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BRCA1/2 种系突变人表皮生长因子受体 2 阴性的晚期乳腺癌患者的真实世界研究:美国、欧洲和以色列的患者人口统计学、治疗模式、不良事件以及医生报告的满意度。

Real-world study of patients with germline BRCA1/2-mutated human epidermal growth factor receptor 2‒Negative advanced breast cancer: Patient demographics, treatment patterns, adverse events, and physician-reported satisfaction in the United States, Europe, and Israel.

机构信息

Miami Cancer Institute, 1228 S Pine Island Road, Plantation, FL, 33324, USA.

Pfizer Inc, 235 42nd St, New York, NY, 10017, USA.

出版信息

Breast. 2022 Dec;66:236-244. doi: 10.1016/j.breast.2022.10.009. Epub 2022 Oct 18.

Abstract

BACKGROUND

Current guidelines for the treatment of human epidermal growth factor receptor 2‒negative (HER2-) advanced breast cancer (ABC) are informed by tumor characteristics and include platinum- and non-platinum-based chemotherapy, chemotherapy plus immunotherapy, endocrine monotherapy, or endocrine therapy plus a targeted therapy. In addition, poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPi) have recently demonstrated improved clinical and patient-reported outcomes and manageable toxicity profiles compared with chemotherapy in patients with germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2)‒mutated HER2- ABC in clinical trials and are now approved to treat this patient population. This study provides complementary real-world data regarding treatment patterns, adverse events, and physician-reported treatment satisfaction in this population.

METHODS

This retrospective analysis using the Adelphi Real World ABC Disease Specific Programme in the United States, European Union, and Israel included patients aged ≥18 years receiving therapy for stage IIIb or IV gBRCA1/2-mutated HER2- ABC. Oncologists completed a patient record form detailing patient demographics, clinical assessments, and treatment history and a survey regarding their use of and satisfaction with treatments.

RESULTS

Among the 543 patients, mean age was 55 years, 25% were premenopausal, 70% had hormone receptor‒positive (HR+) ABC, and 30% had triple-negative breast cancer (TNBC). PARPi were used in 5%, 11%, and 12% of first-line, second-line, and third-line therapies, respectively, for patients with HR+ ABC; for TNBC, percentages were 18%, 44%, and 36%. Across treatment lines, neutropenia, anemia, and nausea occurred in 16%, 24%, and 32% of patients receiving PARPi, respectively; 22%, 38%, and 33% of patients receiving platinum chemotherapy; and 20%, 20%, and 33% of patients receiving non-platinum-based chemotherapy. Physician satisfaction was highest with PARPi and with chemotherapy plus immunotherapy.

CONCLUSIONS

Findings in this real-world population complement clinical trial observations and provide further support for treatment of patients with PARPi in gBRCA1/2-mutated HER2- ABC.

摘要

背景

目前针对人表皮生长因子受体 2 阴性(HER2-)晚期乳腺癌(ABC)的治疗指南基于肿瘤特征,包括铂类和非铂类化疗、化疗联合免疫治疗、内分泌单药治疗或内分泌治疗联合靶向治疗。此外,聚(腺苷二磷酸核糖)聚合酶抑制剂(PARPi)在临床试验中与化疗相比,在具有种系乳腺癌易感基因 1 或 2(gBRCA1/2)突变的 HER2- ABC 患者中,改善了临床和患者报告的结局以及可管理的毒性特征,现已批准用于治疗该患者人群。本研究提供了关于该人群治疗模式、不良反应和医生报告的治疗满意度的补充真实世界数据。

方法

本研究使用 Adelphi 真实世界 ABC 疾病专项计划,在美国、欧盟和以色列进行了回顾性分析,纳入了年龄≥18 岁、接受治疗的 IIIb 期或 IV 期 gBRCA1/2 突变 HER2- ABC 患者。肿瘤学家填写了一份患者记录表格,详细说明患者的人口统计学、临床评估和治疗史,并对他们使用和对治疗的满意度进行了调查。

结果

在 543 例患者中,平均年龄为 55 岁,25%为绝经前,70%为激素受体阳性(HR+)ABC,30%为三阴性乳腺癌(TNBC)。PARPi 分别用于 HR+ ABC 患者的一线、二线和三线治疗的 5%、11%和 12%;TNBC 患者的比例分别为 18%、44%和 36%。在各线治疗中,接受 PARPi 治疗的患者中性粒细胞减少、贫血和恶心的发生率分别为 16%、24%和 32%;接受铂类化疗的患者分别为 22%、38%和 33%;接受非铂类化疗的患者分别为 20%、20%和 33%。医生对 PARPi 和化疗联合免疫治疗的满意度最高。

结论

本真实世界人群的研究结果补充了临床试验观察结果,并进一步支持对 gBRCA1/2 突变的 HER2- ABC 患者使用 PARPi 治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c71/9650077/533e2e47cf50/gr1.jpg

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