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高级别浆液性卵巢癌的内分泌维持治疗:一项回顾性非标签真实世界队列研究

Endocrine Maintenance Therapy in High-Grade Serous Ovarian Cancer: A Retrospective Off-Label Real-World Cohort Study.

作者信息

Geissler Franziska, Graf Flurina, Zwimpfer Tibor A, Eller Ruth S, Nguyen-Sträuli Bich Doan, Schötzau Andreas, Heinzelmann-Schwarz Viola, Gobrecht-Keller Ursula

机构信息

Gynaecological Cancer Centre, University Hospital Basel, 4031 Basel, Switzerland.

Ovarian Cancer Research, Department of Biomedicine, University of Basel, 4031 Basel, Switzerland.

出版信息

Cancers (Basel). 2025 Apr 12;17(8):1301. doi: 10.3390/cancers17081301.

DOI:10.3390/cancers17081301
PMID:40282477
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12025638/
Abstract

BACKGROUND

Endocrine therapy is the standard-of-care maintenance treatment for estrogen receptor (ER)-positive breast cancers and is increasingly used in low-grade serous ovarian cancer. However, its therapeutic role in the early maintenance setting for ER-positive high-grade serous ovarian cancer (HGSC) remains undefined.

METHODS

A retrospective analysis was conducted on clinicopathological data from patients with newly diagnosed ER-positive HGSC following completion of adjuvant chemotherapy. Patients received maintenance therapy either with or without the aromatase inhibitor letrozole, in addition to standard maintenance care. ER expression levels and the administration of letrozole were analyzed, along with outcome measures for the entire cohort, with stratification based on residual disease status.

RESULTS

A total of 102 patients with newly diagnosed HGSC were included in the analysis, with 64 (62.7%) receiving letrozole and 38 (37.3%) not receiving letrozole. The median ER expression was 70%, with higher expression observed in the letrozole group compared to the no letrozole group (77.5% vs. 60%). No significant correlation was found between ER expression status and therapy response ( = 0.295 and = 0.176, respectively). Letrozole therapy was well tolerated with no major adverse effects reported. In the overall cohort, maintenance letrozole therapy did not confer a significant improvement in progression-free survival (median 20.56 months vs. 29.34 months, = 0.53) or overall survival (OS) (median 79.48 months vs. 46.85 months, = 0.71) over a median follow-up duration of 23.5 months. However, among patients with no residual disease, maintenance letrozole therapy was associated with a statistically significant improvement in OS compared to those not receiving letrozole (median 114 months vs. 46.9 months, = 0.006).

CONCLUSIONS

Maintenance letrozole therapy appears to be a well-tolerated and potentially beneficial intervention in a subset of patients with ER-positive HGSC with no residual disease post-treatment. These findings highlight the need for further validation through prospective randomized trials to comprehensively assess the efficacy of endocrine therapy in this setting and its implications for patient quality of life.

摘要

背景

内分泌治疗是雌激素受体(ER)阳性乳腺癌的标准维持治疗方法,并且越来越多地用于低级别浆液性卵巢癌。然而,其在ER阳性高级别浆液性卵巢癌(HGSC)早期维持治疗中的作用仍不明确。

方法

对新诊断的ER阳性HGSC患者完成辅助化疗后的临床病理数据进行回顾性分析。除标准维持治疗外,患者接受或不接受芳香化酶抑制剂来曲唑的维持治疗。分析ER表达水平和来曲唑的使用情况,以及整个队列的结局指标,并根据残留疾病状态进行分层。

结果

共有102例新诊断的HGSC患者纳入分析,其中64例(62.7%)接受来曲唑治疗,38例(37.3%)未接受来曲唑治疗。ER表达中位数为70%,来曲唑组的表达高于未接受来曲唑组(77.5%对60%)。未发现ER表达状态与治疗反应之间存在显著相关性(分别为 = 0.295和 = 0.176)。来曲唑治疗耐受性良好,未报告重大不良反应。在整个队列中,中位随访23.5个月,维持来曲唑治疗在无进展生存期(中位数20.56个月对29.34个月, = 0.53)或总生存期(OS)(中位数79.48个月对46.85个月, = 0.71)方面未带来显著改善。然而,在无残留疾病的患者中,与未接受来曲唑治疗的患者相比,维持来曲唑治疗与OS的统计学显著改善相关(中位数114个月对46.9个月, = 0.006)。

结论

维持来曲唑治疗似乎是一种耐受性良好且对一部分治疗后无残留疾病的ER阳性HGSC患者可能有益的干预措施。这些发现凸显了通过前瞻性随机试验进行进一步验证的必要性,以全面评估内分泌治疗在此情况下的疗效及其对患者生活质量的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/f5537f571cc9/cancers-17-01301-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/a6d6804d7e35/cancers-17-01301-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/4f238fe6ab50/cancers-17-01301-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/5464c8f45989/cancers-17-01301-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/f5537f571cc9/cancers-17-01301-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/a6d6804d7e35/cancers-17-01301-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/4f238fe6ab50/cancers-17-01301-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/5464c8f45989/cancers-17-01301-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e292/12025638/f5537f571cc9/cancers-17-01301-g004.jpg

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本文引用的文献

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Novel Endocrine Therapeutic Opportunities for Estrogen Receptor-Positive Ovarian Cancer-What Can We Learn from Breast Cancer?雌激素受体阳性卵巢癌的新型内分泌治疗机会——我们能从乳腺癌中学到什么?
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Endocrine therapy in advanced high-grade ovarian cancer: real-life data from a multicenter study and a review of the literature.晚期高级别卵巢癌的内分泌治疗:来自一项多中心研究的真实数据和文献复习。
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Hormone Receptor Expression in Primary and Recurrent High-Grade Serous Ovarian Cancer and Its Implications in Early Maintenance Treatment.激素受体在原发性和复发性高级别浆液性卵巢癌中的表达及其在早期维持治疗中的意义。
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Life Sci. 2022 Dec 1;310:121074. doi: 10.1016/j.lfs.2022.121074. Epub 2022 Oct 13.
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Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial.在 BRCA 突变的新诊断晚期卵巢癌患者中,7 年随访期间维持奥拉帕利的总生存期:SOLO1/GOG 3004 试验。
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Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial.上皮性卵巢癌患者的芳香化酶抑制剂维持治疗(MATAO):一项随机、双盲、安慰剂对照、多中心 III 期临床试验研究方案。
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Gynecol Oncol. 2020 Dec;159(3):601-603. doi: 10.1016/j.ygyno.2020.09.049. Epub 2020 Oct 2.