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2. Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis

Author

Pressiani, T., Boni, C., Rimassa, L., Labianca, R., Fagiuoli, S., Salvagni, S., Ferrari, D., Cortesi, E., Porta, C., Mucciarini, C., Latini, L., Carnaghi, C., Banzi, M., Fanello, S., De Giorgio, M., Lutman, F.R., Torzilli, G., Tommasini, M.A., Ceriani, R., Covini, G., Tronconi, M.C., Giordano, L., Locopo, N., Naimo, S., and Santoro, A.

Published
2013
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5. 7O Updated results from phase I study of CC-90011 in patients (pts) with solid tumours (STs), including neuroendocrine neoplasms (NENs), and relapsed/refractory non-Hodgkin lymphoma (R/R NHL)

Author

Hollebecque, A., primary, de Bono, J.S., additional, Salvagni, S., additional, Plummer, R., additional, Niccoli, P., additional, Capdevila, J., additional, Curigliano, G., additional, Moreno, V., additional, De Braud, F., additional, Gonzalez de Villambrosía, S., additional, Martin-Romano, P., additional, Baudin, E., additional, Arias, M., additional, De Alvaro, J., additional, Parra-Palau, J., additional, Sánchez-Pérez, T., additional, Aronchik, I., additional, Filvaroff, E., additional, Lamba, M., additional, and Nikolova, Z., additional

Published
2021
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6. 528O CC-90011 in patients (Pts) with advanced solid tumours (STs) and relapsed/refractory non-Hodgkin lymphoma (R/R NHL): Updated results of a phase I study

Author

Hollebecque, A., primary, de Bono, J.S., additional, Salvagni, S., additional, Plummer, R., additional, Niccoli, P., additional, Capdevila, J., additional, Curigliano, G., additional, Moreno, V., additional, de Braud, F., additional, López-Brea, M., additional, Martin-Romano, P., additional, Baudin, E., additional, Arias, M., additional, de Alvaro, J., additional, Parra-Palau, J., additional, Sánchez-Pérez, T., additional, Aronchik, I., additional, Filvaroff, E., additional, Lamba, M., additional, and Nikolova, Z., additional

Published
2020
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7. 559P Phase Ib study of CC-90011 plus etoposide and cisplatin (EP) in patients with first-line extensive-stage (ES) small cell lung cancer (SCLC)

Author

Paz-Ares, L., primary, Juan-Vidal, O., additional, Carcereny, E., additional, Greillier, L., additional, Navarro, A., additional, Bennouna, J., additional, Santoro, A., additional, Berardi, R., additional, Besse, B., additional, Salvagni, S., additional, Gonzalez, H., additional, de Alvaro, J., additional, Parra-Palau, J., additional, Sánchez-Pérez, T., additional, Aronchik, I., additional, Filvaroff, E., additional, Lamba, M., additional, Nikolova, Z., additional, and Ponce, S., additional

Published
2020
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8. 18O CC-90011 in patients (Pts) with advanced solid tumors (STs) and relapsed/refractory non-Hodgkin lymphoma (R/R NHL): Updated results of a phase I study

Author

Hollebecque, A., primary, de Bono, J.S., additional, Salvagni, S., additional, Plummer, R., additional, Niccoli, P., additional, Capdevila, J., additional, Curigliano, G., additional, Moreno, V., additional, De Braud, F., additional, López-Brea, M., additional, Martin-Romano, P., additional, Baudin, E., additional, Arias, M., additional, De Alvaro, J., additional, Parra-Palau, J., additional, Sánchez-Pérez, T., additional, Aronchik, I., additional, Filvaroff, E., additional, Lamba, M., additional, and Nikolova, Z., additional

Published
2020
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13. Phase I/II study of spartalizumab (PDR001), an anti-PD1 mAb, in patients with advanced melanoma or non-small cell lung cancer

Author

Lin, C.-C., primary, Taylor, M., additional, Boni, V., additional, Brunsvig, P.F., additional, Geater, S.L., additional, Salvagni, S., additional, Garrido Lopez, P., additional, Özgüroğlu, M., additional, Sriuranpong, V., additional, Ponce Aix, S., additional, Ascierto, P.A., additional, Fasolo, A., additional, Sezer, A., additional, Kowalski, D.M., additional, Faris, J.E., additional, Cameron, S., additional, Mataraza, J., additional, Wu, H., additional, Antona, V., additional, and Ochoa de Olza, M., additional

Published
2018
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14. A Phase II Randomized Dose Escalation Trial of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Author

Rimassa, L, Pressiani, T, Boni, C, Carnaghi, C, Rota Caremoli, E, Fagiuoli, S, Foa, P, Salvagni, S, Cortesi, E, Chiara Tronconi, M, Personeni, N, Bozzarelli, S, Chiara Banzi, M, Fanello, S, Romano Lutman, F, Giordano, L, Santoro, A, Rimassa L, Pressiani T, Boni C, Carnaghi C, Rota Caremoli E, Fagiuoli S, Foa P, Salvagni S, Cortesi E, Chiara Tronconi M, Personeni N, Bozzarelli S, Chiara Banzi M, Fanello S, Romano Lutman F, Giordano L, Santoro A., Rimassa, L, Pressiani, T, Boni, C, Carnaghi, C, Rota Caremoli, E, Fagiuoli, S, Foa, P, Salvagni, S, Cortesi, E, Chiara Tronconi, M, Personeni, N, Bozzarelli, S, Chiara Banzi, M, Fanello, S, Romano Lutman, F, Giordano, L, Santoro, A, Rimassa L, Pressiani T, Boni C, Carnaghi C, Rota Caremoli E, Fagiuoli S, Foa P, Salvagni S, Cortesi E, Chiara Tronconi M, Personeni N, Bozzarelli S, Chiara Banzi M, Fanello S, Romano Lutman F, Giordano L, and Santoro A.

Abstract

Background. Sorafenib has proven survival benefits in patients with advanced hepatocellular carcinoma (HCC). The viability of continuing sorafenib at a higher dosage in patients who experienced radiologic disease progression was investigated. Methods. Patients who experienced disease progression while on sorafenib 400 mg twice daily were randomized to sorafenib 600mgtwice daily (n49) or best supportive care (n52). The primary end point was progression-free survival (PFS). Time to progression, overall survival,andsafetywerealso evaluated. Results. The study did not meet its primary end point. The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). Adverse events were mainly grade 1-2 and similar across both groups. In the sorafenib arm, the most frequent events were diarrhea (80%), weight loss (75%), fatigue (67%), hand-foot-skin reaction (49%), abdominal pain (37%), and stomatitis (26%). Conclusions. Escalated-dose sorafenib in patients with advanced HCC who progressed while on sorafenib, failed to provide any clinical benefit. Second-line treatment still remains an open issue to be explored in appropriate clinical trials

Published
2013

15. Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis.

Author

Pressiani, T, Boni, C, Rimassa, L, Labianca, R, Fagiuoli, S, Salvagni, S, Ferrari, D, Cortesi, E, Porta, C, Mucciarini, C, Latini, L, Carnaghi, C, Banzi, M, Fanello, S, De Giorgio, M, Lutman, F, Torzilli, G, Tommasini, M, Ceriani, R, Covini, G, Tronconi, M, Giordano, L, Locopo, N, Naimo, S, Santoro, A, Pressiani T, Boni C, Rimassa L, Labianca R, Fagiuoli S, Salvagni S, Ferrari D, Cortesi E, Porta C, Mucciarini C, Latini L, Carnaghi C, Banzi M, Fanello S, De Giorgio M, Lutman FR, Torzilli G, Tommasini MA, Ceriani R, Covini G, Tronconi MC, Giordano L, Locopo N, Naimo S, Santoro A., Pressiani, T, Boni, C, Rimassa, L, Labianca, R, Fagiuoli, S, Salvagni, S, Ferrari, D, Cortesi, E, Porta, C, Mucciarini, C, Latini, L, Carnaghi, C, Banzi, M, Fanello, S, De Giorgio, M, Lutman, F, Torzilli, G, Tommasini, M, Ceriani, R, Covini, G, Tronconi, M, Giordano, L, Locopo, N, Naimo, S, Santoro, A, Pressiani T, Boni C, Rimassa L, Labianca R, Fagiuoli S, Salvagni S, Ferrari D, Cortesi E, Porta C, Mucciarini C, Latini L, Carnaghi C, Banzi M, Fanello S, De Giorgio M, Lutman FR, Torzilli G, Tommasini MA, Ceriani R, Covini G, Tronconi MC, Giordano L, Locopo N, Naimo S, and Santoro A.

Abstract

Background: Sorafenib has shown survival benefits in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh (CP) class A liver function. There are few prospective data on sorafenib in patients with HCC and CP class B. Patients and methods: A consecutive prospective series of 300 patients with CP class A or B HCC were enrolled in a dual-phase trial to determine survival and safety data according to liver function (class A or B) in patients receiving oral sorafenib 800 mg daily. [Results of this study were presented in part at the ASCO 2012 Gastrointestinal Cancers Symposium, 19-21 January 2012. J Clin Oncol 2012; 30 (Suppl 4): abstract 306.]. Results: Overall progression-free survival (PFS), time to progression (TTP) and overall survival (OS) were 3.9, 4.1 and 9.1 months, respectively. For patients with CP class A versus B status, PFS was 4.3 versus 2.1 months, TTP was 4.2 versus 3.8 months and OS was 10.0 versus 3. 8 months. Extrahepatic spread was associated with worse outcomes but taken together with CP class, liver function played a greater role in reducing survival. Adverse events for the two CP groups were similar. Conclusion: Although patients with HCC and CP class B liver function have poorer outcomes than those with CP class A function, data suggest that patients with CP class B liver function can tolerate treatment and may still benefit from sorafenib.

Published
2013

18. PALLIATIVE CARE FOR TERMINALLY-ILL CANCER PATIENTS RESIDENT IN PARMA PROVINCE: RATES OF HOSPITALISATION, USE OF HOME CARE AND HOSPICE SERVICES AND PRESCRIPTION OF CHEMOTHERAPY NEAR TO DEATH

Author

Franciosi V, Sgargi P, Melegari E, Bozzani F, Gnappi D, Michiara M, Vasini G, Salvagni S, Bacchini GP, Ghisoni F, De Lisi V, ARDIZZONI, ANDREA, Franciosi V, Sgargi P, Melegari E, Bozzani F, Gnappi D, Michiara M, Vasini G, Salvagni S, Bacchini GP, Ghisoni F, De Lisi V, and Ardizzoni A

Subjects
PALLIATIVE CARE FOR TERMINALLY-ILL CANCER PATIENTS RESIDENT IN PARMA PROVINCE: RATES OF HOSPITALISATION, USE OF HOME CARE AND HOSPICE SERVICES AND PRESCRIPTION OF CHEMOTHERAPY NEAR TO DEATH
Published
2009

21. Prognostic value of the neutrophil-to-lymphocyte ratio in advanced hepatocellular carcinoma: An exploratory analysis from the ARQ197-215 study

Author

Personeni, N., primary, Giordano, L., additional, Abbadessa, G., additional, Porta, C., additional, Borbath, I., additional, Daniele, B., additional, Salvagni, S., additional, van Laethem, J.-L., additional, Van Vlierberghe, H., additional, Trojan, J., additional, Weiss, A., additional, Gasbarrini, A., additional, Shuster, D., additional, De Toni, E.N., additional, Lencioni, M., additional, Miles, S., additional, Lamar, M.E., additional, Schwartz, B., additional, Santoro, A., additional, and Rimassa, L., additional

Published
2016
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22. Prognostic significance of the neutrophil-to-lymphocyte ratio in patients with advanced hepatocellular carcinoma: the ARQ197-215 study

Author

Personeni, N., primary, Giordano, L., additional, Abbadessa, G., additional, Porta, C., additional, Borbath, I., additional, Daniele, B., additional, Salvagni, S., additional, Van Laethem, J.L., additional, Van Vlierberghe, H., additional, Trojan, J., additional, De Toni, E.N., additional, Weiss, A., additional, Miles, S., additional, Gasbarrini, A., additional, Lencioni, M., additional, Lamar, M.E., additional, Shuster, D., additional, Schwartz, B., additional, Santoro, A., additional, and Rimassa, L., additional

Published
2016
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25. Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study

Author

Mieog, Js, Morden, Jp, Bliss, Jm, Coombes, Rc, van de Velde CJ, IES Steering Committee: Delozier, T, Veronesi, A, Vrdoljak, E, Monnier, A, Coombes, C, Nagykalnai, T, Roumen, Rm, Utracka Hutka, B, Pluzanska, A, Porpiglia, M, Genta, F, Benedetto, Chiara, Sozzani, P, Steiner, M, Rubinov, R, Leviov, M, Semiglazov, V, Fox, J, Mayordomo, Ji, Cervek, J, Sleeboom, Hp, Jassem, J, Hinton, Cp, Paulsen, Th, Guleng, Rj, Fein, L, Gutulescu, N, Florián, J, Rosso, R, Rutgers, Ej, Krzakowski, M, Pienkowski, T, Krajina, Z, Siffnerova, H, Pawlicki, M, Drosik, K, Wagnerowa, M, Brunt, M, Vukelja, S, Mitrowic, L, Cataliotti, L, Karnicka Mlodkowska, H, Bonnefoi, H, Tilch, G, Chollet, P, Patel, A, Kamby, C, Giustini, L, Acito, L, Mouridsen, H, Roche, H, De Lafontan, B, Tomczak, P, Petruzelka, L, Lortholary, A, Pacquola, Mg, Skene, A, Rici, S, Michelotti, A, Ghilezan, N, Stewart, A, Beauduin, M, Andersen, J, Vassilaros, S, Celio, L, Bajetta, E, Bastús, R, Marsland, T, Paridaens, R, Tzekova, V, Lichtenegger, W, Piersma, H, Jones, S, Holmberg, S, Verhoeven, D, Hill, A, Porcile, G, Bruno, Mf, Chernozemski, I, Coleman, R, Jadeja, J, Cohn, A, Merlano, M, Perroni, D, Di Costanzo, F, Van Bochove, A, Gerrits, Ma, Malec, V, Balil, A, Mendiola, C, Dodwell, D, Knox, R, Horgan, K, Joannides, T, Leonard, Rc, Cawthorn, Sj, Ghosh, C, Cantrell, J, Campos, D, Orti, R, Diedrich, K, Aas, H, Barnadas, A, Vila, Mm, Makris, A, Anderson, T, Chittor, S, Michel, J, Philip, P, Redmond, P, Mastboom, Wj, Nordenskjöld, B, Simmonds, P, Grieve, Rj, Tomova, A, Piot, G, Borea, G, Ucci, G, Einarsson, E, Nicholson, S, Gardiol, Ea, Kerger, J, Schlosser, J, Namer, M, Pinotti, G, Rutten, Ht, Iversen, T, Nejim, A, Dudov, A, Grundtvig, P, Lang, I, Massidda, B, Van De Velde CH, Gervasio, Mh, Tengrup, I, Tennvall, L, Goodman, S, Modgill, Vk, Vorobiof, Da, Mickiewicz, E, Chirgwin, J, Focan, C, Albin, N, Contu, Aa, Svensson, Jh, Borghede, G, Källström, Ac, Forbes, Jf, Hurtz, Hj, Tubiana Hulin, M, Viens, P, Scanni, A, Arnoldi, E, Nastasi, G, Bottini, A, Alquati, P, Muscat, V, Brincat, S, Holmen, K, Amaral, N, Moreno, I, Trask, C, Robinson, A, Mcintyre, K, Otsuka, A, Hohaus, B, Hoefig, G, Georgoulias, V, Salvagni, S, Bidin, L, Artioli, F, Engan, T, Benedikstsson, Kp, Campbell, I, Harvey, V, Zimbler, H, Mrsic Krmpotic, Z, Canon, Jl, Tchilingirov, Pv, Buser, K, Bolanca, A, Reztke, U, Rhein, U, Jouve, M, Mullins, G, Vesentini, L, Gallo, L, Merlini, L, Decensi, A, Carreca, I, Van Tienhoven, G, Börjesson, B, Hansen, J, Koza, I, Arcusa, A, Inoriza, A, Pelegri, A, Eremin, O, Modiano, Mr, Anthony, S, Donat, D, Richardet, E, Kochli, O, Zeißig, P, Gauch, G, Aabo, K, Fumoleau, P, Erdkamp, Fl, Lovén, L, Jönsson, Pe, Perren, T, Stuart, N, Galindo, E, Marek, Bj, Salmon, Jp, Dohollou, N, Thompson, R, Folco, U, Rosa, A, Tonato, M, Heijmans, Gj, Koralewski, P, Bång, H, Lescure, Ar, Carrato, A, Martin, M, Neave, F, Howell, T, Savin, M, Loesch, D, Hannois, A, Mohr, A, Laube, T, Omar, S, Bonneterre, J, Servent, V, Danese, S, Sertoli, Mr, Butzelaar, Rm, Steller, Ep, Gomez, H, Skoog, P, Alvarez, I, Aguilar, Ea, Giner, Jl, Yosef, Hm, Barrett Lee, P, Buzdar, Au, George, T, Olivaires, J, Vsianska, M, Köhler, U, Lindeløv, B, Toftdahl, Db, Nielsen, Eb, Veyret, C, Castera, D, Kerbrat, P, Vassilaros, P, Yeo, W, Boni, C, Aitini, E, Luporini, G, Herben, Mg, Espelid, H, Dahl, S, Ingvar, C, Meana, A, Pico, C, Garcia, Am, Agrawal, Rk, Gruenberg, D, Nunez de Pierro, A, Gill, G, Nogaret, Jm, Honhon, B, Wassenaar, H, Nielander, R, Warnier, P, Sessa, C, Padrik, P, Guastalla, Jp, Serin, D, Jaubert, D, Dank, M, Given, Fh, Mascia, V, De Fraia, E, Silingardi, V, Conte, Pf, Labianca, R, Tondini, C, Bagnulo, A, Gardani, G, Wils, J, Liem, G, Nuytinck, Jk, Formoe, E, Ambré, T, Alés, J, Aramburo, P, Mansi, J, Graham, J, Joffe, J, Sainsbury, J, Stone, J, Good, Rh, Cartwright, T, Werner, Id, Murray, E, Beith, J, Tigges, Fj, Bojko, P, Sandberg, E, Jensen, B, Lotz, Jp, Carney, D, Shapira, J, Neumann, A, Goldhirsch, A, Dicato, M, de Graaf, H, Maartense, E, Burghouts, J, Cassinello, J, Jones, A, Gaffney, C, Blum, R, Abdi, E, Becquart, D, Dirix, L, Janssens, J, Nmarschner, N, Blaska Jaulerry, B, Prevot, G, Mirah Lev, L, Shani, A, Baruch, Nb, Peretz, T, Gips, M, Cognetti, F, Carlini, P, Nortier, Jw, Huinink D, ten B., Roussel, Jg, Unneberg, K, Kylberg, F, Hovind, H, Nestvold, T, Fogelkvist, R, Due, J, Muller, S, Gilligan, D, Russel, S, Mcaleer, J, Yiangou, C, Foote, L, Schottstaedt, M, Holmes, Fa, Wainstein, R, Contreras, O, Martinez, J, Della Fiorentina, S, Beslija, S, Vermorken, Jb, Thirion, M, Fraikin, J, Castiglione, M, Jäger, W, Fasching, P, Fabriz, H, Neis, K, Kirschbaum, M, Labat, Jp, Dupuis, O, Bernard, J, Datchary, J, Provencal, J, Allain, P, Clerico, M, Lopez, M, Nalli, G, Aspevik, R, Fràguas, A, Curescu, S, Cuevas, Jm, Oltra, A, Bradley, C, Kapoor, R, Akbain, S, Croghan, Mk, Modiano, M, Taetle, R, Beale, P, Gobert, P, Bondue, H, Böhm, R, Møller, Ka, Brettes, Jp, Netter, G, Grogan, L, Klein, B, Botta, M, Barni, S, Van Meerwijk, I, Kåresen, R, Godes, J, Aramburo, A, Jara, C, Zanger, B, Fleagle, Jt, Greenspan, A, Marschke, R, Medgyesy, Dc, Garbo, L., CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, Population, Breast Neoplasms, Disease-Free Survival, chemistry.chemical_compound, Breast cancer, Exemestane, Internal medicine, Surveys and Questionnaires, medicine, Clinical endpoint, Humans, Carpal tunnel syndrome, education, Aged, Retrospective Studies, Aged, 80 and over, education.field_of_study, business.industry, Aromatase Inhibitors, Hazard ratio, Middle Aged, medicine.disease, Carpal Tunnel Syndrome, Surgery, Musculoskeletal Abnormalities, Androstadienes, Postmenopause, Tamoxifen, Treatment Outcome, Oncology, chemistry, Hormonal therapy, Female, business, medicine.drug
Abstract

BACKGROUND: Aromatase inhibitors are more effective than is tamoxifen in prevention of breast-cancer recurrence, but at the expense of increased musculoskeletal side-effects, such as carpal tunnel syndrome. The aim of this study was to assess risk factors and the prognostic value of musculoskeletal symptoms during treatment with the steroidal aromatase inhibitor exemestane or with tamoxifen after 2-3 years of tamoxifen. METHODS: In the Intergroup Exemestane Study, postmenopausal women treated for early invasive breast cancer who remained disease free and on treatment after 2-3 years of tamoxifen were randomised to switch to exemestane or to continue tamoxifen for the remainder of the 5-year period of endocrine treatment. The primary endpoint for this retrospective analysis was occurrence of carpal tunnel syndrome and any musculoskeletal events, analysed in the safety population, which consisted of all patients who had received any trial treatment. As well as case-report forms, questionnaires were distributed retrospectively to gain more details of cases of carpal tunnel syndrome. The relation between musculoskeletal symptoms reported by 6 months from randomisation and survival from 9 months onwards was assessed by Cox proportional hazards models. The trial is registered, number ISRCTN11883920. It has completed accrual and follow-up is continuing for enrolled participants. FINDINGS: After a median follow-up of 91·0 months (IQR 83·0-99·2), carpal tunnel syndrome had been reported for 66 (2·8%) of 2319 patients in the exemestane group compared with 13 (0·6%) of 2338 in the tamoxifen group (odds ratio [OR] 5·23, 99% CI 2·39-11·49; p

Published
2012

26. Tivantinib for second-line treatment of advanced hepatocellular carcinoma: a randomised, placebo-controlled phase 2 study

Author

Santoro, A, Rimassa, L, Borbath, I, Daniele, B, Salvagni, S, Van Laethem, Jl, Van Vlierberghe, H, Trojan, J, Kolligs, Ft, Weiss, A, Miles, S, Gasbarrini, Antonio, Lencioni, M, Cicalese, L, Sherman, M, Gridelli, C, Buggisch, P, Gerken, G, Schmid, Rm, Boni, C, Personeni, N, Hassoun, Z, Abbadessa, G, Schwartz, B, Von Roemeling, R, Lamar, Me, Chen, Y, Porta, C., Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Santoro, A, Rimassa, L, Borbath, I, Daniele, B, Salvagni, S, Van Laethem, Jl, Van Vlierberghe, H, Trojan, J, Kolligs, Ft, Weiss, A, Miles, S, Gasbarrini, Antonio, Lencioni, M, Cicalese, L, Sherman, M, Gridelli, C, Buggisch, P, Gerken, G, Schmid, Rm, Boni, C, Personeni, N, Hassoun, Z, Abbadessa, G, Schwartz, B, Von Roemeling, R, Lamar, Me, Chen, Y, Porta, C., and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)

Abstract

Tivantinib (ARQ 197), a selective oral inhibitor of MET, has shown promising antitumour activity in hepatocellular carcinoma as monotherapy and in combination with sorafenib. We aimed to assess efficacy and safety of tivantinib for second-line treatment of advanced hepatocellular carcinoma.

Published
2013

29. Met as Prognostic Factor and Therapeutic Target in Pretreated Hepatocellular Carcinoma (HCC): Final Results of a Randomized Controlled Phase 2 Trial (RCT) with Tivantinib (ARQ 197)

Author

Daniele, B., primary, Rimassa, L., additional, Porta, C., additional, Borbath, I., additional, Salvagni, S., additional, van Laethem, J., additional, van Vlierberghe, H., additional, von Roemeling, R., additional, Abbadessa, G., additional, and Santoro, A., additional

Published
2012
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30. Zweitlinientherapie des hepatozellulären Karzinoms (HCC): Ergebnisse einer randomisierten, placebo-kontrollierten Phase 2-Studie mit Tivantinib (ARQ197)

Author

Trojan, J, primary, Kolligs, F, additional, Buggisch, P, additional, Gerken, G, additional, Schmid, R, additional, de Toni, EN, additional, Zeuzem, S, additional, Porta, C, additional, Borbath, I, additional, Rimassa, L, additional, Daniele, B, additional, Salvagni, S, additional, van Laethem, JL, additional, van Vlierberghe, H, additional, Gasbarrini, A, additional, Lencioni, M, additional, Roemeling, R von, additional, Abbadessa, G, additional, Schwartz, B, additional, and Santoro, A, additional

Published
2012
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31. P4-13-01: Pain Severity and Analgesic Use Associated with Skeletal-Related Events in Patients with Advanced Breast Cancer and Bone Metastases.

Author

Fallowfield, L, primary, Cleeland, CS, additional, Body, J-J, additional, Stopeck, A, additional, von, Moos R, additional, Patrick, DL, additional, Clemons, M, additional, Tonkin, K, additional, Masuda, N, additional, Lipton, A, additional, De, Boer R, additional, Salvagni, S, additional, Tosello, Oliveira C, additional, Ying, W, additional, Braun, A, additional, and Cong, Z, additional

Published
2011
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34. No Clinical Evidence for Increase in Tumour Malignant Potential in Patients (Pts) with Metastatic Breast Cancer (mBC) Treated with Bevacizumab (BV) and Docetaxel (D) in the Phase III AVADO Study.

Author

Harbeck, N., primary, Chan, A., additional, ten Bokkel Huinink, D., additional, Chollet, P., additional, Gimenes, D., additional, Fabiani, C., additional, Salvagni, S., additional, Pérez-Michel, L., additional, Schneeweiss, A., additional, Chlistalla, A., additional, and Miles, D., additional

Published
2009
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36. A combination of gefitinib and FOLFOX-4 as first-line treatment in advanced colorectal cancer patients. A GISCAD multicentre phase II study including a biological analysis of EGFR overexpression, amplification and NF-kB activation

Author

Cascinu, S, primary, Berardi, R, additional, Salvagni, S, additional, Beretta, G D, additional, Catalano, V, additional, Pucci, F, additional, Sobrero, A, additional, Tagliaferri, P, additional, Labianca, R, additional, Scartozzi, M, additional, Crocicchio, F, additional, Mari, E, additional, and Ardizzoni, A, additional

Published
2007
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40. High curative resection rate with weekly cisplatin, 5-fluorouracil, epidoxorubicin, 6S-leucovorin, glutathione, and filgastrim in patients with locally advanced, unresectable gastric cancer: a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD)

Author

Cascinu, S, primary, Scartozzi, M, additional, Labianca, R, additional, Catalano, V, additional, Silva, R R, additional, Barni, S, additional, Zaniboni, A, additional, D'Angelo, A, additional, Salvagni, S, additional, Martignoni, G, additional, Beretta, G D, additional, Graziano, F, additional, Berardi, R, additional, and Franciosi, V, additional

Published
2004
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42. O-143 Gemcitabine-oxaliplatin (GEMOX) chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC): Preliminary results of a multicenter phase II study

Author

Crino, Lucio, primary, Novello, Silvia, additional, De Marinis, Filippo, additional, Maur, Michela, additional, Scagliotti, Giorgio, additional, Salvagni, S., additional, Crucitta, E., additional, Maestri, Antonio, additional, Bartolini, Stefania, additional, and Cappuzzo, Federico, additional

Published
2003
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43. Infusional 5-fluorouracil, cisplatin and mitomycin C in advanced gastric cancer: A low cost effective regimen

Author

Cascinu, S, primary, Baldelli, A M, additional, Catalano, V, additional, Giordani, P, additional, Beretta, G D, additional, Silva, R R, additional, Gasparini, G, additional, Mari, D, additional, Maisano, R, additional, Salvagni, S, additional, Barni, S, additional, Labianca, R, additional, Frontini, L, additional, Curti, C, additional, and Catalano, G, additional

Published
2002
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46. Pertuzumab monotherapy after trastuzumab-based treatment and subsequent reintroduction of trastuzumab: activity and tolerability in patients with advanced human epidermal growth factor receptor 2-positive breast cancer.

Author

Cortés J, Fumoleau P, Bianchi GV, Petrella TM, Gelmon K, Pivot X, Verma S, Albanell J, Conte P, Lluch A, Salvagni S, Servent V, Gianni L, Scaltriti M, Ross GA, Dixon J, Szado T, Baselga J, Cortés, Javier, and Fumoleau, Pierre

Published
2012
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48. A combination of gefitinib and FOLFOX-4 as first-line treatment in advanced colorectal cancer patients. A GISCAD multicentre phase II study including a biological analysis of EGFR overexpression, amplification and NF-kB activation.

Author

Cascinu, S., Berardi, R., Salvagni, S., Beretta, G. D., Catalano, V., Pucci, F., Sobrero, A., Tagliaferri, P., Labianca, R., Scartozzi, M., Crocicchio, F., Mari, E., and Ardizzoni, A.

Subjects
DRUG therapy, CETUXIMAB, COLON cancer, PROTEIN-tyrosine kinases, TUMORS, FLUORESCENCE in situ hybridization, CANCER patients
Abstract

Interesting activity has been reported by combining chemotherapy with cetuximab. An alternative approach for blocking EGFR function has been the development of small-molecule inhibitors of tyrosine kinase domain such as gefitinib. We designed a multicentre phase II study in advanced colorectal cancer combining gefitinib+FOLFOX in order to determine the activity and to relate EGFR expression and gene amplification and NF-kB activation to therapeutic results. Patients received FOLFOX-4 regimen plus gefitinib as first-line treatment. Tumour samples were analysed for EGFR protein expression by immunohistochemical analysis and for EGFR gene amplification by fluorescence in situ hybridisation (FISH), chromogenic in situ hybridisation (CISH) and NF-kB activation. Forty-three patients were enrolled into this study; 15 patients experienced a partial response (response rate=34.9%), whereas other 12 (27.9%) had a stable disease. Median progression-free survival (PFS) was 7.8 months and median overall survival (OS) was 13.9 months. We did not find any relationship with EGFR overexpression, gene amplification, while NF-kB activation was associated with a resistance to therapy. Gefitinib does not seem to increase the activity of FOLFOX in advanced colorectal cancer even in patients overexpressing EGFR or with EGFR amplification. Furthermore, while NF-kB activation seems to predict resistance to chemotherapy as demonstrated ‘in vitro’ models, gefitinib does not overcome this mechanism of resistance, as reported for cetuximab.British Journal of Cancer (2008) 98, 71–76. doi:10.1038/sj.bjc.6604121 www.bjcancer.com Published online 4 December 2007 [ABSTRACT FROM AUTHOR]

Published
2008
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49. A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study.

Author

Gridelli, C., Gallo, C., Di Maio, M., Barletta, E., Illiano, A., Maione, P., Salvagni, S., Piantedosi, F. V., Palazzolo, G., Caffo, O., Ceribelli, A., Falcone, A., Mazzanti, P., Brancaccio, L., Capuano, M. A., Isa, L., Barbera, S., and Perrone, F.

Subjects
CLINICAL trials, DOCETAXEL, LUNG cancer, QUALITY of life, DIARRHEA, FEBRILE neutropenia
Abstract

Docetaxel (75 mg m(-2) 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m(-2) for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, < or =75 years, ECOG PS < or =2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77-1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival. [ABSTRACT FROM AUTHOR]

Published
2004
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50. Clinical activity of <scp>CC‐90011</scp> , an oral, potent, and reversible <scp>LSD1</scp> inhibitor, in advanced malignancies

Author

Antoine Hollebecque, Stefania Salvagni, Ruth Plummer, Patricia Niccoli, Jaume Capdevila, Giuseppe Curigliano, Victor Moreno, Filippo de Braud, Sonia Gonzalez de Villambrosia, Patricia Martin‐Romano, Eric Baudin, Marina Arias, Juan de Alvaro, Josep L. Parra‐Palau, Tania Sánchez‐Pérez, Ida Aronchik, Ellen H. Filvaroff, Manisha Lamba, Zariana Nikolova, Johann S. de Bono, Institut Català de la Salut, [Hollebecque A] Gustave Roussy, Département d’innovation thérapeutique et essais précoces, Villejuif, France. [Salvagni S] S. Orsola Polyclinic, Malpighi University Hospital, Bologna, Italy. [Plummer R] Clinical and Translational Research Institute Northern, Newcastle University, Newcastle, UK. [Niccoli P] Department of Medical Oncology, ENETS Center of Excellence, IPC NET Center, Institut Paoli-Calmettes, Marseille, France. [Capdevila J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. IOB-Teknon, Barcelona, Spain. [Curigliano G] European Institute of Oncology, IRCCS, University of Milan, Milan, Italy, and Vall d'Hebron Barcelona Hospital Campus

Subjects
enzimas y coenzimas::enzimas::oxidorreductasas::oxidorreductasas que actúan sobre donantes de grupos CH-NH::oxidorreductasas N-desmetilantes::histona desmetilasas [COMPUESTOS QUÍMICOS Y DROGAS], Histone Demethylases, Cancer Research, Maximum Tolerated Dose, Càncer - Tractament, Enzymes and Coenzymes::Enzymes::Oxidoreductases::Oxidoreductases Acting on CH-NH Group Donors::Oxidoreductases, N-Demethylating::Histone Demethylases [CHEMICALS AND DRUGS], Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell::Lymphoma, B-Cell, Marginal Zone [DISEASES], neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B::linfoma de células B de la zona marginal [ENFERMEDADES], Investigative Techniques::Toxicity Tests::Maximum Tolerated Dose [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Lymphoma, B-Cell, Marginal Zone, Posologia, Neoplasms [DISEASES], neoplasias [ENFERMEDADES], Oncology, Neoplasms, Medicaments - Eficàcia, técnicas de investigación::pruebas de toxicidad::dosis máxima tolerada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Humans, Organic Chemicals
Abstract

Lysine-specific demethylase 1 (LSD1) inhibitor; Neuroendocrine tumor; Non-Hodgkin lymphoma Tumor neuroendocrino; Linfoma no Hodgkin; Inhibidores de desmetilasa-1 específica a lisina Tumor neuroendocrí; Limfoma no Hodgkin; Inhibidor de la desmetilasa-1 específica a la lisina Background CC-90011 is an oral, potent, selective, reversible inhibitor of lysine-specific demethylase 1 (LSD1) that was well tolerated, with encouraging activity in patients who had advanced solid tumors or relapsed/refractory marginal zone lymphoma. The authors present long-term safety and efficacy and novel pharmacodynamic and pharmacokinetic data from the first-in-human study of CC-90011. Methods CC-90011-ST-001 (ClincalTrials.gov identifier NCT02875223; Eudract number 2015–005243-13) is a phase 1, multicenter study in which patients received CC-90011 once per week in 28-day cycles. The objectives were to determine the safety, maximum tolerated dose, and/or recommended phase 2 dose (primary) and to evaluate preliminary efficacy and pharmacokinetics (secondary). Results Sixty-nine patients were enrolled, including 50 in the dose-escalation arm and 19 in the dose-expansion arm. Thrombocytopenia was the most common treatment-related adverse event and was successfully managed with dose modifications. Clinical activity with prolonged, durable responses were observed, particularly in patients who had neuroendocrine neoplasms. In the dose-escalation arm, one patient with relapsed/refractory marginal zone lymphoma achieved a complete response (ongoing in cycle 58). In the dose-expansion arm, three patients with neuroendocrine neoplasms had stable disease after nine or more cycles, including one patient who was in cycle 46 of ongoing treatment. CC-90011 decreased levels of secreted neuroendocrine peptides chromogranin A, progastrin-releasing peptide, and RNA expression of the blood pharmacodynamic marker monocyte-to-macrophage differentiation–associated. Conclusions The safety profile of CC-90011 suggested that its reversible mechanism of action may provide an advantage over other irreversible LSD1 inhibitors. The favorable tolerability profile, clinical activity, durable responses, and once-per-week dosing support further exploration of CC-90011 as monotherapy and in combination with other treatments for patients with advanced solid tumors and other malignancies. This study was supported by Bristol Myers Squibb, Princeton, New Jersey, USA. Writing and editorial assistance was provided by Bio Connections, LLC, funded by Bristol Myers Squibb.

Published
2022
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