Cancer Res Treat.  2016 Oct;48(4):1177-1186. 10.4143/crt.2015.401.

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)

• Park K
• Kim JH
• Cho EK
• Kang JH
• Shih JY
• Zimmermann AH
• Lee P
• Alexandris E
• Puri T
• Orlando M

• KMID: 2356220
• DOI: http://doi.org/10.4143/crt.2015.401

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.

Keyword

Ramucirumab; Docetaxel; Non-small-cell lung carcinoma; East Asia

MeSH Terms

Asian Continental Ancestry Group*
Carcinoma, Non-Small-Cell Lung*
Disease Progression*
Disease-Free Survival
Drug Therapy
Far East
Febrile Neutropenia
Humans
Incidence
Kaplan-Meier Estimate
Neutropenia

Figure

• 

  Fig. 1. Kaplan-Meier estimates of overall survival for East Asian patients (A) and non–East Asian patients (B). CI, confidence interval; HR, hazard ratio.

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  Fig. 2. Kaplan-Meier estimates of progression-free survival for East Asian patients (A) and non–East Asian patients (B). CI, confidence interval; HR, hazard ratio.

Reference

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