RAINBOW: A global, phase 3, double-blind study of ramucirumab (RAM) plus paclitaxel (PTX) versus placebo (PL) plus PTX in the treatment of advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line platinum- and fluoropyrimidine-containing combination therapy—An age-group analysis.

Authors

Kei Muro

Kei Muro

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

Organizations

Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, Szent László Hospital, Budapest, Hungary, Klaipeda University Hospital, Klaipeda, Lithuania, Taipei Veterans General Hospital, Taipei, Taiwan, Sydney Cancer Centre, Sydney, Australia, Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan, Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan, Specialized Hospital for Active Treatment, Sofia, Bulgaria, Bashkortostan Clinical Oncology Center, Ufa, Russia, Department of Gastroenterology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan, Korea University Guro Hospital, Seoul, South Korea, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, Japan, National Cancer Center Hospital, Tokyo, Japan, Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, Eli Lilly Italia S.p.A., Sesto Fiorentino FL, Italy, Eli Lilly and Company, Bridgewater, NJ, Kliniken Essen-Mitte Center of Pallative Care, Essen, Germany

Research Funding

No funding sources reported

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 armsRAM+PTXPL+PTXRAM+PTXPL+PTX
N (665 total)204212126123
Outcome measures
Median OS (m)9.37.110.78.7
HR (95% C.I.)0.753 (0.604-0.939)0.861 (0.636-1.165)
Median PFS4.32.84.62.9
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)
ORR28%14%27%20%
Adverse effects (AEs) Grade ≥ 3
Overall AEs (%)79648560
Neutropenia36164924
Leukopenia156227
Hypertension12*2*19*4*
Febrile neutropenia2.02.94.91.6
*Grade 3 only

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Prevention, Diagnosis, and Screening

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 11)

DOI

10.1200/jco.2015.33.3_suppl.11

Abstract #

11

Poster Bd #

A11

Abstract Disclosures