Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

Abstract

Background: The RAINBOW trial established ramucirumab combined with paclitaxel as a second-line option in metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was given on days 1 and 15 with paclitaxel on days 1, 8, and 15 of a 28-day cycle. The median overall survival (OS) was significantly longer with ramuciru­mab plus paclitaxel (p = 0.017), and it led to 41% grade 3 or higher neutropenia. We review our experience with both ramucirumab plus paclitaxel given biweekly (mRAINBOW) to assess efficacy and safety. Objectives: The primary objective was to assess OS. Secondary end points were progression-free survival (PFS), overall response, and safety. Methods: We identified 129 patients retrospectively from our database between November 2014 and May 2017. Patients were included if they were followed up at our institution. Results: Median doses given were ramucirumab 8 mg/kg i.v. plus paclitaxel 110 mg/m² i.v. given once every 2 weeks. The median performance status was 1, and ∼60% had poorly differentiated histology; 55.8% had progression in < 6 months on first-line therapy, and the majority had measurable cancer. Median overall OS and PFS for the entire cohort was 9.4 months (95% CI: 8.05–10.74) and 3.68 months (95% CI: 2.73–4.5), respectively. Median OS was 9.46 months (95% CI: 8.05–14.95) and median PFS was 4.14 months (95% CI: 2.96–5.29) in those patients that received ramucirumab plus paclitaxel in the second-line setting. Conclusion: Biweekly administration of ramucirumab plus paclitaxel did not compromise efficacy. Delays, adjustments, or doses held were similar to the RAINBOW trial, with 31% requiring a dose or schedule modification.

Optimizing treatment duration with ramucirumab and paclitaxel by managing chemotherapy-associated toxicity: Review of four cases

“…12,13 The alternative schedule of ramucirumab 8 mg/kg plus paclitaxel 110 mg/m 2 given once every 2 weeks has also been evaluated in a retrospective single-center database analysis. 14 The authors of that analysis considered that this amended dosage regimen did not compromise efficacy in the second-line setting (overall survival 9.46 months 14 vs 9.6 months in RAINBOW 5 ), although dose delays, adjustments, and omissions were similar to those reported in the RAINBOW trial. Overall, 31% of patients receiving the alternative treatment regimen as second-line therapy, and 32.5% receiving this regimen as second-line or greater therapy, required a dose or schedule modification, most commonly because of neutropenia (44% of delays or adjustments in the total population), and occasionally neuropathy (3.6%).…”

“…Overall, 31% of patients receiving the alternative treatment regimen as second-line therapy, and 32.5% receiving this regimen as second-line or greater therapy, required a dose or schedule modification, most commonly because of neutropenia (44% of delays or adjustments in the total population), and occasionally neuropathy (3.6%). 14 In RAINBOW, 24% of patients randomized to ramucirumab plus paclitaxel had a paclitaxel dose reduction, and among this treatment group, 38%, 8%, 0%, and 0% experienced grades 1–2, 3 and 4, neuropathy, respectively, and 14%, 71%, and 62% experienced these grades of neutropenia, respectively. 5 …”

Managing a gastrointestinal oncology practice in Japan during the COVID-19 pandemic: single institutional experience in The Cancer Institute Hospital of Japanese Foundation for Cancer Research

“…We propose skipping the administration of paclitaxel /nab-paclitaxel at day 8 to avoid neutropenia and to reduce the frequency of hospital visits. A previously published study has indicated that biweekly administration of ramucirumab plus paclitaxel did not compromise efficacy [45].…”

Systemic Treatment of Patients With Gastrointestinal Cancers During the COVID-19 Outbreak: COVID-19-adapted Recommendations of the National Cancer Institute of Milan

“…We selected the modified RAINBOW (mRAIN-BOW) bi-weekly simplified regimen (paclitaxel 110 mg/m 2 plus ramucirumab 8 mg/kg every 2 weeks) as our standard according to the MD Anderson study. 23 Whenever ramucirumab was contraindicated or not available, second-line chemotherapy consisted of 3weekly courses of docetaxel or irinotecan (provided pharmacogenomic testing results were available).…”