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

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

3.  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

4. 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

5.  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

6. 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

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

8. 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

9. Thank you!