Even as our understanding of tumor biology improves, the infrastructure for integrating precision medicine into clinical practice remains limited.
To illustrate this point, researchers at the Cleveland Clinic conducted a study to identify the feasibility of implementing precision medicine in a real-world context, including the quality of tissue samples collected for sequencing and turnaround time for results. Below, we highlight their key findings.
Sequencing feasible in the majority of samples, but turnaround time for results may be detrimental
The prospective study enrolled 250 patients between 2013 and 2014 who were treated at Cleveland Clinic. Archival formalin-fixed, paraffin-embedded (FFPE) samples were sequenced using FoundationOne. Importantly, tumor profiling was feasible in 89% of the cases, which is higher than the industry standard of about 80%. This suggests that the collection of high-quality samples is feasible in a real-world context.
Shipment of the specimen to the lab only took a median of 7 days and results were available within a median of 19 days. Overall, the total turnaround time for results was 26 days. While the shipment time reported here is significantly lower than what we have seen in other studies, the 26-day turnaround time could restrict access for many patients who can’t afford to delay treatment.
This was illustrated in the Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) trial, which was unable to treat any patients, due in large part to the extended wait time for test results. The trial had a median turnaround time of 21.5 days; unfortunately, 27% of eligible patients died before results were obtained.
Diagnostics revealed actionable mutations in almost half of patients, but access to treatment limited
In addition to long turnaround times for test results, lack of treatment options are also a major limiting factor in patient access to precision medicine. Of the samples that underwent sequencing, 63% had a potentially actionable mutation, and 49% received specific therapeutic recommendations. However, few of these patients (11%) actually received targeted therapies based on the recommendations.
Major barriers cited included the inability to identify appropriate clinical trials and to secure reimbursement, particularly for off-label use.
Innovations could potentially overcome operational and access challenges
This study demonstrates that while molecular diagnostics can yield clinically actionable mutations, we have a long way to go in making sure all patients who could benefit have access to recommended targeted therapies. Fortunately, a number of emerging innovations have the potential to improve access in the future.
For example, partnerships with services like MolecularMatch can enable organizations to match patients to appropriate clinical trials. Technology solutions, such as Syapse, can improve operational efficiencies in test ordering and turnaround time for the communication of results.