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

Background: There is limited real-world evidence regarding the safety of ramucirumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC).

Objective: We evaluated the safety of ramucirumab plus FOLFIRI in patients with mCRC by age and initial dose of irinotecan.

Patients and methods: This single-arm, prospective, multicenter, non-interventional, observational study was conducted between December 2016 and April 2020. Patients were observed for 12 months.

Results: Of 366 enrolled Japanese patients, 362 were eligible for study inclusion. The frequency of grade ≥ 3 adverse events (AEs) by age (≥ 75 years vs < 75 years) 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 ≥ 75 years than in those aged < 75 years (7.0% vs 1.3%). The frequency of grade ≥ 3 AEs was slightly lower in patients receiving > 150 mg/m² of irinotecan than in those receiving ≤ 150 mg/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 > 150 mg/m² of irinotecan than in those receiving ≤ 150 mg/m² of irinotecan (4.6% vs 1.9% and 9.1% vs 2.3%, respectively).

Conclusions: The safety profile of ramucirumab plus FOLFIRI in mCRC patients was similar in subgroups by age and initial irinotecan dose in real-world settings.