Do elderly patients benefit from enrollment into Phase I Trials?

Journal of Geriatric Oncology
Wai Meng TaiDaniel Shao Weng Tan

Abstract

Despite the significant burden of cancer in the older population, their outcomes in the context of phase I studies have been poorly studied. While the Royal Marsden Hospital (RMH) prognostic score (albumin, lactate dehydrogenase [LDH], number of metastatic sites) is validated in this setting, its utility among the elderly is uncertain. A total of 296 consecutive patients who were treated in 20 phase I trials from 2005 to 2012 in our unit were analysed. Clinical characteristics and outcomes between young (<65, n=202) and older patients (≥65, n=94) were compared. The median age of the older patients was 69 years (65-84) and 71% were males. Although elderly patients had more co-morbidities and lower albumin levels at baseline, there was no significant difference in survival (8.8 months versus 9.9 months, p=0.68) and clinical benefit rate (69% versus 56%, p=0.07) compared to younger patients after median follow-up of 7.1 months (0.36-50.6 months). Age (p=0.23) did not have any bearing on occurrence of grade 3/4 toxicities. Twenty-six percent of elderly patients experienced grade 3/4 toxicities. The prognostic factors for overall survival (OS) identified in multivariate analysis were prior lines of chemotherapy (0-2 versus ≥3), base...Continue Reading

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Citations

Jan 13, 2016·British Journal of Cancer·K H KhanS B Kaye
Apr 1, 2021·Expert Review of Gastroenterology & Hepatology·Alessandro RizzoGiovanni Brandi

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