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一项回顾性图表研究显示,在欧洲,先前接受过系统治疗的复发性或晚期子宫内膜癌患者在疾病进展后,其真实世界的治疗模式和临床结局。

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe.

机构信息

Eisai Inc, Nutley, New Jersey, USA.

OPEN Health, Bethesda, Maryland, USA.

出版信息

BMJ Open. 2024 Apr 2;14(4):e079447. doi: 10.1136/bmjopen-2023-079447.

Abstract

OBJECTIVE

To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.

DESIGN

Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study.

SETTING

ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain.

PARTICIPANTS

Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021.

PRIMARY AND SECONDARY OUTCOME MEASURES

Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS).

RESULTS

A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB-IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3).

CONCLUSIONS

Patients had poor clinical outcomes with a median OS of <1 year and rwPFS of approximately 7 months, highlighting the significant unmet medical need in pretreated recurrent/advanced endometrial cancer patients. Novel therapies with potential to improve PFS and OS over conventional therapies could provide significant clinical benefit.

摘要

目的

评估在欧洲的临床实践中,既往全身治疗后进展的复发性/晚期子宫内膜癌患者的真实世界治疗模式和临床结局。

设计

子宫内膜癌健康结局-欧洲(ECHO-EU)是一项回顾性患者病历回顾研究。

设置

ECHO-EU 是一项在英国、德国、意大利、法国和西班牙进行的多中心研究。

参与者

符合条件的患者为在既往一线全身治疗后,于 2016 年 7 月 1 日至 2019 年 6 月 30 日期间进展为复发性/晚期子宫内膜癌的患者,并在 2021 年 11 月之前通过最后一次可用随访收集数据。

主要和次要结局测量

收集的数据包括患者人口统计学、临床和治疗特征以及临床结局。从二线治疗开始进行 Kaplan-Meier 分析,以估计治疗中断时间、真实世界无进展生存期(rwPFS)和总生存期(OS)。

结果

来自欧盟 5 国的共纳入 475 名患者。诊断为晚期子宫内膜癌时的中位年龄为 69 岁,78.7%的患者有 IIIB-IV 期疾病,45.9%的患者在二线治疗开始时 ECOG 状态≥2。在二线治疗中,大多数患者接受了非铂类化疗(55.6%)或内分泌治疗(16.2%)。医生报告的二线治疗真实世界总体缓解率(定义为完全或部分缓解)为 34.5%,中位 rwPFS 为 7.4 个月(95%CI 6.2 至 8.0),中位 OS 为 11.0 个月(95%CI 9.9 至 12.3)。

结论

患者的临床结局较差,中位 OS 不足 1 年,rwPFS 约为 7 个月,突出表明在既往治疗的复发性/晚期子宫内膜癌患者中存在显著的未满足的医疗需求。具有改善 PFS 和 OS 优于传统疗法潜力的新型疗法可能为患者带来显著的临床获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ea7/10989146/f147463f949c/bmjopen-2023-079447f01.jpg

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