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Most people with cancer are over 65 but most trial patients are younger and fitter. We guess how to treat the majority.
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.
People with dementia who develop cancer are often either overtreated or written off, and decisions are made without them. A clear pathway for assessment, consent and treatment planning would improve both.
Most people with cancer are over 65, but trials mostly enrol younger, fitter people. Requiring a group of older patients, assessed for frailty, in every big trial would show whether the drug works and is safe for those most likely to receive it.
Cancer care has more handoffs than most conditions, hospital to home, surgery to chemotherapy, oncology back to the family doctor, and information and medications are lost at each. A standard handoff checklist plus pharmacist medication reconciliation covering oral anticancer drugs, steroids, anticoagulants and opioids at every transition would prevent avoidable adverse drug events cheaply.
Most people with cancer are over 65, but most trial patients are younger and fitter. A dedicated fund would pay for trials designed for the patients we actually treat.
Drugs are approved on trials of fit, younger patients and then given to everyone. A required follow-on trial in older, sicker and more diverse patients would show whether the benefit holds in real life.
Frailty is the strongest predictor of who will be harmed by treatment, but it is rarely measured. Software can estimate it automatically from existing records and flag patients who need a closer look.
Hormone-blocking treatments for prostate and breast cancer, taken for years, raise the risk of diabetes, heart disease and bone fractures. Survivors on these drugs should get the same preventive care as diabetics.
Older cancer patients depend on family carers who receive no training or support. Paying for carer training and short breaks would keep patients at home and out of hospital.
Trials usually take only patients who are up and about most of the day. Those who spend more time resting, a common group in real clinics, are excluded, so nobody knows how to treat them. A dedicated group in each trial would answer that.
The dose for a frail 80-year-old is guessed from what fit 55-year-olds tolerated. Running dose-finding in older patients directly, using frailty assessment, would give doses they can actually take.
Most people with pancreatic cancer lose muscle and weight in a way food alone cannot reverse, and that wasting is a common reason chemotherapy is cut or stopped. A 2024 trial showed an antibody against the hormone GDF-15 restored weight and activity in twelve weeks, a third of the patients having pancreatic cancer. The proposal is to test it inside the chemotherapy trials, not alongside them.
Family doctors often do not know who is responsible for a cancer patient's blood pressure, diabetes or new symptom. Written agreements plus a same-day electronic question line to the oncologist would fill the gap.
Most cancer patients are over 65, yet treatment is chosen by age and guesswork and trials exclude them. Assess fitness properly and design trials that include real older patients.
A short structured check of memory, mobility, nutrition and medicines before treatment cuts serious side effects in older patients without reducing benefit. It should be automatic, not optional.
When a geriatrician co-manages patients over 75 around a cancer operation, as in the POSH programme at Duke and POPS in the UK, complications, delirium, length of stay and readmissions fall. Preoperative optimisation and postoperative geriatric review should be a standard part of surgical oncology pathways for this age group.
For frail older patients, the journey to hospital can be the hardest part of treatment. Nurses can safely give some cancer treatments at home, which may help more people complete their course.
Frail women over 80 with small hormone-sensitive breast cancers may do as well with a daily tablet as with surgery. A trial would define who can safely avoid the operation.
Hospital-at-home programmes deliver intravenous antibiotics, fluids, monitoring and daily nurse and physician visits in the patient's home, with equivalent or better outcomes and lower costs in general medicine. Extending them to low-risk fever after chemotherapy and dehydration, with payer recognition, would keep older cancer patients out of hospital beds, where they are most at risk of harm.
Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one.
Most cancer patients are over 65 and a large share have other illnesses, yet trials routinely exclude them on organ function, prior cancers, HIV or brain metastases. Regulators should require sponsors to justify each exclusion, include patients with controlled comorbidities by default, drop upper age limits, and report enrolment over 75 in labels.
Older, frailer and sicker patients are usually kept out of trials but make up most of those treated. Require companies to report how these patients do in practice.
A few weeks of exercise, nutrition and mental preparation before a big operation helps older patients recover faster and with fewer complications. It costs little and should be routine.
Instead of excluding sicker patients entirely, trials would run a side group for them, receiving the new drug with closer monitoring, so we learn how it behaves in the people who will actually get it.
Oral kinase inhibitors, CDK4/6 inhibitors and hormonal agents interact with proton pump inhibitors, anticoagulants, statins and antiarrhythmics, and are increasingly prescribed to older patients taking all of them. A mandatory oncology pharmacist review at initiation, dose change and refill, with a structured monitoring plan, would catch these interactions systematically.
For a frail 80-year-old, staying independent may matter more than living a few months longer. Trials designed for older patients should measure what they care about.
In England and Wales a national audit now reports each year what share of people diagnosed with pancreatic cancer receive any treatment aimed at the cancer, how many are discussed by a specialist team and how many see a specialist nurse. The proposal is a national target for the treatment rate, published by hospital, so the trusts furthest behind are visible.
Most trials copy the same kidney and liver cut-offs, such as creatinine clearance above 60, regardless of how the drug is cleared. Setting each threshold from the drug's own clearance route and organ-impairment pharmacokinetic studies would let patients with mild organ impairment join safely instead of being excluded.
When Black and white men in the United States are given the same treatment, the gap in dying of prostate cancer largely closes. The gap in dying of everything else does not. Cancer services measure the first and not the second, which means the surviving disparity is invisible to the people best placed to act on it.
A treatment that adds two months of life but takes up most of those days in hospitals and clinics may not be worth it to an older patient. Trials should report how many days treatment consumes.
New cancer drugs are approved on trials of younger, fitter patients, then given mostly to older ones. Regulators should require real-world safety and benefit data in the over-75s and put it on the label.
Screening someone unlikely to live ten years causes harm without benefit. A life-expectancy estimate in the medical record could stop invitations and prompt a conversation.
Older cancer patients often take ten or more medicines, some of which no longer help and may interact with cancer treatment. A pharmacist review to stop unnecessary ones, at diagnosis and when goals change, would reduce harm.
Most cancer patients are older and have other illnesses, but nearly all animal experiments use young healthy mice. Results may not transfer.
Frail older patients are often given full doses and then have them cut after bad side effects, or are given nothing. Trials should test starting at a lower dose from the beginning.
Most kidney tumours under 3 cm found by chance grow under 0.3 cm a year, rarely spread, and a fifth are benign. Surveillance with a biopsy for grade as the default in patients over 65, with a national registry and set triggers for surgery, could spare most of these operations.
An option with a demonstrated survival benefit for transplant-ineligible relapsed diffuse large B-cell lymphoma, a group for whom very little has ever shown one. The fatal adverse event imbalance belongs in the conversation alongside the survival figure.
A second randomised confirmation that adding a Bruton tyrosine kinase inhibitor to first-line bendamustine-rituximab delays progression in older patients with mantle cell lymphoma, with a toxicity profile that did not improve as much as the drug's selectivity promised.
The evidence behind the United States approval of brentuximab vedotin with lenalidomide and a rituximab product for relapsed or refractory diffuse large B-cell lymphoma after two or more lines in patients not eligible for an autologous transplant or CAR-T. It is also the first demonstration that a CD30-directed conjugate helps in a disease where CD30 expression is variable.
The authors' conclusion is that ibrutinib-rituximab should be considered a new standard-of-care option for first-line treatment of older patients with mantle-cell lymphoma. The subgroup split means it is clearly better than R-CHOP and roughly equivalent to bendamustine-rituximab.
Twenty-eight extra months of progression-free survival, with no survival gain and a high rate of severe adverse events in both arms. It set up the two trials that followed: ECHO, which substituted a more selective inhibitor, and ENRICH, which removed the chemotherapy.
Older patients are more likely to be harmed by standard-dose chemotherapy, and a structured assessment of function, cognition, nutrition and social support lets oncologists adjust treatment safely. Starting lower does not appear to shorten life. Most older patients still do not get such an assessment.
One bottleneck page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
The evidence that made lisocabtagene maraleucel the CD19 CAR-T product most often chosen for older or frailer patients, because its severe cytokine release syndrome rate is a fraction of the other two products'.
Shares Make sponsors justify every trial exclusion of older and multimorbid patients, Parallel real-world cohorts for sicker patients alongside every pivotal trial, A mandatory over-70s cohort with geriatric assessment in every pivotal trial, Geriatric assessment by default for every older patient, and trials that admit them.
Shares Brentuximab vedotin combination for relapsed diffuse large B-cell lymphoma, CLL14, PRIMA-CNS, Polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in relapsed or refractory diffuse large B-cell lymphoma: results from the phase III, randomized POLARGO trial.
Shares A standard handoff with medication reconciliation at every cancer care transition, Hospital-at-home for oncology: treating low-risk febrile neutropenia and dehydration at home, Structured deprescribing review at cancer diagnosis and again at transition to palliative care, Report time toxicity, the days spent in healthcare, as a standard outcome for older patients.
Shares ARCHED, Acalabrutinib plus bendamustine-rituximab in untreated mantle cell lymphoma, Ibrutinib plus bendamustine and rituximab in untreated mantle-cell lymphoma, SHINE.
Shares REMARC, Lenalidomide maintenance compared with placebo in responding elderly patients with diffuse large B-cell lymphoma treated with first-line R-CHOP, ARCHED, POLAR BEAR.
Shares A mandatory over-70s cohort with geriatric assessment in every pivotal trial, Kidney and liver impairment dosing studies completed before approval, not years after, Dose-finding in older and frail patients, not extrapolation from fit ones, Replace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholds.
Shares Formal shared-care agreements between oncology and family doctors, with same-day e-consult, A defined pathway for patients with both dementia and cancer, A standard handoff with medication reconciliation at every cancer care transition, Home administration of selected chemotherapy and immunotherapy for older and frail patients.
Shares REMARC, Lenalidomide maintenance compared with placebo in responding elderly patients with diffuse large B-cell lymphoma treated with first-line R-CHOP, Ibrutinib plus bendamustine and rituximab in untreated mantle-cell lymphoma, SHINE.