A phase II FOLFOX-4 regimen as second-line treatment in advanced biliary tract cancer refractory to gemcitabine/cisplatin. (August 2014)

• Record Type: Journal Article
• Authors: He, Shengli; Shen, Jie; Sun, Xianjun; Liu, Luming; Dong, Jingcheng
• Is Part Of: Journal of chemotherapy. Volume 26:Number 4(2014:Aug.)
• Page Start: 243
• Page End: 247
• Publication Date: 2014-08
• Subjects: Biliary tract cancer, -- FOLFOX-4, -- Gemcitabine, -- Cisplatin, -- Second line; Chemotherapy -- Periodicals; Drug Therapy -- Periodicals; 615.58
• DOI: 10.1179/1973947813Y.0000000133
• Languages: English
• ISSNs: 1120-009X

Abstract

Abstract : Objective: We aimed to evaluate the efficacy and safety of oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV) (FOLFOX-4) as second-line treatment in patients with advanced biliary tract cancer (BTC) failing gemcitabine/cisplatin first-line chemotherapy. Methods: Thirty-seven patients with advanced BTC refractory to gemcitabine/cisplatin chemotherapy were included in the study. FOLFOX-4 regimen consisted of oxaliplatin (85 mg/m 2 ) as a 2-hour infusion on day 1 and 2-hour infusion of LV (200 mg/m 2 /day) followed by a 5-FU bolus (400 mg/m 2 /day) and 22-hour infusion of 5-FU (600 mg/m 2 /day) for two consecutive days every 2 weeks. The primary end point was the time to progression (TTP). Results: Between January 2009 and January 2012, a total of 37 patients were enrolled. The median age was 57 years (range 32–70) and male to female ratio was 21:16. Median TTP was 3·1 months (95% CI 2·3–3·6). The objective response rate was 21·6% (eight partial responses), and disease control rate was 62·2% (15 stable disease). Grade 3–4 toxicities were observed in 37·8% of the patients with neutropenia and fatigue being the most frequent (21·6%). Conclusions: FOLFOX-4 regimen is a feasible and moderately efficacious second-line chemotherapy for advanced BTC.