A study assessing the health records of 10,500 advanced non-small cell lung cancer patients has discovered that using an expanded clinical trial inclusion criteria would nearly double the percentage of patients eligible to enroll in clinical trials.
The study, presented at the American Society of Clinical Oncology Annual Meeting (ASCO; May 31 – June 4, Chicago, IL, USA), looked at electronic health records in ASCO’s CancerLinQ database from 2011–2018, focusing on adults with aNSCLC who had visited oncologists two or more times and had at least one dose of systemic treatment.
Using this dataset, the team evaluated how many paitents would be eligible for clinical trials using traditional criteria and using the criteria proposed by ASCO and Friends of Cancer Research in 2017, which would allow aNSCLC patients with brain metastases, previous or concurrent cancers, and limited kidney function to enroll in clinical trials.
The researchers discovered that 60% of the assessed individuals had an advanced stage IV diagnosis, and 80% were former of current smokers. The median age was 67.6 years, with 44% being female and 56% male. When the team applied traditional clinical trial criteria, 5005 (47.7% of patients) would not have been eligible for inclusion. However, when the expanded criteria were applied only 154 (1.5% of patients) didn’t meet the eligibility criteria, demonstrating that use of the expanded criteria would result in nearly twice as many people with aNSCLC being eligible.
In addition, use of the expanded criteria could also enhance the criteria of aNSCLC in other ways, for example, raising the median age from 66.1 to 67.5 years and raising the proportion of stage IV diagnoses from 55% to 60%. Expanded eligibility should thus help to reduce disparities in enrollment, both socially and economically.
The team 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.
ASCO Expert David L. Graham (Levine Cancer Institute, NC, USA) commented: “Only about 3% of patients with cancer in the United States currently enroll in a clinical trial, and restrictive eligibility criteria established in an era before advances we have made in supportive care is one reason for this low number.”
“This study makes the case for universal adoption of broader clinical trial eligibility criteria, such as that proposed by ASCO and Friends of Cancer Research, so that more lung cancer patients and others have the opportunity to safely participate in potentially lifesaving research.”
Source: Harvey RD, Rubenstein WS, Ison G et al. Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis. Presented at ASCO, May 31 – June 4, Chicago, IL, USA (Abstract LBA108)