Tsimberidou Apostolia M, Ringborg Ulrik, Schilsky Richard L
From the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX; Cancer Center Karolinska, Karolinska University Hospital, Solna, Sweden; American Society of Clinical Oncology, Alexandria, VA.
Am Soc Clin Oncol Educ Book. 2013:118-25. doi: 10.14694/EdBook_AM.2013.33.118.
This article highlights major developments over the last decade in personalized medicine in cancer. Emerging data from clinical studies demonstrate that the use of targeted agents in patients with targetable molecular aberrations improves clinical outcomes. Despite a surge of studies, however, significant gaps in knowledge remain, especially in identifying driver molecular aberrations in patients with multiple aberrations, understanding molecular networks that control carcinogenesis and metastasis, and most importantly, discovering effective targeted agents. Implementation of personalized medicine requires continued scientific and technological breakthroughs; standardization of tumor tissue acquisition and molecular testing; changes in oncology practice and regulatory standards for drug and device access and approval; modification of reimbursement policies by health care payers; and innovative ways to collect and analyze electronic patient information that are linked to prospective clinical registries and rapid learning systems. Informatics systems that integrate clinical, laboratory, radiologic, molecular, and economic data will improve clinical care and will provide infrastructure to enable clinical research. The initiative of the EurocanPlatform aims to overcome the challenges of implementing personalized medicine in Europe by sharing patients, biologic materials, and technological resources across borders. The EurocanPlatform establishes a complete translational cancer research program covering the drug development process and strengthening collaborations among academic centers, pharmaceutical companies, regulatory authorities, health technology assessment organizations, and health care systems. The CancerLinQ rapid learning system being developed by ASCO has the potential to revolutionize how all stakeholders in the cancer community assemble and use information obtained from patients treated in real-world settings to guide clinical practice, regulatory decisions, and health care payment policy.
本文重点介绍了过去十年癌症个性化医疗的主要进展。临床研究的新数据表明，在具有可靶向分子异常的患者中使用靶向药物可改善临床结局。然而，尽管研究激增，但知识方面仍存在重大差距，尤其是在识别具有多种异常的患者中的驱动分子异常、理解控制致癌作用和转移的分子网络，以及最重要的是发现有效的靶向药物方面。实施个性化医疗需要持续的科技突破；肿瘤组织采集和分子检测的标准化；肿瘤学实践以及药物和设备准入与批准监管标准的改变；医疗保健支付方报销政策的调整；以及收集和分析与前瞻性临床登记和快速学习系统相关的电子患者信息的创新方法。整合临床、实验室、放射、分子和经济数据的信息系统将改善临床护理，并为开展临床研究提供基础设施。欧洲癌症平台计划旨在通过跨境共享患者、生物材料和技术资源，克服在欧洲实施个性化医疗的挑战。欧洲癌症平台建立了一个完整的转化癌症研究项目，涵盖药物研发过程，并加强学术中心、制药公司、监管机构、卫生技术评估组织和医疗保健系统之间的合作。美国临床肿瘤学会正在开发的癌症LinQ快速学习系统有可能彻底改变癌症领域所有利益相关者收集和使用从现实环境中接受治疗的患者那里获得的信息以指导临床实践、监管决策和医疗保健支付政策的方式。
