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Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

2013; Elsevier BV; Volume: 24; Issue: 11 Linguagem: Inglês

10.1093/annonc/mdt371

1569-8041

Suresh S. Ramalingam, Jeffrey Crawford, Alex Y. Chang, C. Manegold, Román Pérez-Soler, Jean-Yves Douillard, Nicholas Thatcher, Fabrice Barlési, Taofeek K. Owonikoko, Y. Wang, Philippe Pultar, Jing Zhu, Rajesh Malik, Giuseppe Giaccone, Stephen Della‐Fiorentina, Stephen Begbie, Ross Jennens, Joshua Dass, K. Pittman, N.M. Ivanova, Tatyana Koynova, Petar Petrov, Antoaneta Tomova, Valentina Tzekova, Félix Couture, Vera Hirsh, Ronald L. Burkes, Randeep Sangha, Miloslav Ambruš, Terezie Janaskova, J Musil, J. Novotny, Petr Zatloukal, Jitka Jakesova, Kamil Klenha, Jaromı́r Roubec, J Vaňásek, Jérôme Fayette, Fabrice Barlési, Jaafar Bennouna-Louridi, C. Chouaïd, Julien Mazières, H. Vallerand, G. Robinet, P.-J. Souquet, D. Spaëth, Roland Schött, H. Léna, Y. Martinet, Claude El Kouri, Nathalie Baize, Arnaud Scherpereel, O. Molinier, F. Fuchs, K. Josten, C. Manegold, Norbert Marschner, Folker Schneller, Tobias R. Overbeck, Michael Thomas, Joachim von Pawel, Martin Reck, Wolfgang Schuette, Volker Hagen, Claus-Peter Schneider, V. Georgoulias, Ioannis Varthalitis, Kostas Zarogoulidis, K. Syrigos, Christos N. Papandreou, Csaba Böcskei, Eszter Csánky, Erzsébet Juhász, György Losonczy, Z. Mark, István Molnár, Zsolt Pápai-Székely, S. Tehenes, Ilona Vinkler, Sachin Almel, Ashish Bakshi, Shailesh Bondarde, A Maru, Ashutosh Pathak, R.M. Pedapenki, Krishna Prasad, S.V.S.S. Prasad, Nalini Kilara, D. Gorijavolu, Chetan Deshmukh, S.K.P. John, Lalit Mohan Sharma, D. Amoroso, Emilio Bajetta, Paolo Bidoli, Andrea Bonetti, Filippo de Marinis, Massimo Di Maïo, Rodolfo Passalacqua, Stefano Cascinu, Alessandra Bearz, Marianna Bitiņa, Arija Brize, Gunta Purkalne, M. Skrodele, Asami Baba, Kananathan Ratnavelu, Maximilian Saw, M.C. Samson-Fernando, Guia Ladrera, Jacek Jassem, P. Koralewski, Piotr Serwatowski, Maciej Krzakowski, C. Cebotaru, Filip Dumitru, Doina Elena Ganea-Motan, Carmen Ianuli, Ileana Manolescu, Anghel Adrian Udrea, Olga Burdaeva, M. Byakhov, Aleksandr Filippov, Sergey Lazarev, Igor Mosin, С. В. Орлов, Dmitry Udovitsa, Andrey V. Khorinko, Светлана Проценко, Alex Y. Chang, Hong Liang Lim, Yuping Tan, E.H. Tan, R. Bastus Piulats, Jesús García‐Foncillas, Javier Valdivia, Julio Castro, M. Dómine Gómez, S.W. Kim, J.-S. Lee, H.K. Kim, J.S. Lee, S.‐W. Shin, Dong‐Wook Kim, Y.-C. Kim, K.C. Park, C.-S. Chang, Gee‐Chen Chang, Yih‐Gang Goan, Wu‐Chou Su, Chun‐Ming Tsai, H.‐P. Kuo, Mustafa Beneklı, Gökhan Demir, Erhan Gökmen, A. Sevinç, Jeffrey Crawford, Giuseppe Giaccone, Missak Haigentz, Taofeek K. Owonikoko, Meetesh Agarwal, Sarbagya Pandit, Raphael L. C. Araújo, N. Vrindavanam, Philip Bonomi, Anke van den Berg, J. Wade, Roy D. Bloom, B. Amin, D. Ross Camidge, Debbie Hill, Mark U. Rarick, P. Flynn, Linda Klein, Katherine L. Russo, M. Neubauer, P. Richards, Robert L. Ruxer, Michael A. Savin, Douglas Weckstein, Robert Rosenberg, T. Whittaker, Donald Richards, Wade Berry, Christian H. Ottensmeier, Adam Dangoor, N. Steele, Yvonne Summers, Elaine M. Rankin, Kate Rowley, Selvaraj Giridharan, Hartmut Kristeleit, Caroline Humber, Paul Taylor,

Acute Lymphoblastic Leukemia research

Abstract Background Talactoferrin alfa is an oral dendritic cell (DC)-mediated immunotherapy (DCMI). We tested whether talactoferrin was superior to placebo in advanced non-small-cell lung cancer (NSCLC). Patients and methods An FORTIS-M trial was an international, multicenter, randomized, double-blind comparison of talactoferrin (1.5g p.o. BID) versus placebo BID, in patients with stage IIIB/IV NSCLC whose disease had failed two or more prior regimens. Treatment was administered for a maximum of five 14-week cycles. The primary efficacy end point was overall survival (OS); secondary end points included 6- and 12-month survival, progression-free survival (PFS), and disease control rate (DCR). Results Seven hundred and forty-two patients were randomly assigned (2:1) to talactoferrin (497) or placebo (245). The median OS in the intent-to-treat (ITT) population was 7.66 months in the placebo arm and 7.49 months in the talactoferrin arm [hazard ratio (HR), 1.04; 95% CI, 0.873–1.24; P = 0.6602]. The 6-month survival rates were 59.9% (95% CI, 53.4% to 65.8%) and 55.7% (95% CI, 51.1% to 59.9%), respectively. The 12-month survival rates were 32.2% (95% CI, 26.3% to 38.2%) and 30.9% (95% CI, 26.8% to 35%), respectively. The median PFS rates were 1.64 months and 1.68 months, respectively (HR, 0.99; 95% CI, 0.835–1.16; P = 0.8073). The DCRs were 38.4 and 37.6%, respectively [stratified odds ratio (OR), 0.96; 95% CI, 0.698–1.33; P = 0.8336]. The safety profiles were comparable between arms. Conclusions There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.