美国非微卫星高度不稳定（非MSI-H）或错配修复功能正常（pMMR）的晚期子宫内膜癌患者的治疗模式及真实世界临床结局
Treatment patterns and real-world clinical outcomes in patients with advanced endometrial cancer that are non-microsatellite instability high (non-MSI-high) or mismatch repair proficient (pMMR) in the United States.
作者信息
Kelkar Sneha S, Prabhu Vimalanand S, Zhang Jingchuan, Corman Shelby, Macahilig Cynthia, Rusibamayila Nifasha, Odak Shardul, Duska Linda R
机构信息
OPEN Health, Bethesda, MD, USA.
Merck & Co., Inc., Rahway, NJ, USA.
出版信息
Gynecol Oncol Rep. 2022 Jun 17;42:101026. doi: 10.1016/j.gore.2022.101026. eCollection 2022 Aug.
OBJECTIVE
Microsatellite instability (MSI) due to defective DNA mismatch repair has emerged as an actionable biomarker in advanced endometrial cancer (aEC). Currently, there are no treatment patterns and outcomes data in non-MSI-high (non-MSI-H) or mismatch repair proficient (pMMR) aEC patients following prior systemic therapy (FPST). Our goal was to describe real-world data in this population in the US in 2019 and prior years.
METHODS
Endometrial Cancer Health Outcomes (ECHO) is a retrospective patient chart review study conducted in the US. Patients with non-MSI-H/pMMR aEC and progression between 06/01/2016-06/30/2019 FPST were eligible. Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS), and overall survival (OS), separately by treatment category.
RESULTS
A total of 165 eligible patients initiated second-line therapy with chemotherapy ± bevacizumab (n = 140) or hormonal therapy (n = 25). Median age was 66.0 years at aEC diagnosis, 70.2% were Stage IIIB-IV, 40.0% had ECOG ≥ 2 at second-line therapy initiation. Median rwPFS was 5.0 months (95% CI: 4.0-6.0) for patients receiving chemotherapy ± bevacizumab and 5.5 months (95% CI: 3.0-29.0) for those receiving hormonal therapy. Median OS was 10.0 months (95% CI: 8.0-13.0) and 9.0 months (95% CI: 6.0-NA) in these groups, respectively.
CONCLUSIONS
Non-MSI-H/pMMR patients who initiated second-line therapy with chemotherapy ± bevacizumab or hormonal therapy had poor clinical outcomes with a median survival less than 1 year and rwPFS less than 6 months. This was the first study to define the clinical unmet need in patients with non-MSI-H/pMMR aEC with conventional therapy.
目的
由于DNA错配修复缺陷导致的微卫星不稳定性（MSI）已成为晚期子宫内膜癌（aEC）中一种可采取行动的生物标志物。目前，对于非微卫星高度不稳定（非MSI-H）或错配修复功能正常（pMMR）的aEC患者，在接受过一线全身治疗（FPST）后的治疗模式和结局数据尚不存在。我们的目标是描述2019年及此前几年美国该人群的真实世界数据。
方法
子宫内膜癌健康结局（ECHO）是一项在美国开展的回顾性患者病历审查研究。符合条件的患者为非MSI-H/pMMR的aEC患者，且在2016年6月1日至2019年6月30日期间接受FPST后病情进展。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。通过Kaplan-Meier分析分别按治疗类别估计治疗中断时间、真实世界无进展生存期（rwPFS）和总生存期（OS）。
结果
共有165例符合条件的患者开始二线治疗，其中接受化疗±贝伐单抗治疗的有140例，接受激素治疗的有25例。aEC诊断时的中位年龄为66.0岁，70.2%为IIIB-IV期，40.0%在开始二线治疗时ECOG评分≥2。接受化疗±贝伐单抗治疗的患者中位rwPFS为5.0个月（95%CI：4.0-6.0），接受激素治疗的患者为5.5个月（95%CI：3.0-29.0）。这些组的中位OS分别为10.0个月（95%CI：8.0-13.0）和9.0个月（95%CI：6.0-NA）。
结论
开始接受化疗±贝伐单抗或激素治疗的二线治疗的非MSI-H/pMMR患者临床结局较差，中位生存期不到1年，rwPFS不到6个月。这是第一项明确非MSI-H/pMMR的aEC患者接受传统治疗后临床未满足需求的研究。
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