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
- Authors
- Park, Keunchil; Cho, Eun Kyung; Bello, Maximino; Ahn, Myung-Ju; Thongprasert, Sumitra; Song, Eun-Kee; Soldatenkova, Victoria; Depenbrock, Henrik; Puri, Tarun; Orlando, Mauro
- Issue Date
- Oct-2017
- Publisher
- KOREAN CANCER ASSOCIATION
- Keywords
- Non-small-cell lung carcinoma; Cisplatin; East Asian; Gemcitabine; Necitumumab; Epidermal growth factor receptor
- Citation
- CANCER RESEARCH AND TREATMENT, v.49, no.4, pp.937 - 946
- Journal Title
- CANCER RESEARCH AND TREATMENT
- Volume
- 49
- Number
- 4
- Start Page
- 937
- End Page
- 946
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/5667
- DOI
- 10.4143/crt.2016.423
- ISSN
- 1598-2998
- Abstract
- Purpose 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 1,093 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. Materials and Methods All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m.) and cisplatin (day 1, 75 mg/m.). Patients in the neci+ GC arm also received necitumumab (days 1 and 8, 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from stratified Cox proportional hazards models. Results In EA patients, there were improvements for neci+ GC (n=43) versus GC (n=41) in OS (HR, 0.805; 95% CI, 0.484 to 1.341) and PFS (HR, 0.720; 95% CI, 0.439 to 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 neci+ GC versus GC in EA patients and EA patients versus non-EA patients for neci+ GC. Conclusion 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.
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