title: Phase I Cancer Trials and Palliative Care: Antagonism, Irrelevance, or Synergy?
abstract: 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.
authors.affiliation: Virginia Commonwealth University, Richmond, Virginia, USA. Electronic address: jbcassel@vcu.edu.
authors.forename: J Brian
authors.initials: JB
authors.lastname: Cassel
authors.affiliation: Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: Egidio
authors.initials: E
authors.lastname: Del Fabbro
authors.affiliation: Sarah Cannon Research Institute and University College London, London, United Kingdom.
authors.forename: Tobias
authors.initials: T
authors.lastname: Arkenau
authors.affiliation: Cicely Saunders Institute, King's College London, London, United Kingdom.
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
authors.affiliation: Institut d'éthique biomedicale, Centre médical universitaire, Geneva, Switzerland.
authors.forename: Samia
authors.initials: S
authors.lastname: Hurst
authors.affiliation: Oregon Health and Science University, Portland, Oregon, USA.
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Jansen
authors.affiliation: Virginia Commonwealth University, Richmond, Virginia, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Poklepovic
authors.affiliation: King's College London, London, United Kingdom.
authors.forename: Annette
authors.initials: A
authors.lastname: Rid
authors.affiliation: Vall d'Hebron Institut d'Oncologia, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Rodón
authors.affiliation: ABHPM, Kantonsspital St. Gallen, St. Gallen, Switzerland.
authors.forename: Florian
authors.initials: F
authors.lastname: Strasser
authors.affiliation: National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000941:ethics / Q000379:methods; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D010166:Palliative Care / Q000941:ethics
keywords: Palliative care; Phase I clinical trials; cancer; end-of-life care; ethics; informed consent