吉西他滨联合卡培他滨治疗进展期胆道癌37例回顾性分析

Retrospective analysis of the combination treatment of Gemcitabine and Capecitabine (GemCap) in patients with advanced biliary cancer (37 cases)

目的回顾性分析吉西他滨联合卡培他滨治疗进展期胆道癌患者的的疗效和安全情况。方法该科自2006年1月～2010年1月共入选37例患者,均为进展期胆道癌患者。口服卡培他滨650 mg/m2,2次/d,共14 d;吉西他滨1 000 mg/m2在1 d和8 d静脉滴注,21 d为1个周期,2个周期后评价疗效。结果全组37例患者均可评价疗效。其中未见完全缓解患者,部分缓解率为30%(11/37),稳定49%(18/37),进展22%(8/37)。中位进展时间7.2个月(4.2～11.9,95%CI),中位生存时间11.3个月(6.1～21.9,95%CI)。无治疗相关死亡,常见毒性反应是外周血粒细胞下降、血小板减少、轻度贫血、消化道反应、疲劳及偶发的腹泻和皮疹。结论吉西他滨联合卡培他滨方案治疗进展期胆道癌具有显著的抗肿瘤活性和较温和的毒性反应,可使进展期胆道癌患者受益,值得进一步研究和推广。

【Objective】 To determine the response rate,time to disease progression,survival,and safety profile of the combination of Gemcitabine and Capecitabine（GemCap） in patients with advanced biliary cancer.【Methods】 From January 2006 to January 2010,37 advanced biliary cancer patients were enrolled.Chemotherapy dosage and method of setting： Capecitabine（Cap） 650 mg/m2 orally twice a day for 14 days,Gemcitabine at a fixed dose of 1 000 mg/m2 intravenously over 30 minutes on days 1 and 8.21 days for one cycle,two cycles were evaluated.【Results】 37 patients total effective rate was 30%,with an additional 49% of patients with stable disease,for a disease control rate of 79%,complete response rate was 0.0%（0 / 37）,partial remission rate was 30%（11 / 37）,stable was 49%（18 / 37）,progress was 22%（8 / 37）.The median time to progression was 7.2（4.2 ~ 11.9,95%CI） months,median survival time of 11.3（6.1 ~ 21.9,95%CI） months.No treatment-related deaths.This chemotherapy combination was generally well tolerated.Decline in peripheral blood granulocytes,thrombocytopenia,mild anemia,gastrointestinal reactions,fatigue and occasional diarrhea and rash were commonly observed but were easily managed without discontinuing further treatment.【Conclusion】The significant antitumor activity combined with a mild toxicity profile seen in this study argue that GemCap chemotherapy may benefit patients with advanced biliary cancer.This regimen warrants further evaluation in a randomized study with survival and quality of life end points.