Memorial Sloan Kettering Cancer Center, New York, NY.
American Society of Clinical Oncology, Alexandria, VA.
J Clin Oncol. 2020 Oct 20;38(30):3468-3493. doi: 10.1200/JCO.20.01924. Epub 2020 Aug 13.
To provide recommendations on the use of poly(ADP-ribose) polymerase inhibitors (PARPis) for management of epithelial ovarian, tubal, or primary peritoneal cancer (EOC).
Randomized, controlled, and open-labeled trials published from 2011 through 2020 were identified in a literature search. Guideline recommendations were based on the review of the evidence, US Food and Drug Administration approvals, and consensus when evidence was lacking.
The systematic review identified 17 eligible trials.
The guideline pertains to patients who are PARPi naïve. All patients with newly diagnosed, stage III-IV EOC whose disease is in complete or partial response to first-line, platinum-based chemotherapy with high-grade serous or endometrioid EOC should be offered PARPi maintenance therapy with niraparib. For patients with germline or somatic pathogenic or likely pathogenic variants in (g/s1) or (g/s2) genes should be treated with olaparib. The addition of olaparib to bevacizumab may be offered to patients with stage III-IV EOC with g/s2 and/or genomic instability and a partial or complete response to chemotherapy plus bevacizumab combination. Maintenance therapy (second line or more) with single-agent PARPi may be offered for patients with EOC who have not received a PARPi and have responded to platinum-based therapy regardless of mutation status. Treatment with a PARPi should be offered to patients with recurrent EOC that has not recurred within 6 months of platinum-based therapy, who have not received a PARPi and have a g/s, or whose tumor demonstrates genomic instability. PARPis are not recommended for use in combination with chemotherapy, other targeted agents, or immune-oncology agents in the recurrent setting outside the context of a clinical trial. Recommendations for managing specific adverse events are presented. Data to support reuse of PARPis in any setting are needed.Additional information is available at www.asco.org/gynecologic-cancer-guidelines.
为上皮性卵巢癌、输卵管或原发性腹膜癌(EOC)的管理提供聚 ADP-核糖聚合酶抑制剂(PARPi)使用的建议。
通过文献检索,确定了 2011 年至 2020 年期间发表的随机、对照和开放标签试验。指南建议基于证据审查、美国食品和药物管理局批准以及缺乏证据时的共识。
系统评价确定了 17 项合格试验。
本指南适用于 PARPi 初治患者。所有新诊断为 III-IV 期 EOC 且疾病对一线基于铂类化疗伴有高级别浆液性或子宫内膜样 EOC 的完全或部分缓解的患者,均应给予尼拉帕利的 PARPi 维持治疗。对于存在种系或体细胞致病性或可能致病性 (g/s1) 或 (g/s2) 基因突变的患者,应使用奥拉帕利治疗。对于存在 III-IV 期 EOC 且 g/s2 和/或基因组不稳定性且对化疗加贝伐珠单抗联合治疗有部分或完全缓解的患者,可加用奥拉帕利治疗。对于未接受 PARPi 治疗且对铂类治疗有反应的 EOC 患者,无论 突变状态如何,均可给予单药 PARPi 维持治疗(二线或以上)。对于在铂类治疗后 6 个月内未复发、未接受 PARPi 治疗且存在 g/s 或肿瘤表现出基因组不稳定性的复发性 EOC 患者,应给予 PARPi 治疗。PARPi 不推荐与化疗、其他靶向药物或免疫肿瘤药物联合用于临床试验以外的复发性疾病的治疗。本文还介绍了处理特定不良反应的建议。需要提供有关在任何情况下重复使用 PARPi 的额外数据。更多信息可在 www.asco.org/gynecologic-cancer-guidelines 上获取。