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新辅助治疗与直接手术切除治疗可切除胰腺腺癌患者的疗效比较:工具变量分析。

Comparative Effectiveness of Neoadjuvant Therapy and Upfront Resection for Patients with Resectable Pancreatic Adenocarcinoma: An Instrumental Variable Analysis.

机构信息

Department of Medicine, Epidemiology, and Population Sciences, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA.

Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Ann Surg Oncol. 2021 Jun;28(6):3186-3195. doi: 10.1245/s10434-020-09327-3. Epub 2020 Nov 10.

DOI:10.1245/s10434-020-09327-3
PMID:33174146
Abstract

BACKGROUND

Neoadjuvant therapy (NAT) is increasingly being used in the management of patients with resectable pancreatic ductal adenocarcinoma (PDAC); however, there is a lack of evidence regarding the benefit among these patients.

OBJECTIVE

The aim of this study was to evaluate overall survival (OS) in PDAC patients with resectable disease treated with NAT or upfront resection through instrumental variable (IV) analysis.

DESIGN

A national cohort study of resectable PDAC patients in the National Cancer Data Base (2007-2015) treated with either upfront surgery or resection after NAT. Using multivariable modeling and IV methods, OS was compared between those treated with NAT and upfront resection. The IV was hospital-level NAT utilization in the most recent year prior to treatment.

RESULTS

The cohort included 16,666 patients (14,012 upfront resection; 2654 NAT) treated at 779 hospitals. Among those treated with upfront resection, 59.9% received any adjuvant therapy. NAT patients had higher median (27.9 months, 95% confidence interval [CI] 26.2-29.1) and 5-year OS (24.1%, 95% CI 21.9-26.3%) compared with those treated with upfront surgery (median 21.2 months, 95% CI 20.7-21.6; 5-year survival 20.9%, 95% CI 20.1-21.7%). After multivariable modeling, NAT was associated with an approximately 20% decrease in the risk of death (hazard ratio [HR] 0.78, 95% CI 0.73-0.84), and this effect was magnified in the IV analysis (HR 0.61, 95% CI 0.47-0.79).

CONCLUSIONS

In patients with resectable PDAC, NAT is associated with improved survival relative to upfront resection. Given the benefits of multimodality therapy and the challenges in receiving adjuvant therapy, consideration should be given to treating all PDAC patients with NAT.

摘要

背景

新辅助治疗(NAT)越来越多地被用于可切除胰腺导管腺癌(PDAC)患者的治疗;然而,目前缺乏关于此类患者受益的证据。

目的

本研究旨在通过工具变量(IV)分析评估接受 NAT 或直接手术切除治疗的可切除 PDAC 患者的总生存(OS)。

设计

这是一项全国性队列研究,纳入了国家癌症数据库(2007-2015 年)中接受直接手术或 NAT 后切除的可切除 PDAC 患者。通过多变量模型和 IV 方法,比较了接受 NAT 和直接手术切除治疗的患者的 OS。IV 是治疗前最近一年的医院级 NAT 使用率。

结果

该队列纳入了 16666 名患者(14012 名直接手术切除;2654 名接受 NAT),他们在 779 家医院接受了治疗。在接受直接手术切除的患者中,59.9%接受了任何辅助治疗。与接受直接手术切除的患者相比,接受 NAT 的患者的中位 OS(27.9 个月,95%置信区间 [CI]26.2-29.1)和 5 年 OS(24.1%,95% CI 21.9-26.3%)更高。在多变量模型校正后,NAT 与死亡风险降低约 20%相关(风险比 [HR]0.78,95% CI 0.73-0.84),且在 IV 分析中这种效果更为显著(HR 0.61,95% CI 0.47-0.79)。

结论

在可切除 PDAC 患者中,NAT 与直接手术切除相比,可提高生存。鉴于多模式治疗的益处以及接受辅助治疗的挑战,应考虑对所有 PDAC 患者进行 NAT 治疗。

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