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

View/ Open
Date
2018-04Author
Muro, K
Cho, JY
Bodoky, G
Goswami, C
Chao, Y
Dos Santos, LV
Shimada, Y
Topuzov, E
Van Cutsem, E
Tabernero, J
Zalcberg, J
Chau, I
Cascinu, S
Cheng, R
Hsu, Y
Emig, M
Orlando, M
Fuchs, C
Type
Journal Article
Metadata
Show full item recordAbstract
Background and aim REGARD 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 < 65 years) and elderly (≥ 65, ≥ 70, and ≥ 75 years) patients.Methods Patients 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.Results The hazard ratios (HRs) for overall survival favored treatment with ramucirumab: REGARD ≤ 45 years (HR: 0.59, 95% confidence interval: 0.27-1.26), < 65 years (0.80, 0.59-1.10), ≥ 65 years (0.72, 0.48-1.08), ≥ 70 years (0.73, 0.44-1.23), and ≥ 75 years (0.59, 0.25-1.37); and RAINBOW ≤ 45 years (0.56, 0.33-0.93), < 65 years (0.78, 0.63-0.97), ≥ 65 years (0.88, 0.66-1.18), and ≥ 70 years (0.88, 0.60-1.28). The exception was elderly patients aged ≥ 75 years 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.Conclusions In 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.
Collections
Subject
Esophagogastric Junction
Humans
Adenocarcinoma
Stomach Neoplasms
Paclitaxel
Antineoplastic Combined Chemotherapy Protocols
Antibodies, Monoclonal
Neoplasm Staging
Treatment Outcome
Survival Rate
Double-Blind Method
Age Factors
Placebo Effect
Adult
Aged
Aged, 80 and over
Middle Aged
Female
Male
Randomized Controlled Trials as Topic
Clinical Trials, Phase III as Topic
Young Adult
Antibodies, Monoclonal, Humanized
Language
eng
Date accepted
2017-09-24
License start date
2018-04
Citation
Journal of gastroenterology and hepatology, 2018, 33 (4), pp. 814 - 824