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对比边界可切除和局部进展期胰导管腺癌患者新辅助放疗的疗效和安全性:系统评价和网络荟萃分析方案。

Comparative efficacy and safety of neoadjuvant radiotherapy for patients with borderline resectable, and locally advanced pancreatic ductal adenocarcinoma: a systematic review and network meta-analysis protocol.

机构信息

Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China

出版信息

BMJ Open. 2022 Jul 13;12(7):e050558. doi: 10.1136/bmjopen-2021-050558.

Abstract

INTRODUCTION

The optimal dose and treatment modality of neoadjuvant radiotherapy applied for treating borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC) have been debated topics in oncology. The objective of the present network meta-analysis (NMA) is to study and compare the efficacy and safety of neoadjuvant radiotherapy comprehensively using different doses in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC).

METHODS AND ANALYSIS

Four electronic databases, including PubMed, EMBASE, Cochrane library and Web of science, will be searched thoroughly to identify relevant studies published from 2006 to October 2020. Electronic searching by titles using neoadjuvant treatments for PDAC will be performed in the annual meetings of European Society of Medical Oncology and American Society of Clinical Oncology (2018-2020).

CLINICALTRIALS

gov will also be searched for grey literature. Two reviewers will perform search strategies and extract data independently. R0 resection rate and local control rate are defined as primary outcomes. Secondary outcomes include overall survival, disease-free survival and acute and late grade 3 and grade 4 toxicities. For randomised control trials, the risk of bias will be assessed using the Cochrane Risk of Bias Tool, while the risk of bias for non-randomised, observational studies will be evaluated using the Risk Of Bias In Non-randomised Studies-of Interventions. The quality of evidence will be evaluated using the version of Cochrane tool and Grades of Recommendation, Assessment, Development and Evaluation. Subgroup analysis and sensitivity analysis will be conducted in the present NMA.

ETHICS AND DISSEMINATION

This study will synthesise the evidence regarding dose schedule of neoadjuvant radiotherapy in patients with BRPC and LAPC. We hope the findings from this NMA will help clinicians and patients select the optimal modality and dose schedule of neoadjuvant radiotherapy with respect to patient-reported outcomes. As no primary data collection will be undertaken, no ethics approval is required. The results will be disseminated through peer-reviewed journal.

PROSPERO REGISTRATION NUMBER

CRD42020222408.

摘要

简介

新辅助放疗在局部进展期和交界可切除胰腺癌(BRPC 和 LAPC)中的最佳剂量和治疗方式一直是肿瘤学领域的争论话题。本网络荟萃分析(NMA)旨在综合研究和比较不同剂量新辅助放疗在 BRPC 患者中的疗效和安全性。

方法和分析

我们将全面检索 4 个电子数据库,包括 PubMed、EMBASE、Cochrane 图书馆和 Web of Science,以识别自 2006 年至 2020 年 10 月发表的相关研究。还将通过标题在欧洲肿瘤内科学会和美国临床肿瘤学会年会上进行针对 PDAC 的新辅助治疗的电子搜索(2018-2020 年)。还将在 gov 上搜索灰色文献。两名评审员将独立执行搜索策略和提取数据。R0 切除率和局部控制率定义为主要结局。次要结局包括总生存率、无病生存率以及急性和迟发性 3 级和 4 级毒性。对于随机对照试验,使用 Cochrane 偏倚风险工具评估偏倚风险,对于非随机、观察性研究,使用干预措施非随机研究的偏倚风险评估工具评估偏倚风险。使用 Cochrane 工具和推荐、评估、发展和评估等级评估证据质量。本 NMA 将进行亚组分析和敏感性分析。

伦理和传播

本研究将综合 BRPC 和 LAPC 患者新辅助放疗剂量方案的证据。我们希望本 NMA 的研究结果将帮助临床医生和患者根据患者报告的结果选择新辅助放疗的最佳方式和剂量方案。由于不进行原始数据收集,因此无需伦理批准。结果将通过同行评议的期刊发表。

前瞻性注册号

CRD42020222408。

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