PMID- 30085888
OWN - NLM
STAT- MEDLINE
DCOM- 20191115
LR  - 20231213
IS  - 2378-9506 (Electronic)
IS  - 2378-9506 (Linking)
VI  - 4
DP  - 2018 Jul
TI  - Ramucirumab Safety in East Asian Patients: A Meta-Analysis of Six Global, 
      Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trials.
PG  - 1-12
LID - 10.1200/JGO.17.00227 [doi]
LID - JGO.17.00227
AB  - 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.
FAU - Yen, Chia-Jui
AU  - Yen CJ
AD  - 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.
FAU - Muro, Kei
AU  - Muro K
AD  - 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.
FAU - Kim, Tae-Won
AU  - Kim TW
AD  - 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.
FAU - Kudo, Masatoshi
AU  - Kudo M
AD  - 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.
FAU - Shih, Jin-Yuan
AU  - Shih JY
AD  - 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.
FAU - Lee, Keun-Wook
AU  - Lee KW
AD  - 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.
FAU - Chao, Yee
AU  - Chao Y
AD  - 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.
FAU - Kim, Sang-We
AU  - Kim SW
AD  - 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.
FAU - Yamazaki, Kentaro
AU  - Yamazaki K
AD  - 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.
FAU - Sohn, JooHyuk
AU  - Sohn J
AD  - 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.
FAU - Cheng, Rebecca
AU  - Cheng R
AD  - 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.
FAU - Zhang, Yawei
AU  - Zhang Y
AD  - 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.
FAU - Binder, Polina
AU  - Binder P
AD  - 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.
FAU - Mi, Gu
AU  - Mi G
AD  - 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.
FAU - Orlando, Mauro
AU  - Orlando M
AD  - 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.
FAU - Chung, Hyun Cheol
AU  - Chung HC
AD  - 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.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Glob Oncol
JT  - Journal of global oncology
JID - 101674751
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal/*administration & dosage/*adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/administration & dosage/adverse effects
MH  - Clinical Trials, Phase III as Topic
MH  - Double-Blind Method
MH  - Asia, Eastern
MH  - Female
MH  - Humans
MH  - Male
MH  - Randomized Controlled Trials as Topic
MH  - Ramucirumab
PMC - PMC6223521
EDAT- 2018/08/08 06:00
MHDA- 2019/11/16 06:00
PMCR- 2018/06/08
CRDT- 2018/08/08 06:00
PHST- 2018/08/08 06:00 [entrez]
PHST- 2018/08/08 06:00 [pubmed]
PHST- 2019/11/16 06:00 [medline]
PHST- 2018/06/08 00:00 [pmc-release]
AID - 1700227 [pii]
AID - 10.1200/JGO.17.00227 [doi]
PST - ppublish
SO  - J Glob Oncol. 2018 Jul;4:1-12. doi: 10.1200/JGO.17.00227.