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Medline ® Abstract for Reference 45

of 'Systemic therapy for advanced cholangiocarcinoma'

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A phase II FOLFOX-4 regimen as second-line treatment in advanced biliary tract cancer refractory to gemcitabine/cisplatin.
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He S, Shen J, Sun X, Liu L, Dong J
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J Chemother. 2014 Aug;26(4):243-7. Epub 2013 Dec 6.
 
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.
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PMID