A phase II FOLFOX-4 regimen as second-line treatment in advanced biliary tract cancer refractory to gemcitabine/cisplatin.
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.
Shengli
S
He
Jie
J
Shen
Xianjun
X
Sun
Luming
L
Liu
Jingcheng
J
Dong
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
Biliary tract cancer,; Cisplatin,; FOLFOX-4,; Gemcitabine,; Second line