Background

Treatment options for pre-treated patients with metastatic triple-negative breast cancer (mTNBC) remain limited. This is the first study to assess the real-world safety and efficacy of sacituzumab govitecan (SG) in the UK.

Methods

Data was retrospectively collected from 16 tertiary UK cancer centres. Pts had a diagnosis of mTNBC, received at least two prior lines of treatment (with at least one being in the metastatic setting) and received at least one dose of SG.

Results

132 pts were included. Median age was 56 years (28–91). All patients were ECOG performance status (PS) 0-3 (PS0; 39, PS1; 76, PS2; 16, PS3;1). 75% (99/132) of pts had visceral metastases including 18% (24/132) of pts with CNS disease. Median PFS (mPFS) was 5.2 months (95% CI 4.5–6.6) with a median OS (mOS) of 8.7 months (95% CI 6.8-NA). The most common adverse events (AEs) were fatigue (all grade; 82%, G3/4; 14%), neutropenia (all grade; 55%, G3/4; 29%), diarrhoea (all grade; 58%, G3/4, 15%), and nausea (all grade; 38%, G3/4; 3%). SG dose reduction was required in 54% of pts.

Conclusion

This study supports significant anti-tumour activity in heavily pre-treated pts with mTNBC. Toxicity data aligns with clinical trial experience.

中文翻译：

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sacituzumab govitecan 在英国治疗转移性三阴性乳腺癌的真实世界研究

背景

接受过治疗的转移性三阴性乳腺癌 (mTNBC) 患者的治疗选择仍然有限。这是英国第一项评估 sacituzumab govitecan (SG) 现实世界安全性和有效性的研究。

方法

数据是从英国 16 个三级癌症中心回顾性收集的。患者被诊断为 mTNBC，之前接受过至少两种治疗（其中至少一种处于转移状态）并接受了至少一剂 SG。

结果

计入132分。中位年龄为 56 岁 (28-91)。所有患者的ECOG体力状态（PS）0-3（PS0；39，PS1；76，PS2；16，PS3；1）。 75% (99/132) 的患者有内脏转移，其中 18% (24/132) 的患者患有 CNS 疾病。中位 PFS (mPFS) 为 5.2 个月 (95% CI 4.5-6.6)，中位 OS (mOS) 为 8.7 个月 (95% CI 6.8-NA)。最常见的不良事件 (AE) 是疲劳（所有级别；82%，G3/4；14%）、中性粒细胞减少症（所有级别；55%，G3/4；29%）、腹泻（所有级别；58%，G3） /4, 15%) 和恶心（所有等级；38%，G3/4；3%）。 54% 的患者需要减少 SG 剂量。

结论

这项研究支持在接受过大量 mTNBC 治疗的患者中具有显着的抗肿瘤活性。毒性数据与临床试验经验一致。