Adjuvant chemotherapy with gemcitabine and S‐1 after surgical resection for advanced biliary carcinoma: outcomes and prognostic factors

BACKGROUND/PURPOSE: The aims of this study were to evaluate long-term outcomes and to determine prognostic factors for survival in patients with resected biliary carcinoma who received adjuvant gemcitabine plus S-1 chemotherapy. METHODS: Seventy patients with International Union Against Cancer (UICC) stage II, III, or IV biliary carcinoma received postoperative adjuvant chemotherapy consisting of intravenous gemcitabine 700 mg/m(2) on day 1 and oral S-1 60-100 mg/body for seven consecutive days, followed by a 1-week pause of chemotherapy. Patients received up to ten 2-week cycles. Long-term outcomes and predictors of survival with this adjuvant chemotherapy regimen were analyzed. RESULTS: The median duration of follow-up was 47 months. Fifty-six percent of patients had node-positive disease, and 80% of patients underwent R0 resection. Overall and disease-free survival rates were 91 and 81% at 1 year, 56 and 55% at 3 years, and 40 and 46% at 5 years, respectively. Lymph node status (p = 0.025) and surgical margin status (p = 0.033) were independently associated with long-term survival by multivariate analysis. CONCLUSIONS: Adjuvant gemcitabine plus S-1 chemotherapy may be a promising strategy for patients with resected biliary carcinoma, and nodal status and surgical margin status may be predictors of survival with this treatment strategy.