目的:转移性三阴性乳腺癌(mTNBC)患者预后差,治疗选择有限。Sacituzumabgovitecan(SG),Trop-2定向抗体-药物偶联物,根据ASCENT研究(NCT02574455),已批准用于接受≥2次全身治疗(转移情况下≥1次)的mTNBC患者。目前的研究描述了在美国mTNBC患者的真实世界SG使用和结果。
方法:本回顾性研究,观察性研究纳入了来自ConcertAIPatient360™数据库的mTNBC成年患者,这些患者在第二行(2L)接受SG治疗,随后于2020年4月至2022年5月接受SG治疗.SG使用模式,有效性,描述了耐受性。
结果:该分析包括230名患者(中位年龄60岁,26%黑色,ECOG表现状态≥2的占17%,社区环境中占66%;转移环境中2种先前治疗方案的中位数);中位随访时间为7.2个月。所有患者的中位(95%CI)真实世界总生存期为10.0(8.3-11.1)个月,2L亚组为13.9(9.8-不可估计)个月(n=77)。134例(58%)患者与SG同时施用粒细胞集落刺激因子(G-CSF);35例(15%)首次接受G-CSF。从SG开始到G-CSF使用的中位数(IQR)时间为8.5(8.0-29.0)天。17名(7%)患者因毒性而停用SG。
结论:使用真实世界,不同种族的mTNBC患者预后不良,这些数据强化了ASCENT的发现.在常规临床实践中,SG在2L设置中是一种有效的治疗方法,符合治疗指南。
OBJECTIVE: 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.