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.

• Authors: 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, G Giaccone, FORTIS-M Study Investigators
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 24 Issue 11 Pg. 2875-80 (Nov 2013) ISSN: 1569-8041 [Electronic] England
• PMID: 24050956 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• talactoferrin alfa
• Lactoferrin

Topics

• Aged
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• Disease-Free Survival
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Immunotherapy
• Kaplan-Meier Estimate
• Lactoferrin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Neoplasm Staging
• Placebos
• Treatment Outcome