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Ann Oncol. 2013 Nov;24(11):2875-80. doi: 10.1093/annonc/mdt371. Epub 2013 Sep 19.

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

Collaborators (180)

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, El Kouri C, Baize N, Scherpereel A, Molinier O, Fuchs F, Josten KM, Manegold C, 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, Prasad SV, 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, 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 D, Berry W, Ottensmeier C, Dangoor A, Steele N, Summers Y, Rankin E, Rowley K, Giridharan S, Kristeleit H, Humber C, Taylor P.

Author information

1
Department of Oncology, Robert W. Woodruff Health Sciences Center of Emory University, Atlanta.

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.

KEYWORDS:

immunotherapy; non-small-cell lung cancer; phase III study; talactoferrin

PMID:
24050956
DOI:
10.1093/annonc/mdt371
[Indexed for MEDLINE]

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