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

Publication ,  Journal Article
Ramalingam, S; Crawford, J; Chang, A; Manegold, C; Perez-Soler, R; Douillard, J-Y; Thatcher, N; Barlesi, F; Owonikoko, T; Wang, Y; Pultar, P ...
Published in: Ann Oncol
November 2013

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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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

November 2013

Volume

24

Issue

11

Start / End Page

2875 / 2880

Location

England

Related Subject Headings

  • Treatment Outcome
  • Placebos
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lactoferrin
  • Kaplan-Meier Estimate
  • Immunotherapy
  • Humans
 

Citation

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Ramalingam, S., Crawford, J., Chang, A., Manegold, C., Perez-Soler, R., Douillard, J.-Y., … FORTIS-M Study Investigators, . (2013). Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). Ann Oncol, 24(11), 2875–2880. https://doi.org/10.1093/annonc/mdt371
Ramalingam, S., J. Crawford, A. Chang, C. Manegold, R. Perez-Soler, J. -. Y. Douillard, N. Thatcher, et al. “Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial).Ann Oncol 24, no. 11 (November 2013): 2875–80. https://doi.org/10.1093/annonc/mdt371.
Ramalingam S, Crawford J, Chang A, Manegold C, Perez-Soler R, Douillard J-Y, et al. Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). Ann Oncol. 2013 Nov;24(11):2875–80.
Ramalingam, S., et al. “Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial).Ann Oncol, vol. 24, no. 11, Nov. 2013, pp. 2875–80. Pubmed, doi: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, Giaccone G, FORTIS-M Study Investigators. Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). Ann Oncol. 2013 Nov;24(11):2875–2880.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

November 2013

Volume

24

Issue

11

Start / End Page

2875 / 2880

Location

England

Related Subject Headings

  • Treatment Outcome
  • Placebos
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lactoferrin
  • Kaplan-Meier Estimate
  • Immunotherapy
  • Humans