Neoadjuvant therapy versus upfront surgery in resectable pancreatic cancer: reconstructed patient-level meta-analysis of randomized clinical trials.

IF 3.5 3区 医学 Q1 SURGERY
BJS Open Pub Date : 2024-09-03 DOI:10.1093/bjsopen/zrae087
Daniel Aliseda, Pablo Martí-Cruchaga, Gabriel Zozaya, Nuria Blanco, Mariano Ponz, Ana Chopitea, Javier Rodríguez, Eduardo Castañón, Fernando Pardo, Fernando Rotellar
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Abstract

Background: Neoadjuvant treatment has shown promising results in patients with borderline resectable pancreatic ductal adenocarcinoma. The potential benefits of neoadjuvant treatment on long-term overall survival in patients with resectable pancreatic ductal adenocarcinoma have not yet been established. The aim of this study was to compare long-term overall survival of patients with resectable pancreatic ductal adenocarcinoma based on whether they received neoadjuvant treatment or underwent upfront surgery.

Methods: A systematic review including randomized clinical trials on the overall survival outcomes between neoadjuvant treatment and upfront surgery in patients with resectable pancreatic ductal adenocarcinoma was conducted up to 1 August 2023 from PubMed, MEDLINE and Web of Science databases. Patient-level survival data was extracted and reconstructed from available Kaplan-Meier curves. A frequentist one-stage meta-analysis was employed, using Cox-based models and a non-parametric method (restricted mean survival time), to assess the difference in overall survival between groups. A Bayesian meta-analysis was also conducted.

Results: Five randomized clinical trials comprising 625 patients were included. Among patients with resectable pancreatic ductal adenocarcinoma, neoadjuvant treatment was not significantly associated with a reduction in the hazard of death compared with upfront surgery (shared frailty HR 0.88, 95% c.i. 0.72 to 1.08, P = 0.223); this result was consistent in the non-parametric restricted mean survival time model (+2.41 months, 95% c.i. -1.22 to 6.04, P < 0.194), in the sensitivity analysis that excluded randomized clinical trials with a high risk of bias (shared frailty HR 0.91 (95% c.i. 0.72 to 1.15; P = 0.424)) and in the Bayesian analysis with a posterior shared frailty HR of 0.86 (95% c.i. 0.70 to 1.05).

Conclusion: Neoadjuvant treatment does not demonstrate a survival advantage over upfront surgery for patients with resectable pancreatic ductal adenocarcinoma.

可切除胰腺癌的新辅助治疗与前期手术:随机临床试验的患者层面重构荟萃分析》(Neoadjuvant therapy versus upfront surgery in resectable pancreatic cancer: reconstructed patient-level metaalysis of randomized clinical trials)。
背景:新辅助治疗在边缘可切除胰腺导管腺癌患者中显示出良好的效果。新辅助治疗对可切除胰腺导管腺癌患者长期总生存期的潜在益处尚未确定。本研究旨在根据可切除胰腺导管腺癌患者是接受新辅助治疗还是接受前期手术,比较他们的长期总生存率:截至2023年8月1日,从PubMed、MEDLINE和Web of Science数据库中对可切除胰腺导管腺癌患者的新辅助治疗和前期手术的总体生存结果进行了系统性回顾,包括随机临床试验。研究人员从现有的 Kaplan-Meier 曲线中提取并重建了患者生存数据。采用基于 Cox 模型和非参数方法(受限平均生存时间)的频数主义单阶段荟萃分析来评估组间总生存率的差异。此外还进行了贝叶斯荟萃分析:结果:共纳入了五项随机临床试验,包括 625 名患者。在可切除的胰腺导管腺癌患者中,与前期手术相比,新辅助治疗与死亡风险的降低无显著相关性(共享虚弱 HR 0.88,95% c.i.0.72~1.08,P = 0.223);这一结果在非参数限制性平均生存时间模型中也是一致的(+2.41个月,95% c.i.-1.22至6.04,P <0.194)、排除了高偏倚风险随机临床试验的敏感性分析(共享虚弱HR为0.91(95% c.i.0.72至1.15;P = 0.424))以及贝叶斯分析中的后验共享虚弱HR为0.86(95% c.i.0.70至1.05):结论:对于可切除的胰腺导管腺癌患者,新辅助治疗与前期手术相比并不具有生存优势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BJS Open
BJS Open SURGERY-
CiteScore
6.00
自引率
3.20%
发文量
144
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