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

RAINBOW: A global, phase 3, double-blind study of ramucirumab (RAM) plus paclitaxel (PTX) versus placebo (PL) + PTX in the treatment of advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line platinum- and fluoropyrimidine-containing combination therapy: A subgroup analysis of Western population (#362)

Hansjochen Wilke 1 , Philip Clingan 2 , Sumi Ananda 3 , Galina Kurteva 4 , Tiit Suuroja 5 , Gunnar Folprecht 6 , Alexander Beny 7 , Davide Pastorelli 8 , Alvydas Cesas 9 , Zbigniew Nowecki 10 , Cornelia Toganel 11 , György Bodoky 12 , Oleg Lipatov 13 , Maria Limon Miron 14 , David Cunningham 15 , Sebastian Cummins 16 , Zev Wainberg 17 , Andrew Ko 18 , Michael Emig 19 , Kumari Chandrawansa 20 , Eric van Cutsem 21
  1. Kliniken Essen-Mitte, Essen, Germany
  2. Southern Medical Day Care Centre, Wollongong, NSW, Australia
  3. Western Health, Melbourne, Victoria, Australia
  4. Specialised Hospital For Active Treatment in Oncology, Sofia, Bulgaria
  5. North Estonia Medical Centre, Tallinn, Estonia
  6. Universitaetsklinikum Carl Gustav Carus, Dresden, Germany
  7. Rambam Health Care Campus, Haifa, Israel
  8. Istituto Oncologico Veneto IRCCS, Padova, Italy
  9. Klaipeda University Hospital, Klaipeda, Lithuania
  10. Centrum Onkologii Instytut M. Sklodowskiej-Curie, Warszawa, Poland
  11. Spitalul Clinic Judetean Mures, Targu-Mures, Romania
  12. St. László Hospital, Dept. of Oncology, Budapest, Hungary
  13. Republican Clinical Oncology Dispensary, Ufa, Ufa, Russia
  14. H.U.V. del Rocío, Seville, Spain
  15. Royal Marsden Hospital, London, United kingdom
  16. Royal Surrey County Hospital, Guilford, United Kingdom
  17. Ronald Reagan UCLA Medical Center, Los Angeles, USA
  18. University of California, San francisco, United States
  19. Eli Lilly and Co , Homburg, Germany GmBH
  20. Eli Lilly, Indianapolis, USA
  21. Digestive Oncology, University Hospitals Gasthuisberg/Leuven, Leuven, belgium

Aims: RAINBOW, a global, placebo-controlled, double-blind, phase III trial, demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and response rates (ORR) in advanced gastric or GEJ adenocarcinoma patients receiving ramucirumab (RAM), a human IgG1 VEGF receptor 2 targeted antibody, plus paclitaxel (PTX). We present the pre-planned subgroup analysis of Western patients (Region 1). Methods: Pts received RAM (8 mg/kg IV q2w) or placebo (PL) plus PTX (80 mg/m2 d1, 8, 15 of a 4 week cycle) until disease progression, unacceptable toxicity, or until other discontinuation criteria were met. Eligible pts had ECOG PS ≤ 1; and adequate organ function. Randomization was stratified by geographic region (Region 1: Europe, Israel, Australia, and United States, Region 2: Argentina, Brazil, Chile, and Mexico, and Region 3: Asia), time to progression after first dose of first line therapy, and disease measurability. OS and PFS were compared between treatment arms using a stratified log-rank test. ORR was analyzed using a CMH test. Results: Of the 665 randomized patients, 398 (RAM+PTX: 198; PTX: 200) were Western patients. Baseline characteristics were generally balanced between arms. The OS Hazard Ratio (HR) was 0.726 (95% CI 0.580, 0.909; p = 0.0050). Median OS was 8.57m for RAM+PTX and 5.91m for PTX. The HR for PFS was 0.631 (95% CI 0.506, 0.786; p <0.0001). Median PFS was 4.24m and 2.83m. Grade ≥ 3 adverse events (AEs) occurring in >5% of patients on RAM+PTX were: neutropenia, hypertension, leukopenia, fatigue, asthenia, anemia, abdominal pain, and general physical health deterioration. Conclusions: In the Western population of the RAINBOW study, the significant benefits observed in OS, PFS, and ORR were consistent with those in the overall ITT population. The adverse event profile was similar to the overall population.

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