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曲妥珠单抗-德鲁替康:在不可切除或转移性 HER2 阳性乳腺癌中的应用评价。

Trastuzumab Deruxtecan: A Review in Unresectable or Metastatic HER2-Positive Breast Cancer.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Target Oncol. 2023 May;18(3):463-470. doi: 10.1007/s11523-023-00971-9. Epub 2023 May 2.

DOI:10.1007/s11523-023-00971-9
PMID:37129796
Abstract

Trastuzumab deruxtecan (Enhertu) is a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate approved in several countries, including the USA and those of the EU, for adults with unresectable or metastatic HER2-positive breast cancer who have previously received at least one prior anti-HER2-based regimen. In a pivotal phase 3 trial in this setting, intravenous trastuzumab deruxtecan demonstrated prolonged progression-free survival compared with trastuzumab emtansine (previously the recommended second-line therapy in this indication). Trastuzumab deruxtecan had a generally manageable safety and tolerability profile. Common treatment-related adverse events included haematological and gastrointestinal disorders. Interstitial lung disease (ILD)/pneumonitis is associated with a regulatory warning and requires careful monitoring. In conclusion, trastuzumab deruxtecan is a valuable new treatment option for HER2-positive breast cancer, having been shown to be effective with a generally manageable safety and tolerability profile in adults with unresectable or metastatic disease who have received one or more prior anti-HER2-based regimens.

摘要

恩美曲妥珠单抗(Enhertu)是一种人表皮生长因子受体 2(HER2)靶向抗体-药物偶联物,已在包括美国和欧盟在内的多个国家获得批准,用于治疗先前接受过至少一种抗 HER2 为基础的方案治疗的不可切除或转移性 HER2 阳性乳腺癌成人患者。在这一适应证的一项关键性 3 期试验中,与曲妥珠单抗-美坦新偶联物(先前是该适应证的二线推荐治疗药物)相比,静脉注射恩美曲妥珠单抗显示出了延长的无进展生存期。恩美曲妥珠单抗具有总体可控的安全性和耐受性。常见的治疗相关不良事件包括血液学和胃肠道疾病。间质性肺病(ILD)/肺炎与监管警告相关,需要仔细监测。总之,恩美曲妥珠单抗是一种治疗 HER2 阳性乳腺癌的有价值的新选择,已显示在先前接受过一种或多种抗 HER2 为基础的方案治疗的不可切除或转移性疾病的成人中具有疗效,且安全性和耐受性总体可控。

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本文引用的文献

1
Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial.曲妥珠单抗-德鲁替康对比曲妥珠单抗-美坦新用于治疗 HER2 阳性转移性乳腺癌患者:来自随机、开放标签、III 期 DESTINY-Breast03 研究的更新结果。
Lancet. 2023 Jan 14;401(10371):105-117. doi: 10.1016/S0140-6736(22)02420-5. Epub 2022 Dec 7.
2
Systemic Therapy for Patients with HER2-Positive Breast Cancer and Brain Metastases: A Systematic Review and Meta-Analysis.HER2阳性乳腺癌合并脑转移患者的全身治疗:一项系统评价和荟萃分析
Cancers (Basel). 2022 Nov 15;14(22):5612. doi: 10.3390/cancers14225612.
3
系统给予低亲和力 HER2 CAR T 细胞可介导抗肿瘤疗效而无毒性。
J Immunother Cancer. 2024 Feb 7;12(2):e008566. doi: 10.1136/jitc-2023-008566.
Trastuzumab deruxtecan versus trastuzumab emtansine for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: A cost-effectiveness analysis.
曲妥珠单抗 deruxtecan 对比曲妥珠单抗 emtansine 用于人表皮生长因子受体 2 阳性转移性乳腺癌患者:一项成本效果分析。
Breast. 2022 Dec;66:191-198. doi: 10.1016/j.breast.2022.10.010. Epub 2022 Oct 21.
4
Therapeutic landscape of advanced HER2-positive breast cancer in 2022.2022 年晚期 HER2 阳性乳腺癌的治疗性景观。
Med Oncol. 2022 Oct 12;39(12):258. doi: 10.1007/s12032-022-01849-y.
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Cost-effectiveness analysis of trastuzumab deruxtecan versus trastuzumab emtansine for HER2-positive breast cancer.曲妥珠单抗德鲁昔单抗与曲妥珠单抗恩坦辛治疗HER2阳性乳腺癌的成本效益分析。
Front Pharmacol. 2022 Sep 9;13:924126. doi: 10.3389/fphar.2022.924126. eCollection 2022.
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Cost-Effectiveness Analysis of Trastuzumab Deruxtecan versus Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer in the USA.曲妥珠单抗-德鲁替康与曲妥珠单抗-美坦新在 USA 人表皮生长因子受体 2 阳性转移性乳腺癌中的成本效果分析。
Adv Ther. 2022 Oct;39(10):4583-4593. doi: 10.1007/s12325-022-02273-4. Epub 2022 Aug 9.
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Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.
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Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Guideline Update.晚期人表皮生长因子受体 2 阳性乳腺癌的全身治疗:ASCO 指南更新。
J Clin Oncol. 2022 Aug 10;40(23):2612-2635. doi: 10.1200/JCO.22.00519. Epub 2022 May 31.
9
Trastuzumab deruxtecan in patients with central nervous system involvement from HER2-positive breast cancer: The DEBBRAH trial.曲妥珠单抗 deruxtecan 治疗人表皮生长因子受体 2 阳性乳腺癌伴中枢神经系统转移患者:DEBBRAH 试验。
Neuro Oncol. 2023 Jan 5;25(1):157-166. doi: 10.1093/neuonc/noac144.
10
Trastuzumab Deruxtecan Improves Progression-Free Survival and Intracranial Response in Patients with HER2-Positive Metastatic Breast Cancer and Brain Metastases.曲妥珠单抗-德鲁替康改善 HER2 阳性转移性乳腺癌和脑转移患者的无进展生存期和颅内应答。
Oncologist. 2022 Mar 28;27(Suppl 1):S3-S4. doi: 10.1093/oncolo/oyac009.