Meta-analysis of individual patient data from randomized trials of chemotherapy plus cetuximab as first-line treatment for advanced non-small cell lung cancer

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• 作者：Jean-Louis Pujol ; Robert Pirker ; Thomas J. Lynch ; Charles A. Butts ; Rafael Rosell ; Frances A. Shepherd ; Johan Vansteenkiste ; Kenneth J. O鈥橞yrne ; Barbara de Blas ; Jim Heighway ; Anja von Heydebreck ; Nick Thatcher
• 关键词：Cetuximab ; First-line ; NSCLC ; Meta-analysis ; Chemotherapy ; Tumor
• 刊名：Lung Cancer
• 出版年：February, 2014
• 年：2014
• 卷：83
• 期：2
• 页码：211-218
• 全文大小：805 K

文摘

Objectives

Four randomized phase II/III trials investigated the addition of cetuximab to platinum-based, first-line chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). A meta-analysis was performed to examine the benefit/risk ratio for the addition of cetuximab to chemotherapy.

Materials and methods

The meta-analysis included individual patient efficacy data from 2018 patients and individual patient safety data from 1970 patients comprising respectively the combined intention-to-treat and safety populations of the four trials. The effect of adding cetuximab to chemotherapy was measured by hazard ratios (HRs) obtained using a Cox proportional hazards model and odds ratios calculated by logistic regression. Survival rates at 1 year were calculated. All applied models were stratified by trial. Tests on heterogeneity of treatment effects across the trials and sensitivity analyses were performed for all endpoints.

Results

The meta-analysis demonstrated that the addition of cetuximab to chemotherapy significantly improved overall survival (HR 0.88, p = 0.009, median 10.3 vs 9.4 months), progression-free survival (HR 0.90, p = 0.045, median 4.7 vs 4.5 months) and response (odds ratio 1.46, p < 0.001, overall response rate 32.2% vs 24.4%) compared with chemotherapy alone. The safety profile of chemotherapy plus cetuximab in the meta-analysis population was confirmed as manageable. Neither trials nor patient subgroups defined by key baseline characteristics showed significant heterogeneity for any endpoint.

Conclusion

The addition of cetuximab to platinum-based, first-line chemotherapy for advanced NSCLC significantly improved outcome for all efficacy endpoints with an acceptable safety profile, indicating a favorable benefit/risk ratio.