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; Fabrice Barlési; T. Owonikoko; Y. Wang; P. Pultar; J. Zhu; R. Malik; G. Giaccone; S. Della-Fiorentina; S. Begbie; R. Jennens; J. Dass; K. Pittman; N. Ivanova; T. 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; J. Bennouna-Louridi; C. Chouaid; J. Mazières; H. Vallerand; G. Robinet; P. J. Souquet; D. Spaeth; R. Schott; H. Lena; Y. Martinet; C. El Kouri; N. Baize; A. Scherpereel; O. Molinier; F. Fuchs; K. M. Josten; N. Marschner; F. Schneller; T. Overbeck; M. Thomas; J. von Pawel; M. Reck; W. 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; 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; 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; M. Haigentz; 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; W. Berry; C. Ottensmeier; A. Dangoor; N. Steele; Y. Summers; E. Rankin; K. Rowley; S. Giridharan; H. Kristeleit; C. Humber; P. Taylor

doi:10.1093/annonc/mdt371

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, Fabrice Barlési, T. Owonikoko, Y. Wang, P. Pultar, J. Zhu, R. Malik, G. 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, J. Bennouna-Louridi, C. Chouaid, J. Mazières, H. Vallerand, G. Robinet, P. J. Souquet, D. Spaeth, R. Schott, H. Lena, Y. Martinet, C. El Kouri, N. Baize, A. Scherpereel, O. Molinier, F. Fuchs, K. M. Josten, N. Marschner, F. Schneller, T. Overbeck, M. Thomas, J. von Pawel, M. Reck, W. 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, 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, 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, M. Haigentz, 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, W. 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 journal › Article › peer-review

51 Scopus citations

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)
Pages (from-to)	2875-2880
Number of pages	6
Journal	Annals of Oncology
Volume	24
Issue number	11
DOIs	https://doi.org/10.1093/annonc/mdt371
State	Published - Nov 2013

All Science Journal Classification (ASJC) codes

Hematology
Oncology

Access to Document

10.1093/annonc/mdt371

Cite this

Ramalingam, S., Crawford, J., Chang, A., Manegold, C., Perez-Soler, R., Douillard, J. Y., Thatcher, N., Barlési, F., Owonikoko, T., Wang, Y., Pultar, P., Zhu, J., Malik, R., Giaccone, G., Della-Fiorentina, S., Begbie, S., Jennens, R., Dass, J., Pittman, K., ... 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. https://doi.org/10.1093/annonc/mdt371

@article{d5330619a7dc4254bb7f9279a13d4969,

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 Fabrice Barl{\'e}si and T. Owonikoko and Y. Wang and P. Pultar and J. Zhu and R. Malik and G. Giaccone 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 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 {El Kouri}, C. and N. Baize and A. Scherpereel and O. Molinier and F. Fuchs and Josten, {K. M.} and N. Marschner and F. Schneller and T. Overbeck and M. Thomas and {von Pawel}, J. and M. Reck and W. Schuette 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 {V S S Prasad}, 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 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 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 M. Haigentz 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 D. Richards and W. Berry 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 = nov,

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, Barlési, F, Owonikoko, T, Wang, Y, Pultar, P, Zhu, J, Malik, R, Giaccone, G, 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, PJ, Spaeth, D, Schott, R, Lena, H, Martinet, Y, El Kouri, C, Baize, N, Scherpereel, A, Molinier, O, Fuchs, F, Josten, KM, Marschner, N, Schneller, F, Overbeck, T, Thomas, M, von Pawel, J, Reck, M, Schuette, W, 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, V S S Prasad, S, 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, 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, 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, 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, D, Berry, W, 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, pp. 2875-2880. https://doi.org/10.1093/annonc/mdt371

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 - Barlési, Fabrice

AU - Owonikoko, T.

AU - Wang, Y.

AU - Pultar, P.

AU - Zhu, J.

AU - Malik, R.

AU - Giaccone, G.

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 - 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 - El Kouri, C.

AU - Baize, N.

AU - Scherpereel, A.

AU - Molinier, O.

AU - Fuchs, F.

AU - Josten, K. M.

AU - Marschner, N.

AU - Schneller, F.

AU - Overbeck, T.

AU - Thomas, M.

AU - von Pawel, J.

AU - Reck, M.

AU - Schuette, W.

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 - V S S Prasad, 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 - 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 - 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 - Haigentz, M.

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, D.

AU - Berry, W.

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

Y1 - 2013/11

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.

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U2 - 10.1093/annonc/mdt371

DO - 10.1093/annonc/mdt371

M3 - Article

C2 - 24050956

AN - SCOPUS:84887121328

SN - 0923-7534

VL - 24

SP - 2875

EP - 2880

JO - Annals of Oncology

JF - Annals of Oncology

IS - 11

ER -

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

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