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East Asian Subgroup Analysis of a Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy (REVEL)

Cancer Research and Treatment
2016년 48권 4호 p.1177 ~ p.1186
박근칠 ( Park Keun-Chil ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Medicine Division of Hematology-Oncology

김주항 ( Kim Joo-Hang ) - CHA University CHA Bundang Medical Center Department of Internal Medicine
조은경 ( Cho Eun-Kyung ) - Gachon University Gil Hospital Department of Internal Medicine
강진형 ( Kang Jin-Hyoung ) - Catholic University Seoul St. Mary’s Hospital Department of Medical Oncology
 ( Jin-Yuan Shih ) - National Taiwan University Hospital Department of Internal Medicine
 ( Annamaria Hayden Zimmermann ) - Eli Lilly and Company
 ( Pablo Lee ) - Eli Lilly and Company
 ( Alexandris Ekaterine ) - Eli Lilly and Company
 ( Tarun Puri ) - Eli Lilly and Company
 ( Mauro Orlando ) - Eli Lilly Interamerica Inc.

Abstract

Purpose : REVEL demonstrated improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) with docetaxel+ramucirumab versus docetaxel+placebo in 1,253 intent-to-treat (ITT) stage IV non-small cell lung cancer patients with disease progression following platinum-based chemotherapy. Results from the East Asian subgroup analysis are reported.

Materials and Methods : Subgroup analyses were performed in the East Asian ITT population (n=89). Kaplan-Meier analysis and Cox proportional hazards regression were performed for OS and PFS, and the Cochran-Mantel-Haenszel test was performed for response rate.

Results : In docetaxel+ramucirumab (n=43) versus docetaxel+placebo (n=46), median OS was 15.44 months versus 10.17 months (hazard ratio [HR], 0.762; 95% confidence interval [CI], 0.444 to 1.307), median PFS was 4.88 months versus 2.79 months (HR, 0.658; 95% CI, 0.408 to 1.060), and ORR was 25.6% (95% CI, 13.5 to 41.2) versus 8.7% (95% CI, 2.4 to 20.8). Due to increased incidence of neutropenia and febrile neutropenia in East Asian patients, starting dose of docetaxel was reduced for newly enrolled East Asian patients (75 to 60 mg/m2, n=24). In docetaxel+ramucirumab versus docetaxel+placebo, incidence of neutropenia was 84.4% versus 72.7% (75 mg/m2) and 54.5% versus 38.5% (60 mg/m2). Incidence of febrile neutropenia was 43.8% versus 12.1% (75 mg/m2) and 0% versus 7.7% (60 mg/m2).

Conclusion : Results of this subgroup analysis showed a trend favoring ramucirumab+docetaxel for median OS, PFS, and improved ORR in East Asian patients, consistent with ITT population results. Reduction of starting dose of docetaxel in East Asian patients was associated with improved safety.

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