Phase I trial outcomes in older patients with advanced solid tumours

Area of Science:

• Oncology
• Clinical Trials
• Geriatric Medicine

Background:

• Investigating the hypothesis that advanced age correlates with reduced tolerability and clinical benefit in Phase I trial agents.
• Assessing the Royal Marsden Hospital (RMH) prognostic score's validity for selecting older patients in clinical trials.

Purpose of the Study:

• To determine if older patients experience different outcomes in Phase I clinical trials compared to younger patients.
• To validate the RMH prognostic score for patient selection in older individuals undergoing Phase I trials.

Main Methods:

• Retrospective analysis of clinico-pathological characteristics and treatment outcomes for patients in Phase I trials at RMH (2005-2009).
• Comparison of toxicity and clinical outcome data between patients under and over 65 years of age.
• Multivariate analysis to evaluate the predictive accuracy of the RMH prognostic score.

Main Results:

• No significant differences in Grade 3-5 toxicities, trial discontinuation, or dose interruptions between older and younger patient groups.
• Comparable overall response rates, progression-free survival, and clinical benefit rates at 6 months across age groups.
• The RMH prognostic score, incorporating albumin and lactate dehydrogenase levels, accurately predicted patient outcomes.

Conclusions:

• Phase I clinical trials are suitable for patients with advanced cancers, irrespective of age, showing similar safety and efficacy in older populations.
• The RMH prognostic score is a valuable tool for selecting appropriate older patients for Phase I trials.