title: 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.
authors.affiliation: Department of Hematology and Oncology, Chang Gung Memorial Hospital, Chiayi, Taiwan.
authors.forename: Kuan-Der
authors.initials: KD
authors.lastname: Lee
authors.forename: Hong-Hwa
authors.initials: HH
authors.lastname: Chen
authors.forename: Hwei-Ming
authors.initials: HM
authors.lastname: Wang
authors.forename: Chao-Jung
authors.initials: CJ
authors.lastname: Tsao
authors.forename: Tzu-Chi
authors.initials: TC
authors.lastname: Hsu
authors.forename: Chang-Fang
authors.initials: CF
authors.lastname: Chiu
authors.forename: Wu-Chou
authors.initials: WC
authors.lastname: Su
authors.forename: Jeng-Yi
authors.initials: JY
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D044466:Asian People; D000068258:Bevacizumab; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D061214:Patient Safety; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068258:Bevacizumab