An Open-Label Safety Study of First-Line Bevacizumab in Combination with Standard Chemotherapy in Chinese Patients with Metastatic Colorectal Cancer Treated in an Expanded Access Program in Taiwan

Abstract

Objective: An increased risk of serious adverse effects related to bevacizumab has been observed in many Western studies for metastatic colorectal cancer. To evaluate the safety of bevacizumab in Chinese patients, a safety study was conducted in Taiwan. Methods: Bevacizumab was provided by the Expanded Access Program in combination with first-line chemotherapy per investigator's choice. The primary objective is the safety profile, particularly the targeted adverse events such as proteinuria, bowel perforation, hypertension, wound healing complication, thromboembolism and bleeding. The second objectives include time to disease progression and overall survival time. Patients with major surgical procedure performed within the 28 days of bevacizumab were excluded from this study. Results: Forty patients were eligible for intent-to-treat analysis. The overall rate of objective response and disease control was 55.2 and 81.6%. The median time to disease progression and overall survival were 11.9 and 22.9 months. The actuarial 2-year survival was 46.6%. Regarding toxicity, 7 subjects (17.5%) had serious adverse effects related to study treatment. None of the patients in this cohort had arterial thrombotic events and bowel perforation. Conclusions: Bevacizumab demonstrates a similar activity and safety profile in Chinese patients. Life-threatening bowel complications were avoided in this study by excluding patients with major surgery within the first 28 days.

Colorectal cancer in Chinese patients: current and emerging treatment options

“…In a report from Taiwan where bevacizumab is reimbursed by the government for the first-line treatment of metastatic CRC when combined with irinotecan-based chemotherapy, the efficacy and toxicity of bevacizumab-based chemotherapy seemed to be comparable with the Western studies. 108 …”

Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy: A Systematic Review and Meta-Analysis

“…Fifteen included studies encompassing 5891 patients reported on the prevalence of VTE in colorectal cancer patients undergoing chemotherapy [ 34 , 42 , 44 , 53 , 55 , 59 , 88 , 102 , 106 , 110 , 111 , 118 , 122 , 125 , 126 ]. The meta-analysis revealed a pooled estimated prevalence of 5%, ranging from 3 to 7% (ES 5%; 95% CI 3–7%; z = 8.16; p < 0.001) ( Table 4 and Supplemental SI Figure S4 ).…”