Cancer Res Treat.  2017 Oct;49(4):937-946. 10.4143/crt.2016.423.

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

• Park K
• Cho EK
• Bello M
• Ahn MJ
• Thongprasert S
• Song EK
• Soldatenkova V
• Depenbrock H
• Puri T
• Orlando M

• KMID: 2394813
• DOI: http://doi.org/10.4143/crt.2016.423

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.

Keyword

Non-small-cell lung carcinoma; Cisplatin; East Asian; Gemcitabine; Necitumumab; Epidermal growth factor receptor

MeSH Terms

Arm
Asian Continental Ancestry Group*
Carcinoma, Non-Small-Cell Lung*
Cisplatin*
Disease Progression
Disease-Free Survival
Humans
Proportional Hazards Models
Receptor, Epidermal Growth Factor
Sample Size
Cisplatin
Receptor, Epidermal Growth Factor

Figure

• 

  Fig. 1. Patient flow for EA patients enrolled in the SQUIRE study. Note that patients in the neci+GC arm who had not progressed at the end of the induction phase could continue to receive single-agent necitumumab in the continuation phase until radiographic documentation of disease progression, unacceptable toxicity, or withdrawal of consent. EA, East Asian; neci+GC, necitumumab plus gemcitabine and cisplatin; GC, gemcitabine and cisplatin; ITT, intent-to-treat.

• 

  Fig. 2. Kaplan-Meier analysis of overall survival and progression-free survival in the EA and non-EA subpopulations. Overall survival in the neci+GC and GC arms in the EA subpopulation (A) and non-EA subpopulation (B). Progression-free survival in the neci+GC and GC arms in the EA subpopulation (C) and non-EA subpopulation (D). EA, East Asian; neci+GC, necitumumab plus gemcitabine and cisplatin; GC, gemcitabine and cisplatin; HR, hazard ratio; CI, confidence interval.

Reference

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