{"entity":{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","aka":[],"tldr":"Most people with cancer are over 65 but most trial patients are younger and fitter. We guess how to treat the majority.","summary":"More than half of cancers and most cancer deaths occur in people over 65, yet older adults have been under-represented in registration trials for decades, and those enrolled are fitter than the general older population. Frailty, renal and hepatic function, polypharmacy, cognitive impairment and competing causes of death all change the balance of benefit and harm, but they are rarely measured in trials or in clinics, so older patients are both over-treated (full-dose regimens they cannot tolerate) and under-treated (denied curative therapy on the basis of age alone). Geriatric assessment with management is proven in randomised trials to cut severe toxicity by a fifth or more without compromising survival, and is recommended by ASCO, yet it is done in a minority of clinics. Age-specific dosing, endpoints that capture function and independence, and trial designs that include the patients who actually get cancer are the gap.","asOf":"2026-09-08","links":[{"label":"Mohile et al., Evaluation of geriatric assessment and management on toxic effects of cancer treatment (GAP70+, Lancet 2021)","url":"https://doi.org/10.1016/S0140-6736(21)01789-X"},{"label":"Sedrak et al., Older adult participation in cancer clinical trials: systematic review (CA 2021)","url":"https://doi.org/10.3322/caac.21638"},{"label":"Mohile et al., ASCO guideline: practical assessment and management of vulnerabilities in older patients receiving chemotherapy (JCO 2018)","url":"https://doi.org/10.1200/JCO.2018.78.8687"},{"label":"Cancer and Aging Research Group","url":"https://www.mycarg.org/"}],"tags":[],"related":["idea-shortened-venetoclax","fda-approvals","idea-acc-broad-eligibility-as-regulatory-default","idea-acc-pragmatic-trials-over-75-function-endpoints","idea-acc-home-chemotherapy-older-patients","idea-acc-hospital-at-home-oncology","idea-acc-electronic-frailty-index-oncology","idea-acc-geriatric-co-management-surgery","idea-acc-post-approval-evidence-over-75","idea-acc-caregiver-training-as-covered-service","idea-acc-pharmacist-interaction-review-oral-anticancer","idea-acc-time-toxicity-reporting","idea-acc-dementia-and-cancer-pathway"],"cancers":["aml","cll","dlbcl","multiple-myeloma","prostate","nsclc","colorectal"],"sections":[],"technologies":["geriatric-assessment","exercise-oncology","cardio-oncology"],"targets":[],"drugs":["venetoclax"],"companies":["alliance-oncology","ecog-acrin","swog"],"institutions":["asco","esmo"],"pathways":[],"terms":["standard-of-care","hazard-ratio"],"trials":["viale-a","cll14"],"people":[],"bottlenecks":[],"keyPapers":["paper-mohile-j-clin-oncol","paper-sedrak-ca-cancer-j-clin"],"journals":[],"dependsOn":[],"notes":[],"stage":"access-delivery","severity":"major","metrics":[{"label":"Patients aged 65 or older in SWOG treatment trials 1993-1996 vs their share of US cancer incidence","value":"25% vs 63%","source":"Hutchins et al., NEJM 1999","url":"https://doi.org/10.1056/NEJM199912303412706"},{"label":"Grade 3-5 toxicity with geriatric assessment-guided management vs usual care in patients aged 70 or older starting chemotherapy (GAP70+)","value":"51% vs 71%","source":"Mohile et al., Lancet 2021","url":"https://doi.org/10.1016/S0140-6736(21)01789-X"},{"label":"Grade 3-5 chemotherapy toxicity with geriatric assessment-driven intervention vs standard care (GAIN)","value":"50.5% vs 60.6%","source":"Li et al., JAMA Oncology 2021","url":"https://doi.org/10.1001/jamaoncol.2021.4158"}],"causes":["Eligibility criteria on organ function and performance status exclude many older patients from trials.","Sponsors prefer younger, fitter populations to maximise the apparent effect and minimise toxicity signals.","Chronological age is used as a proxy for fitness in clinical decisions instead of measured frailty.","Geriatric assessment takes time and is not reimbursed in most systems.","Trial endpoints (progression-free survival, response) do not capture what matters most to older patients: function, independence and cognition."],"currentEfforts":["GAP70+ and GAIN randomised trials showed geriatric assessment-guided management reduces severe toxicity, and the ASCO geriatric oncology guideline (2018, updated 2023) recommends it for all patients aged 65 or older receiving systemic therapy.","FDA guidance on inclusion of older adults in cancer clinical trials (2022) encourages removal of age-based exclusions and enrolment of the very old.","NIH's Inclusion Across the Lifespan policy (2019) requires justification for any age-based exclusion.","The Cancer and Aging Research Group (CARG) provides validated toxicity prediction tools and runs trials designed for older adults.","The International Society of Geriatric Oncology (SIOG) publishes age-specific treatment recommendations.","Venetoclax-based and other lower-intensity regimens (VIALE-A in AML, CLL14 in CLL) were developed specifically for patients unfit for standard therapy."],"successLooksLike":"Enrolment of patients over 70 in pivotal trials matches their share of incidence, geriatric assessment is performed for most older patients before systemic therapy, and age-specific treatment recommendations exist for every major cancer."},"route":"/bottlenecks/b-aging-comorbidity/","neighbours":{"idea":[{"id":"idea-acc-dementia-and-cancer-pathway","kind":"idea","name":"A defined pathway for patients with both dementia and cancer","route":"/ideas/idea-acc-dementia-and-cancer-pathway/"},{"id":"idea-tr1-mandatory-older-adult-cohort","kind":"idea","name":"A mandatory over-70s cohort with geriatric assessment in every pivotal trial","route":"/ideas/idea-tr1-mandatory-older-adult-cohort/"},{"id":"idea-acc-transition-handoff-medication-reconciliation","kind":"idea","name":"A standard handoff with 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