Are ECOG Scores Restricting Patient Access to Clinical Trials?

A recent poster presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium showcased the negative impact of Eastern Cooperative Oncology Group (ECOG) performance status scores on cancer patients’ eligibility to enroll in clinical trials. The poster, “ECOG score as a barrier for clinical trial eligibility in the patient population with genitourinary cancer: Is it time to adapt this criterion to real-world data?” was presented by Liat Edry-Botzer, PhD, Medical Director at Leal Health.

An ECOG score, which indicates a patient’s level of disability through a 0 to 5 scale (0 indicates a fully active patient, while 5 represents a deceased patient), is a common eligibility criterion used to assess patients for clinical trial enrollment. Pharmaceutical companies developing and executing clinical trials have historically recruited patients in relatively good physical condition (i.e., minimal comorbidities and with a favorable ECOG performance score). This is despite the fact that many cancer patients have significant disability, manifesting in higher ECOG scores and resulting in their exclusion from clinical trials.

To assess the impact of a patient's ECOG score on clinical trial eligibility, Leal analyzed ECOG performance scores for two genitourinary cancers patients (prostate and urinary bladder cancer) who used Leal’s AI-powered platform to find relevant clinical trials online. Leal adjusted the dataset to reflect a higher ECOG score per patient and discovered a significant and consistent increase in the number of trial matches. A decrease in the ECOG score from 3 to 2 resulted in a 262% and 111% increase in trial matches for prostate cancer and urinary bladder cancer patients, respectively. Additionally, among prostate and urinary bladder cancer patients reducing the ECOG score from 2 to 1 resulted in 107% and 68% percent increase in trial matches, respectively.

“Conducting trials that are weighted toward testing relatively healthy people, as opposed to including specific patient populations that these drugs are ultimately intended to treat, have a huge impact on the relevance of trial outcomes, and the drug’s safety and efficacy profile. Furthermore, if we exclude patients based on their subjective ECOG scores alone, we are excluding high potential clinical trial seekers whose ECOG score may be temporarily negatively impacted by cancer treatments.” said Edry-Botzer.
Leal Health, formerly known as Trialjectory, an AI-powered decision support platform for industry to execute patient-centric clinical trials.

Reference: Leal Health Presents Poster Highlighting Negative Impact of Patient ECOG Scores on Clinical Trial Enrollment Eligibility at 2023 ASCO GU Cancers Symposium