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一项针对接受过至少两种先前治疗的中国转移性三阴性乳腺癌患者的戈沙妥珠单抗单臂多中心IIb期试验。

A Phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments.

作者信息

Xu Binghe, Ma Fei, Wang Tao, Wang Shusen, Tong Zhongsheng, Li Wei, Wu Xinhong, Wang Xiaojia, Sun Tao, Pan Yueyin, Yao Herui, Wang Xian, Luo Ting, Yang Jin, Zeng Xiaohua, Zhao Weihong, Cong Xiuyu Julie, Chen Jiongjie

机构信息

Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Breast Cancer, The Fifth Medical Center of PLA General Hospital, Beijing, China.

出版信息

Int J Cancer. 2023 May 15;152(10):2134-2144. doi: 10.1002/ijc.34424. Epub 2023 Jan 30.


DOI:10.1002/ijc.34424
PMID:36621000
Abstract

Refractory or relapsing metastatic triple-negative breast cancer (mTNBC) has a poor prognosis. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate, targeting human trophoblast cell-surface antigen 2 (Trop-2). This is the first report of SG's efficacy and safety in Chinese patients with mTNBC. EVER-132-001 (NCT04454437) was a multicenter, single-arm, Phase IIb study in Chinese patients with mTNBC who failed ≥2 prior chemotherapy regimens. Eligible patients received 10 mg/kg SG on Days 1 and 8 of each 21-day treatment cycle, until disease progression/unacceptable toxicity. The primary endpoint was objective response rate (ORR) assessed by the Independent Review Committee. Secondary endpoints included: duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS) and safety. Eighty female Chinese patients (median age 47.6 years; range 24-69.9 years) received ≥1 SG dose with a median of 8 treatment cycles by the cutoff date (August 6, 2021). Median number of prior systemic cancer treatments was 4.0 (range 2.0-8.0). ORR and CBR were reported 38.8% (95% confidence interval [CI]: 28.06-50.30) and 43.8% (95% CI, 32.68-55.30) of patients, respectively. The median PFS was 5.55 months (95% CI, 4.14-N/A). SG-related Grade ≥3 treatment-emergent adverse events (TEAEs) were reported in 71.3%, the most common were neutrophil count decreased (62.5%), white blood cell count decreased (48.8%) and anemia (21.3%); 6.3% discontinued SG because of TEAEs. SG demonstrated substantial clinical activity in heavily pretreated Chinese patients with mTNBC. The observed safety profile was generally manageable.

摘要

难治性或复发性转移性三阴性乳腺癌(mTNBC)预后较差。戈沙妥珠单抗(SG)是一种新型抗体偶联药物,靶向人滋养层细胞表面抗原2(Trop-2)。这是关于SG在中国mTNBC患者中的疗效和安全性的首份报告。EVER-132-001(NCT04454437)是一项针对既往接受过≥2种化疗方案治疗失败的中国mTNBC患者的多中心、单臂IIb期研究。符合条件的患者在每21天治疗周期的第1天和第8天接受10mg/kg的SG治疗,直至疾病进展或出现不可接受的毒性。主要终点是由独立审查委员会评估的客观缓解率(ORR)。次要终点包括:缓解持续时间(DOR)、临床获益率(CBR)、无进展生存期(PFS)、总生存期(OS)和安全性。截至截止日期(2021年8月6日),80名中国女性患者(中位年龄47.6岁;范围24 - 69.9岁)接受了≥1剂SG治疗,中位治疗周期数为8个。既往全身癌症治疗的中位次数为4.0次(范围2.0 - 8.0)。报告的ORR和CBR分别为38.8%(95%置信区间[CI]:28.06 - 50.30)和43.8%(95%CI,32.68 - 55.30)患者。中位PFS为5.55个月(95%CI,4.14 - N/A)。71.3%的患者报告了与SG相关的≥3级治疗中出现的不良事件(TEAE),最常见的是中性粒细胞计数减少(62.5%)、白细胞计数减少(48.8%)和贫血(21.3%);6.3%的患者因TEAE停用SG。SG在经过大量治疗的中国mTNBC患者中显示出显著的临床活性。观察到的安全性特征总体上是可控的。

相似文献

[1]
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Int J Cancer. 2023-5-15

[2]
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Breast Cancer Res Treat. 2022-9

[3]
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N Engl J Med. 2019-2-21

[4]
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Ann Pharmacother. 2021-7

[5]
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Ann Oncol. 2020-12

[6]
Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer.

Ann Oncol. 2021-9

[7]
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[8]
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Future Oncol. 2022-9

[9]
Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer.

J Clin Oncol. 2017-7-1

[10]
Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression.

J Clin Oncol. 2024-5-20

引用本文的文献

[1]
Efficacy and safety of Sacituzumab govitecan in solid tumors: a systematic review and meta-analysis.

Front Oncol. 2025-6-20

[2]
Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial.

Nat Med. 2025-4-11

[3]
Antibody-drug conjugates in breast cancer: current evidence and future directions.

Exp Hematol Oncol. 2025-3-20

[4]
Advances in antibody-drug conjugates in the treatment of advanced triple-negative breast cancer: a narrative review.

Transl Breast Cancer Res. 2025-1-21

[5]
Antibody-drug conjugates in breast cancer: advances and prospects.

Cancer Biol Med. 2025-2-17

[6]
The Mode of Action and Clinical Outcomes of Sacituzumab Govitecan in Solid Tumors.

Clin Cancer Res. 2025-4-14

[7]
Recent advances in systematic therapy of breast cancer: Chinese contribution for international progress.

Chin J Cancer Res. 2024-12-30

[8]
Targeting Refractory Triple-Negative Breast Cancer with Sacituzumab Govitecan: A New Era in Precision Medicine.

Cells. 2024-12-22

[9]
Incidence of antibody-drug conjugate-related hepatotoxicity in breast cancer: a systematic review and meta-analysis.

Ther Adv Drug Saf. 2024-12-18

[10]
Safety profile of sacituzumab govitecan in patients with breast cancer: A systematic review and meta-analysis.

Breast. 2025-2

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