Low Enrollment in Genomically Matched Clinical Trials After Genomic Testing
In an analysis reported in the Journal of Clinical Oncology, Meric-Bernstam and colleagues at The University of Texas MD Anderson Cancer Center found that a small minority of patients with potentially actionable genes identified in large-scale testing were enrolled onto clinical trials targeting the alterations.
Study Details
The study included 2,000 consecutive patients with advanced cancer who underwent testing in a genomic testing protocol. Standardized hotspot mutation analysis was performed using either an 11-gene (251 patients) or a 46- or 50-gene (1,749 patients) multiplex platform. A total of 35 genes were considered potentially actionable, given the potential to be targeted with approved or investigational therapies.
Actionable Mutations and Trial Enrollment
In total, 789 patients (39%) had at least one mutation in potentially actionable genes. Of them, 83 (11%) were enrolled in genotype-matched trials targeting these alterations. Among 230 patients with PIK3CA/AKT1/PTEN/BRAF mutations who returned for therapy, 116 (50%) received a genotype-matched drug; of them, 40 (17%) were treated in a genotype-selected trial requiring a mutation for eligibility, 16 (7%) were treated in a genotype-relevant trial targeting a genomic alteration without biomarker selection, and 40 (17%) received a genotype-relevant drug off trial.
Impediments to enrollment of patients in genomically matched trials included patient preference for noninvestigational treatment or local treatment, poor performance status or other factors rendering patients ineligible for study entry, lack of relevant trials or slots in trials, and insurance denial.
The investigators concluded, “Broad implementation of multiplex hotspot testing is feasible; however, only a small portion of patients with actionable alterations were actually enrolled onto genotype-matched trials. Increased awareness of therapeutic implications and access to novel therapeutics are needed to optimally leverage results from broad-based genomic testing.”
Funda Meric-Bernstam, MD, of The University of Texas MD Anderson Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported by the Sheikh Khalifa Al Nahyan Ben Zayed Institute for Personalized Cancer Therapy, The National Cancer Institute, National Center for Advancing Translational Sciences, Nellie B. Connally Breast Cancer Research Endowment, Cancer Prevention Research Institute of Texas, National Institutes of Health, and The University of Texas MD Anderson Cancer Center.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
