Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
Kei Muro , Gyorgy Bodoky , Alvydas Cesas , Yee Chao , Philip Clingan , Shuichi Hironaka , Yoshito Komatsu , Galina Petrova Kurteva , Oleg N. Lipatov , Tomohiro Nishina , Sang Cheul Oh , Atsushi Ohtsu , Yasuhiro Shimada , Naotoshi Sugimoto , Eric Van Cutsem , Roberto Carlesi , Kumari Chandrawansa , Hansjochen Wilke
Background: RAM is a human IgG1 monoclonal antibody VEGF-R2 antagonist. The RAINBOW trial demonstrated that RAM added to PTX significantly improved overall survival (OS), progression free survival (PFS), and objective response rates (ORR) in 2nd-line gastric and GEJ adenocarcinoma patients (pts). Outcomes are reported by pts aged <65 and ≥65 yrs. Methods: Pts with advanced gastric and GEJ adenocarcinoma after disease progression on platinum- and fluoropyrimidine-based chemotherapy were randomized 1:1 to receive RAM (8 mg/kg) or placebo (PL) on days 1 and 15 plus PTX 80 mg/m2IV on days 1, 8, and 15 of a 28-day cycle. Eligible pts had ECOG PS ≤ 1 and adequate organ function. OS was the primary endpoint. Secondary endpoints included PFS, ORR, and safety. Results: Baseline characteristics were generally well balanced. Outcomes are summarized in the Table. The incidence of Grade ≥3 adverse events (AEs) was higher in the RAM+PTX arms for both age groups and similar across age groups. Grade ≥3 AEs occurring in ≥10% of pts and at higher rate in the RAM+PTX arm, and febrile neutropenia are shown in the Table. Conclusions: RAM+PTX conferred similar improvements over PL+PTX for OS, PFS, and ORR in both age groups. Toxicity profiles were similar in both groups, although a relatively higher incidence of Grade ≥3 neutropenia and leukopenia in pts ≥65 years was noted.
Age group | < 65 years | ≥65 years | |||
---|---|---|---|---|---|
Median age (range) | 56 (25-64) | 70 (65-84) | |||
Treatment arms | RAM+PTX | PL+PTX | RAM+PTX | PL+PTX | |
N (665 total) | 204 | 212 | 126 | 123 | |
Outcome measures | |||||
Median OS (m) | 9.3 | 7.1 | 10.7 | 8.7 | |
HR (95% C.I.) | 0.753 (0.604-0.939) | 0.861 (0.636-1.165) | |||
Median PFS | 4.3 | 2.8 | 4.6 | 2.9 | |
HR (95% C.I.) | 0.572 (0.460-0.711) | 0.673 (0.506-0.894) | |||
No statistically significant treatment-by-age group interaction was shown for OS (p=0.3712) and PFS (p=0.1776) | |||||
ORR | 28% | 14% | 27% | 20% | |
Adverse effects (AEs) Grade ≥ 3 | |||||
Overall AEs (%) | 79 | 64 | 85 | 60 | |
Neutropenia | 36 | 16 | 49 | 24 | |
Leukopenia | 15 | 6 | 22 | 7 | |
Hypertension | 12* | 2* | 19* | 4* | |
Febrile neutropenia | 2.0 | 2.9 | 4.9 | 1.6 | |
*Grade 3 only |
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2021 Gastrointestinal Cancers Symposium
First Author: Rui-hua Xu
2023 ASCO Gastrointestinal Cancers Symposium
First Author: Nick Pavlakis
2023 ASCO Gastrointestinal Cancers Symposium
First Author: Nick Pavlakis
2023 ASCO Gastrointestinal Cancers Symposium
First Author: Markus H. Moehler