Crimini Edoardo, Repetto Matteo, Tarantino Paolo, Ascione Liliana, Antonarelli Gabriele, Rocco Elena Guerini, Barberis Massimo, Mazzarella Luca, Curigliano Giuseppe
Division of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Department of Oncology and Hematology (DIPO), University of Milan, 20122 Milan, Italy.
Cancers (Basel). 2022 Jun 29;14(13):3193. doi: 10.3390/cancers14133193.
Considering the rapid improvement of cancer drugs' efficacy and the discovery of new molecular targets, the formulation of therapeutical indications based on the multidisciplinary approach of MTB is becoming increasingly important for attributing the correct salience to the targets identified in a single patient. Nevertheless, one of the biggest stumbling blocks faced by MTBs is not the bare indication, but its implementation in the clinical practice. Indeed, administering the drug suggested by MTB deals with some relevant difficulties: the economical affordability and geographical accessibility represent some of the major limits in the patient's view, while bureaucracy and regulatory procedures are often a disincentive for the physicians. In this review, we explore the current literature reporting MTB experiences and precision medicine clinical trials, focusing on the challenges that authors face in applying their therapeutical indications. Furthermore, we analyze and discuss some of the solutions devised to overcome these difficulties to support the MTBs in finding the most suitable solution for their specific situation. In conclusion, we strongly encourage regulatory agencies and pharmaceutical companies to develop effective strategies with medical centers implementing MTBs to facilitate access to innovative drugs and thereby allow broader therapeutical opportunities to patients.
考虑到癌症药物疗效的迅速提高以及新分子靶点的发现,基于多学科肿瘤专家委员会(MTB)方法制定治疗适应症对于正确突出单一患者中确定的靶点的重要性日益增加。然而,肿瘤专家委员会面临的最大绊脚石之一不是单纯的适应症,而是其在临床实践中的实施。事实上,使用肿瘤专家委员会建议的药物存在一些相关困难:从患者角度来看,经济可承受性和地理可及性是一些主要限制因素,而官僚作风和监管程序往往会使医生望而却步。在这篇综述中,我们探讨了报告肿瘤专家委员会经验和精准医学临床试验的当前文献,重点关注作者在应用其治疗适应症时面临的挑战。此外,我们分析并讨论了为克服这些困难而设计的一些解决方案,以支持肿瘤专家委员会为其特定情况找到最合适的解决方案。总之,我们强烈鼓励监管机构和制药公司与实施肿瘤专家委员会的医疗中心制定有效策略,以促进获得创新药物,从而为患者提供更广泛的治疗机会。