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

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Research output: Contribution to journalArticle

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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
Article numbermdt371
Pages (from-to)2875-2880
Number of pages6
JournalAnnals of Oncology
Volume24
Issue number11
DOIs
Publication statusPublished - 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

Keywords

  • Immunotherapy
  • Non-small-cell lung cancer
  • Phase III study
  • Talactoferrin

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

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

In: Annals of Oncology, Vol. 24, No. 11, mdt371, 01.11.2013, p. 2875-2880.

Research output: Contribution to journalArticle

@article{f86fd94de7e64df2b6c8bde6239f9e0c,
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.",
keywords = "Immunotherapy, Non-small-cell lung cancer, Phase III study, Talactoferrin",
author = "Unknown and 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 Kuo, {H. P.}",
year = "2013",
month = "11",
day = "1",
doi = "10.1093/annonc/mdt371",
language = "English",
volume = "24",
pages = "2875--2880",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
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TY - JOUR

T1 - Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

AU - Unknown

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 - Kuo, H. 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.

KW - Immunotherapy

KW - Non-small-cell lung cancer

KW - Phase III study

KW - Talactoferrin

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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 -