[Comparative Safety Assessment of Ramucirumab plus FOLFIRI and Bevacizumab plus FOLFIRI in Second- and Later-Line Treatment in Japanese Patients with Metastatic Colorectal Carcinoma].

ABSTRACT

The addition of anti-angiogenic agents to cytotoxic agents to improve outcomes has become the standard treatment for metastatic colorectal carcinoma. In this study, we evaluated the safety of bevacizumab plus FOLFIRI with that of ramucirumab plus FOLFIRI in second- and later-line treatment in Japanese patients with metastatic colorectal carcinoma. Patients who received ramucirumab or bevacizumab as a second- and later-line treatment between January 2016 and March 2020 were included. Treatment regimens, body surface area, dosage, number of treatment courses, and adverse events( AEs) were evaluated. There were 66 and 17 patients in the bevacizumab plus FOLFIRI and ramucirumab plus FOLFIRI groups, respectively. All patients developed AEs. AEs of grade 3/4 were documented in 84.8% and 100% of the patients in the bevacizumab plus FOLFIRI and ramucirumab plus FOLFIRI groups, respectively. Progressive disease was the most common reason for treatment discontinuation in both groups. Twelve (18.2%) and 5 (29.4%) patients in the bevacizumab plus FOLFIRI and ramucirumab plus FOLFIRI groups, respectively, discontinued treatment due to AEs. The most common AEs leading to discontinuation were malaise and decreased performance status. The findings of our study indicated that both bevacizumab plus FOLFIRI and ramucirumab plus FOLFIRI groups have a high incidence of AEs, and that medical professionals need to be aware of the frequent development of malaise and decreased performance status.