Designing Geriatric Oncology Research Studies Arti Hurria, MD Director, Cancer and Aging Research Program City of Hope

Eligibility Interventions Outcomes Goal How do we “geriatricize” the standard oncology study design?  Standard Oncology Design  Adding Geriatric Oncology Components  Gaps in Knowledge

 Therapeutic - Drug AB vs. Drug AB + C  Non-Therapeutic - Exercise - Nutrition Eligibility Interventions Outcomes  Age  Disease  Organ function  Performance status  Comorbidities (sometimes)  Cancer-specific -Disease-free survival -Overall survival Standard Trial Design

Geriatricizing the Trial Design  Age  Older adults - Healthy vs. Oncologically frail  All ages - Pharmacokinetics - Biology  Disease  Tumor type and goals (curative vs. not)  Organ function  Creatinine clearance  Hepatic function  Performance status (less important)  Comorbidity (Dr. Holmes to address)  Age  Disease  Organ Function  Performance Status  Comorbidities (sometimes) Eligibility

 Therapeutic - Drug AB vs. Drug AB + C  Non-Therapeutic - Exercise - Nutrition Interventions Geriatricizing the Trial Design  Therapeutic  Consider novel study design -U13 white paper: JCO 2013  Non-Therapeutic  GA-based intervention (Dr. Mohile)  Collaboration between geriatrics and oncology  Research infrastructure  Tailor to needs of oncologically frail -Geriatric training -Environmental considerations (wheelchair access, safe exam tables, space for caregivers)  Leveraging IT  Time

Outcomes Geriatricizing the Trial Design  Moving beyond the disease  Patient-centered outcomes  Function  Cognition  Toxicity  Cost  Caregiver needs  Melding oncology outcomes and geriatric outcomes  Cancer-specific -Disease-free survival -Overall survival

Melding Oncology Outcomes & Geriatric Outcomes Oncology Outcomes Overall Survival Quality GERIATRIC ONCOLOGY OUTCOMES Length Disease-Specific Survival Geriatric Outcomes Function Cognition Nutrition Toxicity

Key Gaps  Few studies in patients age 75+  Few studies in frail older adults  Lack of a standard definition for frailty Eligibility  Great need for more intervention studies  We are poised and ready  Optimal design and implementation  Research infrastructure needed  Define outcomes  Melding geriatrics and oncology outcomes  Statistical considerations Interventions Outcomes

Thank you!