Evaluation of safety of bevacizumab as second-line treatment of patients with metastatic colorectal cancer.

PURPOSE: Bevacizumab is a relatively new monoclonal antibody introduced in the treatment of metastatic colorectal cancer (CRC). Since varied efficiency and adverse events of this drug were reported, the purpose of this study was to assess the safety of bevacizumab as second-line treatment of patients with metastatic CRC.

METHODS: This observational, non-interventional study involved 35 patients with metastatic CRC treated with bevacizumab. Patients were from the Oncology Clinic, Clinical Centre of Montenegro. Monitoring of patients was done according to the study protocol.

RESULTS: The number of subjects with abnormal values of tumor marker CEA has decreased from 56.8% (enrollment visit) to 50% in the sixth visit (p<0.01). The number of subjects with abnormal values for tumor marker Ca19-9 ranged from initial 45% (enrollment visit) to 50% on the sixth visit (p>0.05). No significant differences in the average values of hematological and biochemical parameters and the average values of the CEA and Ca19-9 were noticed. In 26 (46.2%) patients, adverse events were recorded. Of 72 adverse events, 31 (43.05%) were related to bevacizumab. Regarding adverse events intensity, 68.1% were moderate. The most common adverse event was hypertension, which was recorded in 12 patients. There was no life-threatening adverse event connected with the drug use.

CONCLUSION: Use of bevacizumab caused moderate adverse effects, none of which was life-threatening.