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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
2017년 49권 4호 p.937 ~ p.946
박근칠 ( Park Keun-Chil ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Medicine

조은경 ( Cho Eun-Kyung ) - Gachon University Gil Medical Center Department of Internal Medicine
 ( Bello Maximino ) - Saint Luke’s Medical Center
안명주 ( Ahn Myung-Ju ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Medicine
 ( Thongprasert Sumitra ) - Chiang Mai University Faculty of Medicine Department of Medicine
송은기 ( Song Eun-Kee ) - Jeonbuk National University Hospital Department of Internal Medicine
 ( Soldatenkova Victoria ) - Lilly Deutschland GmbH
 ( Depenbrock Henrik ) - Lilly Deutschland GmbH
 ( Puri Tarun ) - Eli Lilly and Company
 ( Orlando Mauro ) - Eli Lilly and Company

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/m²) and cisplatin (day 1, 75 mg/m²). 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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