Background Sacituzumab govitecan has been recently approved by the USFDA and EMA for the treatment of patients with metastatic triple-negative breast cancer (mTNBC). We report real-world safety and effectiveness in patients with mTNBC receiving sacituzumab govitecan treatment at a breast cancer centre in Germany. Methods Data from patients who had received sacituzumab govitecan as treatment for mTNBC, in both de novo and relapsed disease, at the Kliniken Essen-Mitte, Essen, Germany, were collected through institutional records. Data were analysed for safety parameters and survival outcomes and reported using descriptive statistics. Results Patients (N = 43) received a median (range) of 5 (1-28) cycles of sacituzumab govitecan and were followed up for a median of 12.9 months. The most reported adverse events (AEs) of any grade were alopecia (n = 39; 90.7%), diarrhoea (n = 16; 37.2%), fatigue (n = 15, 34.9%), anaemia (n = 15, 34.9%) and neutropenia (n = 14, 32.6%). AEs ⩾ Grade 3 with the highest incidence were neutropenia (n = 12; 27.9%) and diarrhoea (n = 8; 18.6%). In eight (18.6%) patients, dose of sacituzumab govitecan dose was reduced due to patients' clinical condition prior to commencing treatment; in further 17 (39.5%) patients, sacituzumab govitecan dose had to be reduced or treatment interrupted on account of AEs associated with the drug after treatment had commenced. Median progression-free survival and median overall survival were calculated to be 5.0and 13.1 months, respectively. Conclusion The real-world safety and effectiveness profile of sacituzumab govitecan in patients with mTNBC are in line with clinical trial data. Further studies are required to guide optimal use of sacituzumab govitecan against mTNBC, especially in context of management of accompanying AEs.

中文翻译：

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sacituzumab govitecan 在现实环境中对转移性三阴性乳腺癌患者的安全性和有效性：来自德国跨学科乳腺癌中心的首次观察。

背景 Sacituzumab govitecan 最近已获得 USFDA 和 EMA 批准用于治疗转移性三阴性乳腺癌 (mTNBC) 患者。我们报告了在德国乳腺癌中心接受 sacituzumab govitecan 治疗的 mTNBC 患者的真实安全性和有效性。方法 通过机构记录收集在德国埃森埃森米特诊所接受 sacituzumab govitecan 作为 mTNBC 治疗的患者的数据，无论是新发疾病还是复发性疾病。对数据进行安全参数和生存结果分析，并使用描述性统计进行报告。结果 患者 (N = 43) 接受中位（范围）为 5 (1-28) 个周期的 sacituzumab govitecan，并随访中位 12.9 个月。报告最多的任何级别的不良事件 (AE) 为脱发 (n = 39; 90.7%)、腹泻 (n = 16; 37.2%)、疲劳 (n = 15, 34.9%)、贫血 (n = 15, 34.9%) ）和中性粒细胞减少症（n = 14, 32.6%）。发生率最高的 AE ⩾ 3 级是中性粒细胞减少症（n = 12；27.9%）和腹泻（n = 8；18.6%）。在 8 名 (18.6%) 患者中，由于开始治疗前患者的临床状况，sacituzumab govitecan 的剂量被减少；在另外 17 名 (39.5%) 患者中，由于治疗开始后出现与药物相关的 AE，必须减少 sacituzumab govitecan 剂量或中断治疗。中位无进展生存期和中位总生存期经计算分别为 5.0 个月和 13.1 个月。结论 sacituzumab govitecan 在 mTNBC 患者中的真实安全性和有效性与临床试验数据一致。需要进一步的研究来指导 sacituzumab govitecan 对抗 mTNBC 的最佳使用，特别是在管理伴随的 AE 的情况下。