Do elderly patients benefit from enrollment into Phase I Trials?

Area of Science:

• Oncology
• Clinical Trials
• Geriatric Medicine

Background:

• Cancer disproportionately affects older adults, yet their outcomes in phase I trials are understudied.
• The Royal Marsden Hospital (RMH) prognostic score is validated but its utility in elderly populations is uncertain.

Purpose of the Study:

• To compare outcomes and toxicity profiles of elderly (≥65 years) versus younger (<65 years) patients in phase I cancer trials.
• To evaluate the utility of existing prognostic scores in elderly patients undergoing phase I trials.

Main Methods:

• Analysis of 296 patients from 20 phase I trials (2005-2012).
• Comparison of clinical characteristics and outcomes between elderly (n=94) and younger (n=202) patient cohorts.
• Multivariate analysis to identify prognostic factors for overall survival (OS).

Main Results:

• Elderly patients had more comorbidities and lower baseline albumin but similar survival (8.8 vs 9.9 months) and clinical benefit rates (69% vs 56%) compared to younger patients.
• Age did not significantly impact grade 3/4 toxicities, with 26% of elderly patients experiencing them.
• Prognostic factors for OS included prior chemotherapy lines, baseline sodium, and platelet levels. A risk nomogram achieved a concordance index of 0.65, while the RMH model yielded 0.635.

Conclusions:

• Elderly patients in phase I trials exhibit comparable survival and toxicity to younger counterparts.
• Existing risk-scoring models require further refinement for optimal patient selection in this demographic.