CAJ | 학술논문

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。
목적：평고동보방화료대불능수술절제적국부만기간외담관암환자적림상료효급불량반응。방법：선취2007년2월지2012년2월소흥시인민의원종류방료과수치적38례불능수술절제적국부만기간외담관암환자，수궤분성서관방화료조（19례）여동보방화료조（19례），균채용조강괄형방료，기중동보방화료조접수길서타빈연합오사리박화료。치료결속후관찰비교량조환자적료효、불량반응，병진행생존분석。결과：서관방화료조화동보방화료조유효솔분별위42.1％（8／19）화63.2％（12／19），질병공제솔분별위78.9％（15／19）화84.2％（16／19），중위질병무진전생존시간분별위8.3화10.4개월，중위총생존시간분별위14.2화15.6개월，기중중위질병무진전생존시간량조간차이유통계학의의（ P＝0.037）。량조환자방화료불량반응균가공，기발생솔차이균무통계학의의（균P＞0.05）。결론：대우불능수술차체력상황평분≤2분적국부만기간외담관암환자，서관방화료여동보방화료균능유효연장질병무진전생존시간화총생존시간，차내수성량호，기중동보방화료효과가능경가。
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.