可切除或交界可切除胰腺癌新辅助放化疗+手术对比直接手术疗效及安全性Meta分析

目的 系统评价可切除或交界可切除胰腺癌新辅助放化疗+手术与直接手术治疗模式有效性及安全性差异。方法 以pancreatic neoplasm、pancreatic cancer、surgery、preoperative chemoradiotherapy、neoadjuvant chemoradiotherapy及胰腺癌、新辅助放化疗、手术为检索词,检索Pubmed、Embase、Cochrane Library、Web of Science、中国生物医学文献数据库、万方、中国知网和维普数据库。检索时间为建库至 2020年2月。纳入新辅助放化疗+手术对比直接手术治疗可切除或交界可切除胰腺癌的随机对照试验(RCT)研究,由两名研究者独立筛选文献、提取数据和进行质量评价。总生存时间的评价采用HR及 95%CI表示,R0切除率、组间术后并发症发生率和治疗期间死亡率的评价采用RR及 95%CI表示,并且采用I²对纳入文献进行异质性检验。结果 最终纳入4项RCT研究,共 400例患者,其中新辅助放化疗+手术组 197例,直接手术组 203例。结果显示新辅助放化疗+手术组较直接手术组提高了总生存期(HR=0.76,95%CI为 0.60~0.97,P=0.03)以及R0切除率(RR=1.72,95%CI为 1.40~2.13,P<0.01),组间术后并发症发生率和治疗期间死亡率差异均无统计学意义(RR=1.02,95%CI为 0.73~1.43,P=0.90;RR=1.19,95%CI为 0.48~2.93,P=0.71)。结论 在可切除或交界可切除胰腺癌治疗中,新辅助放化疗+手术较直接手术可能会带来更多生存获益,且未增加术后不良反应发生率和治疗期间死亡率。新辅助放化疗+手术可作为可切除或交界可切除胰腺癌患者一种推荐治疗方式。

Comparison of efficacy and safety between neoadjuvant chemoradiotherapy followed by surgery and immediate surgery in the treatment of resectable and borderline resectable pancreatic cancer:a Meta-analysis

Objective To systematically evaluate the efficacy and safety between neoadjuvant chemoradiotherapy followed by surgery and immediate surgery in the treatment of resectable and borderline resectable pancreatic cancer. Methods Literature review was performed from PubMed, Embase, Cochrane Library, Web of Science, CBM, Wanfang, CNKI and VIP from the inception date to February, 2020 using the key words including “pancreatic neoplasm, pancreatic cancer, surgery, preoperative chemoradiotherapy, neoadjuvant chemoradiotherapy”in both English and Chinese. The randomized controlled clinical trials (RCTs) of neoadjuvant chemoradiotherapy followed by surgery versus immediate surgery in the treatment of resectable and borderline resectable pancreatic cancer were searches. Literature screening, data extraction and estimation of the risk of bias were independently conducted by two researchers. The HR and 95%CI were used for estimating the overall survival time. The R0 resection rate, overall incidence of postoperative complications, and mortality rate throughout treatment were assessed by the RR and 95%CI. The heterogeneity of the studies was analyzed using the I² test. Results A total of 4 RCTs were included. Among 400 patients, 197 cases were assigned into the neoadjuvant chemoradiotherapy combined with surgery group and 203 in the immediate surgery group. The results of Meta-analysis showed that patients in the neoadjuvant chemoradiotherapy followed by surgery group obtained longer overall survival (HR=0.76, 95%CI:0.60-0.97, P=0.03) and higher R0 resection rate (RR=1.72, 95%CI:1.40-2.13, P<0.01). Besides, the overall incidence of postoperative complications (RR=1.02, 95%CI:0.73-1.43, P=0.90) and mortality rate throughout treatment (RR=1.19, 95%CI:0.48-2.93, P=0.71) did not significantly differ between two groups. Conclusions During the treatment of resectable or borderline resectable pancreatic cancer, neoadjuvant chemoradiotherapy followed by surgery may bring more survival benefits than immediate surgery and does not increase the incidence of postoperative complications and mortality rate throughout treatment. Therefore, neoadjuvant chemoradiotherapy followed by surgery can be used as a recommended treatment for patients with resectable or borderline resectable pancreatic cancer.