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

ABSTRACT:

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

SUBMITTER: Masuishi T 

PROVIDER: S-EPMC10491555 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature