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边界可切除和局部进展不可切除胰腺导管腺癌中转化手术的生存分析:解决选择和不朽时间偏倚的回顾性单中心研究。

Survival Analysis of Conversion Surgery in Borderline Resectable and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma Addressing Selection and Immortal Time Bias: A Retrospective Single-Center Study.

机构信息

Department of Hepatobiliary-Pancreatic Surgery, Juntendo University Graduate School of Medicine, Tokyo, Japan.

Medical Technology Innovation Centre, Juntendo University Graduate School of Medicine, Tokyo, Japan.

出版信息

Ann Surg Oncol. 2024 Dec;31(13):8744-8755. doi: 10.1245/s10434-024-16203-x. Epub 2024 Oct 3.

Abstract

BACKGROUND

The purpose of this study was to provide a detailed evaluation of the oncological advantages of surgery following neoadjuvant chemotherapy (NAC) for patients with borderline resectable (BR) or unresectable (UR) pancreatic ductal adenocarcinoma (PDAC), with a focus on minimizing biases. Recently, NAC has become the standard care for BR or UR locally advanced (UR-LA) PDAC, however, many studies have assessed survival benefits and favorable variables without consideration for biases, particularly immortal time bias.

PATIENTS AND METHODS

This study included patients diagnosed with BR or UR-LA PDAC at Juntendo University Hospital from 2019 to 2022. To mitigate bias, we applied methods such as propensity score matching (PSM), time-dependent covariate Cox proportional hazard regression analysis (TDC), landmark analysis, and multivariable Cox proportional hazards regression model.

RESULTS

The study analyzed 124 patients, dividing them into a surgery group (n = 57) and a chemotherapy-only group (n = 67). After PSM, there were 21 matched pairs. Survival analysis using TDC analysis showed that the surgery group had significantly better overall survival compared with the chemotherapy-only group in both the entire cohort and the matched pairs. Cox regression analysis of the entire cohort also revealed a similar superiority of surgery, while the landmark analysis showed varying results depending on the landmark setting.

CONCLUSIONS

After careful adjustment for selection and immortal time biases, surgery following NAC appears to significantly extend survival in patients with BR or UR PDAC.

摘要

背景

本研究旨在详细评估新辅助化疗(NAC)后对边界可切除(BR)或不可切除(UR)胰腺导管腺癌(PDAC)患者手术的肿瘤学优势,重点是最大限度地减少偏倚。最近,NAC 已成为 BR 或 UR 局部晚期(UR-LA)PDAC 的标准治疗方法,然而,许多研究评估了生存获益和有利因素,但没有考虑到偏倚,特别是无事件时间偏倚。

患者和方法

本研究纳入了 2019 年至 2022 年期间在顺天堂大学医院诊断为 BR 或 UR-LA PDAC 的患者。为了减轻偏倚,我们应用了倾向评分匹配(PSM)、时依协变量 Cox 比例风险回归分析(TDC)、 landmark 分析和多变量 Cox 比例风险回归模型等方法。

结果

本研究共分析了 124 例患者,分为手术组(n=57)和单纯化疗组(n=67)。经过 PSM 后,有 21 对匹配。TDC 分析的生存分析显示,在整个队列和匹配对中,手术组的总生存率明显优于单纯化疗组。整个队列的 Cox 回归分析也显示了手术的相似优势,而 landmark 分析则显示了不同的结果,这取决于 landmark 的设置。

结论

在仔细调整选择和无事件时间偏倚后,NAC 后手术似乎显著延长了 BR 或 UR PDAC 患者的生存时间。

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