Francis J, Coakley N, Elit L, Mackay H
Department of Obstetrics and Gynecology, Queen's University, Kingston.
Department of Oncology, McMaster University, and Cancer Care Ontario's Program in Evidence-Based Care, Hamilton.
Curr Oncol. 2017 Dec;24(6):e540-e546. doi: 10.3747/co.24.3824. Epub 2017 Dec 20.
The purpose of this guideline is to recommend systemic therapy options for women with recurrent epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers.
This document updates the recommendations published in the 2011 guideline from Cancer Care Ontario. Draft recommendations were formulated based on evidence obtained through a systematic review of phase ii and iii randomized controlled trials (rcts). The draft recommendations underwent internal review by clinical and methodology experts, and external review by clinical practitioners through a survey assessing the clinical relevance and overall quality of the guideline. Feedback from the internal and external reviews was integrated into the clinical practice guideline.
The primary literature search yielded thirty-six primary research papers representing thirty rcts that met the eligibility criteria. The guideline provides recommendations for patients with serous tumour histologies and with recurrent, platinum-resistant, and platinum-sensitive ovarian cancer.
The body of evidence from trials that included olaparib and bevacizumab consistently shows a benefit in progression-free survival (pfs) without a corresponding benefit in overall survival (os). The Working Group for this guideline designated pfs, which is associated with symptom control, as a critical outcome. A finding of net benefit can therefore be concluded based on significant differences in pfs. However, that benefit is not without identified harms. Given the identified harms, patient involvement in the decision-making process must take into consideration the side effect profiles of olaparib and bevacizumab within the context of improved pfs but minimal change in os.
本指南旨在为复发性上皮性卵巢癌(包括输卵管癌和原发性腹膜癌)女性推荐全身治疗方案。
本文档更新了安大略癌症护理中心2011年指南中发布的建议。基于对II期和III期随机对照试验(RCT)进行系统评价所获得的证据制定了建议草案。建议草案经过临床和方法学专家的内部评审,并通过一项评估指南临床相关性和整体质量的调查由临床医生进行外部评审。内部和外部评审的反馈意见被纳入临床实践指南。
初步文献检索得到36篇代表30项符合入选标准的RCT的主要研究论文。该指南为浆液性肿瘤组织学类型以及复发性、铂耐药和铂敏感卵巢癌患者提供了建议。
纳入奥拉帕利和贝伐单抗的试验所提供的证据一致表明,其在无进展生存期(PFS)方面有获益,但在总生存期(OS)方面无相应获益。本指南工作组将与症状控制相关的PFS指定为关键结局。因此,基于PFS的显著差异可得出有净获益的结论。然而,这种获益并非没有已明确的危害。鉴于已明确的危害,患者参与决策过程时必须在PFS改善但OS变化极小的背景下考虑奥拉帕利和贝伐单抗的副作用情况。