title: 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).
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
authors.forename: Joo-Hang
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Division of Hematology, Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Korea.
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.affiliation: Department of Medical Oncology, College of Medicine, The Catholic University of Korea, St. Mary's Hospital, Seoul, Korea.
authors.forename: Jin-Hyoung
authors.initials: JH
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Jin-Yuan
authors.initials: JY
authors.lastname: Shih
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Annamaria Hayden
authors.initials: AH
authors.lastname: Zimmermann
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Pablo
authors.initials: P
authors.lastname: Lee
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Ekaterine
authors.initials: E
authors.lastname: Alexandris
authors.affiliation: Eli Lilly and Company, Gurgaon, Haryana, India.
authors.forename: Tarun
authors.initials: T
authors.lastname: Puri
authors.affiliation: Eli Lilly Interamerica, Buenos Aires, Argentina.
authors.forename: Mauro
authors.initials: M
authors.lastname: Orlando
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010919:Placebos; D010984:Platinum / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D010919:Placebos; D010984:Platinum; D043823:Taxoids; D000096662:Ramucirumab
keywords: Docetaxel; East Asia; Non-small-cell lung carcinoma; Ramucirumab