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人表皮生长因子受体2阳性乳腺癌治疗的演变格局与生物类似药的未来。

Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars.

作者信息

Jackisch Christian, Lammers Philip, Jacobs Ira

机构信息

Sana Klinikum Offenbach, Starkenburgring 66, D-63069 Offenbach, Germany.

Meharry Medical College, 1005 Dr. D.B. Todd Jr. Blvd., Nashville, TN 37208-3501, USA.

出版信息

Breast. 2017 Apr;32:199-216. doi: 10.1016/j.breast.2017.01.010. Epub 2017 Feb 23.

Abstract

Human epidermal growth factor receptor 2-positive (HER2+) breast cancer comprises approximately 15%-20% of all breast cancers and is associated with a poor prognosis. The introduction of anti-HER2 therapy has significantly improved clinical outcomes for patients with HER2+ breast cancer, and multiple HER2-directed agents (ie, trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine [T-DM1]) are approved for clinical use in various settings. The treatment landscape for patients with HER2+ breast cancer is continuing to evolve. While novel agents and therapeutic strategies are emerging, biologic therapies, particularly trastuzumab, are likely to remain a mainstay of treatment. However, access issues create barriers to the use of biologics, and there is evidence for underuse of trastuzumab worldwide. A biosimilar is a biologic product that is highly similar to a licensed biologic in terms of product safety and effectiveness. Biosimilars of trastuzumab are in development and may soon become available. The introduction of biosimilars may improve access to anti-HER2 therapies by providing additional treatment options and lower-cost alternatives. Because HER2-targeted drugs may be administered for extended periods of time and in combination with other systemic therapies, biosimilars have the potential to result in significant savings for healthcare systems. Herein we review current and emerging treatment options for, and discuss the possible role of biosimilars in, treating patients with HER2+ breast cancer.

摘要

人表皮生长因子受体2阳性(HER2+)乳腺癌约占所有乳腺癌的15%-20%,且预后较差。抗HER2治疗的引入显著改善了HER2+乳腺癌患者的临床结局,多种HER2靶向药物(即曲妥珠单抗、帕妥珠单抗、拉帕替尼和ado曲妥珠单抗 emtansine [T-DM1])已获批在各种情况下临床使用。HER2+乳腺癌患者的治疗格局仍在不断演变。虽然新型药物和治疗策略不断涌现,但生物疗法,尤其是曲妥珠单抗,可能仍将是治疗的主要手段。然而,获取问题给生物制剂的使用造成了障碍,且有证据表明全球范围内曲妥珠单抗的使用不足。生物类似药是一种在产品安全性和有效性方面与已获许可的生物制剂高度相似的生物制品。曲妥珠单抗的生物类似药正在研发中,可能很快上市。生物类似药的引入可能通过提供更多治疗选择和低成本替代方案来改善抗HER2治疗的可及性。由于HER2靶向药物可能需要长期给药并与其他全身治疗联合使用,生物类似药有可能为医疗保健系统节省大量费用。在此,我们综述了HER2+乳腺癌患者当前及新出现的治疗选择,并讨论了生物类似药在治疗此类患者中可能发挥的作用。

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