title: Participation and survival of geriatric patients in Phase I clinical trials: the Karmanos Cancer Institute (KCI) experience.
abstract: BACKGROUND: Geriatric cancer patients (age 65 or older) comprise a majority of cancer cases in the United States, yet they are underrepresented in therapeutic clinical trials. It is therefore important to increase our understanding of their participation, survival outcomes, and recruitment barriers. This study aims to describe the demographics, treatment, toxicity, and overall survival (OS) of all patients ≥ 65 years of age who presented to the Phase I Clinical Trials service at Karmanos Cancer Institute (KCI).  METHODS: A retrospective chart review was performed of all referred and seen patients ≥ 65 years of age at Phase I clinical service at KCI between 1995-2005. Data on demographics, co-morbidities, tumor type, reason not enrolled, toxicities and OS were obtained.  RESULTS: A total of 216 patients met the study criteria. The median age was 71 years. 114 (59%) patients were performance status 1. 102 (47%) patients were enrolled and of those 95 (44%) patients were treated. More than half of the patients failed to enroll with predominant reasons being protocol ineligibility (30%), loss to follow up (12%), patient refusal (8%), or unavailability of trial (2%). The median OS duration of treated patients was 8.4 months (95% CI: 6.2-10.5). This was significantly longer than the patients who failed to enroll or did not receive treatment (p < 0.0001).  CONCLUSION: This study suggests that elderly patients who were treated on a Phase I clinical trial(s) at our institution survived significantly longer than our elderly patients who did not receive treatment.
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.
authors.forename: Syed F
authors.initials: SF
authors.lastname: Zafar
authors.forename: Lance K
authors.initials: LK
authors.lastname: Heilbrun
authors.forename: Prakash
authors.initials: P
authors.lastname: Vishnu
authors.forename: Pallavi
authors.initials: P
authors.lastname: Jasti
authors.forename: Raghu
authors.initials: R
authors.lastname: Venkatramanamoorthy
authors.forename: Li
authors.initials: L
authors.lastname: Ding
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Lorusso
authors.forename: Elisabeth I
authors.initials: EI
authors.lastname: Heath