# Dedicated cohorts for patients with performance status 2 in first-line trials

Source: https://onco.cc/ideas/idea-tr1-ecog-2-dedicated-cohorts/  
OnCo record `idea-tr1-ecog-2-dedicated-cohorts` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: PS2 cohorts will show that benefit is preserved for some regimens and absent or harmful for others, information that changes real-world prescribing for a population that currently receives extrapolated care.
- Rationale: PS2 patients are a sizeable share of real-world first-line recipients, especially in lung, pancreatic and upper gastrointestinal cancers, and receive full-dose regimens tested only in fitter patients.
- Proposed test: Require PS2 cohorts in first-line registrational trials for three cancers with high PS2 prevalence and track the resulting label statements and real-world outcomes.
- Maturity: early-clinical
- Actor: industry

## Sources

- Bottleneck evidence (Trials do not represent the people who get cancer): Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019): https://doi.org/10.1001/jamaoncol.2019.1870

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/)
- key papers: [Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018](https://onco.cc/key-papers/paper-loree-jama-oncol/)

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