Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup…

Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup Analysis of the Phase 3, Open-Label, Randomized SQUIRE Study

Cancer Research and Treatment : Official Journal of Korean Cancer Association, January 2017

28111429

Keunchil Park, Eun Kyung Cho, Maximino Bello, Myung-Ju Ahn, Sumitra Thongprasert, Eun-Kee Song, Victoria Soldatenkova, Henrik Depenbrock, Tarun Puri, Mauro Orlando

The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study. All patients received up to six 3-week cycles of gemcitabine (Days 1, 8; 1250 mg/m²) and cisplatin (Day 1; 75 mg/m²). Patients in the neci+GC arm also received necitumumab (Days 1, 8; 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% CIs were estimated from stratified Cox proportional hazards models. In EA patients, there were improvements for neci+GC (n=43) vs GC (n=41) in OS (HR: 0.805, 95% CI: 0.484-1.341) and PFS (HR: 0.720, 95% CI: 0.439-1.180), consistent with the results for non-EA patients observed in the present study. The overall safety data were consistent between EA and non-EA patients. A numerically higher proportion of patients experienced serious adverse events (AEs), Grade ≥3 AEs, and AEs with an outcome of death for (i) neci+GC vs GC in EA patients and (ii) EA patients vs non-EA patients for neci+GC. Although limited by the small sample size and post hoc nature of the analysis, these findings are consistent with those of the overall study and suggest that neci+GC offers a survival advantage and favorable benefit/risk for EA patients with advanced squamous NSCLC.