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February 6, 2026ESMO Open0 citationsOpen Access

Impact of ECOG performance status 2 participants on outcomes of pivotal cancer clinical trials: a meta-analysis and meta-regression

GIG.M. IannantuonoAgostino Gemelli University Polyclinic TGT. GiovagnoliAgostino Gemelli University Polyclinic LML. MastrantoniUniversità Cattolica del Sacro Cuore

Key Points

To evaluate the impact of ECOG performance status 2 participants on outcomes in clinical trials.
Conducted a meta-analysis to aggregate data from multiple cancer clinical trials.
Performed meta-regression analysis to compare toxicity and efficacy outcomes between PS 2 and PS ≤1 participants.
Included studies that reported outcomes specific to ECOG performance status.
No significant differences in efficacy outcomes were found between PS 2 and PS ≤1.
Participants with PS 2 experienced greater serious toxicity.
Findings support the inclusion of PS 2 in clinical trials for enhanced generalizability.

Abstract

Although PS 2 participants showed a greater propensity to serious toxicity, no significant differences in efficacy outcomes were observed compared with those with PS ≤1. Our results support the inclusion of PS 2 participants in clinical trials, as their exclusion limits the generalizability of results.

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