研究动态
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可切除胰腺癌的新辅助治疗与前期手术:随机临床试验的重建患者水平荟萃分析。

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

发表日期:2024 Sep 03
作者: Daniel Aliseda, Pablo Martí-Cruchaga, Gabriel Zozaya, Nuria Blanco, Mariano Ponz, Ana Chopitea, Javier Rodríguez, Eduardo Castañón, Fernando Pardo, Fernando Rotellar
来源: BJS Open

摘要:

新辅助治疗在边缘性可切除胰腺导管腺癌患者中显示出有希望的结果。新辅助治疗对可切除胰腺导管腺癌患者长期总体生存的潜在益处尚未确定。本研究的目的是根据是否接受新辅助治疗或接受前期手术来比较可切除胰腺导管腺癌患者的长期总体生存率。一项系统评价,包括关于新辅助治疗和前期手术之间总体生存结果的随机临床试验截至 2023 年 8 月 1 日,根据 PubMed、MEDLINE 和 Web of Science 数据库对可切除的胰腺导管腺癌患者进行了研究。从可用的 Kaplan-Meier 曲线中提取并重建患者水平的生存数据。采用频率论一阶段荟萃分析,使用基于 Cox 的模型和非参数方法(限制平均生存时间)来评估组间总生存率的差异。还进行了贝叶斯荟萃分析。纳入了包含 625 名患者的五项随机临床试验。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并无显着相关性(共同衰弱 HR 0.88,95% c.i. 0.72 至 1.08,P = 0.223);这一结果与非参数限制平均生存时间模型(2.41 个月,95% c.i. -1.22 至 6.04,P < 0.194)、排除具有高偏倚风险的随机临床试验(共同衰弱 HR)的敏感性分析一致。 0.91(95% c.i. 0.72 至 1.15;P = 0.424)),在贝叶斯分析中,后部共同衰弱 HR 为 0.86(95% c.i. 0.70 至 1.05)。对于患有以下疾病的患者,新辅助治疗并未表现出比前期手术具有生存优势。可切除的胰腺导管腺癌。© 作者 2024。由牛津大学出版社代表 BJS Foundation Ltd 出版。
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.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.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).Neoadjuvant treatment does not demonstrate a survival advantage over upfront surgery for patients with resectable pancreatic ductal adenocarcinoma.© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.