Subgroup analysis of East Asians in RAINBOW: A phase 3 trial of ramucirumab plus paclitaxel for advanced gastric cancer.

Autor: Muro K; Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan., Oh SC; Division of Oncology and Hematology, Department of Internal Medicine, College of Medicine, Korea University., Shimada Y; National Cancer Center Hospital, Tokyo., Lee KW; Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea., Yen CJ; Graduate Institute of Clinical Medicine, National Cheng Kung University, Tainan.; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan., Chao Y; Faculty of Medicine, , National Yang-Ming University, Taipei.; Department of Oncology, Taipei Veterans General Hospital, Taipei., Cho JY; Department of Medical Oncology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul., Cheng R; Eli Lilly and Company, Taipei, Taiwan., Carlesi R; Eli Lilly and Company, Sesto Fiorentino, Florence, Italy., Chandrawansa K; Eli Lilly and Company, Bridgewater, New Jersey, USA., Orlando M; Eli Lilly and Company, Buenos Aires, Argentina., Ohtsu A; Exploratory Oncology Research & Clinical Trial Center (EPOC), National Cancer Center, Kashiwa, Japan.
Jazyk: angličtina
Zdroj: Journal of gastroenterology and hepatology [J Gastroenterol Hepatol] 2016 Mar; Vol. 31 (3), pp. 581-9.
DOI: 10.1111/jgh.13153
Abstrakt: 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.
(© 2015 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)
Databáze: MEDLINE
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