Nanda R, Yam C, Spring L, Bhave M A, Ntalla I, Valdez T, Stwalley B, Liang C, Wu W-H, Sjekloca N, Sadetsky N, Lai C, Kalinsky K
Section of Hematology/Oncology, University of Chicago Comprehensive Cancer Center, Chicago, USA.
Department of Breast Medical Oncology, MD Anderson Cancer Center, Houston, USA.
ESMO Open. 2025 Jun;10(6):105308. doi: 10.1016/j.esmoop.2025.105308. Epub 2025 Jun 5.
BACKGROUND: Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, demonstrated efficacy and manageable safety in second-line or later (2L+) metastatic triple-negative breast cancer (mTNBC) in clinical trials. We describe the real-world effectiveness of SG as 2L+ mTNBC treatment and the proportion of patients with neutropenia and its management. PATIENTS AND METHODS: This study used a nationwide electronic health record-derived de-identified database. Patients with mTNBC receiving SG in 2L+ from April 2020 through June 2023 were included. Real-world overall survival (rwOS) and time to next treatment or death (TTNTD) were assessed using the Kaplan-Meier method. SG use patterns, rates of neutropenia, and granulocyte colony-stimulating factor (G-CSF) use were described. RESULTS: For 381 patients included in the analysis, the median [interquartile range (IQR)] age was 61 years (52-69 years); 17% (n = 66) had ECOG PS ≥2; 18% (n = 70) were black; 78% (n = 298) were treated in community settings. Patients received a median (IQR) of 2 (1-3) prior treatment lines for metastatic disease. Median (IQR) SG treatment duration was 4.0 months (1.9-7.6 months) (maximum 32.7 months). At a median (IQR) follow-up of 8.7 months (4.5-14.6 months), the median rwOS and TTNTD were 11.3 months [95% confidence (CI) 10.0-12.9 months] and 5.6 months (95% CI 5.0-6.4 months), respectively. Grade 2 and 3/4 neutropenia during SG treatment occurred in 25% (n = 94) and 27% (n = 101) of patients, respectively. Any G-CSF use (primary + secondary prophylaxis and/or treatment) was observed in 59% (n = 225) of patients; 31% (n = 117) received any G-CSF prophylaxis. Any-grade neutropenia occurred in 25% (n = 29) of patients receiving any G-CSF prophylaxis versus 44% (n = 68) of patients who did not receive G-CSF. CONCLUSIONS: SG demonstrated real-world effectiveness and manageable safety, consistent with findings from ASCENT and other published real-world studies. Patients receiving any G-CSF prophylaxis had low rates of any-grade neutropenia, suggesting SG-related neutropenia can be effectively managed with G-CSF in patients with increased risk for febrile neutropenia.
背景：戈沙妥珠单抗（SG）是一种靶向Trop-2的抗体药物偶联物，在临床试验中显示出对二线及以上（2L+）转移性三阴性乳腺癌（mTNBC）有效且安全性可控。我们描述了SG作为2L+ mTNBC治疗的真实世界有效性以及中性粒细胞减少症患者的比例及其管理情况。 患者与方法：本研究使用了一个全国性的源自电子健康记录的去识别数据库。纳入2020年4月至2023年6月期间接受2L+ SG治疗的mTNBC患者。使用Kaplan-Meier方法评估真实世界总生存期（rwOS）和至下次治疗或死亡时间（TTNTD）。描述了SG的使用模式、中性粒细胞减少症发生率和粒细胞集落刺激因子（G-CSF）的使用情况。 结果：纳入分析的381例患者中，中位[四分位间距（IQR）]年龄为61岁（52 - 69岁）；17%（n = 66）的东部肿瘤协作组（ECOG）体能状态≥2；18%（n = 70）为黑人；78%（n = 298）在社区环境中接受治疗。患者转移性疾病的既往治疗线数中位数（IQR）为2（1 - 3）线。SG治疗持续时间中位数（IQR）为4.0个月（1.9 - 7.6个月）（最长32.7个月）。中位（IQR）随访8.7个月（4.5 - 14.6个月）时，rwOS和TTNTD的中位数分别为11.3个月[95%置信区间（CI）10.0 - 12.9个月]和5.6个月（95% CI 5.0 - 6.4个月）。SG治疗期间2级和3/4级中性粒细胞减少症分别发生在25%（n = 94）和27%（n = 101）的患者中。59%（n = 225）的患者使用了任何G-CSF（一级 + 二级预防和/或治疗）；31%（n = 117）接受了任何G-CSF预防。接受任何G-CSF预防治疗的患者中25%（n = 29）发生了任何级别的中性粒细胞减少症，而未接受G-CSF的患者中这一比例为44%（n = 68）。 结论：SG显示出真实世界有效性和可控安全性，与ASCENT及其他已发表的真实世界研究结果一致。接受任何G-CSF预防治疗的患者任何级别的中性粒细胞减少症发生率较低，提示对于有发热性中性粒细胞减少症风险增加的患者，G-CSF可有效管理与SG相关的中性粒细胞减少症。
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