Bevacizumab in association with de Gramont 5-fluorouracil/folinic acid in patients with oxaliplatin-, irinotecan-, and cetuximab-refractory colorectal cancer: a single-center phase 2 trial.

摘要: BACKGROUND: The aim of the current study was investigation value bevacizumab + 5-fluorouracil(5–FU)/folinic acid in patients with advanced colorectal cancers who have exhausted standard chemotherapy options. METHODS: The authors included 48 heavily pretreated (colon:rectum, 33:15; men:women, 23:25; median age, 63 years; range, 27-79 years) whose disease had progressed during or within an oxaliplatin-based first-line chemotherapy, irinotecan-based second-line regimen, and a third-line treatment cetuximab plus weekly irinotecan. Bevacizumab given at dose 5 mg/kg. 5-FU/folinic administered according to de Gramont schedule. RESULTS: The response rate 6.25%, 30.4% demonstrated stable as best response. The time progression 3.5 months (95% confidence interval [95% CI], 2.3-6.9 months), survival 7.7 CI, 3.9-11.9 months). most common grade 3 4 side toxicities (graded National Cancer Institute Common Toxicity Criteria [version 2.0]) were: diarrhea (20.8%), fatigue (14.5%), stomatitis (12.5%). Grade hemorrhage occurred 8 (16.6%), including cases bleeding gastrointestinal tract. Other relatively adverse events such hypertension, thrombosis, bowel perforation were reported 50%, 18.7%, 4.16%, respectively. CONCLUSIONS: The data from suggest modest but significant clinical benefit schedule cancer patients. 2009. © 2009 American Society.