Post-Marketing Safety Study of Ramucirumab Plus FOLFIRI: Analysis of Age and Initial Dose of Irinotecan in Patients with Metastatic Colorectal Cancer.

Abstract

There is limited real-world evidence regarding the safety of ramucirumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC). We evaluated the safety of ramucirumab plus FOLFIRI in patients with mCRC by age and initial dose of irinotecan. This single-arm, prospective, multicenter, non-interventional, observational study was conducted between December 2016 and April 2020. Patients were observed for 12months. Of 366 enrolled Japanese patients, 362 were eligible for study inclusion. The frequency of grade ≥3 adverse events (AEs) by age (≥75years vs <75years) was 56.1% versus 50.2%, indicating no substantial differences between age groups. Grade ≥3 notable AEs, including neutropenia, proteinuria, and hypertension, were also similar in both age groups, but the frequency of any grade venous thromboembolic events was higher in those aged ≥75years than in those aged <75years (7.0% vs 1.3%). The frequency of grade ≥3 AEs was slightly lower in patients receiving >150mg/m2 of irinotecan than in those receiving ≤150mg/m2 of irinotecan (42.1% vs 53.6%); however, the frequency of grade ≥3 diarrhea, but not any grade diarrhea, and liver failure/injury was higher in patients receiving >150mg/m2 of irinotecan than in those receiving ≤150mg/m2 of irinotecan (4.6% vs 1.9% and 9.1% vs 2.3%, respectively). The safety profile of ramucirumab plus FOLFIRI in mCRC patients was similar in subgroups by age and initial irinotecan dose in real-world settings.