Background: Bevacizumab (BV) prolongs overall survival and progression-free survival when combined with standard chemotherapy for metastatic colorectal cancer (mCRC). However, because this drug was approved in Japan only in 2007, there has been little experience in Japan. This study was conducted to evaluate retrospectively the safety of BV in clinical practice.
Methods: Sixty-five consecutive mCRC patients who received BV at our institution between June 2007 and March 2008 were selected. All patients were treated with chemotherapy in combination with BV. We surveyed the medical records of all patients for adverse events (AEs). We assessed the AEs using the Common Terminology Criteria for Adverse Events version 3.0.
Results: The characteristics of the subjects were: male, 45 patients; median age, 57 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, 62 patients; number of prior chemotherapy regimens 0/1/ > 2, 15/28/22 patients. The incidence of BV therapy-related AEs of all grades was: hypertension, 47.7%; proteinuria, 33.8%; bleeding, 35.3%; gastrointestinal (GI) perforation, 3.1%; thrombosis, 7.7%; and wound-healing complications, 6.2%. The incidence of grade 3/4 AEs related to BV therapy was: hypertension, 13.8%; bleeding, 1.5%; GI perforation, 1.5%; and thrombosis, 4.6%. Four patients (6.2%) had to stop chemotherapy because of the development of BV therapy-related AEs. New events of hypertension, bleeding, and proteinuria emerged until 120 days and thereafter.
Conclusion: The incidence of BV therapy-related AEs in this study was consistent with that observed in Western prospective clinical trials, with the exception of hypertension and proteinuria. A careful follow up is recommended for up to 120 days after the initiation of BV administration.