Adjuvant Gemcitabine Plus S-1 Chemotherapy Improves Survival After Aggressive Surgical Resection for Advanced Biliary Carcinoma

Objective: The aim of this study was to evaluate the efficacy of adjuvant gemcitabine plus S-1 chemotherapy after aggressive surgical resection for advanced biliary carcinoma. Summary Background Data: No effective adjuvant therapy for advanced biliary carcinoma has been reported although its prognosis is extremely poor. Methods: Medical records were reviewed for 103 patients with International Union Against Cancer (UICC) stage 11 biliary carcinoma who underwent aggressive surgical resection. About 50 patients received 10 cycles of adjuvant gemcitabine plus S-1 chemotherapy and 53 patients did not. Clinicopathological factors and patient survival were compared between the 2 groups using univariate and multivariate analysis. A cycle of chemotherapy consisted of intravenous gemcitabine 700 mg/m(2) on day 1 and oral S-1 50 mg/m(2) for 7 consecutive days, followed by a 1-week break from chemotherapy. Results: Patient demographics, tumor characteristics, and surgical procedures did not differ between the 2 groups. Aggressive surgical procedures including major hepatectomy or pancreatoduodenectomy were performed for 94 of 103 patients. In the chemotherapy group, 37 patients (74%) were given the full number of 10 cycles. The use of postoperative adjuvant chemotherapy (P < 0.001) and surgical margin status (P = 0.003) were independently associated with long-term survival by multivariate analysis. Five-year survival rates of patients who did or did not receive postoperative adjuvant chemotherapy were 57% and 24%, respectively (P < 0.001). Toxicity during chemotherapy was mild. Conclusions: Adjuvant gemcitabine plus S-1 chemotherapy may be one of several factors contributing to improved outcomes after aggressive surgical resection of advanced biliary carcinoma in recent years.