coate, Paolo Marchetti, Theresa Howe, Carlos Alberto Hernandez, Roberto Torres, Konstanta Timcheva, Evaristo Maiello, Anita Prechtl, Jamil Asselah, Branislav Bystricky, Kate Scatchard, Zeba Aziz, Jaroslava Leskova, Sherko Kuemmel, Paolo Bidoli, Richard Ashford, Piotr Sawrycki, Claude Bressac, Alberto Bottini, Pilar Lopez Alvarez, Nadine Dohollou, Alejandro Andres Acevedo Gaete, M. De Laurentiis, T.J. Smilde, Andrew Proctor, Catherine Prady, Michele Aieta, Jan Henry Svensson, Reda Garidi, Erik Wist, Antonia Perello Martorell, Mohammed Jaloudi, Graeme Lumsden, Eva-Maria Grischke, Ali Youssef, Annemieke van der Padt, Kadri Altundag, Christina Bechtner, Mireille Mousseau, Heba El Zawahry, Maartje Los, Alvydas Česas, Alfredo Falcone, Salima Hamizi, Franchette W P J van den Berkmortel, Cesar Estuardo Hernandez-Monroy, K.H. Jung, Swati Kulkarni, R.K. Agrawal, Hwei Chung Wang, Hany Eldeeb, Fredrika Killander, Jose Luis Alonso Romero, Antonio Pazzola, Daan ten Bokkel Huinink, Mario Campone, Beena C.R. Devi, Florence Dalenc, Pedro Jimenez Gallego, Mawin Vongsaisuwon, Timur Ceric, Chantal Bernard Marty, R. A. Popescu, J. van den Bosch, Luis Matamala, Sylvia Ruth, Maria Litwiniuk, Maria Lomas Garrido, Mark Churn, Christian Kersten, Francesco Del Piano, Eddie Herman Tanggo, Antonio Fernandez Aramburo, Kyung Hae Jung, Christos Papadimitriou, Hamdy Abdel Azeem, Patricia Bastick, Tobias Hesse, Maree Colosimo, Lucia Gonzalez Cortijo, Mark Verrill, Gligorov, J, Ataseven, B, Verrill, M, De Laurentiis, M, Jung, K. H, Azim, H. A, Al-sakaff, N, Lauer, S, Shing, M, Pivot, X., de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, and Van Thuan, T

Subjects
0301 basic medicine, Oncology, Cancer Research, Receptor, ErbB-2, medicine.medical_treatment, Medizin, Antineoplastic Agent, 0302 clinical medicine, Breast cancer, Trastuzumab, Adjuvant, Aged, 80 and over, education.field_of_study, Middle Aged, HER2/neu, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Herceptin, Subcutaneous, subcutaneous, Female, Survival Analysi, Breast Neoplasm, medicine.drug, Human, Adult, medicine.medical_specialty, Injections, Subcutaneous, Population, Socio-culturale, Antineoplastic Agents, Breast Neoplasms, Injections, Subcutaneou, 03 medical and health sciences, Young Adult, Internal medicine, medicine, Adjuvant therapy, Humans, Subcutaneou, education, Adverse effect, Aged, Chemotherapy, Adjuvant, breast cancer, HER2/neu, herceptin, trastuzumab, business.industry, medicine.disease, Survival Analysis, Surgery, Discontinuation, 030104 developmental biology, business
Abstract

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin ® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Published
2017

29. Kidney Dysfunction Is Associated with Thrombosis and Disease Severity in Myeloproliferative Neoplasms: Implications from the German Study Group for MPN Bioregistry.

Author

Gecht J, Tsoukakis I, Kricheldorf K, Stegelmann F, Klausmann M, Griesshammer M, Schulz H, Hollburg W, Göthert JR, Sockel K, Heidel FH, Gattermann N, Maintz C, Al-Ali HK, Platzbecker U, Hansen R, Hänel M, Parmentier S, Bommer M, Pahl HL, Lang F, Kirschner M, Isfort S, Brümmendorf TH, Döhner K, and Koschmieder S

Abstract

Inflammation-induced thrombosis represents a severe complication in patients with myeloproliferative neoplasms (MPN) and in those with kidney dysfunction. Overlapping disease-specific attributes suggest common mechanisms involved in MPN pathogenesis, kidney dysfunction, and thrombosis. Data from 1420 patients with essential thrombocythemia (ET, 33.7%), polycythemia vera (PV, 38.5%), and myelofibrosis (MF, 27.9%) were extracted from the bioregistry of the German Study Group for MPN. The total cohort was subdivided according to the calculated estimated glomerular filtration rate (eGFR, (mL/min/1.73 m 2 )) into eGFR1 (≥90, 21%), eGFR2 (60-89, 56%), and eGFR3 (<60, 22%). A total of 29% of the patients had a history of thrombosis. A higher rate of thrombosis and longer MPN duration was observed in eGFR3 than in eGFR2 and eGFR1. Kidney dysfunction occurred earlier in ET than in PV or MF. Multiple logistic regression analysis identified arterial hypertension, MPN treatment, increased uric acid, and lactate dehydrogenase levels as risk factors for kidney dysfunction in MPN patients. Risk factors for thrombosis included arterial hypertension, non-excessive platelet counts, and antithrombotic therapy. The risk factors for kidney dysfunction and thrombosis varied between MPN subtypes. Physicians should be aware of the increased risk for kidney disease in MPN patients, which warrants closer monitoring and, possibly, early thromboprophylaxis.

Published
2021
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30. Rare lymphomas in routine practice - Treatment and outcome in marginal zone lymphoma in the prospective German Tumour Registry Lymphatic Neoplasms.

Author

Knauf W, Abenhardt W, Koenigsmann M, Maintz C, Sandner R, Zahn MO, Schnell R, Tech S, Kaiser-Osterhues A, Houet L, and Marschner N

Subjects
Aged, Bendamustine Hydrochloride administration & dosage, Disease-Free Survival, Female, Germany epidemiology, Humans, Male, Middle Aged, Prospective Studies, Rituximab administration & dosage, Survival Rate, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Lymphoma, B-Cell, Marginal Zone drug therapy, Lymphoma, B-Cell, Marginal Zone mortality, Registries
Abstract

Owing to its heterogeneity and rarity, management of disseminated marginal zone B-cell lymphoma (MZL) remains largely understudied. We present prospective data on choice of systemic treatment and survival of patients with MZL treated in German routine practice. Of 175 patients with MZL who had been documented in the prospective clinical cohort study Tumour Registry Lymphatic Neoplasms (NCT00889798) collecting data on systemic treatment, 58 were classified as extranodal MZL of mucosa-associated lymphoid tissue (MALT) and 117 as non-MALT MZL. We analyzed the most commonly used first-line and second-line chemo(immuno)therapies between 2009 and 2016 and examined objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and prognostic factors for survival. Compared to patients with MALT MZL, those with non-MALT MZL more often presented with bone marrow involvement (43% vs. 14%), Ann Arbor stage III/IV (72% vs. 57%) and were slightly less often in good general condition (ECOG = 0; 41% vs. 47%). In German routine practice, rituximab-bendamustine for a median of 6 cycles was the most frequently used first-line (76%) and second-line treatment (36%), with no major differences between MZL subtypes. The ORR for patients encompassing any positive response was 81%. For patients with MALT and non-MALT MZL, respectively, 5-years PFS was 69% (95% CI 52%-81%) and 66% (95% CI 56%-75%), 5-years OS 79% (95% CI 65%-89%) and 75% (95% CI 66%-83%). Cox proportional hazards models showed a significantly increased risk of mortality for higher age in all patient groups. Our prospective real world data give valuable insights into the management and outcome of non-selected patients with MZL requiring systemic treatment and can help optimize therapy recommendations., (© 2021 The Authors. Hematological Oncology published by John Wiley & Sons Ltd.)

Published
2021
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31. Corrigendum to "Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP registry (AIO-TRK-0315)" [Lung Cancer 152 (2021) 174-184].

Author

Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Büttner R, Marschner N, Jänicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, and Thomas M

Published
2021
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32. Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and Austria.

Author

Rinke A, Maintz C, Müller L, Weber MM, Lahner H, Pavel M, Saeger W, Houchard A, Ungewiss H, and Petersenn S

Subjects
Aged, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Austria, Female, Germany, Humans, Male, Middle Aged, Peptides, Cyclic administration & dosage, Peptides, Cyclic adverse effects, Quality of Life, Somatostatin administration & dosage, Somatostatin adverse effects, Somatostatin pharmacology, Antineoplastic Agents pharmacology, Malignant Carcinoid Syndrome drug therapy, Neuroendocrine Tumors drug therapy, Outcome Assessment, Health Care, Peptides, Cyclic pharmacology, Somatostatin analogs & derivatives
Abstract

Background: The long-acting somatostatin analog lanreotide autogel is effective in the treatment of patients with neuroendocrine tumors., Objective: To evaluate the long-term treatment response in patients with neuroendocrine tumors receiving lanreotide autogel in routine clinical practice., Methods: Non-interventional, 24-month study in patients with neuroendocrine tumors treated with lanreotide autogel (NCT01840449)., Results: Patients (n=80) from 26 centers in Germany and Austria were enrolled. Neuroendocrine tumors were mainly grade 1/2, metastasized, intestinal, and associated with carcinoid syndrome; 88.9% had received previous neuroendocrine tumor treatment. Of those, 84.4% had previous surgery, 18.7% had received octreotide. The primary endpoint, defined by a <50% chromogranin A increase at month 12 compared with the lowest value between baseline and month 3 was achieved by 89.5% patients. Stable disease according to Response Evaluation Criteria in Solid Tumors 1.1 was observed in 76.9 and 75.0% patients at months 12 and 24 of lanreotide treatment, respectively. Mean change of chromogranin A levels from baseline to month 24 was -0.12 × upper limit of normal (95% CI, -0.22; -0.45). In a post hoc analysis, 38.5% of the subgroup of patients with carcinoid syndrome had daily diarrhea at baseline vs. 21.4% at month 24. At baseline, 27.8% of patients received lanreotide 120 mg every 4 weeks vs. 56.7% at month 24. Quality of life data were heterogeneous. No new safety issues arose and/or required further investigation., Conclusions: Our study reflects routine lanreotide autogel use in patients with advanced/metastatic neuroendocrine tumors. This analysis shows effectiveness with stabilization of disease-related symptoms and good tolerability of lanreotide autogel in clinical practice., Competing Interests: A.R. has received honoraria for presentations by AAA, Falk, IPSEN and Novartis. She also received honoraria for attendance at advisory board meetings (Ipsen, Novartis) and travel/congress reimbursements (Ipsen, Novartis). H.L. has received honoraria for presentations by Pfizer, Ipsen and Novartis. He also received honoraria for attendance at advisory board meetings (Pfizer, Ipsen, Novartis) and travel/congress reimbursements (Pfizer, Ipsen, Novartis). C.M. has no COI. S.P. has served as an advisory board member for Ipsen, Crinetics, Takeda, and Novartis, and has received honoraria for speaking at symposia for Ipsen, Novartis, Takeda, and Pfizer. A.H., H.U. are Ipsen employee. L.M. has served as an advisory board member for Ipsen. M.P. received honoraria for presentations by IPSEN, AAA, Novartis, Falk, and Boehringer-Ingelheim, and for advisory role from AAA, IPSEN, Riemser, Lilly, Amgen. W.S. has no COI. M.M.W. has received honoraria as a speaker and consultant from Ipsen and Novartis., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Published
2021
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33. Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315).

Author

Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Büttner R, Marschner N, Jänicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, and Thomas M

Subjects
Biomarkers, Tumor, Germany epidemiology, Humans, Mutation, Prospective Studies, Registries, Carcinoma, Non-Small-Cell Lung diagnosis, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms diagnosis, Lung Neoplasms epidemiology, Lung Neoplasms genetics
Abstract

Objectives: An increasing number of treatment-determining biomarkers has been identified in non-small cell lung cancer (NSCLC) and molecular testing is recommended to enable optimal individualized treatment. However, data on implementation of these recommendations in the "real-world" setting are scarce. This study presents comprehensive details on the frequency, methodology and results of biomarker testing of advanced NSCLC in Germany., Patients and Methods: This analysis included 3,717 patients with advanced NSCLC (2,921 non-squamous; 796 squamous), recruited into the CRISP registry at start of systemic therapy by 150 German sites between December 2015 and June 2019. Evaluated were the molecular biomarkers EGFR, ALK, ROS1, BRAF, KRAS, MET, TP53, RET, HER2, as well as expression of PD-L1., Results: In total, 90.5 % of the patients were tested for biomarkers. Testing rates were 92.2 % (non-squamous), 70.7 % (squamous) and increased from 83.2 % in 2015/16 to 94.2% in 2019. Overall testing rates for EGFR, ALK, ROS1, and BRAF were 72.5 %, 74.5 %, 66.1 %, and 53.0 %, respectively (non-squamous). Testing rates for PD-L1 expression were 64.5 % (non-squamous), and 58.5 % (squamous). The most common testing methods were immunohistochemistry (68.5 % non-squamous, 58.3 % squamous), and next-generation sequencing (38.7 % non-squamous, 14.4 % squamous). Reasons for not testing were insufficient tumor material or lack of guideline recommendations (squamous). No alteration was found in 37.8 % (non-squamous), and 57.9 % (squamous), respectively. Most common alterations in non-squamous tumors (all patients/all patients tested for the respective biomarker): KRAS (17.3 %/39.2 %), TP53 (14.1 %/51.4 %), and EGFR (11.0 %/15.1 %); in squamous tumors: TP53 (7.0 %/69.1 %), MET (1.5 %/11.1 %), and EGFR (1.1 %/4.4 %). Median PFS (non-squamous) was 8.7 months (95 % CI 7.4-10.4) with druggable EGFR mutation, and 8.0 months (95 % CI 3.9-9.2) with druggable ALK alterations., Conclusion: Testing rates in Germany are high nationwide and acceptable in international comparison, but still leave out a significant portion of patients, who could potentially benefit. Thus, specific measures are needed to increase implementation., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2021
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34. Clinical Practice Observation of Trastuzumab in Patients with Human Epidermal Growth Receptor 2-Positive Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction.

Author

Al-Batran SE, Moorahrend E, Maintz C, Goetze TO, Hempel D, Thuss-Patience P, Gaillard VE, and Hegewisch-Becker S

Subjects
Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Combined Chemotherapy Protocols, Esophagogastric Junction, Germany, Humans, Receptor, ErbB-2 genetics, Receptor, ErbB-2 therapeutic use, Trastuzumab therapeutic use, Adenocarcinoma drug therapy, Stomach Neoplasms drug therapy
Abstract

Background: The observational study HerMES collected primary data on effectiveness and safety of trastuzumab in patients with human epidermal growth receptor 2 (HER2)-positive cancer of the stomach or gastroesophageal junction (GEJ) in routine clinical practice, exploring the treatment with trastuzumab, chemotherapy backbones used, and the HER2 testing in a real-world setting in Germany., Subjects, Materials, and Methods: This noninterventional study observed patients with histologically confirmed, HER2-positive metastatic adenocarcinoma of the stomach or GEJ, who were treated with trastuzumab according to the physicians' judgement and clinical practice. The observation phase per patient took as long as the duration of the trastuzumab therapy, but for a maximum of 12 months. A subsequent extended follow-up phase lasted until the patient's death or the end of the study, that is, 2 years from start of the follow-up phase of the last patient. All data were analyzed descriptively., Results: Between February 2010 and July 2016, 364 patients were observed at 171 sites throughout Germany. The median overall survival was 14.1 months and the median progression-free survival was 7.9 months. The overall response rate was 43%. Safety was in line with previous reports. This study observed a high diversity of chemotherapy regimens that were combined with trastuzumab. Post hoc subgroup analyses showed differences in outcomes according to the chemotherapy regimen used., Conclusion: Trastuzumab treatment in everyday practice as observed in HerMES confirmed the positive results of the pivotal study ToGA in an observational, real-world setting., Implications for Practice: Real-world data of trastuzumab treatment of patients with gastroesophageal or gastric metastatic adenocarcinoma confirmed the positive results of the pivotal clinical trial. The observed median overall survival was 14.1 months and the median progression-free survival was 7.9 months. Although recommendations concerning administration of trastuzumab were well implemented, a high diversity of chemotherapy regimens were combined with trastuzumab. Regimens other than the in-label regimens, especially oxaliplatin-based doublets or 5-fluorouracil, leucovorin, oxaliplatin, taxane triplets, were used in 29% of patients. Observation of a second, marginal HER2-positivity population confirmed the benefit of trastuzumab predominantly for well-confirmed human epidermal growth receptor 2 (HER2)-positive tumors and the requirement of reliable HER2 testing., (© 2020 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press.)

Published
2020
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35. Final results from IMPROVE: a randomized, controlled, open-label, two-arm, cross-over phase IV study to determine patients' preference for everolimus in combination with exemestane or capecitabine in combination with bevacizumab in advanced HR-positive, HER2-negative breast cancer.

Author

Decker T, Söling U, Hahn A, Maintz C, Kurbacher CM, Vehling-Kaiser U, Sent D, Klare P, Hagen V, Chiabudini M, Falkenstein J, Indorf M, Runkel E, and Potthoff K

Subjects
Aged, Aged, 80 and over, Androstadienes administration & dosage, Bevacizumab administration & dosage, Breast Neoplasms mortality, Breast Neoplasms pathology, Capecitabine administration & dosage, Cross-Over Studies, Everolimus administration & dosage, Female, Humans, Middle Aged, Prognosis, Survival Rate, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Estrogen Receptor alpha metabolism, Patient Preference statistics & numerical data, Quality of Life, Receptor, ErbB-2 metabolism, Receptors, Progesterone metabolism
Abstract

Background: The objective of the IMPROVE study was patients' preference for either endocrine-based therapy or combined chemo- and anti-angiogenic therapy in advanced HR-positive/HER2-negative breast cancer., Methods: In this randomized, cross-over phase IV study, 77 patients were recruited in 26 sites in Germany. Patients were randomized 1:1 to receive either capecitabine plus bevacizumab (Cap+Bev) as first-line therapy followed by cross-over to everolimus plus exemestane (Eve+Exe) as second-line therapy (Arm A) or the reverse sequence (Arm B). The primary endpoint was patients' preference for either regimen, assessed by the Patient Preference Questionnaire 12 weeks after cross-over. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life (QoL)., Results: 61.5% of patients preferred Cap+Bev (p = 0.1653), whereas 15.4% preferred Eve+Exe and 23.1% were indecisive. Physicians showed a similar tendency towards Cap+Bev (58.1%) as the preferred regimen versus Eve+Exe (32.3%). Median first-line PFS was longer for Cap+Bev than for Eve+Exe (11.1 months versus 3.5 months). Median second-line PFS was similar between Cap+Bev and Eve+Exe (3.6 months versus 3.7 months). Median OS was comparable between Arm A (28.8 months) and Arm B (24.7 months). 73.0% and 52.6% (first-/second-line, Cap+Bev) and 54.1% and 52.9% (first-/second-line, Eve+Exe) of patients experienced grade 3/4 TEAEs. No treatment-related deaths occurred. QoL and treatment satisfaction were not significantly different between arms or treatment lines., Conclusions: Patients tended to favor Cap+Bev over Eve+Exe, which was in line with physicians' preference. Cap+Bev showed superior first-line PFS, while QoL was similar in both arms. No new safety signals were reported., Trial Registration: EudraCT No: 2013-005329-22. Registered on 19 August 20.

Published
2020
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36. Efficacy and safety of irinotecan-based chemotherapy for advanced colorectal cancer outside clinical trials: an observational study.

Author

Moehler M, Ababneh Y, Verpoort K, Schmidt B, Musch R, Soeling U, Maintz C, Siebler J, Schimanski CC, Galle PR, and Fahlke J

Subjects
Adenocarcinoma mortality, Adenocarcinoma pathology, Adenocarcinoma surgery, Adult, Age Factors, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols toxicity, Camptothecin administration & dosage, Camptothecin toxicity, Chemotherapy, Adjuvant, Clinical Trials as Topic, Colorectal Neoplasms mortality, Colorectal Neoplasms pathology, Colorectal Neoplasms surgery, Combined Modality Therapy, Disease Progression, Drug Administration Schedule, Drug-Related Side Effects and Adverse Reactions, Female, Fluorouracil administration & dosage, Fluorouracil toxicity, Humans, Irinotecan, Leucovorin administration & dosage, Leucovorin toxicity, Male, Middle Aged, Neoplasm Staging, Organoplatinum Compounds administration & dosage, Organoplatinum Compounds toxicity, Prospective Studies, Survival Rate, Treatment Outcome, Tumor Burden, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Camptothecin analogs & derivatives, Colorectal Neoplasms drug therapy
Abstract

Background: This prospective observational study in typical community-based outpatient clinics evaluated the efficacy and toxicity of weekly and biweekly irinotecan-based chemotherapies and their compatibility depending on age., Methods: 601 patients with advanced or metastatic colorectal cancer receiving first-, second-, or third-line irinotecan-based therapy were regularly analyzed for response and toxicity until the end of therapy., Results: The median age was 65 (28-87) years, approximately one-third of the patients were ≥70 years old. Of all patients, 405 were treated weekly and 68 biweekly. Median overall survival (OS) for first-line therapy was 26.5 months for the <70-year-old patients and 19.4 months for the ≥70-year-old patients. Toxicities were moderate in all groups. Tumor growth control rates (TCR) and median time to progression (TTP) were marginally better for patients <70 years old. Median TTP was 9.9 months in first-line therapy, 9.8 months after adjuvant therapy, 7.7 months in second-line, and 6.4 months in third-line therapy., Conclusions: Toxicity and response data from this observational study clearly confirm the positive results from previous clinical studies and show a slight ad-vantage in efficacy for the <70-year-old patients., (Copyright © 2010 S. Karger AG, Basel.)

Published
2010
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37. [Gastrointestinal stromal tumors: a broad clinical spectrum from incidental -discovery to acute gastrointestinal bleeding].

Author

Siewert E, Tietze L, Maintz C, Geier A, Dietrich CG, Matern S, and Gartung C

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents therapeutic use, Benzamides, Biomarkers, Tumor analysis, Chemotherapy, Adjuvant, Combined Modality Therapy, Diagnosis, Differential, Dose-Response Relationship, Drug, Drug Resistance, Neoplasm, Esophageal Neoplasms drug therapy, Esophageal Neoplasms pathology, Esophageal Neoplasms surgery, Esophagectomy, Female, Gastrectomy, Gastric Mucosa pathology, Gastrointestinal Hemorrhage pathology, Gastrointestinal Hemorrhage surgery, Gastroscopy, Humans, Imatinib Mesylate, Incidental Findings, Male, Neoplasm Recurrence, Local diagnosis, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local pathology, Neoplasm Recurrence, Local surgery, Neoplasms, Connective Tissue drug therapy, Neoplasms, Connective Tissue pathology, Neoplasms, Connective Tissue surgery, Piperazines therapeutic use, Polyps diagnosis, Polyps drug therapy, Polyps pathology, Polyps surgery, Prognosis, Proto-Oncogene Proteins c-kit analysis, Pyrimidines therapeutic use, Receptor Protein-Tyrosine Kinases antagonists & inhibitors, Shock, Hemorrhagic etiology, Stomach Neoplasms drug therapy, Stomach Neoplasms pathology, Stomach Neoplasms surgery, Stromal Cells pathology, Tomography, X-Ray Computed, Treatment Outcome, Abdominal Pain etiology, Cardia pathology, Cardia surgery, Esophageal Neoplasms diagnosis, Gastrointestinal Hemorrhage etiology, Neoplasms, Connective Tissue diagnosis, Stomach Neoplasms diagnosis
Abstract

Three cases of gastrointestinal stromal tumors (GIST) are reported as typical examples of the broad clinical spectrum in which these rare tumors can be detected. The first case describes an 82-year-old patient with a hemorrhagic shock due to upper gastrointestinal bleeding from a GIST of the stomach. GIST most frequently present with either gastrointestinal bleeding, abdominal pain or a detectable mass on physical examination or by ultrasound imaging. Clinically asymptomatic tumor growth also occurs as demonstrated by the second case of a 44-year-old -woman with an incidental finding of GIST during surgery of the esophagus. The cases are used to discuss the consequences for therapy and prognosis resulting from the heterogeneity of this tumor entity; the relevant immunohistochemical markers used to distinguish between various tumor subtypes of gastrointestinal mesenchymal tumors (GIMT) are listed. Since gastrointestinal stromal tumors (GIST) represent the most common subgroup of GIMT, we focus on the clinicopathological prognostic factors of GIST. The third case of a 40-year-old patient with a malignant GIST recurrence after surgery and exhibiting secondary resistance after one year of successful therapy with the receptor tyrosine kinase inhibitor imatinib (Gleevec), antagonizing pathogenetically relevant constitutive c-KIT activation, illustrates the potential and limitations of the only effective drug treatment for advanced GIST.

Published
2004
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38. Thrombolytic therapy in acute ischaemic stroke.

Author

Thomassen L, Waje-Andreassen U, Morsund AH, Hordnes J, Maintz C, Smievoll AI, and Russell D

Subjects
Aged, Cerebral Angiography, Cerebral Hemorrhage etiology, Cerebral Hemorrhage mortality, Decision Making, Female, Follow-Up Studies, Humans, Infarction, Middle Cerebral Artery diagnostic imaging, Infarction, Middle Cerebral Artery mortality, Infusions, Intravenous, Male, Middle Aged, Norway, Severity of Illness Index, Survival Analysis, Time Factors, Tissue Plasminogen Activator therapeutic use, Tomography, X-Ray Computed, Treatment Outcome, Fibrinolytic Agents therapeutic use, Infarction, Middle Cerebral Artery drug therapy
Abstract

Background: The aim of this study was to assess the feasibility, clinical effect and safety of intravenous thrombolysis with tissue plasminogen activator in patients with acute ischaemic stroke treated in an acute stroke unit., Methods: All patients admitted within 3 h after an acute ischaemic stroke were considered for thrombolysis. Twenty-four patients were treated., Results: Ten patients demonstrated early clinical improvement compatible with a positive effect of thrombolysis. Five patients demonstrated a substantial but slow clinical improvement with an uncertain relationship to thrombolysis. Nine patients did not improve. One patient developed an intracerebral haematoma and 2 developed a haemorrhagic infarction without clinical deterioration. Five patients (21%) died within the first 3 months. At follow-up after 6 months, 10 patients (42%) had achieved independence [modified Rankin Scale (mRS) 0-2], 9 (33%) had an unfavourable outcome (mRS 3-5) and 5 patients (21%) had died. None of these 5 patients died due to a treatment complication., Conclusions: This study in a small patient population suggests that thrombolysis may be administered relatively safely in an acute stroke unit without intensive care facilities. The clinical effect and safety were similar to those which have been found in large randomised studies and clinical series., (Copyright 2002 S. Karger AG, Basel)

Published
2002
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39. [Thrombolytic therapy in acute cerebral infarction--a time study when organizing a new therapeutic option].

Author

Thomassen L, Waje-Andreassen U, and Maintz C

Subjects
Acute Disease, Adult, Aged, Efficiency, Organizational, Humans, Middle Aged, Patient Admission, Prospective Studies, Referral and Consultation, Registries, Time Factors, Cerebral Infarction drug therapy, Cerebrovascular Disorders drug therapy, Emergency Medical Services organization & administration, Thrombolytic Therapy methods
Abstract

Cerebral thrombolysis is a therapeutic option for patients with acute cerebral infarction, but its use can be limited by delayed hospital admission. The aim of this study was to examine this delay, to improve admission routines and thus increase the number of potential candidates for treatment. In the first part of the study, time from first symptoms until hospital admission (time from first symptoms to contact with the primary health care system, and from contact to admission) was registered for 100 patients with acute stroke. Time spent to cerebral CT scan, and within the hospital was also registered. Measures to shorten admission time were then instituted, including information to the public and to primary health care professionals. An identical study was then performed on another 124 patients. Referral procedures were significantly improved, whereas time taken for patients to contact the primary health care system remained unchanged. Direct contact by emergency telephone secured the fastest admissions. The number of patients admitted within two hours after stroke onset increased from 17% to 26%. Four patients (3%) were treated with thrombolysis. Our study indicates that improved admission routines reduce admission delay. More public information is necessary to change patient behaviour.

Published
1999

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