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2016年新型及扩展型肿瘤药物批准情况——第1部分:实体瘤治疗新选择

Novel and Expanded Oncology Drug Approvals of 2016-PART 1: New Options in Solid Tumor Management.

作者信息

Knepper Todd C, Saller James, Walko Christine M

出版信息

Oncology (Williston Park). 2017 Feb 15;31(2):110-21.

Abstract

The nonradiologic medical management of solid tumors has evolved from the use of traditional cytotoxic agents to modern targeted therapies, monoclonal antibodies, and immunotherapies. Advances in the understanding of cancer biology and therapeutic strategies have resulted in increasing numbers of new drug applications and approvals. Consequently, practicing oncologists need to learn how the newly available agents function and what toxicities to watch for, as well as ways to optimize the use of both new drugs and previously approved drugs with new indications. In 2016, the US Food and Drug Administration approved three novel drugs for the treatment of solid malignancies-olaratumab in selected patients with soft-tissue sarcoma, atezolizumab for the treatment of bladder cancer, and rucaparib for the treatment of ovarian cancer; also in 2016, the use of previously approved anticancer agents (including atezolizumab) was expanded into 11 new patient populations. The diversity of options for patients is evident in the broad range of the 2016 approvals, which include immune checkpoint inhibitors, targeted therapies, monoclonal antibodies, and traditional cytotoxic agents. This article focuses on the new agents and indications that emerged in 2016 for solid tumor treatment. We review the drug indications, mechanisms of action, pivotal trial data, pertinent toxicities, use in special populations, and the appropriate clinical contexts for treatment planning.

摘要

实体瘤的非放射医学管理已从使用传统细胞毒性药物发展到现代靶向疗法、单克隆抗体和免疫疗法。对癌症生物学和治疗策略认识的进步导致新药申请和获批数量不断增加。因此,执业肿瘤学家需要了解新可用药物的作用机制、需要关注的毒性,以及优化新药和有新适应症的先前获批药物使用的方法。2016年,美国食品药品监督管理局批准了三种用于治疗实体恶性肿瘤的新药——奥拉单抗用于特定软组织肉瘤患者、阿特珠单抗用于治疗膀胱癌、鲁卡帕尼用于治疗卵巢癌;同样在2016年,先前获批的抗癌药物(包括阿特珠单抗)的应用扩展到11个新的患者群体。2016年获批范围广泛,包括免疫检查点抑制剂、靶向疗法、单克隆抗体和传统细胞毒性药物,这体现了患者选择的多样性。本文重点关注2016年出现的实体瘤治疗新药物和新适应症。我们回顾了药物适应症、作用机制、关键试验数据、相关毒性、在特殊人群中的使用以及治疗规划的适当临床背景。

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