Background/Objectives:Sacituzumab govitecan (SG) is an antibody–drug conjugate targeting Trop-2, approved for use in metastatic triple-negative breast cancer (mTNBC) and more recently in the hormone receptor-positive/HER2-negative (mHRPBC) subtype. While clinical trials have demonstrated its efficacy, real-world data—especially those involving both molecular subtypes—remain scarce. This multicenter, retrospective study aimed to evaluate real-world observational data describing the clinical outcomes, safety, and prognostic factors associated with SG treatment in patients with mTNBC or mHRPBC.Methods:A total of 68 patients treated with SG between 2022 and 2025 were included from multiple oncology centers in Turkey. Patients with mTNBC were required to have received at least one prior chemotherapy line, while mHRPBC patients had received at least two prior chemotherapy lines in addition to cyclin-dependent kinase 4 and 6 inhibitors (CDK 4/6) plus hormone therapy. The clinical outcomes—including the progression-free survival (PFS), overall survival (OS), and objective response rate (ORR)—were evaluated. Univariate and multivariate analyses were performed to identify factors influencing outcomes. Adverse events (AEs) were also documented and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.0).Results:The cohort included 35 (51.5%) mTNBC and 33 (48.5%) mHRPBC patients. The median PFS was 6.1 months, and the median OS was 12.5 months, with no significant differences between subtypes. The ORR was 52.9%, with a complete response observed in 10.3% of patients. A high Eastern Cooperative Oncology Group Performance Status (ECOG PS) and liver metastasis were independent predictors of poorer PFS and OS. Prior immunotherapy did not negatively impact SG’s efficacy. SG was generally well tolerated; the most common AEs were alopecia, anemia, neutropenia, and diarrhea. Treatment discontinuation due to AEs was rare (2.9%).Conclusions:SG was associated with similar clinical outcomes and tolerability in both the mTNBC and mHRPBC subtypes. Although the real-world PFS and OS outcomes mirror those seen in clinical trials, the absence of a control group means that these findings should be interpreted descriptively rather than as confirmation of treatment efficacy. Importantly, this study provides one of the first real-world datasets evaluating SG in the mHRPBC subgroup, highlighting its potential role beyond clinical trials. These results support SG as a valuable therapeutic option in heavily pretreated patients, warranting further prospective and biomarker-driven studies.
背景/目的：Sacituzumab govitecan（SG）是一种靶向Trop-2的抗体偶联药物，已获批用于转移性三阴性乳腺癌（mTNBC），近期亦获批用于激素受体阳性/HER2阴性（mHRPBC）亚型。尽管临床试验已证实其疗效，但真实世界数据——尤其是同时涵盖两种分子亚型的数据——仍较为缺乏。这项多中心回顾性研究旨在评估真实世界观察性数据，以描述SG治疗mTNBC或mHRPBC患者的临床结局、安全性及相关预后因素。 方法：研究纳入了2022年至2025年间土耳其多家肿瘤中心接受SG治疗的68例患者。mTNBC患者需至少接受过一线化疗，而mHRPBC患者除接受过细胞周期蛋白依赖性激酶4和6抑制剂（CDK 4/6）联合激素治疗外，还需至少接受过两线化疗。评估的临床结局包括无进展生存期（PFS）、总生存期（OS）和客观缓解率（ORR）。通过单变量和多变量分析确定影响结局的因素。不良事件（AEs）依据美国国家癌症研究所不良事件通用术语标准5.0版（NCI-CTCAE v5.0）进行记录和分级。 结果：队列包括35例（51.5%）mTNBC患者和33例（48.5%）mHRPBC患者。中位PFS为6.1个月，中位OS为12.5个月，亚型间无显著差异。ORR为52.9%，其中10.3%的患者达到完全缓解。较高的美国东部肿瘤协作组体能状态评分（ECOG PS）和肝转移是PFS和OS较差的独立预测因素。既往免疫治疗未对SG疗效产生负面影响。SG总体耐受性良好；最常见的AEs为脱发、贫血、中性粒细胞减少和腹泻。因AEs导致治疗中止的情况罕见（2.9%）。 结论：SG在mTNBC和mHRPBC亚型中表现出相似的临床结局和耐受性。尽管真实世界的PFS和OS结果与临床试验数据一致，但由于缺乏对照组，这些发现应作为描述性结果解读，而非治疗疗效的确证。重要的是，本研究提供了首批评估SG在mHRPBC亚组中应用的真实世界数据集之一，凸显了其在临床试验之外的潜在作用。这些结果支持SG作为经多线治疗患者的一种有价值的治疗选择，值得进一步开展前瞻性及生物标志物驱动的研究。
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