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

摘要: 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 international, multicenter, randomized, double-blind comparison of (1.5 g p.o. BID) versus BID, patients with stage IIIB/IV NSCLC whose disease had failed two or more prior regimens. Treatment administered for a maximum five 14-week cycles. The primary efficacy end point overall survival (OS); secondary points included 6- 12-month survival, progression-free (PFS), control rate (DCR). Results Seven hundred forty-two were randomly assigned (2:1) (497) (245). median OS the intent-to-treat (ITT) population 7.66 months arm 7.49 [hazard ratio (HR), 1.04; 95% CI, 0.873–1.24; P = 0.6602]. 6-month rates 59.9% (95% 53.4% 65.8%) 55.7% 51.1% 59.9%), respectively. 32.2% 26.3% 38.2%) 30.9% 26.8% 35%), PFS 1.64 1.68 months, respectively (HR, 0.99; 0.835–1.16; 0.8073). DCRs 38.4 37.6%, [stratified odds (OR), 0.96; 0.698–1.33; 0.8336]. safety profiles comparable between arms. Conclusions There no improvement previous