Age does not influence efficacy of ramucirumab in advanced gastric cancer: Subgroup analyses of REGARD and RAINBOW

作者：Muro Kei; Cho Jae Yong; Bodoky Gyorgy; Goswami Chanchal; Chao Yee; dos Santos Lucas V; Shimada Yasuhiro; Topuzov Eldar; Van Cutsem Eric; Tabernero Josep; Zalcberg John; Chau Ian; Cascinu Stefano; Cheng Rebecca; Hsu Yanzhi; Emig Michael; Orlando Mauro; Fuchs Charles^*

来源：Journal of Gastroenterology and Hepatology, 2018, 33(4): 814-824.

DOI：10.1111/jgh.14007

• elderly
• gastroesophageal neoplasms
• ramucirumab
• vascular endothelial growth factor receptor-2
• young patients

Background and AimREGARD and RAINBOW were global, phase 3, randomized, double-blind trials of second-line ramucirumab for metastatic gastric or gastroesophageal junction adenocarcinoma. Exploratory subgroup analyses were described to assess the efficacy and safety of ramucirumab in REGARD and RAINBOW in young (45 and <65years) and elderly (65, 70, and 75years) patients.
MethodsPatients were randomized 2:1 to receive ramucirumab plus best supportive care or placebo plus best supportive care (REGARD) or 1:1 to ramucirumab plus paclitaxel or placebo plus paclitaxel (RAINBOW). Subpopulation Treatment Effect Pattern Plots assessed efficacy and adverse events by age groups for ramucirumab versus placebo.
ResultsThe hazard ratios (HRs) for overall survival favored treatment with ramucirumab: REGARD 45years (HR: 0.59, 95% confidence interval: 0.27-1.26), <65years (0.80, 0.59-1.10), 65years (0.72, 0.48-1.08), 70years (0.73, 0.44-1.23), and 75years (0.59, 0.25-1.37); and RAINBOW 45 years (0.56, 0.33-0.93), <65years (0.78, 0.63-0.97), 65years (0.88, 0.66-1.18), and 70years (0.88, 0.60-1.28). The exception was elderly patients aged 75years in RAINBOW (0.97, 0.47-2.01); however, patient numbers were low in this subgroup (n=36). Similar findings were observed for progression-free survival, for which HRs numerically favored ramucirumab-treated patients. Adverse events (including grade 3) were not associated with age.
ConclusionsIn comparison with placebo, ramucirumab conferred improvements in efficacy across age groups with a tolerable safety profile. Despite some limitations, these exploratory analyses support the use of ramucirumab in advanced gastric cancer, irrespective of age.

• 出版日期2018-4