■这个多中心的目标,观察,回顾性分析旨在评估sacituzumabgovitecan在根据意大利常规临床实践治疗的转移性三阴性乳腺癌(mTNBC)患者中的安全性和有效性.
■数据由7个站点检索。三阴性BC的定义是缺乏雌激素受体的表达(ER<1%),孕激素受体(PgR<1%)和人表皮生长因子受体2(HER20,1+,2+ISH-未扩增)根据标准ASCO-CAP标准。收集人口统计学和临床特征。术前用药,剂量调整和治疗方案基于批准的产品标签.根据NCI-CTCAEv5.0评估不良事件(AE)。
■57名符合条件的患者接受sacituzumabgovitecan治疗mTNBC。中位年龄为53岁(25-75岁)。大约70%的患者最初诊断为TNBC。从诊断为转移性BC到开始使用sacituzumabgovitecan的中位时间为17个月(范围0-97),先前治疗的中位次数为3(范围1-7)。最常见的转移部位是淋巴结(63.1%的患者),肺(57.9%),骨(50.8%)和肝(38.6%)。8例(14.0%)患者的无病间隔≤12个月。共观察到32例(56.1%)死亡,中位总生存期(OS)为12.43个月(95%CI,7.97个月-未达到)。中位随访时间为10.6个月,45例患者(78.9%)进展,中位无进展生存期(PFS)为4.9个月(95%CI,3.7-7.1个月)。在19例患者中观察到部分肿瘤反应(33.3%),16例(28.1%)病情稳定,22例(38.6%)病情进展。最常见的治疗相关不良事件是贫血(66.6%的患者),脱发(66.6%),中性粒细胞减少症(59.6%),恶心(42.1%)和腹泻(38.6%)。中性粒细胞减少症是最常见的严重治疗相关不良事件:21.0%和8.7%的患者经历3级或4级中性粒细胞减少症,分别。22例患者(38.6%)减少了剂量,5.3%的患者永久停止治疗。
■这项真实世界分析的结果表明,sacituzumabgovitecan在mTNBC患者中的安全性和有效性与先前在监管试验中报道的一致。使用前用药和支持性措施与令人满意的毒性特征相关。
UNASSIGNED: The objective of this multicenter, observational, retrospective analysis was to evaluate the safety and efficacy of sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) patients managed according to common clinical practice in Italy.
UNASSIGNED: Data were retrieved by 7 sites. Triple-negative BC was defined by the lack of expression of estrogen receptor (ER <1%), progesterone receptor (PgR <1%) and human-epidermal growth factor receptor-2 (HER2 0, 1+, 2+ ISH-not amplified) according to standard ASCO-CAP criteria. Demographic and clinical characteristics were collected. Premedication, dose modifications and treatment schedule were based on the approved label of the product. Adverse events (AEs) were assessed according to NCI-CTCAE v5.0.
UNASSIGNED: Fifty-seven eligible patients who received sacituzumab govitecan for mTNBC were included. Median age was 53 years (range 25-75). Approximately 70% of patients had an initial diagnosis of TNBC. Median time from the diagnosis of metastatic BC to start of sacituzumab govitecan was 17 months (range 0-97) and median number of previous therapies was 3 (range 1-7). The most common sites of metastasis were lymph nodes (63.1% of patients), lung (57.9%), bone (50.8%) and liver (38.6%). Eight (14.0%) patients had a disease-free interval ≤12 months. A total of 32 (56.1%) deaths were observed and the median overall survival (OS) was 12.43 months (95% CI, 7.97 months-not reached). At a median follow-up of 10.6 months, 45 patients (78.9%) had progression and the median progression-free survival (PFS) was 4.9 months (95% CI, 3.7-7.1 months). Partial tumour response was observed in 19 patients (33.3%), stable disease in 16 (28.1%) and disease progression in 22 patients (38.6%). The most common treatment-related AEs were anemia (66.6% of patients), alopecia (66.6%), neutropenia (59.6%), nausea (42.1%) and diarrhea (38.6%). Neutropenia was the most common serious treatment-related AE: 21.0% and 8.7% of patients experienced grade 3 or 4 neutropenia, respectively. Twenty-two patients (38.6%) reduced the dose and 5.3% permanently discontinued treatment.
UNASSIGNED: The results of this real-world analysis showed that both safety and efficacy of sacituzumab govitecan in mTNBC patients are consistent with that previously reported in regulatory trials. The use of premedication and supportive measures was associated with a satisfactory toxicity profile.