HER2阳性乳腺癌治疗进展与生物仿制药前景一览
2017年4月，欧洲乳腺癌专家学会、乳腺中心协作网络、澳大利亚乳腺疾病学会官方期刊《BREAST》将正式发表德国奥芬巴赫萨纳医院、美国梅哈里医学院、美国辉瑞的系统回顾：HER2阳性乳腺癌治疗进展与生物仿制药前景一览。全文18页，要点如下：
HER2阳性乳腺癌患者抗HER2治疗获益匪浅
患者获取曲妥珠单抗等生物制剂存在障碍
HER2阳性乳腺癌患者的治疗方法不断发展
生物仿制药可能会解决患者和医生的需求
人表皮生长因子受体2（HER2）阳性乳腺癌占所有乳腺癌约15%～20%，并且与不良预后密切相关。抗HER2治疗的引入显著改善了HER2阳性乳腺癌患者的临床结局，并且多种HER2靶向药物（曲妥珠单抗、帕妥珠单抗、拉帕替尼、T-DM1）获得批准用于临床。HER2阳性乳腺癌患者治疗方案正在不断发展。虽然新的药物和治疗策略正在出现，但是生物疗法，尤其是曲妥珠单抗，可能仍然是治疗主体。然而，获取问题对使用生物制剂造成障碍，并且有证据表明世界范围内曲妥珠单抗使用不足。生物仿制药是与已经获批生物制品安全性和有效性高度相似的生物制品。曲妥珠单抗生物仿制药正在开发中，可能很快就会出现。生物仿制药的引入可以通过提供更多治疗选择和更低成本替代品改善对抗HER2疗法的获取。因为HER2靶向药物可以长时间使用并与其他全身疗法联合，所以生物仿制药具有显著节约医疗费用的潜力。本文复习了目前以及将来的治疗选择，并讨论了生物仿制药治疗HER2阳性乳腺癌患者的可能作用。
Breast. 2017 Apr;32:199-216.
Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars.
Jackisch C, Lammers P, Jacobs I.
Sana Klinikum Offenbach, Starkenburgring, Offenbach, Germany; Meharry Medical College, Nashville, TN, USA; Pfizer Inc., New York, NY, USA.
Highlights
Patients with HER2+ breast cancer derive substantial benefit from anti-HER2 therapy.
Patients encounter barriers to access of biologic agents, including trastuzumab.
The treatment landscape for patients with HER2+ breast cancer is evolving.
Biosimilars may address patient and physician needs as anti-HER2 therapy evolves.
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.
KEYWORDS: Anti-HER2 therapy; Biosimilars; HER2-Positive breast cancer; Trastuzumab
PMID: 28236776
PII: S0960-9776(17)30010-3
DOI: 10.1016/j.breast.2017.01.010