肝外胆管癌和胆囊癌术后辅助放疗与未放疗疗效比较的Meta分析

A meta-analysis of the efficacy of postoperative adjuvant radiotherapy and non-radiotherapy for extrahepatic cholangiocarcinoma and gallbladder carcinoma

目的采用Meta分析方法比较肝外胆管癌和胆囊癌术后辅助放疗与未放疗间的疗效差异。方法计算机检索PubMed、EMbase、Cochrane图书馆、万方、维普、CNKI及中国生物医学等数据库,搜集有关肝外胆管癌和胆囊癌术后辅助放疗与未放疗比较的临床对照研究资料,汇总数据采用RevMan5.3和Stata14.0软件进行分析。两组间差异采用OR及95%CI描述。结果最终纳入20个包括1258例患者的临床对照研究资料。Meta分析结果显示,与肝外胆管癌和胆囊癌术后未行放疗相比,辅助放疗组5年生存率更高(OR=1.67,95%CI为1.29~2.18,P=0.001)。术后辅助放疗能明显提高切缘阳性(OR=3.43,95%CI为1.56~7.75,P=0.002)以及淋巴结阳性(OR=7.44;95%CI为1.24~44.72,P=0.03)患者的5年生存率。此外,术后辅助放疗组的局部复发率更低(OR=0.56,95%CI为0.39~0.80,P=0.01),但远处转移率两组相似(OR=1.22,95%CI为0.86~1.73,P=0.270)。放疗所致≥3级急性毒性及慢性毒性反应发生率分别为0~11.9%和0~21.7%。结论与肝外胆管癌和胆囊癌术后未行放疗相比,术后辅助放疗是有效且安全的治疗方法。

Objective To compare the efficacy of postoperative adjuvant radiotherapy and non-radiotherapy in patients with extrahepatic cholangiocarcinoma and gallbladder carcinoma by a meta-analysis.Methods The controlled clinical trials of postoperative adjuvant radiotherapy versus non-radiotherapy of extrahepatic cholangiocarcinoma and gallbladder carcinoma were searched from PubMed,EMbase,Cochrane Library,Wanfang database,CNKI,Chongqing VIP and CBM databases.The obtained data were analyzed using RevMan 5.3 and Stata 14.0 statistical software.The difference between two groups was estimated by calculating the odds ratio(OR)with 95%confidence interval(CI).Results A total of 20 controlled clinical trials involving 1258 extrahepatic cholangiocarcinoma and gallbladder carcinoma patients were included in this meta-analysis.The meta-analysis demonstrated that the 5-year survival rate in the adjuvant radiotherapy group was significantly higher than that in the non-radiotherapy group(OR=1.67,95%CI:1.29-2.18,P=0.001).The 5-year survival rates in those with lymph node positive disease(OR=7.44,95%CI:1.24-44.72,P=0.03)and positive margins disease(OR=3.43,95%CI:1.56-7.75,P=0.002)were significantly enhanced by postoperative adjuvant radiotherapy.The local recurrence rate in the adjuvant radiotherapy group was significantly lower than that in the non-radiotherapy group(OR=0.56,95%CI:0.39-0.80,P=0.01),whereas the distant metastasis rate did not significantly differ between two groups(OR=1.22,95%CI:0.86-1.73,P=0.27).The incidence rates of acute toxicity and chronic toxicity of grade≥3 caused by radiotherapy were 0-11.9%and 0-21.7%,respectively.Conclusion Compared with non-radiotherapy,postoperative adjuvant radiotherapy is a safer and more effective postoperative treatment for extrahepatic cholangiocarcinoma and gallbladder carcinoma.