Department of Cancer Pharmacology and Pharmacogenomics, Levine Cancer Institute, Atrium Health, Charlotte, NC, United States of America.
Department of Pharmacy, Specialty Pharmacy Services, Atrium Health, Charlotte, NC, United States of America.
Contemp Clin Trials. 2021 Jun;105:106391. doi: 10.1016/j.cct.2021.106391. Epub 2021 Apr 2.
Cancer-related symptoms, like depression, nausea, and pain, are common and negatively affect quality of life. Unfortunately, there is large inter-individual variability in response to supportive care medications for these symptoms. Pharmacogenomics may inform prescribing by identification of those genetically at risk for drug related adverse events or therapeutic failure. While such information can be applied to many drugs, there are specific oncology populations that could greatly benefit from pharmacogenomics-guided supportive care management due to high symptom burden, including those receiving palliative medicine and hematopoietic stem cell transplantation. The goal of this paper is to provide an overview of, and lessons learned from, the development of two prospective pharmacogenomics-guided interventional trials ("Supportive Care PGx Trial" and "Transplant PGx Trial") across two different clinical settings at the Levine Cancer Institute: the Department of Supportive Oncology and the Transplant and Cellular Therapy section. Key considerations included the appropriate study design and endpoints (balancing study goals and resources), dissemination and application of individual pharmacogenetics results, technical details about assay development, and overall care coordination to minimize clinic disruption.
癌症相关症状，如抑郁、恶心和疼痛，很常见，会降低生活质量。不幸的是，对于这些症状的支持性护理药物，个体间的反应存在很大差异。药物基因组学可以通过识别那些有药物相关不良反应或治疗失败风险的基因来指导处方。虽然这种信息可以应用于许多药物，但由于症状负担高，包括接受姑息治疗和造血干细胞移植的患者，特定的肿瘤学人群可以从基于药物基因组学的支持性护理管理中极大地受益。本文的目的是提供对在两个不同临床环境下开发的两项前瞻性药物基因组学指导干预试验（“支持性护理 PGx 试验”和“移植 PGx 试验”）的概述，并从中吸取经验教训，这两个试验是在莱文癌症研究所的支持肿瘤学系和移植与细胞治疗科进行的。关键考虑因素包括适当的研究设计和终点（平衡研究目标和资源）、个体药物基因组学结果的传播和应用、关于检测方法开发的技术细节，以及整体护理协调以最大程度减少临床干扰。
