Division of Clinical Medical Science, Department of Surgery, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
Ann Surg. 2009 Dec;250(6):950-6. doi: 10.1097/sla.0b013e3181b0fc8b.
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.
No effective adjuvant therapy for advanced biliary carcinoma has been reported although its prognosis is extremely poor.
Medical records were reviewed for 103 patients with International Union Against Cancer (UICC) stage II 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.
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.
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.
本研究旨在评估吉西他滨联合替吉奥辅助化疗对晚期胆道癌根治性手术后的疗效。
尽管晚期胆道癌的预后极差，但目前尚无有效的辅助治疗方法。
回顾性分析了 103 例国际抗癌联盟（UICC）Ⅱ期胆道癌患者的病历资料，这些患者均接受了积极的手术切除。其中约 50 例患者接受了 10 个周期的辅助吉西他滨联合替吉奥化疗，53 例患者未接受。采用单因素和多因素分析比较两组患者的临床病理因素和生存情况。化疗周期为静脉滴注吉西他滨 700mg/m2，第 1 天，口服替吉奥 50mg/m2，连续 7 天，然后化疗休息 1 周。
两组患者的人口统计学特征、肿瘤特征和手术方式无差异。94 例患者接受了包括大范围肝切除术或胰十二指肠切除术在内的积极手术治疗。在化疗组中，37 例（74%）患者接受了完整的 10 个周期治疗。多因素分析显示，术后辅助化疗（P < 0.001）和手术切缘状态（P = 0.003）是影响长期生存的独立因素。接受和未接受术后辅助化疗的患者 5 年生存率分别为 57%和 24%（P < 0.001）。化疗期间的毒性反应较轻。
近年来，吉西他滨联合替吉奥辅助化疗可能是提高晚期胆道癌根治性手术后疗效的因素之一。
