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目的对术前放化疗(新辅助放化疗,CRTS)与单纯手术(S)治疗食管癌的随机对照试验研究(RCTs)进行Me-ta分析,探讨CRTS对食管癌手术及预后的影响。方法 PubMed及手工检索所有已发表的关于CRTS与S治疗食管癌的RCTs。检验异质性,并根据异质性结果选择相应的效应模型。结果 14项RCTs纳入本研究,共1737例食管癌患者,文献质量评价根据Cochrane Reviewers′ Handbook4.2.2为A或B。CRTS组与S组比较,1年生存率差异无统计学意义,但CRTS组2年、3年、4年、5年生存率明显提高。相对危险度(RR)分别为1.06(95%CI0.99～1.13;P=0.1)、1.18(95%CI1.04～1.33;P=0.01)、1.39(95%CI1.23～1.58;P<0.00001)、1.27(95%CI1.04～1.55;P=0.02)、1.41(95%CI1.18～1.69;P=0.0001)。切除率二者差异无统计学意义,RR1.01(95%CI0.97～1.05;P=0.67),但CRTS组有较高的完全切除率,RR1.44(95%CI1.23～2.74;P=0.008)。总体死亡率二者比较,差异无统计学意义,RR1.12(95%CI0.89～2.48;P=0.503),但CRTS组手术相关死亡率相对较高,RR1.70(95%CI1.12～2.56;P=0.01)。二者并发症发生率差异无统计学意义,RR1.23(95%CI0.93～1.78;P=0.13)。二组远处转移率及总体肿瘤复发率比较,均差异无统计学意义,RR分别为1.18(95%CI0.75～1.68;P=0.71)、1.07(95%CI0.76～1.56;P=0.18),但CRTS组局部区域复发率降低,RR1.18(95%CI1.22～1.61;P=0.0001)。CRTS组病理完全缓解率达10.0%～45.5%。同步CRTS与序贯性CRTS比较,前者(RR1.34,95%CI1.06～1.89,P=0.013)比后者(RR0.86,95%CI0.67～1.38,P=0.29)更有益于提高患者5年生存率。结论与S治疗食管癌相比,CRTS降低了肿瘤局部区域复发率,提高了患者的3年、5年生存率;手术切除率二者差异无统计学意义,而CRTS完全切除率提高,但其手术相关死亡率相对较高。二者并发症发生率比较差异无统计学意义。
Objective To evaluate the effect of CRTS on the operation and prognosis of esophageal cancer by Me-ta analysis on preoperative radiotherapy (neoadjuvant chemoradiation, CRTS) and surgery alone (S) for esophageal cancer. Methods PubMed and hand-searched all published RCTs on CRTS and S for esophageal cancer. Heterogeneity is checked and the corresponding effect model is chosen based on the heterogeneity. Results A total of 1737 RCTs were included in this study. The quality of the literature was evaluated as A or B according to Cochrane Reviewers’ Handbook 4.2.2. CRTS group and S group, 1-year survival rate was no significant difference, but CRTS group 2 years, 3 years, 4 years, 5-year survival rate was significantly improved. The relative risk (RR) were 1.06 (95% CI 0.99-1.13; P = 0.1), 1.18 (95% CI 1.04-1.33; P 0.01), 1.39 (95% CI 1.23-1.58, P < 0.00001), 1.27 (95% CI 1.04-1.55; P = 0.02), 1.41 (95% CI 1.18-1.69; P = 0.0001). There was no significant difference in the resection rate between the two groups (RR1.01, 95% CI 0.97-1.05; P = 0.67), but the CRTS group had a high complete resection rate (RR1.44; 95% CI 1.23-2.74; P = 0.008). There was no significant difference in overall mortality between the two groups (RR1.12 (95% CI: 0.89-2.48; P = 0.503)). However, the CRTS group had a higher operative-related mortality rate and RR1.70 (95% CI 1.12 ~ 2.56; P = 0.01). There was no significant difference in the incidence of complications between the two groups, RR1.23 (95% CI 0.93-1.78; P = 0.13). There was no significant difference in distant metastasis rate and overall tumor recurrence between the two groups (RR = 1.18, 95% CI: 0.75-1.68, P = 0.71, 1.07, 95% CI: 0.18). However, the recurrence rate in the CRTS group was decreased (RR 1.18 (95% CI 1.22-1.61; P = 0.0001). CRTS group pathological complete remission rate of 10.0% to 45.5%. The former (RR1.34, 95% CI1.06 ~ 1.89, P = 0.013) was more beneficial than the latter (RR 0.86, 95% CI 0.67 ~ 1.38, P = 0.29) Improve patient 5-year survival rate. Conclusion Compared with S treatment of esophageal cancer, CRTS reduces the recurrence rate in the local area of the tumor and improves the 3-year and 5-year survival rate of the patients. There is no significant difference between the two groups in the rate of resection and the complete resection rate of CRTS Surgery-related mortality is relatively high. There was no significant difference in the complication rates between the two groups.