Gaspar Nathalie, Fern Lorna
Prog Tumor Res. 2016;43:38-49. doi: 10.1159/000447043. Epub 2016 Sep 5.
The inclusion of teenagers and young adults (TYAs) in cancer clinical trials is focal point for many countries with a specific TYA program. This objective has arisen from data which suggests that lower trial entry may, in part, contribute to lesser survival gains observed in this group when compared to children and some older adult cancers. In this chapter, we discuss obstacles to clinical trials and innovative therapies for TYA. Limited clinical trial availability is discussed in the context of the rarity of TYA cancers and our limited understanding of cancer biology in this group, other obstacles include inappropriate age eligibility criteria, limited accessibility to available trials, a lack of physicians and patients awareness and poor acceptability of trial design. We propose several strategies which could be applied to overcome these obstacles, some ready for implementation and others which require further exploration. Strengthening pediatric and adult oncology collaboration at the individual level and through oncology societies will undoubtedly positively impact accrual to trials for TYA, as will abolishing the use of age as a barrier to drug and trial access. This will allow us to create biologically driven trials and facilitate early new drug access and the creation of biobank collections to drive our understanding of the biology of cancers in this age group. Involving multiple stakeholders in trial design will facilitate acceptable trials to both healthcare professionals and young people themselves. The support of the multidisciplinary TYA team and a culture of research embedded within this are the keys to improving access and participation of TYA in cancer trials.
在许多设有特定青少年和青年成人(TYA)项目的国家,将青少年和青年成人纳入癌症临床试验是一个重点。这一目标源于相关数据,这些数据表明,与儿童癌症和一些老年成人癌症相比,该群体较低的试验入组率可能在一定程度上导致其生存率提升幅度较小。在本章中,我们将讨论TYA临床试验的障碍以及创新疗法。在TYA癌症罕见以及我们对该群体癌症生物学了解有限的背景下,讨论了临床试验可及性有限这一问题,其他障碍包括不合适的年龄资格标准、获取现有试验的机会有限、医生和患者缺乏认识以及试验设计可接受性差。我们提出了几种可用于克服这些障碍的策略,有些已准备好实施,有些则需要进一步探索。在个体层面并通过肿瘤学学会加强儿科和成人肿瘤学合作无疑将对TYA临床试验的入组产生积极影响,取消将年龄作为药物和试验准入障碍也会如此。这将使我们能够开展基于生物学的试验,促进新药早日获得以及建立生物样本库,以推动我们对该年龄组癌症生物学的理解。让多个利益相关者参与试验设计将有助于使试验对医疗保健专业人员和年轻人自身都具有可接受性。多学科TYA团队的支持以及其中所蕴含的研究文化是提高TYA参与癌症试验的可及性和参与度的关键。