Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trial / 癌症
Chinese Journal of Cancer
; (12): 682-689, 2011.
Article
in English
| WPRIM (Western Pacific)
| ID: wpr-294476
Responsible library:
WPRO
ABSTRACT
The efficacy and safety of bevacizumab with modified irinotecan, leucovorin bolus, and 5-fluorouracil intravenous infusion (mIFL) in the first-line treatment of metastatic colorectal cancer (mCRC) has not been well evaluated in randomized clinical trials in Chinese patients. We conducted a phrase III trial in which patients with previously untreated mCRC were randomized 21 to the mIFL [irinotecan (125 mg/m(2)), leucovorin (20 mg/m(2)) bolus, and 5-fluorouracil intravenous infusion (500 mg/m(2)) weekly for four weeks every six weeks] plus bevacizumab (5 mg/kg every two weeks) group and the mIFL group, respectively. Co-primary objectives were progression-free survival (PFS) and 6-month PFS rate. In total, 214 patients were enrolled. Our results showed that addition of bevacizumab to mIFL significantly improved median PFS (4.2 months in the mIFL group vs. 8.3 months in the bevacizumab plus mIFL group, P < 0.001), 6-month PFS rate (25.0% vs. 62.6%, P < 0.001), median overall survival (13.4 months vs. 18.7 months, P = 0.014), and response rate (17% vs. 35%, P = 0.013). Grades 3 and 4 adverse events included diarrhea (21% in the mIFL group and 26% in the bevacizumab plus mIFL group) and neutropenia (19% in the mIFL group and 33% in the bevacizumab plus mIFL group). No wound-healing complications or congestive heart failure occurred. Our results suggested that bevacizumab plus mIFL is effective and well tolerated as first-line treatment for Chinese patients with mCRC. Clinical benefit and safety profiles were consistent with those observed in pivotal phase III trials with mainly Caucasian patients.
Full text:
Available
Health context:
Neglected Diseases
Health problem:
Diarrhea
/
Neglected Diseases
Database:
WPRIM (Western Pacific)
Main subject:
Pathology
/
Camptothecin
/
Colorectal Neoplasms
/
Antineoplastic Combined Chemotherapy Protocols
/
Leucovorin
/
Survival Rate
/
Prospective Studies
/
Disease-Free Survival
/
Angiogenesis Inhibitors
/
Therapeutic Uses
Type of study:
Controlled clinical trial
/
Observational study
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
Language:
English
Journal:
Chinese Journal of Cancer
Year:
2011
Document type:
Article