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Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer.铂类敏感复发性卵巢癌日本患者维持用尼拉帕利的安全性的 2 期单臂研究。
J Gynecol Oncol. 2021 Mar;32(2):e21. doi: 10.3802/jgo.2021.32.e21. Epub 2021 Jan 6.
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Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer.尼拉帕利治疗既往大量治疗、同源重组缺陷型复发性卵巢癌日本患者的 II 期单臂研究。
J Gynecol Oncol. 2021 Mar;32(2):e16. doi: 10.3802/jgo.2021.32.e16. Epub 2020 Dec 10.
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Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer.奥拉帕利联合贝伐珠单抗作为卵巢癌一线维持治疗。
N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.
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Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma treatment (ICON8): primary progression free survival analysis results from a GCIG phase 3 randomised controlled trial.在一线上皮性卵巢癌、输卵管癌或原发性腹膜癌治疗中进行每周剂量密集化疗(ICON8):GCIG 三期随机对照试验的主要无进展生存分析结果。
Lancet. 2019 Dec 7;394(10214):2084-2095. doi: 10.1016/S0140-6736(19)32259-7. Epub 2019 Nov 29.
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Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.尼拉帕利治疗新诊断的晚期卵巢癌患者。
N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.
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Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial.尼拉帕利维持治疗在 ENGOT-OV16/NOVA 试验中对末次基于铂类化疗有部分缓解的复发性卵巢癌患者中的应用。
J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.
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Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial.尼拉帕利单药治疗卵巢癌的后线治疗(QUADRA):一项多中心、开放标签、单臂、2 期临床试验。
Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1.
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Annual Report of the Committee on Gynecologic Oncology, Japan Society of Obstetrics and Gynecology: Patient Annual Report for 2014 and Treatment Annual Report for 2009.日本妇产科学会妇科肿瘤委员会年度报告:2014年患者年度报告及2009年治疗年度报告。
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Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial.奥拉帕利片作为 BRCA1/2 突变的铂敏感复发性卵巢癌患者的维持治疗(SOLO2/ENGOT-Ov21):一项双盲、随机、安慰剂对照、III 期临床试验。
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晚期卵巢癌一线维持治疗的期望与挑战。

Expectations and Challenges of First-Line Maintenance Therapy for Advanced Ovarian Cancer.

机构信息

Department Obstetrics and Gynecology, Iwate Medical University School of Medicine, Iwate 028-3695, Japan.

出版信息

Medicina (Kaunas). 2021 May 15;57(5):501. doi: 10.3390/medicina57050501.

DOI:10.3390/medicina57050501
PMID:34063455
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8155998/
Abstract

The incidence of ovarian cancer, which has had a poor prognosis, is increasing annually. Currently, the prognosis is expected to improve with the use of molecular-targeted drugs and immune checkpoint inhibitors as maintenance therapies after the first-line chemotherapy. The GOG218 and ICON7 studies reported the usefulness of bevacizumab and the SOLO-1 and PRIMA (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy) studies have reported the usefulness of olaparib and niraparib, respectively. The ATHENA study investigating the usefulness of rucaparib is currently ongoing. Although clinical studies of immune checkpoint inhibitors are lagging in the field of gynecology, many clinical studies using programmed death cell-1 (PD-1) and PD-1 ligand 1 (PD-L1) antibodies are currently ongoing. Some biomarkers have been identified for molecular-targeted drugs, but none have been identified for immune checkpoint inhibitors, which is a challenge that should be addressed in the future.

摘要

卵巢癌的发病率一直居高不下,且预后较差。目前,随着分子靶向药物和免疫检查点抑制剂在一线化疗后的维持治疗中的应用,预计预后将会得到改善。GOG218 和 ICON7 研究报告了贝伐珠单抗的有效性,SOLO-1 和 PRIMA(奥拉帕利维持治疗在一线含铂化疗后有缓解的晚期卵巢癌患者中的 III 期、随机、双盲、安慰剂对照、多中心研究)研究报告了奥拉帕利和尼拉帕利的有效性。正在进行一项研究鲁卡帕利有效性的 ATHENA 研究。尽管免疫检查点抑制剂在妇科领域的临床研究滞后,但目前正在进行许多使用程序性死亡受体 1(PD-1)和 PD-1 配体 1(PD-L1)抗体的临床研究。已经确定了一些用于分子靶向药物的生物标志物,但尚未确定用于免疫检查点抑制剂的生物标志物,这是未来需要解决的一个挑战。