Dedicated cohorts for patients with performance status 2 in first-line trials
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.
First-line trials of new regimens include a pre-specified ECOG performance status 2 cohort, randomised where feasible, with safety-led dose modification, primary endpoints appropriate to the population (OS, time on treatment, QoL) and reporting in the label. Some lung cancer trials have run dedicated PS2 studies; the proposal generalises this.
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
- Older and multimorbid patients are excluded and undertreated · Most people with cancer are over 65 but most trial patients are younger and fitter. We guess how to treat the majority.
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not linked directly; found by shared links- IdeaParallel real-world cohorts for sicker patients alongside every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- InstitutionHenan Cancer Hospital
Shares Oesophageal cancer, Gastric & gastro-oesophageal junction cancer, Non-small-cell lung cancer.
- PersonHaruhiko Fukuda
Shares Oesophageal cancer, Gastric & gastro-oesophageal junction cancer, Non-small-cell lung cancer.
- IdeaStomach cancer serology screening for high-risk migrant communities in low-incidence countries
Shares Trials do not represent the people who get cancer, Gastric & gastro-oesophageal junction cancer.
- IdeaMake sponsors justify every trial exclusion of older and multimorbid patients
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- InstitutionUniversity of Hawai'i Cancer Center
Shares Trials do not represent the people who get cancer, Gastric & gastro-oesophageal junction cancer, Non-small-cell lung cancer.
- IdeaA mandatory over-70s cohort with geriatric assessment in every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
- IdeaUpfront reduced-dose regimens tested head-to-head in frail older patients
Shares Older and multimorbid patients are excluded and undertreated, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.