美国用于转移性三阴性乳腺癌二线和晚线治疗的sacituzumab govitecan的实际使用模式、有效性和耐受性。

IF 3 3区 医学 Q2 ONCOLOGY Breast Cancer Research and Treatment Pub Date : 2024-11-01 Epub Date: 2024-06-21 DOI:10.1007/s10549-024-07412-9
Kevin Kalinsky, Laura Spring, Clinton Yam, Manali Ajay Bhave, Ioanna Ntalla, Catherine Lai, Nikoleta Sjekloca, Brian Stwalley, Michael Stokes, Aliki Taylor, Rita Nanda
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引用次数: 0

摘要

目的:转移性三阴性乳腺癌(mTNBC)患者预后较差,治疗选择有限。根据ASCENT研究(NCT02574455),萨妥珠单抗-戈维替康(SG)是一种Trop-2导向的抗体-药物共轭物,已被批准用于接受过≥2次全身治疗(转移性治疗≥1次)的mTNBC患者。本研究描述了美国 mTNBC 患者使用 SG 的实际情况和结果:这项回顾性观察研究纳入了 ConcertAI Patient360™ 数据库中 2020 年 4 月至 2022 年 5 月期间在二线(2L)及以后接受 SG 治疗的 mTNBC 成年患者。结果:本次分析共纳入 230 名患者(中位年龄 60 岁,26% 为黑人,17% ECOG 表 现状态≥ 2,66% 在社区环境中;中位在转移性环境中接受过 2 线治疗);中位随访时间为 7.2 个月。所有患者的实际总生存期中位数(95% CI)为10.0(8.3-11.1)个月,2L亚组(n = 77)为13.9(9.8-无法估计)个月。134例(58%)患者在使用SG的同时使用了粒细胞集落刺激因子(G-CSF);35例(15%)患者首次使用G-CSF。从开始使用 SG 到使用 G-CSF 的中位(IQR)时间为 8.5(8.0-29.0)天。17名(7%)患者因毒性而停用SG:这些数据利用真实世界中不同种族的预后不良的 mTNBC 患者,加强了 ASCENT 的研究结果。在常规临床实践中,SG 是一种有效的 2L 治疗方法,符合治疗指南的要求。
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Real-world use patterns, effectiveness, and tolerability of sacituzumab govitecan for second-line and later-line treatment of metastatic triple-negative breast cancer in the United States.

Purpose: Patients with metastatic triple-negative breast cancer (mTNBC) have poor prognosis and limited treatment options. Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved for patients with mTNBC who have received ≥ 2 systemic therapies (≥ 1 in the metastatic setting) based on the ASCENT study (NCT02574455). The current study describes real-world SG use and outcomes in patients with mTNBC in the United States.

Methods: This retrospective, observational study included adult patients with mTNBC from the ConcertAI Patient360™ database who received SG in the second line (2L) and later from April 2020 to May 2022. SG use patterns, effectiveness, and tolerability are described.

Results: This analysis included 230 patients (median age 60 years, 26% Black, 17% with ECOG performance status ≥ 2, 66% in community settings; median of 2 prior lines of treatment in the metastatic setting); median follow-up was 7.2 months. Median (95% CI) real-world overall survival was 10.0 (8.3-11.1) months for all patients and 13.9 (9.8-not estimable) months in the 2L subgroup (n = 77). Granulocyte-colony stimulating factor (G-CSF) was administered concomitantly with SG in 134 (58%) patients; 35 (15%) received G-CSF for the first time. Median (IQR) time from SG start to G-CSF use was 8.5 (8.0-29.0) days. Seventeen (7%) patients discontinued SG due to toxicity.

Conclusions: Using a real-world, ethnically diverse population of patients with mTNBC presenting with poor prognosis, these data reinforced the findings from ASCENT. In routine clinical practice, SG is an effective treatment in the 2L setting, consistent with treatment guidelines.

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来源期刊
CiteScore
6.80
自引率
2.60%
发文量
342
审稿时长
1 months
期刊介绍: Breast Cancer Research and Treatment provides the surgeon, radiotherapist, medical oncologist, endocrinologist, epidemiologist, immunologist or cell biologist investigating problems in breast cancer a single forum for communication. The journal creates a "market place" for breast cancer topics which cuts across all the usual lines of disciplines, providing a site for presenting pertinent investigations, and for discussing critical questions relevant to the entire field. It seeks to develop a new focus and new perspectives for all those concerned with breast cancer.
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Correction: FBLN2 is associated with basal cell markers Krt14 and ITGB1 in mouse mammary epithelial cells and has a preferential expression in molecular subtypes of human breast cancer. A randomised trial comparing 6-monthly adjuvant zoledronate with a single one-time dose in patients with early breast cancer. Alterations in the expression of homologous recombination repair (HRR) genes in breast cancer tissues considering germline BRCA1/2 mutation status. Efficacy of antiobesity medications among breast cancer survivors taking aromatase inhibitors. Cost containment analysis of superparamagnetic iron oxide (SPIO) injection in patients with ductal carcinoma in situ.
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