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铂敏感型卵巢癌聚(ADP-核糖)聚合酶(PARP)抑制剂治疗方案的随机、双盲、III期对照试验:系统评价与网状Meta分析方案

Poly-ADP ribose polymerase (PARP) inhibitor regimens for platinum-sensitive ovarian cancer in randomized, double-blind, phase III controlled trials: protocol for a systematic review and network meta-analysis.

作者信息

Peng Xiaolian, Liu Jie

机构信息

Department of Obstetrics and Gynecology, Xiegang Branch, Dongguan Municipal People's Hospital, Guang Dong Province, China.

Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, China.

出版信息

Front Med (Lausanne). 2025 Jan 23;12:1539880. doi: 10.3389/fmed.2025.1539880. eCollection 2025.

Abstract

INTRODUCTION

Clinical trials have shown that PARP inhibitors are effective in treating patients with platinum-sensitive ovarian cancer. They have been indicated to improve progression-free survival or overall survival in patients with patients with platinum-sensitive ovarian cancer. However, there is insufficient comprehensive evidence regarding the comparison of different agents. To evaluate and compare the efficacy and side effects of various PARP inhibitors.

METHODS

We plan to conduct a network meta-analysis that includes randomized, double-blind, controlled phase III trials of Niraparib, Rucaparib, Olaparib, or Veliparib in patients with Platinum-sensitive ovarian cancer. The primary outcomes will be progression-free survival or overall survival. The secondary outcome will be grade ≥ 3 of treatment-emergent adverse events. Published and unpublished studies will be retrieved through PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform from 1990 to 2023. We will use STATA V.14.0 to perform all analyses, and the RevMan software to report the risk of bias in the included studies. We will determine the quality of evidence using the GRADEpro GDT software online version. This is a protocol description only. Results and conclusions are subject to completion. This study will be based on published studies, since no primary data collection will be carried out, no formal ethical assessment is required. The network graph and meta-analysis will be used to compare all PARP inhibitors. Their ranking will employ a rankogram, surface under the cumulative ranking curves, and mean ranks.

DISCUSSION

Our study will answer the most important question in platinum-sensitive ovarian cancer: which PARPi should be preferred regarding efficacy and side effects? Trials of platinum-resistant or refractory ovarian cancer will be excluded. The limitation is that the results of network meta-analyses do not yet have the same level of evidence as direct head-to-head trials. However, it is a useful complementary method when direct comparative studies cannot be performed. We plan to publish the results of this systematic review and network meta-analysis in peer-reviewed scientific journals, conferences, and the mass media.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO, CRD42024511248, available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024511248.

摘要

引言

临床试验表明,PARP抑制剂在治疗铂敏感型卵巢癌患者方面有效。已证实其可改善铂敏感型卵巢癌患者的无进展生存期或总生存期。然而,关于不同药物比较的全面证据不足。为评估和比较各种PARP抑制剂的疗效和副作用。

方法

我们计划进行一项网络荟萃分析,纳入尼拉帕利、鲁卡帕利、奥拉帕利或维利帕利治疗铂敏感型卵巢癌患者的随机、双盲、对照III期试验。主要结局将是无进展生存期或总生存期。次要结局将是治疗中出现的≥3级不良事件。将通过PubMed、Embase、Cochrane图书馆、ClinicalTrials.gov以及世界卫生组织(WHO)国际临床试验注册平台检索1990年至2023年发表和未发表的研究。我们将使用STATA V.14.0进行所有分析,并使用RevMan软件报告纳入研究的偏倚风险。我们将使用在线版本的GRADEpro GDT软件确定证据质量。这仅是方案描述。结果和结论有待完成。本研究将基于已发表的研究,由于不进行原始数据收集,无需进行正式的伦理评估。网络图和荟萃分析将用于比较所有PARP抑制剂。它们的排名将采用排名图、累积排名曲线下面积和平均排名。

讨论

我们的研究将回答铂敏感型卵巢癌中最重要的问题:就疗效和副作用而言,哪种PARP抑制剂更值得首选?铂耐药或难治性卵巢癌的试验将被排除。局限性在于网络荟萃分析的结果尚未具有与直接头对头试验相同水平的证据。然而,当无法进行直接比较研究时,它是一种有用的补充方法。我们计划在同行评审的科学期刊、会议和大众媒体上发表本系统评价和网络荟萃分析的结果。

系统评价注册

PROSPERO,CRD42024511248,可从:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024511248获取。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfaa/11798772/c1bb4e1e89c0/fmed-12-1539880-g001.jpg

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