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…

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 : Official Journal of Korean Cancer Association, February 2016

26910471

Keunchil Park, Joo-Hang Kim, Eun Kyung Cho, Jin-Hyoung Kang, Jin-Yuan Shih, Annamaria Hayden Zimmermann, Pablo Lee, Ekaterine Alexandris, Tarun Puri, Mauro Orlando

REVEL demonstrated improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) with docetaxel + ramucirumab vs. docetaxel + placebo in 1253 intent-to-treat (ITT) stage IV non-small-cell lung cancer (NSCLC) patients with disease progression following platinum-based chemotherapy. Results from the East Asian subgroup analysis are reported. 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. In docetaxel + ramucirumab (n=43) vs. docetaxel + placebo (n=46), median OS was 15.44 months vs. 10.17 months (hazard ratio [HR]: 0.762, 95% confidence interval [CI]: 0.444-1.307), median PFS was 4.88 months vs. 2.79 months (HR: 0.658, 95% CI: 0.408-1.060), and ORR was 25.6% (95% CI: 13.5-41.2) vs. 8.7% (95% CI: 2.4-20.8). 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/m(2), n=24). In docetaxel + ramucirumab vs. docetaxel + placebo, incidence of neutropenia was 84.4% vs. 72.7% (75 mg/m(2)) and 54.5% vs. 38.5% (60 mg/m(2)). Incidence of febrile neutropenia was 43.8% vs. 12.1% (75 mg/m(2)) and 0 vs. 7.7% (60 mg/m(2)). 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.