FOLFOX-4 Regimen or Single-agent Gemcitabine as First-line Chemotherapy in Advanced Biliary Tract Cancer
ABSTRACT OBJECTIVES:: We conducted a retrospective cohort study to compare 2 different chemotherapy regimens for advanced biliary tract cancer (BTC). METHODS:: 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. RESULTS:: 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. CONCLUSIONS:: 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.Journal of chemotherapy (Florence, Italy) 09/2013; 26(4). DOI:10.1179/1973947813Y.0000000133 · 0.83 Impact Factor