There have been few reports of CapeIRI plus bevacizumab (BEV) for treatment of patients with metastatic colorectal cancer (mCRC). The objectives of this study was to evaluate the efficacy and safety of CapeIRI plus BEV therapy as a second-line setting for the mCRC patients treated with oxaliplatin-based chemotherapy combined with BEV therapy.
This was a multicenter, single-armed phase II study in Japan. The primary endpoint was progression-free survival (PFS), and the secondary objectives included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.
After a median follow-up period of 14.2 months, the disease progressed in 29 patients (96.7%) and 22 deaths (73.3%) occurred in the 30 patients enrolled. The median PFS and OS were 6.4 months (95%CI 3.7-9.1) and 17.0 months (95%CI 9.5-18.4), respectively. The ORR and DCR were 11.5% and 88.5%, respectively. The incidence of hematological and non-hematological adverse events above grade three were 22.6% and 19.4%, respectively.
CapeIRI plus bevacizumab therapy is a feasible second-line treatment for Japanese patients with mCRC.
Clinical trial identification
Legal entity responsible for the study
Chubu Clinical Oncology Group
All authors have declared no conflicts of interest.