Oncology
Clinical Study
Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal AdenocarcinomaRogers J.E.a · Xiao L.b · Amlashi F.G.c · Elimova E.c · Blum Murphy M.A.c · Sanders E.c · Shanbhag N.c · Thomas I.c · Ajani J.A.caPharmacy Clinical Programs, MD Anderson Cancer Center, University of Texas, Houston, TX, USA
bDepartment of Biostatistics, MD Anderson Cancer Center, University of Texas, Houston, TX, USA cDepartment of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, University of Texas, Houston, TX, USA |
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Article / Publication Details
Received: December 31, 2018
Accepted: January 07, 2019
Published online: March 20, 2019
Issue release date: May 2019
Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 3
ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)
For additional information: https://www.karger.com/OCL
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.
© 2019 S. Karger AG, Basel
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Article / Publication Details
Received: December 31, 2018
Accepted: January 07, 2019
Published online: March 20, 2019
Issue release date: May 2019
Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 3
ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)
For additional information: https://www.karger.com/OCL
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