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

S. Ramalingam, J. Crawford, A. Chang, C. Manegold, R. Perez-Soler, J. Y. Douillard, N. Thatcher, F. Barlesi, T. Owonikoko, Y. Wang, P. Pultar, J. Zhu, R. Malik, R. Malik Giaccone, S. Della-Fiorentina, S. Begbie, R. Jennens, J. Dass, K. Pittman, N. IvanovaT. Koynova, P. Petrov, A. Tomova, V. Tzekova, F. Couture, V. Hirsh, R. Burkes, R. Sangha, M. Ambrus, T. Janaskova, J. Musil, J. Novotny, P. Zatloukal, J. Jakesova, K. Klenha, J. Roubec, J. Vanasek, J. Fayette, F. Barlesi, J. Bennouna-Louridi, C. Chouaid, J. Mazières, H. Vallerand, G. Robinet, P. J. Souquet, D. Spaeth, R. Schott, H. Lena, Y. Martinet, C. E. Kouri, N. Baize, A. Scherpereel, O. Molinier, F. Fuchs, K. M. Josten, C. Manegold, N. Marschner, F. Schneller, T. Overbeck, M. Thomas, J. von Pawel, M. Reck Schuette, V. Hagen, C. P. Schneider, V. Georgoulias, I. Varthalitis, K. Zarogoulidis, K. Syrigos, C. Papandreou, C. Bocskei, E. Csanky, E. Juhasz, G. Losonczy, Z. Mark, I. Molnar, Z. Papai-Szekely, S. Tehenes, I. Vinkler, S. Almel, A. Bakshi, S. Bondarde, A. Maru, A. Pathak, R. M. Pedapenki, K. Prasad, S. V.S.S. Prasad, N. Kilara, D. Gorijavolu, C. D. Deshmukh, S. John, L. M. Sharma, D. Amoroso, E. Bajetta, P. Bidoli, A. Bonetti, F. De Marinis, M. Maio, R. Passalacqua, S. Cascinu, A. Bearz, M. Bitina, A. Brize, G. Purkalne, M. Skrodele, A. A. Baba, K. Ratnavelu, M. H. Saw, M. C. Samson-Fernando, G. E. Ladrera, J. Jassem, P. Koralewski, L. Sikorska, P. Serwatowski, M. Krzakowski, C. Cebotaru, D. Filip, D. E. Ganea-Motan, C. H. Ianuli, I. G. Manolescu, A. Udrea, O. Burdaeva, M. Byakhov, A. Filippov, S. Lazarev, I. Mosin, S. Orlov, D. Udovitsa, A. Khorinko, S. Protsenko, A. Chang, H. L. Lim, Y. O. Tan, E. H. Tan, R. Bastus Piulats, J. Garcia-Foncillas, J. Valdivia, J. de Castro, M. Domine Gomez, S. W. Kim, J. S. Lee, H. K. Kim, J. S. Lee, S. W. Shin, D. W. Kim, Y. C. Kim, K. C. Park, C. S. Chang, G. C. Chang, Y. G. Goan, W. C. Su, C. M. Tsai, H. P. Kuo, M. Benekli, G. Demir, E. Gokmen, A. Sevinc, J. Crawford, G. Giaccone, M. Haigentz, T. Owonikoko, M. Agarwal, S. Pandit, R. Araujo, N. Vrindavanam, P. Bonomi, A. Berg, J. Wade, R. Bloom, B. Amin, R. Camidge, D. Hill, M. Rarick, P. Flynn, L. Klein, K. Lo Russo, M. Neubauer, P. Richards, R. Ruxer, M. Savin, D. Weckstein, R. Rosenberg, T. Whittaker, D. Richards Berry, C. Ottensmeier, A. Dangoor, N. Steele, Y. Summers, E. Rankin, K. Rowley, S. Giridharan, H. Kristeleit, C. Humber, P. Taylor

Research output: Contribution to journalArticle

33 Citations (Scopus)

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 languageEnglish (US)
Article numbermdt371
Pages (from-to)2875-2880
Number of pages6
JournalAnnals of Oncology
Volume24
Issue number11
DOIs
StatePublished - Nov 1 2013

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Non-Small Cell Lung Carcinoma
Placebos
Survival Rate
Disease-Free Survival
Survival
Immunotherapy
Dendritic Cells
talactoferrin alfa
Odds Ratio
Safety
Population

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Ramalingam, S., Crawford, J., Chang, A., Manegold, C., Perez-Soler, R., Douillard, J. Y., ... Taylor, P. (2013). Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). Annals of Oncology, 24(11), 2875-2880. [mdt371]. https://doi.org/10.1093/annonc/mdt371
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. / Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). In: Annals of Oncology. 2013 ; Vol. 24, No. 11. pp. 2875-2880.
@article{6b60902bb017400492db657c1fdc84d3,
title = "Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)",
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.",
author = "S. Ramalingam and J. Crawford and A. Chang and C. Manegold and R. Perez-Soler and Douillard, {J. Y.} and N. Thatcher and F. Barlesi and T. Owonikoko and Y. Wang and P. Pultar and J. Zhu and R. Malik and {Malik Giaccone}, R. and S. Della-Fiorentina and S. Begbie and R. Jennens and J. Dass and K. Pittman and N. Ivanova and T. Koynova and P. Petrov and A. Tomova and V. Tzekova and F. Couture and V. Hirsh and R. Burkes and R. Sangha and M. Ambrus and T. Janaskova and J. Musil and J. Novotny and P. Zatloukal and J. Jakesova and K. Klenha and J. Roubec and J. Vanasek and J. Fayette and F. Barlesi and J. Bennouna-Louridi and C. Chouaid and J. Mazi{\`e}res and H. Vallerand and G. Robinet and Souquet, {P. J.} and D. Spaeth and R. Schott and H. Lena and Y. Martinet and Kouri, {C. E.} and N. Baize and A. Scherpereel and O. Molinier and F. Fuchs and Josten, {K. M.} and C. Manegold and N. Marschner and F. Schneller and T. Overbeck and M. Thomas and {von Pawel}, J. and {Reck Schuette}, M. and V. Hagen and Schneider, {C. P.} and V. Georgoulias and I. Varthalitis and K. Zarogoulidis and K. Syrigos and C. Papandreou and C. Bocskei and E. Csanky and E. Juhasz and G. Losonczy and Z. Mark and I. Molnar and Z. Papai-Szekely and S. Tehenes and I. Vinkler and S. Almel and A. Bakshi and S. Bondarde and A. Maru and A. Pathak and Pedapenki, {R. M.} and K. Prasad and Prasad, {S. V.S.S.} and N. Kilara and D. Gorijavolu and Deshmukh, {C. D.} and S. John and Sharma, {L. M.} and D. Amoroso and E. Bajetta and P. Bidoli and A. Bonetti and {De Marinis}, F. and M. Maio and R. Passalacqua and S. Cascinu and A. Bearz and M. Bitina and A. Brize and G. Purkalne and M. Skrodele and Baba, {A. A.} and K. Ratnavelu and Saw, {M. H.} and Samson-Fernando, {M. C.} and Ladrera, {G. E.} and J. Jassem and P. Koralewski and L. Sikorska and P. Serwatowski and M. Krzakowski and C. Cebotaru and D. Filip and Ganea-Motan, {D. E.} and Ianuli, {C. H.} and Manolescu, {I. G.} and A. Udrea and O. Burdaeva and M. Byakhov and A. Filippov and S. Lazarev and I. Mosin and S. Orlov and D. Udovitsa and A. Khorinko and S. Protsenko and A. Chang and Lim, {H. L.} and Tan, {Y. O.} and Tan, {E. H.} and {Bastus Piulats}, R. and J. Garcia-Foncillas and J. Valdivia and {de Castro}, J. and {Domine Gomez}, M. and Kim, {S. W.} and Lee, {J. S.} and Kim, {H. K.} and Lee, {J. S.} and Shin, {S. W.} and Kim, {D. W.} and Kim, {Y. C.} and Park, {K. C.} and Chang, {C. S.} and Chang, {G. C.} and Goan, {Y. G.} and Su, {W. C.} and Tsai, {C. M.} and Kuo, {H. P.} and M. Benekli and G. Demir and E. Gokmen and A. Sevinc and J. Crawford and G. Giaccone and M. Haigentz and T. Owonikoko and M. Agarwal and S. Pandit and R. Araujo and N. Vrindavanam and P. Bonomi and A. Berg and J. Wade and R. Bloom and B. Amin and R. Camidge and D. Hill and M. Rarick and P. Flynn and L. Klein and {Lo Russo}, K. and M. Neubauer and P. Richards and R. Ruxer and M. Savin and D. Weckstein and R. Rosenberg and T. Whittaker and {Richards Berry}, D. and C. Ottensmeier and A. Dangoor and N. Steele and Y. Summers and E. Rankin and K. Rowley and S. Giridharan and H. Kristeleit and C. Humber and P. Taylor",
year = "2013",
month = "11",
day = "1",
doi = "10.1093/annonc/mdt371",
language = "English (US)",
volume = "24",
pages = "2875--2880",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "11",

}

Ramalingam, S, Crawford, J, Chang, A, Manegold, C, Perez-Soler, R, Douillard, JY, 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, PJ, Spaeth, D, Schott, R, Lena, H, Martinet, Y, Kouri, CE, Baize, N, Scherpereel, A, Molinier, O, Fuchs, F, Josten, KM, Manegold, C, Marschner, N, Schneller, F, Overbeck, T, Thomas, M, von Pawel, J, Reck Schuette, M, Hagen, V, Schneider, CP, 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, RM, Prasad, K, Prasad, SVSS, Kilara, N, Gorijavolu, D, Deshmukh, CD, John, S, Sharma, LM, 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, AA, Ratnavelu, K, Saw, MH, Samson-Fernando, MC, Ladrera, GE, Jassem, J, Koralewski, P, Sikorska, L, Serwatowski, P, Krzakowski, M, Cebotaru, C, Filip, D, Ganea-Motan, DE, Ianuli, CH, Manolescu, IG, Udrea, A, Burdaeva, O, Byakhov, M, Filippov, A, Lazarev, S, Mosin, I, Orlov, S, Udovitsa, D, Khorinko, A, Protsenko, S, Chang, A, Lim, HL, Tan, YO, Tan, EH, Bastus Piulats, R, Garcia-Foncillas, J, Valdivia, J, de Castro, J, Domine Gomez, M, Kim, SW, Lee, JS, Kim, HK, Lee, JS, Shin, SW, Kim, DW, Kim, YC, Park, KC, Chang, CS, Chang, GC, Goan, YG, Su, WC, Tsai, CM, Kuo, HP, 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 2013, 'Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)', Annals of Oncology, vol. 24, no. 11, mdt371, pp. 2875-2880. https://doi.org/10.1093/annonc/mdt371

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 journalArticle

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.

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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 -

Ramalingam S, Crawford J, Chang A, Manegold C, Perez-Soler R, Douillard JY et al. Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). Annals of Oncology. 2013 Nov 1;24(11):2875-2880. mdt371. https://doi.org/10.1093/annonc/mdt371