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

التفاصيل البيبلوغرافية
العنوان:	Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)
المؤلفون:	Ramalingam, S., Crawford, J., Chang, A., Manegold, C., Perez-Soler, R., Douillard, J. -Y., Thatcher, N., Barlesi, F., Owonikoko, T., Wang, Y., Pultar, P., Zhu, J., Malik, R., Malik Giaccone, R., Della-Fiorentina, S., Begbie, S., Jennens, R., Dass, J., Pittman, K., Ivanova, N., Koynova, T., Petrov, P., Tomova, A., Tzekova, V., Couture, F., Hirsh, V., Burkes, R., Sangha, R., Ambrus, M., Janaskova, T., Musil, J., Novotny, J., Zatloukal, P., Jakesova, J., Klenha, K., Roubec, J., Vanasek, J., Fayette, J., Bennouna-Louridi, J., Chouaid, C., Mazières, J., Vallerand, H., Robinet, G., Souquet, P. -J., Spaeth, D., Schott, R., Lena, H., Martinet, Y., Kouri, C. E., Baize, N., Scherpereel, A., Molinier, O., Fuchs, F., Josten, K. M., Marschner, N., Schneller, F., Overbeck, T., Thomas, M., von Pawel, J., Reck Schuette, M., Hagen, V., Schneider, C. -P., Georgoulias, V., Varthalitis, I., Zarogoulidis, K., Syrigos, K., Papandreou, C., Bocskei, C., Csanky, E., Juhasz, E., Losonczy, G., Mark, Z., Molnar, I., Papai-Szekely, Z., Tehenes, S., Vinkler, I., Almel, S., Bakshi, A., Bondarde, S., Maru, A., Pathak, A., Pedapenki, R. M., Prasad, K., Prasad, S. V. S. S., Kilara, N., Gorijavolu, D., Deshmukh, C. D., John, S., Sharma, L. M., Amoroso, D., Bajetta, E., Bidoli, P., Bonetti, A., De Marinis, F., Maio, M., Passalacqua, R., Cascinu, S., Bearz, A., Bitina, M., Brize, A., Purkalne, G., Skrodele, M., Baba, A. A., Ratnavelu, K., Saw, M. H., Samson-Fernando, M. C., Ladrera, G. E., Jassem, J., Koralewski, P., Sikorska, L., Serwatowski, P., Krzakowski, M., Cebotaru, C., Filip, D., Ganea-Motan, D. E., Ianuli, C. H., Manolescu, I. G., Udrea, A., Burdaeva, O., Byakhov, M., Filippov, A., Lazarev, S., Mosin, I., Orlov, S., Udovitsa, D., Khorinko, A., Protsenko, S., Lim, H. L., Tan, Y. O., Tan, E. H., Bastus Piulats, R., Garcia-Foncillas, J., Valdivia, J., de Castro, J., Domine Gomez, M., Kim, S. W., Lee, J. -S., Kim, H. K., Lee, J. S., Shin, S. W., Kim, D. -W., Kim, Y. -C., Park, K. C., Chang, C. -S., Chang, G. -C., Goan, Y. -G., Su, W. -C., Tsai, C. -M., Kuo, H. -P., Benekli, M., Demir, G., Gokmen, E., Sevinc, A., Giaccone, G., Haigentz, M., Agarwal, M., Pandit, S., Araujo, R., Vrindavanam, N., Bonomi, P., Berg, A., Wade, J., Bloom, R., Amin, B., Camidge, R., Hill, D., Rarick, M., Flynn, P., Klein, L., Lo Russo, K., Neubauer, M., Richards, P., Ruxer, R., Savin, M., Weckstein, D., Rosenberg, R., Whittaker, T., Richards Berry, D., Ottensmeier, C., Dangoor, A., Steele, N., Summers, Y., Rankin, E., Rowley, K., Giridharan, S., Kristeleit, H., Humber, C., Taylor, P.
المساهمون:	Ramalingam, S., Crawford, J., Chang, A., Manegold, C., Perez-Soler, R., Douillard, J. -Y., Thatcher, N., Barlesi, F., Owonikoko, T., Wang, Y., Pultar, P., Zhu, J., Malik, R., Malik Giaccone, R., Della-Fiorentina, S., Begbie, S., Jennens, R., Dass, J., Pittman, K., Ivanova, N., Koynova, T., Petrov, P., Tomova, A., Tzekova, V., Couture, F., Hirsh, V., Burkes, R., Sangha, R., Ambrus, M., Janaskova, T., Musil, J., Novotny, J., Zatloukal, P., Jakesova, J., Klenha, K., Roubec, J., Vanasek, J., Fayette, J., Bennouna-Louridi, J., Chouaid, C., Mazières, J., Vallerand, H., Robinet, G., Souquet, P. -J., Spaeth, D., Schott, R., Lena, H., Martinet, Y., Kouri, C. E., Baize, N., Scherpereel, A., Molinier, O., Fuchs, F., Josten, K. M., Marschner, N., Schneller, F., Overbeck, T., Thomas, M., von Pawel, J., Reck Schuette, M., Hagen, V., Schneider, C. -P., Georgoulias, V., Varthalitis, I., Zarogoulidis, K., Syrigos, K., Papandreou, C., Bocskei, C., Csanky, E., Juhasz, E., Losonczy, G., Mark, Z., Molnar, I., Papai-Szekely, Z., Tehenes, S., Vinkler, I., Almel, S., Bakshi, A., Bondarde, S., Maru, A., Pathak, A., Pedapenki, R. M., Prasad, K., Prasad, S. V. S. S., Kilara, N., Gorijavolu, D., Deshmukh, C. D., John, S., Sharma, L. M., Amoroso, D., Bajetta, E., Bidoli, P., Bonetti, A., De Marinis, F., Maio, M., Passalacqua, R., Cascinu, S., Bearz, A.
سنة النشر:	2013
المجموعة:	Università degli Studi di Siena: USiena air
مصطلحات موضوعية:	Immunotherapy, Non-small-cell lung cancer, Phase III study, Talactoferrin
الوصف:	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 (1.5 g 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. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology All rights reserved.
نوع الوثيقة:	article in journal/newspaper
وصف الملف:	STAMPA
اللغة:	English
العلاقة:	info:eu-repo/semantics/altIdentifier/pmid/24050956; info:eu-repo/semantics/altIdentifier/wos/WOS:000326643200029; volume:24; issue:11; firstpage:2875; lastpage:2880; numberofpages:6; journal:ANNALS OF ONCOLOGY; http://hdl.handle.net/11365/1081322Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84887121328
DOI:	10.1093/annonc/mdt371
الإتاحة:	https://doi.org/10.1093/annonc/mdt371Test http://hdl.handle.net/11365/1081322Test
حقوق:	info:eu-repo/semantics/closedAccess
رقم الانضمام:	edsbas.C0AA604A
قاعدة البيانات:	BASE

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الوصف
DOI:	10.1093/annonc/mdt371