同步放化疗治疗19例不能手术切除的局部晚期肝外胆管癌患者

Concurrent chemoradiotherapy for locally advanced unresectable extrahepatic cholangiocarcinoma:a report of 19 cases

目的：评估同步放化疗对不能手术切除的局部晚期肝外胆管癌患者的临床疗效及不良反应。方法：选取2007年2月至2012年2月绍兴市人民医院肿瘤放疗科收治的38例不能手术切除的局部晚期肝外胆管癌患者，随机分成序贯放化疗组（19例）与同步放化疗组（19例），均采用调强适形放疗，其中同步放化疗组接受吉西他滨联合奥沙利铂化疗。治疗结束后观察比较两组患者的疗效、不良反应，并进行生存分析。结果：序贯放化疗组和同步放化疗组有效率分别为42.1％（8／19）和63.2％（12／19），疾病控制率分别为78.9％（15／19）和84.2％（16／19），中位疾病无进展生存时间分别为8.3和10.4个月，中位总生存时间分别为14.2和15.6个月，其中中位疾病无进展生存时间两组间差异有统计学意义（ P＝0.037）。两组患者放化疗不良反应均可控，其发生率差异均无统计学意义（均P＞0.05）。结论：对于不能手术且体力状况评分≤2分的局部晚期肝外胆管癌患者，序贯放化疗与同步放化疗均能有效延长疾病无进展生存时间和总生存时间，且耐受性良好，其中同步放化疗效果可能更佳。

Obj ective： To evaluate the efficacy and toxicity of concurrent chemoradiotherapy for patients with locally advanced unresectable extrahepatic cholangiocarcinoma.Me thods：Thirty-eight patients with locally advanced unresectable extrahepatic cholangiocarcinoma admitted in Shaoxing People＇s Hospital from February 2007 to February 2012 were enrolled in the study. They were randomized into sequential chemoradiotherapy（ n =19 ） or concurrent chemoradiotherapy group （ n =19 ） .All patients were treated with intensity modulated radiation therapy （ IMRT ） . Patients in concurrent chemoradiotherapy group received the regimen of gemcitabine plus oxaliplatin.Tumor response and adverse effects were observed periodically.The primary end points were disease progression-free survival （ PFS ） and overall survival （ OS） .Results： The response rates of sequential chemoradiotherapy and concurrent chemoradiotherapy groups were 42.1% （ 8/19 ） and 63.2% （ 12/19 ） .The disease control rates of them were 78.9% （15/19） and 84.2% （16/19）, respectively.The median PFS of sequential chemoradiotherapy group and concurrent chemoradiotherapy group was 8.3 （95%CI：7.6 -9.0） and 10.4 months （95%CI： 9.4 -11.4, P=0.037） , and the median OS in two groups were 14.2 （ 95%CI： 12.6 -15.8 ） and 15.6 months （95%CI： 14.2 -17.0, P =0.095）, respectively.The major adverse reactions were controllable hematology toxicity and gastrointestinal reaction.There was no significant difference in incidence of adverse reactions between two groups （ P 〉0.05）.Conclusion： Sequential chemoradiotherapy and concurrent chemoradiotherapy may improve PFS and OS in patients with locally advanced unresectable extrahepatic cholangiocarcinoma, and both are well-tolerated.In addition, concurrent chemoradiotherapy might provide additional PFS benefit and would be preferable.