To assess the efficacy and safety of
ramucirumab in combination with FOLFIRI in patients with unresectable metastatic
colorectal cancer under clinical practice in Japan, we reviewed manuscripts reporting clinical research, including case reports, of Japanese patients with FOLFIRI plus
ramucirumab therapy published starting from 2016, when
ramucirumab was approved as a treatment for metastatic
colorectal cancer in Japan, to June 2020. We also reviewed an interim report of post-marketing surveillance study. The efficacy of
ramucirumab in combination with FOLFIRI including
irinotecan 150 mg/m2, which is the recommended dose in Japan and is used as initial dose in Japanese clinical practice, was similar to that of the global, phase 3 RAISE study with
irinotecan 180 mg/m2. The desirable effect of FOLFIRI plus
ramucirumab was observed in patients with wild-type RAS, primary
tumors on the left sides(descending, sigmoid, or rectum colons), or who received anti-
epidermal growth factor receptor agents, including
panitumumab or
cetuximab, as previous treatment. Also, the effectiveness of FOLFIRI plus
ramucirumab as a late-line treatment was suggested. Several patients were reported to have
nephrosis syndrome after starting
ramucirumab, but they recovered with discontinuation of
ramucirumab and appropriate treatment. No new safety concerns were observed from the literature or the interim report of post-marketing surveillance study.