A study looking at 10,500 health records of advanced non-small cell lung cancer (aNSCLC) patients from ASCO’s CancerLinQ database found that the use of expanded clinical trial inclusion criteria, as proposed by ASCO and Friends of Cancer Research in 2017, would nearly double the percentage of patients eligible to enrol in clinical trials – from 52.3% to 98.5%.
The expanded clinical trial eligibility criteria would allow aNSCLC patients with brain metastases, previous or concurrent cancers, and limited kidney function to enrol in clinical trials.
The study was featured in a press briefing and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
“Ongoing use of historic, narrow eligibility criteria based on antiquated safety concerns place potentially unnecessary restrictions on trial participants, thus making it increasingly difficult to conduct the clinical trials necessary to demonstrate safety and efficacy of new therapies,” said lead study author R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, Director of the Winship Cancer Institute of Emory University’s Phase I Clinical Trials Section, Atlanta, GA.
“Changes to eligibility criteria are particularly important as we step further into the era of targeted therapies, including immunotherapies, that have different safety profiles than highly toxic systemic chemotherapies.”
Researchers looked at electronic health records in ASCO’s CancerLinQ database from 2011 to 2018 and focused on adults with aNSCLC who had two or more oncologist visits and at least one dose of a systemic treatment after diagnosis.
CancerLinQ® collects and analyses real-world data from patients at practices nationwide, drawing from electronic health records, to improve the quality of cancer care. CancerLinQ Discovery® provides access to high-quality, de-identified datasets derived from patient data to academic researchers, non-profit organisations, government agencies, and others in the oncology community.
Using this data, researchers evaluated the number of patients eligible for clinical trials using traditional criteria and using the proposed criteria from ASCO and Friends of Cancer Research, which would allow for brain metastases, previous or current cancer diagnoses, and creatinine clearance levels as low as 30 millilitres per minute.
Low levels of creatinine clearance can indicate kidney damage or impaired function.
Traditional criteria, on the other hand, do not allow for these conditions and exclude patients with creatine clearance levels less than 60 millilitres per minute.
In November 2018, the National Cancer Institute revised its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials based on the recommendations of ASCO and Friends of Cancer Research.
More time is needed, however, to assess if these broader criteria are being widely adopted.
Sixty percent of the people had an advanced, stage IV diagnosis, and 80% were former or current smokers.
The median age of patients was 67.6 years; 56% were male and 44% female.
When the researchers applied traditional clinical trial enrolment criteria, 5,005 (47.7% of patients) would not meet trial
If, however, expanded criteria were adopted, only 154 (1.5% of patients) would not meet eligibility criteria.
Use of the expanded criteria would allow 4,851 more people to meet these eligibility criteria, resulting in nearly twice as many people with a NSCLC who would.
Adoption of expanded criteria compared with traditional criteria would also enhance the characteristics of aNSCLC
patients in the following ways:
- Older patients, raising the median age from 66.1 to 67.5 years.
- Females, raising from 40% to 44%.
- Stage IV diagnoses, raising from 55% to 60%.
- Non-squamous types of lung cancer, raising from 45% to 47%.
- Never smokers, raising the rate from 13% to 16%.
Researchers are currently performing other analyses to look at differences between people who have been treated for their disease and remained stable, and people with ongoing brain metastases.
The researchers are also doing sub-analyses to further refine which patients would be eligible for modern-day clinical trials.
They note that none of these efforts would be possible without the use of ‘big data’ via CancerLinQ.
Dr. Harvey remarks that what is most needed is greater knowledge about drug-specific and population-specific outcomes in this disease in order to quickly and safely expand eligibility criteria.
Expanded eligibility should also help to reduce disparities in enrolment, both socially and economically, he concluded.