FOLFOX-4 Regimen or Single-agent Gemcitabine as First-line Chemotherapy in Advanced Biliary Tract Cancer

*Department of Oncology †Unit of Cancer Epidemiology and CPO Piemonte, San Giovanni Battista Hospital ‡Department of Public Health and Microbiology, University of Torino, Torino, Italy.
American journal of clinical oncology (Impact Factor: 3.06). 07/2012; 36(5). DOI: 10.1097/COC.0b013e31825691c3
Source: PubMed


We conducted a retrospective cohort study to compare 2 different chemotherapy regimens for advanced biliary tract cancer (BTC).

Records of patients consecutively treated in our institution for advanced BTC from 2001 to 2006 were retrieved. Chemotherapy treatment with FOLFOX-4 regimen was routinely offered as first option; gemcitabine (GEM) as single agent was proposed as an alternative option to patients who refused central venous catheter implantation. Toxicity, overall response rate, progression-free survival (PFS), and overall survival (OS) obtained with the 2 treatments were evaluated.

Twenty-two patients were treated with FOLFOX-4, whereas 18 patients received GEM. In the FOLFOX-4 group, the overall response rate was 13.6% (95% confidence interval [CI], 4.7-33.3), with 1 complete response and 2 partial responses, and 54.5% (95% CI, 34.7-73.1) of disease control rate (complete response+partial response+stable disease). Median OS was 14.1 months (95% CI, 9.1-18.8) and median PFS 5.44 months (95% CI, 3.2-6.3). In the GEM group, we observed no objective response, whereas 27.7% (95% CI, 12.5-50.9) obtained disease control. Median OS was 8.3 months (95% CI, 4.7-12.9) and median PFS 3.9 months (95% CI, 2.2-5.4). Toxicity, mainly hematological, was acceptable for both treatments. On a multivariable Cox model including a propensity score, only the performance status and chemotherapy regimen were confirmed as strong predictors of OS, with an hazard ratio of 0.49 (95% CI, 0.24-0.99) in favor of FOLFOX-4.

The combination chemotherapy with oxaliplatin and 5-fluorouracil is well tolerated and seems to provide prolonged survival than GEM alone in advanced BTC treatment, but further randomized trials are warranted.

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    ABSTRACT: 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. 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). 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 1.0?2.4). 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%). FOLFOX-4 regimen is a feasible and moderately efficacious second-line chemotherapy for advanced BTC.
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