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Clinical Trial
. 2016 Oct;48(4):1177-1186.
doi: 10.4143/crt.2015.401. Epub 2016 Feb 22.

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)

Keunchil Park  1 , Joo-Hang Kim  2 , Eun Kyung Cho  3 , Jin-Hyoung Kang  4 , Jin-Yuan Shih  5 , Annamaria Hayden Zimmermann  6 , Pablo Lee  6 , Ekaterine Alexandris  6 , Tarun Puri  7 , Mauro Orlando  8
Affiliations
Clinical Trial

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)

Keunchil Park et al. Cancer Res Treat. 2016 Oct.

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.

Keywords: Docetaxel; East Asia; Non-small-cell lung carcinoma; Ramucirumab.

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Conflict of interest statement

Jin-Hyoung Kang and Jin-Yuan Shih received honoraria from Eli Lilly and Company. Annamaria Hayden Zimmermann, Pablo Lee, Ekaterine Alexandris, Tarun Puri, and Mauro Orlando are employees of Eli Lilly & Company. Tarun Puri and Mauro Orlando hold stock with Eli Lilly and Company. All remaining authors have declared no conflicts of interest. This study was sponsored by Eli Lilly and Company.

Figures

Fig. 1.
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.
Fig. 2.
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.
See this image and copyright information in PMC

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