可切除或交界可切除胰腺癌新辅助治疗与优先手术疗效及安全性Meta分析

doi:10.7659/j.issn.1005-6947.2023.03.002

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可切除或交界可切除胰腺癌新辅助治疗与优先手术疗效及安全性Meta分析
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                        10.7659/j.issn.1005-6947.2023.03.002
                    
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作者单位:内蒙古医科大学附属医院 肝胆胰脾外科，内蒙古 呼和浩特 010000
作者简介:牛河源，内蒙古医科大学附属医院住院医师，主要从事肝胆胰脾相关基础与临床应用方面的研究。
通信作者:李军，Email: ljdoctor1982@163.com
基金项目:内蒙古自治区草原英才创新人才团队基金资助项目（060073）；内蒙古医科大学附属医院重大课题基金资助项目（NYFYZD2014005）；内蒙古医科大学科技百万工程联合基金资助项目[YKD2020KJBW（LA）027]。

Meta-analysis of efficacy and safety of neoadjuvant therapy versus priority surgery for resectable or borderline resectable pancreatic cancer

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Department of Hepatobiliary Pancreato-Splenic Surgery, Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, China

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摘要:

背景与目的 随着多学科治疗模式的发展及精准医学的兴起，新辅助治疗（NAT）可以改善非转移性胰腺癌的根治性切除率已基本达成共识，然而，由于缺乏结论性的随机对照试验，其在可切除及交界可切除患者中的作用仍有争议。因此，本研究通过Meta分析的方法比较可切除或交界可切除胰腺癌NAT后手术与优先手术两种治疗模式的有效性及安全性，为临床提供循证参考。方法检索多个国内外数据库，搜集关于可切除或交界可切除胰腺癌NAT与优先手术的临床随机对照试验（RCT），检索时限均从建库至2022年11月29日。应用Cochrane系统评价方法评价纳入研究，对同质研究采用RevMan 5.4软件进行Meta分析。结果最终共纳入7个RCT研究，共计938例患者。其中NAT组466例，优先手术组472例。Meta分析结果显示，与优先手术组比较，NAT组R₀切除率增加（RR=1.65，95% CI=1.35~2.02，P<0.000 01），阳性淋巴结发生率降低（RR=0.67，95% CI=0.52~0.85，P=0.001），手术切除率降低（RR=0.91，95% CI=0.84~0.98，P=0.02），而中位生存时间（MD=4.95，95% CI=-3.26~13.15，P>0.05），手术并发症发生率差异无统计学意义（RR=1.19，95% CI=0.97~1.46，P>0.05）。结论对于可切除或交界可切除胰腺癌，NAT可增加R₀切除率，降低阳性淋巴结发生率，降低手术切除率。关于NAT是否能提高可切除或交界可切除胰腺癌患者的总生存率，仍需要更多高质量的多中心随机对照试验予以验证。

Abstract:

Background and Aims With the development of multidisciplinary treatment modalities and the rise of precision medicine, there is a general consensus that neoadjuvant therapy (NAT) can improve the radical resection rate of non-metastatic pancreatic cancer. However, due to the lack of conclusive randomized controlled trials, its role in resectable and borderline resectable patients is still controversial. Therefore, this study was conducted to compare the effectiveness and safety of surgical resection after NAT versus upfront surgery in resectable or borderline resectable pancreatic cancer patients using a Meta-analysis approach, so as to provide evidence-based reference for clinical practice.Methods Randomized controlled trials (RCTs) on NAT and upfront surgery for resectable or borderline resectable pancreatic cancer were searched from several domestic and international databases. The search time limit was from the establishment of the database to November 29, 2022. Cochrane systematic review method was used to evaluate the included studies, and RevMan 5.4 software was used for Meta-analysis of homogeneous studies.Results A total of 7 RCTs with 938 patients were finaly included. Among them, there were 466 patients in NAT group and 472 patients in upfront surgery group. The results of Meta-analysis showed that compared with upfront surgery group, the NAT group had an increased R₀ resection rate (RR=1.65, 95% CI=1.35-2.02, P<0.000 01), a decreased incidence of positive lymph nodes (RR=0.67, 95% CI=0.52-0.85, P=0.001), and a decreased surgical resection rate (RR=0.91, 95% CI=0.84-0.98, P=0.02), while there was no statistically significant difference in median survival time (MD=4.95, 95% CI=-3.26-13.15, P>0.05) or the incidence of surgical complications (RR=1.19, 95% CI=0.97-1.46, P>0.05).Conclusion For resectable or borderline resectable pancreatic cancer, NAT can increase the R₀ resection rate, reduce the incidence of positive lymph nodes, and decrease the surgical resection rate. Whether NAT can improve the overall survival rate of patients with resectable or borderline resectable pancreatic cancer still needs to be verified by more high-quality multicenter randomized controlled studies.