Ramucirumab Safety in East Asian Patients: A Meta-Analysis of Six Global, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trials.

Autor:	Yen CJ; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Muro K; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Kim TW; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Kudo M; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Shih JY; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Lee KW; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Chao Y; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Kim SW; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Yamazaki K; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Sohn J; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Cheng R; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Zhang Y; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Binder P; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Mi G; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Orlando M; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina., Chung HC; Chia-Jui Yen, National Cheng Kung University Hospital, Tainan; Jin-Yuan Shih, National Taiwan University Hospital; Yee Chao, National Yang-Ming University and Taipei Veterans General Hospital; Rebecca Cheng, Eli Lilly and Company, Taipei, Taiwan; Kei Muro, Aichi Cancer Center Hospital, Nagoya; Masatoshi Kudo, Kindai University School of Medicine, Osaka-Sayama City, Osaka; Kentaro Yamazaki, Shizuoka Cancer Center, Shizuoka, Japan; Tae-Won Kim and Sang-We Kim, Asan Medical Center; JooHyuk Sohn and Hyun Cheol Chung, Yonsei University College of Medicine, Seoul; Keun-Wook Lee, Seoul National University College of Medicine, Seongnam, South Korea; Yawei Zhang and Polina Binder, Eli Lilly and Company, Bridgewater, NJ; Gu Mi, Eli Lilly and Company, Indianapolis, IN, USA; and Mauro Orlando, Eli Lilly and Company, Buenos Aires, Argentina.
Jazyk:	angličtina
Zdroj:	Journal of global oncology [J Glob Oncol] 2018 Jul; Vol. 4, pp. 1-12.
DOI:	10.1200/JGO.17.00227
Abstrakt:	Purpose Several ramucirumab trials have reported a higher incidence of selected adverse events (AEs) in East Asian (EA) patients with cancer versus non-EA patients. A meta-analysis was conducted across six completed phase III trials to establish the safety parameters of ramucirumab in EA compared with non-EA patients. Materials and Methods Six global, randomized, double-blind, placebo-controlled, phase III registration trials investigating ramucirumab were assessed. Relative risks (RRs) and 95% CIs were calculated for selected all-grade and grade ≥ 3 AEs using fixed-effects and mixed-effects models. Ratio of RR and number needed to harm were calculated for AEs (all grade and grade ≥ 3) between EA and non-EA patients. Results Of 4,996 randomly assigned patients receiving ramucirumab or placebo, 802 (16.1%) were EA (ramucirumab, n = 411; placebo, n = 391) and 4,194 were non-EA (ramucirumab, n = 2,337; placebo, n = 1,857). Patient baseline characteristics were generally balanced between treatment arms in EA and non-EA patients, excluding sex and body weight. Grade ≥ 3 AEs possibly associated with ramucirumab, which were increased in EA versus non-EA patients, included neutropenia (42.1% v 25.5%, respectively) and proteinuria (3.9% v 0.6%, respectively). There was an increase in the RR of several grade ≥ 3 AEs, including hypertension and proteinuria, in ramucirumab-treated EA and non-EA patients compared with placebo. The ratio of RR revealed no significant differences between EA and non-EA patients for all-grade and grade ≥ 3 AEs. Conclusion Despite the enhanced propensity of selected AEs in EA patients relative to non-EA patients, there were no substantial differences in the RR for AEs possibly associated with ramucirumab in these phase III trials.
Databáze:	MEDLINE
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