Only 3% of patients with cancer in the US enrol on a clinical trial – and the American Society of Clinical Oncology (ASCO) is concerned that outdated and restrictive eligibility criteria could be hindering research.
The organisation has used its annual meeting in Chicago to call for some of these outmoded eligibility criteria to be dropped after a study showed that relaxing three rules used to screen patients almost doubled the number of patients on a dummy lung cancer trial.
The research looked at the health records of 10,500 patients from 2011 to 2018 with advanced non-small cell lung cancer on ASCO’s cancer database.
Researchers looked at the number of patients eligible for trials using traditional criteria, and using new proposed criteria from ASCO and Friends Of Cancer Research.
These allow for brain metastases, previous or current cancer diagnoses, and creatine clearance levels as low as 30 millilitres per minute, which can indicate kidney damage or impaired function.
Traditional criteria do not allow for these conditions and exclude patients with creatine clearance levels less than 60 millilitres per minute
Using expanded criteria would nearly double the percentage of patients eligible to sign up, from 52.3% to 98.5%.
The criteria would allow for patients with brain metastases, previous or concurrent cancers, and limited kidney function to sign up, and would also result in a higher percentage of older patients joining.
In the broadened trial 22% of patients were older than 75, compared with 16% using the traditional criteria.
There were more women on the trial, rising from 40% to 44%, more Stage IV diagnosis, increasing from 55% to 60%.
Non-squamous types of lung cancer increased from 45% to 47% and there were more never smokers, raising the rate from 13% to 16%.
Lead study author Donald Harvey, director of the Winship Cancer Institute of Emory University’s Phase 1 Clinical Trials Section, noted that eligibility criteria are based on “antiquated safety concerns” that are no longer valid because of developments in supportive care.
The message from Harvey in a presentation of findings at an ASCO press conference was clear, with a clarion-call to use the more relaxed screening criteria. “We urge all clinical trial sponsors to adopt these criteria,” he said.