Objective  To evaluate safety and efficacy of bevacizumab (AVASTIN) plus chemotherapy for the treatment of gastrointestinal cancer patients.

  Methods  A retrospective study of 77 gastrointestinal (GI) cancer patients treated with bevacizumab plus chemotherapy was performed. Patient information collected included previous disease history, signs, synptom and homological and biochemical profiles. Patients were followed up for eight weeks after the last treatment or death. Statistical tests were used for subgroup analysis.

  Results  All patients had locally advanced or metastatic GI cancer, who were not suitable for surgery. Their pathological diagnosis was adenocarcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma. Among these patients, there were 65 colorectal cancer patients and 12 gastric cancer patients. There were 36 male and 41 female patients with the median age of 49 years (26 ~ 76 years). The incidence of all adverse events among these 77 patients was 89.6 % (69 / 77). The incidence of adverse event (AE) with grade 3 / 4 and SAE was 26.0 % (20 / 77). Stratified analysis on AE with grade of 3 / 4 and SAE indicated that the incidence was 44.4 % (4 / 9) in old-age group (65 years old and older) and 23.5 % (16 / 68) in young-age group (younger than 65 years old). The incidence was 25 % (9 / 36) in male patients and 26. 0 % (11 / 41) in female patients. The incidence was 30.6 %(11 / 36) in the first-line therapy group and 22.0 % (9 / 41) in the second or later line therapy group. There was no statistical difference between each group. For patients treated with bevacizumab plus two-agent chemotherapy, the incidence of AE was 50 % ~ 60 % and most of them were hematological toxicity and gastrointestinal discomforts (such as nausea and vomiting). For bevacizumab combining with single-agent chemotherapy, the incidence of AEs was 5 % ~ 8 %. There were 4 cases of hypertension, 2 cases of proteinuria, 4 cases of bleeding, and 2 cases of delayed wound healing. There was 1 case of SAEs, which might be related to the studied drug.

  Conclusion  The bevacizumab safety profile in this study was consistent with its safety profile in other clinical trials. The incidence of AE was not correlated with chemotherapy, gender or age. The bevacizumab related AE was rare and not accumulative with cytotoxic drug (s).