Alaklabi Sabah, Roy Arya Mariam, Zagami Paola, Chakraborty Anumita, Held Nicole, Elijah Joseph, George Anthony, Attwood Kristopher, Shaikh Saba S, Chaudhary Lubna N, Abdou Yara, Gandhi Shipra
Department of Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Cancer Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
JCO Oncol Pract. 2025 May;21(5):620-628. doi: 10.1200/OP.24.00242. Epub 2024 Oct 1.
Sacituzumab govitecan (SG) is approved for the treatment of metastatic triple-negative breast cancer (mTNBC). We report the real-world clinical effectiveness and toxicity data of SG in patients with mTNBC.
A multi-institution retrospective study of patients with mTNBC treated with SG from January 2021 to May 2023 was conducted. Demographic and clinicopathologic variables were collected. Univariate and multivariate Cox regression models were used for survival analysis.
A total of 115 patients were included. The median age at SG initiation was 60 years (range, 31-85). All patients were female; 73 (63.5%) were White and 31 (27.0%) were Black. The median number of previous therapies in the metastatic setting was two (range, 0-8). Sixty-one (56.0%) patients had primary refractory disease. Median relative dose intensity was 92% (range, 33%-100%). Grade 3 or higher adverse events (AEs) were seen in 50.9% of patients, which included neutropenia (35.7%), anemia (27.0%), vomiting (16.5%), fatigue (8.7%), and diarrhea (7.0%). Dose reductions and treatment discontinuation due to AEs were required in 51.3% and 13.2%, respectively. The objective response rate (ORR) was 27.8%. Median overall survival was 9.6 months (95% CI, 7.8 to 12.9) and median progression-free survival (PFS) was 4.8 months (95% CI, 3.6 to 5.9). In patients with human epidermal growth factor receptor 2 (HER2)-low mTNBC who received trastuzumab deruxtecan (T-DXd) after SG, the ORR to T-DXd was 34.8% and median PFS was 7 months (95% CI, 4.6 to 10.1).
In a real-world cohort of heavily pretreated patients with mTNBC, SG retains its clinical activity. In a subgroup with HER2-low disease, T-DXd continues to demonstrate promising clinical activity after SG, supporting the use of sequential antibody-drug conjugates in this population.
戈沙妥珠单抗(SG)已被批准用于治疗转移性三阴性乳腺癌(mTNBC)。我们报告了SG在mTNBC患者中的真实世界临床疗效和毒性数据。
对2021年1月至2023年5月接受SG治疗的mTNBC患者进行了一项多机构回顾性研究。收集了人口统计学和临床病理变量。采用单因素和多因素Cox回归模型进行生存分析。
共纳入115例患者。开始使用SG时的中位年龄为60岁(范围31 - 85岁)。所有患者均为女性;73例(63.5%)为白人,31例(27.0%)为黑人。转移性疾病既往治疗的中位次数为2次(范围0 - 8次)。61例(56.0%)患者患有原发性难治性疾病。中位相对剂量强度为92%(范围33% - 100%)。50.9%的患者出现3级或更高等级的不良事件(AE),其中包括中性粒细胞减少(35.7%)、贫血(27.0%)、呕吐(16.5%)、疲劳(8.7%)和腹泻(7.0%)。分别有51.3%和13.2%的患者因AE需要减少剂量和停止治疗。客观缓解率(ORR)为27.8%。中位总生存期为9.6个月(95%CI,7.8至12.9),中位无进展生存期(PFS)为4.8个月(95%CI,3.6至5.9)。在SG治疗后接受曲妥珠单抗德鲁替康(T-DXd)治疗的人表皮生长因子受体2(HER2)低表达mTNBC患者中,T-DXd的ORR为34.8%,中位PFS为7个月(95%CI,4.6至10.1)。
在一个接受过大量预处理的mTNBC真实世界队列中,SG保留了其临床活性。在HER2低表达疾病的亚组中,SG治疗后T-DXd继续显示出有前景的临床活性,支持在该人群中序贯使用抗体药物偶联物。