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临床试验中的肿瘤学护士协调员——撼动黑色素瘤治疗团队

Oncology Nurse Coordinators in Clinical Trials - Shaking up the Melanoma Team.

作者信息

Steinberg Hani

机构信息

Department of Oncology, Sharett Institute of Oncology, Hadassah Hebrew University Hospital, Kiryat Hadassah, Jerusalem, Israel.

出版信息

Asia Pac J Oncol Nurs. 2020 Jun 26;7(3):250-254. doi: 10.4103/apjon.apjon_19_20. eCollection 2020 Jul-Sep.

Abstract

In recent years, melanoma research has undergone a renaissance. The disease that was once viewed, at least in a metastatic setting, as intractable and untreatable is now revealing its molecular "weaknesses." The year 2011 was a landmark year for melanoma therapy, with the introduction of two new agents - the anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody ipilimumab and the BRAF (V-raf murine sarcoma viral oncogene homolog B1) inhibitor vemurafenib. These two agents were shown to confer a survival benefit, which was followed by the approval by the Food and Drug Administration (FDA). In 2014, other immune checkpoint inhibitors, such as pembrolizumab and nivolumab, were approved for the treatment of metastatic melanoma. By 2019, the FDA had also approved pembrolizumab as adjuvant therapy. Target therapy and immunotherapy are now the standard of care for melanoma patients. Clinical trials are currently ongoing for new neoadjuvant therapies. Rapidly evolving knowledge will perhaps downgrade melanoma to the level of a chronic, manageable disease from the intractable "black cancer," it was in the past and a disease that struck fear into the hearts of those who were diagnosed. Changes in immunotherapy treatments were followed by a large volume of clinical trials. This situation has resulted in the need for changes in the roles of existing melanoma multidisciplinary team members, including the clinical trials nurse (CTN). The role of the CTN is not suitable for these new conditions. A new role and tasks need to be established, evolving the CTN into an oncology nurse coordinator (ONC). In this article, we have described the role and responsibilities of an ONC and the changes that have taken place within the multidisciplinary melanoma team.

摘要

近年来,黑色素瘤研究迎来了复兴。这种疾病曾被认为,至少在转移情况下,是难以治疗且无法治愈的,如今却逐渐暴露其分子“弱点”。2011年是黑色素瘤治疗的一个里程碑式的年份,两种新型药物问世——抗细胞毒性T淋巴细胞相关蛋白4(CTLA - 4)抗体伊匹单抗和BRAF(V - raf鼠肉瘤病毒癌基因同源物B1)抑制剂维莫非尼。这两种药物被证明能带来生存益处,并随后获得了美国食品药品监督管理局(FDA)的批准。2014年,其他免疫检查点抑制剂,如帕博利珠单抗和纳武利尤单抗,被批准用于治疗转移性黑色素瘤。到2019年,FDA还批准了帕博利珠单抗作为辅助治疗药物。靶向治疗和免疫治疗现在已成为黑色素瘤患者的标准治疗方案。目前针对新辅助治疗的临床试验正在进行。迅速发展的知识或许会将黑色素瘤从过去那种难以治疗的“黑色癌症”,转变为一种慢性的、可控制的疾病,让那些被诊断出的患者不再心生恐惧。免疫治疗方法的变化引发了大量临床试验。这种情况导致包括临床试验护士(CTN)在内的现有黑色素瘤多学科团队成员的角色需要改变。CTN的角色已不适用于这些新情况。需要确立一种新的角色和任务,将CTN转变为肿瘤护理协调员(ONC)。在本文中,我们描述了ONC的角色和职责以及多学科黑色素瘤团队内部发生的变化。

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