國家衛生研究院 NHRI:Item 3990099045/11491

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Title:	Nivolumab safety profile in Asian and Western patients with chemotherapy-refractory (CTx-R) advanced gastric/gastroesophageal junction (adv G/GEJ) cancer from the ATTRACTION-2 and CheckMate-032 trials
Authors:	Haag, GM;Chen, LT;Kang, YK;Satoh, T;Kato, K;Chung, HC;Kang, WK;Chao, Y;Chen, JS;Ott, PA;Le, DT;Zhao, H;Exposito, MJJ;Janjigian, YY;Boku, N;Chau, I
Contributors:	National Institute of Cancer Research
Abstract:	Introduction: Nivolumab (NIVO) monotherapy demonstrated a survival benefit and durable responses in pts with CTx-R adv G/GEJ cancer (Boku N et al ESMO 2017; Janjigian Y et al ASCO 2017). Here we describe the safety profile of NIVO in Asian (A) and Western (W) pts with CTx-R adv G/GEJ who had received ≥ 2 prior CTx in the ATTRACTION-2 and CheckMate-032 trials, respectively. Methods: The safety population included pts who received ≥ 1 dose of study drug at the data cutoff of August 2016 for ATTRACTION-2 and March 2016 for CheckMate-032. Treatment related adverse events (TRAE), serious TRAEs, and select TRAEs (sTRAE; with a potential immune-related etiology) were assessed. sTRAEs were managed using protocol-specified algorithms, which included corticosteroids as immune-modulating treatment (tx). Time to onset and resolution of sTRAEs were also assessed. Results: Median duration of NIVO tx was 1.9 mo in A and 2.3 mo in W pts. TRAEs (any grade) were reported in 43% of A and 64% of W pts; grade 3-4 TRAEs (A pts:10%; W pts:14%), serious TRAEs (A pts:10%; W pts:7%) and TRAEs leading to discontinuation (≤ 3% of pts in both groups) were infrequent. Most sTRAEs were grade 1-2 (Table) and occurred within the first 3 mo of NIVO tx. In A and W pts, median time to resolution of sTRAEs ranged from 3-19 wk. For those sTRAEs that required tx with immune-modulating agents, the median time to resolution of most sTRAEs ranged from 3-35 wk. Conclusions: NIVO demonstrated an acceptable safety profile in both A and W pts with CTx-R adv G/GEJ cancers with no clinically meaningful racial differences. Most sTRAEs were grade 1-2 in both cohorts and manageable using the recommended tx algorithms.
Date:	2018-09
Relation:	Oncology Research and Treatment. 2018 Sep;41(Suppl. 4):285-286.
Link to:	https://doi.org/10.1159/000492737
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=2296-5270&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000446816500694
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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