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

Kuan Der Lee, Hong Hwa Chen, Hwei Ming Wang, Chao Jung Tsao, Tzu Chi Hsu, Chang Fang Chiu, Wu Chou Su, Jeng Yi Wang

研究成果: Article

2 引文 斯高帕斯(Scopus)

摘要

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.

原文English
頁(從 - 到)299-304
頁數6
期刊Oncology (Switzerland)
84
發行號5
DOIs
出版狀態Published - 2013 五月 1

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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