Cassel J Brian, Del Fabbro Egidio, Arkenau Tobias, Higginson Irene J, Hurst Samia, Jansen Lynn A, Poklepovic Andrew, Rid Annette, Rodón Jordi, Strasser Florian, Miller Franklin G
Virginia Commonwealth University, Richmond, Virginia, USA.
Virginia Commonwealth University, Richmond, Virginia, USA.
J Pain Symptom Manage. 2016 Sep;52(3):437-45. doi: 10.1016/j.jpainsymman.2016.02.014. Epub 2016 May 24.
This article synthesizes the presentations and conclusions of an international symposium on Phase 1 oncology trials, palliative care, and ethics held in 2014. The purpose of the symposium was to discuss the intersection of three independent trends that unfolded in the past decade. First, large-scale reviews of hundreds of Phase I trials have indicated there is a relatively low risk of serious harm and some prospect of clinical benefit that can be meaningful to patients. Second, changes in the design and analysis of Phase I trials, the introduction of "targeted" investigational agents that are generally less toxic, and an increase in Phase I trials that combine two or more agents in a novel way have changed the conduct of these trials and decreased fears and apprehensions about participation. Third, the field of palliative care in cancer has expanded greatly, offering symptom management to late-stage cancer patients, and demonstrated that it is not mutually exclusive with disease-targeted therapies or clinical research. Opportunities for collaboration and further research at the intersection of Phase 1 oncology trials and palliative care are highlighted.
本文综合了2014年举行的关于肿瘤学一期试验、姑息治疗和伦理学的国际研讨会的报告及结论。该研讨会的目的是讨论过去十年中出现的三个独立趋势的交叉点。首先,对数百项一期试验的大规模综述表明,严重伤害的风险相对较低,且存在对患者有意义的临床获益前景。其次,一期试验设计与分析的变化、毒性通常较低的“靶向”研究药物的引入,以及以新方式联合两种或更多药物的一期试验的增加,改变了这些试验的开展方式,并减少了对参与试验的恐惧和担忧。第三,癌症姑息治疗领域大幅扩展,为晚期癌症患者提供症状管理,并证明它与针对疾病的疗法或临床研究并非相互排斥。文中强调了肿瘤学一期试验与姑息治疗交叉领域的合作及进一步研究机会。