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 (1.5 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.
Original language | English (US) |
---|---|
Article number | mdt371 |
Pages (from-to) | 2875-2880 |
Number of pages | 6 |
Journal | Annals of Oncology |
Volume | 24 |
Issue number | 11 |
DOIs | |
State | Published - Nov 1 2013 |
Fingerprint
All Science Journal Classification (ASJC) codes
- Hematology
- Oncology
Cite this
}
Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). / 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.; Barlesi, F.; 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.; Manegold, C.; 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.; Chang, A.; 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.; Crawford, J.; Giaccone, G.; Haigentz, M.; Owonikoko, T.; 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.
In: Annals of Oncology, Vol. 24, No. 11, mdt371, 01.11.2013, p. 2875-2880.Research output: Contribution to journal › Article
TY - JOUR
T1 - Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)
AU - Ramalingam, S.
AU - Crawford, J.
AU - Chang, A.
AU - Manegold, C.
AU - Perez-Soler, R.
AU - Douillard, J. Y.
AU - Thatcher, N.
AU - Barlesi, F.
AU - Owonikoko, T.
AU - Wang, Y.
AU - Pultar, P.
AU - Zhu, J.
AU - Malik, R.
AU - Malik Giaccone, R.
AU - Della-Fiorentina, S.
AU - Begbie, S.
AU - Jennens, R.
AU - Dass, J.
AU - Pittman, K.
AU - Ivanova, N.
AU - Koynova, T.
AU - Petrov, P.
AU - Tomova, A.
AU - Tzekova, V.
AU - Couture, F.
AU - Hirsh, V.
AU - Burkes, R.
AU - Sangha, R.
AU - Ambrus, M.
AU - Janaskova, T.
AU - Musil, J.
AU - Novotny, J.
AU - Zatloukal, P.
AU - Jakesova, J.
AU - Klenha, K.
AU - Roubec, J.
AU - Vanasek, J.
AU - Fayette, J.
AU - Barlesi, F.
AU - Bennouna-Louridi, J.
AU - Chouaid, C.
AU - Mazières, J.
AU - Vallerand, H.
AU - Robinet, G.
AU - Souquet, P. J.
AU - Spaeth, D.
AU - Schott, R.
AU - Lena, H.
AU - Martinet, Y.
AU - Kouri, C. E.
AU - Baize, N.
AU - Scherpereel, A.
AU - Molinier, O.
AU - Fuchs, F.
AU - Josten, K. M.
AU - Manegold, C.
AU - Marschner, N.
AU - Schneller, F.
AU - Overbeck, T.
AU - Thomas, M.
AU - von Pawel, J.
AU - Reck Schuette, M.
AU - Hagen, V.
AU - Schneider, C. P.
AU - Georgoulias, V.
AU - Varthalitis, I.
AU - Zarogoulidis, K.
AU - Syrigos, K.
AU - Papandreou, C.
AU - Bocskei, C.
AU - Csanky, E.
AU - Juhasz, E.
AU - Losonczy, G.
AU - Mark, Z.
AU - Molnar, I.
AU - Papai-Szekely, Z.
AU - Tehenes, S.
AU - Vinkler, I.
AU - Almel, S.
AU - Bakshi, A.
AU - Bondarde, S.
AU - Maru, A.
AU - Pathak, A.
AU - Pedapenki, R. M.
AU - Prasad, K.
AU - Prasad, S. V.S.S.
AU - Kilara, N.
AU - Gorijavolu, D.
AU - Deshmukh, C. D.
AU - John, S.
AU - Sharma, L. M.
AU - Amoroso, D.
AU - Bajetta, E.
AU - Bidoli, P.
AU - Bonetti, A.
AU - De Marinis, F.
AU - Maio, M.
AU - Passalacqua, R.
AU - Cascinu, S.
AU - Bearz, A.
AU - Bitina, M.
AU - Brize, A.
AU - Purkalne, G.
AU - Skrodele, M.
AU - Baba, A. A.
AU - Ratnavelu, K.
AU - Saw, M. H.
AU - Samson-Fernando, M. C.
AU - Ladrera, G. E.
AU - Jassem, J.
AU - Koralewski, P.
AU - Sikorska, L.
AU - Serwatowski, P.
AU - Krzakowski, M.
AU - Cebotaru, C.
AU - Filip, D.
AU - Ganea-Motan, D. E.
AU - Ianuli, C. H.
AU - Manolescu, I. G.
AU - Udrea, A.
AU - Burdaeva, O.
AU - Byakhov, M.
AU - Filippov, A.
AU - Lazarev, S.
AU - Mosin, I.
AU - Orlov, S.
AU - Udovitsa, D.
AU - Khorinko, A.
AU - Protsenko, S.
AU - Chang, A.
AU - Lim, H. L.
AU - Tan, Y. O.
AU - Tan, E. H.
AU - Bastus Piulats, R.
AU - Garcia-Foncillas, J.
AU - Valdivia, J.
AU - de Castro, J.
AU - Domine Gomez, M.
AU - Kim, S. W.
AU - Lee, J. S.
AU - Kim, H. K.
AU - Lee, J. S.
AU - Shin, S. W.
AU - Kim, D. W.
AU - Kim, Y. C.
AU - Park, K. C.
AU - Chang, C. S.
AU - Chang, G. C.
AU - Goan, Y. G.
AU - Su, W. C.
AU - Tsai, C. M.
AU - Kuo, H. P.
AU - Benekli, M.
AU - Demir, G.
AU - Gokmen, E.
AU - Sevinc, A.
AU - Crawford, J.
AU - Giaccone, G.
AU - Haigentz, M.
AU - Owonikoko, T.
AU - Agarwal, M.
AU - Pandit, S.
AU - Araujo, R.
AU - Vrindavanam, N.
AU - Bonomi, P.
AU - Berg, A.
AU - Wade, J.
AU - Bloom, R.
AU - Amin, B.
AU - Camidge, R.
AU - Hill, D.
AU - Rarick, M.
AU - Flynn, P.
AU - Klein, L.
AU - Lo Russo, K.
AU - Neubauer, M.
AU - Richards, P.
AU - Ruxer, R.
AU - Savin, M.
AU - Weckstein, D.
AU - Rosenberg, R.
AU - Whittaker, T.
AU - Richards Berry, D.
AU - Ottensmeier, C.
AU - Dangoor, A.
AU - Steele, N.
AU - Summers, Y.
AU - Rankin, E.
AU - Rowley, K.
AU - Giridharan, S.
AU - Kristeleit, H.
AU - Humber, C.
AU - Taylor, P.
PY - 2013/11/1
Y1 - 2013/11/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84887121328&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84887121328&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdt371
DO - 10.1093/annonc/mdt371
M3 - Article
C2 - 24050956
AN - SCOPUS:84887121328
VL - 24
SP - 2875
EP - 2880
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 11
M1 - mdt371
ER -