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)
Journal
Cancer Research and Treatment
Journal Volume
48
Journal Issue
4
Pages
1177-1186
Date Issued
2016
Author(s)
Park K.
Kim J.-H.
Cho E.K.
Kang J.-H.
Zimmermann A.H.
Lee P.
Alexandris E.
Puri T.
Orlando M.
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. ? 2016 by the Korean Cancer Association.
SDGs
Other Subjects
antineoplastic metal complex; bevacizumab; docetaxel; placebo; ramucirumab; taxane derivative; antineoplastic agent; docetaxel; monoclonal antibody; platinum; ramucirumab; taxoid; adult; aged; alopecia; anemia; Article; bleeding; cancer survival; controlled study; coughing; decreased appetite; diarrhea; digestive system perforation; disease course; double blind procedure; drug dose reduction; dyspnea; East Asian; fatigue; febrile neutropenia; female; fever; gastrointestinal hemorrhage; hazard ratio; human; hypertension; infusion related reaction; insomnia; lung hemorrhage; major clinical study; male; multicenter study; myalgia; nausea; neutropenia; non small cell lung cancer; oropharynx pain; overall survival; peripheral neuropathy; phase 3 clinical trial; progression free survival; proteinuria; randomized controlled trial; sensory neuropathy; stomatitis; thrombocytopenia; treatment response; Asian continental ancestry group; cancer staging; clinical trial; disease exacerbation; disease free survival; middle aged; non small cell lung cancer; pathology; treatment outcome; Adult; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Asian Continental Ancestry Group; Carcinoma, Non-Small-Cell Lung; Disease Progression; Disease-Free Survival; Double-Blind Method; Female; Humans; Male; Middle Aged; Neoplasm Staging; Placebos; Platinum; Taxoids; Treatment Outcome
Publisher
Korean Cancer Association
Type
journal article