Do elderly patients benefit from enrollment into Phase I Trials

摘要: Abstract Background Despite the significant burden of cancer in older population, their outcomes context phase I studies have been poorly studied. While Royal Marsden Hospital (RMH) prognostic score (albumin, lactate dehydrogenase [LDH], number metastatic sites) is validated this setting, its utility among elderly uncertain. Methods A total 296 consecutive patients who were treated 20 trials from 2005 to 2012 our unit analysed. Clinical characteristics and between young ( Results The median age was 69years (65–84) 71% males. Although had more co-morbidities lower albumin levels at baseline, there no difference survival (8.8months versus 9.9months, p=0.68) clinical benefit rate (69% 56%, p=0.07) compared younger after follow-up 7.1months (0.36–50.6months). Age (p=0.23) did not any bearing on occurrence grade 3/4 toxicities. Twenty-six percent experienced factors for overall (OS) identified multivariate analysis prior lines chemotherapy (0–2 ≥3), baseline sodium (≥135 400×10 9 ). We developed a risk nomogram based with concordance index 0.65. RMH model yielded 0.635. Conclusion Elderly enrolled into similar toxicity profiles patients. Risk scoring models aid patient selection need further clarification.