Kei Muro1, Sang Cheul Oh2, Yasuhiro Shimada3, Keun-Wook Lee4, Chia-Jui Yen5,6, Yee Chao7,8, Jae Yong Cho9, Rebecca Cheng10, Roberto Carlesi11, Kumari Chandrawansa12, Mauro Orlando13, Atsushi Ohtsu14. 1. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 2. Division of Oncology and Hematology, Department of Internal Medicine, College of Medicine, Korea University. 3. National Cancer Center Hospital, Tokyo. 4. Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. 5. Graduate Institute of Clinical Medicine, National Cheng Kung University, Tainan. 6. Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan. 7. Faculty of Medicine, , National Yang-Ming University, Taipei. 8. Department of Oncology, Taipei Veterans General Hospital, Taipei. 9. Department of Medical Oncology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul. 10. Eli Lilly and Company, Taipei, Taiwan. 11. Eli Lilly and Company, Sesto Fiorentino, Florence, Italy. 12. Eli Lilly and Company, Bridgewater, New Jersey, USA. 13. Eli Lilly and Company, Buenos Aires, Argentina. 14. Exploratory Oncology Research & Clinical Trial Center (EPOC), National Cancer Center, Kashiwa, Japan.
Abstract
BACKGROUND AND AIM: East Asia has higher gastric cancer incidence and mortality rates than other regions. We present a subgroup analysis of East Asians in the positive study RAINBOW. METHODS:Patients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated withplatinum and fluoropyrimidine received ramucirumab 8 mg/kg or placebo on days 1 and 15 plus paclitaxel 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. RESULTS:Of 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1 months for ramucirumab plus paclitaxel and 10.5 months for placebo plus paclitaxel (hazard ratio: 0.986, 95% confidence interval: 0.727-1.337, P = 0.929). Median progression-free survival was 5.5 months for ramucirumab plus paclitaxel and 2.8 months for placebo plus paclitaxel (hazard ratio: 0.628, 95% confidence interval: 0.473-0.834, P = 0.001). Objective response rates were 34% for ramucirumab plus paclitaxel and 20% for placebo plus paclitaxel. Grade ≥ 3 neutropenia (60% vs 28%) and leukopenia (34% vs 13%) were higher for ramucirumab plus paclitaxel. The rate of febrile neutropenia was low (4% vs 4%). Special interest adverse events included any grade bleeding/hemorrhage (55% vs 25%), proteinuria (27% vs 7%), and hypertension (22% vs 2%). CONCLUSIONS:Ramucirumab plus paclitaxel significantly improves progression-free survival and response rate, with prolonged median overall survival and an acceptable safety profile in East Asians with advanced gastric cancer.
RCT Entities:
BACKGROUND AND AIM: East Asia has higher gastric cancer incidence and mortality rates than other regions. We present a subgroup analysis of East Asians in the positive study RAINBOW. METHODS:Patients with advanced gastric or gastroesophageal junction adenocarcinoma previously treated with platinum and fluoropyrimidine received ramucirumab 8 mg/kg or placebo on days 1 and 15 plus paclitaxel 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. RESULTS: Of 665 intention-to-treat patients, 223 were East Asian. Median overall survival was 12.1 months for ramucirumab plus paclitaxel and 10.5 months for placebo plus paclitaxel (hazard ratio: 0.986, 95% confidence interval: 0.727-1.337, P = 0.929). Median progression-free survival was 5.5 months for ramucirumab plus paclitaxel and 2.8 months for placebo plus paclitaxel (hazard ratio: 0.628, 95% confidence interval: 0.473-0.834, P = 0.001). Objective response rates were 34% for ramucirumab plus paclitaxel and 20% for placebo plus paclitaxel. Grade ≥ 3 neutropenia (60% vs 28%) and leukopenia (34% vs 13%) were higher for ramucirumab plus paclitaxel. The rate of febrile neutropenia was low (4% vs 4%). Special interest adverse events included any grade bleeding/hemorrhage (55% vs 25%), proteinuria (27% vs 7%), and hypertension (22% vs 2%). CONCLUSIONS:Ramucirumab plus paclitaxel significantly improves progression-free survival and response rate, with prolonged median overall survival and an acceptable safety profile in East Asians with advanced gastric cancer.
Authors: Vincent T Janmaat; Ewout W Steyerberg; Ate van der Gaast; Ron Hj Mathijssen; Marco J Bruno; Maikel P Peppelenbosch; Ernst J Kuipers; Manon Cw Spaander Journal: Cochrane Database Syst Rev Date: 2017-11-28