Keynote Presentation - Precision Medicine: An Essential Component of Oncology Clinical Pathways
Richard Schilsky, MD, senior vice president and chief medical officer of the American Society of Clinical Oncology kicked off the inaugural Clinical Pathways Congress with a discussion on the relationship between clinical pathways development and the emergence of precision medicine.
To begin, Dr Schilsky said that pathways can generally be defined as the process of translating evidence or guidelines into clinical practice. This process allows for the creation of plans, algorithms, or protocols that encourage best treatment practice for varying disease types. They also aim to standardize care for a specific clinical problem, procedure, or episode of care in a specific population.
Successful pathways can reduce variations in care, improve team-based care, demonstrate quality in care delivery, and improve patient confidence. Additionally, all pathways can and should encourage clinical trial enrollment. However, while pathways have been lauded for their ability to improve the quality of care patients receive, there are questions about whether pathways are intrinsically opposed to precision medicine, an emerging approach to disease treatment and prevention that takes into account the specific genetic and environmental circumstances of each individual patient.
One of the most important products to come out of precision medicine research has been targeted therapeutics. Research into the cancer genome has revealed specific mechanisms that stimulate cancer growth and progression. More recent data also suggest that one form of cancer may in fact be several distinct diseases.
However, these profound advancements in cancer research are also the source of the underlying tension between clinical pathways, which seek to standardize care for all patients, and precision medicine, which looks to provide care that is specific to each individual. The solution, said Dr Schilsky is the development of pathways that are robust, transparent, and easily changed in the event that new evidence becomes available.
One area of principle importance for these pathways will be their use of biomarkers, which can be used to assess patient risk, provide more accurate prognosis, predict pathology, and determine how well patients are responding to treatment.
Currently, a very small number of patients benefit from conventional screening. However, this entire framework is set to change as clinicians start using diagnostic biomarkers to evaluate patient risk. And tests such as the OnotypeDx Recurrence Score and TAILORx now have sufficient data supporting their inclusion in clinical pathways, which will allow for more accurate prognosis. Additionally, comprehensive genomic profiling to identify targetable mutations has been shown to significantly improve patient outcomes. But while this approach of treatment is effective in most patients, there is not yet enough evidence supporting the inclusion of comprehensive genomic profiling in pathways for advanced disease, where only about 5% of patients achieve a response. Lastly, Dr Schilsky explained that biomarkers could also be utilized to track patient response to treatment. Already, there are liquid biopsies available for patients with non-small cell lung cancer and while these tests are not yet widely used, their incorporation into pathways could provide a more feasible option for tracking how well treatments are performing than standard biopsies.
To conclude the keynote, Dr Schilsky provided some considerations to ease tension between pathways and precision medicine. First, oncology pathways should always include precision medicine approaches when they are supported by high-level evidence. These pathways should also recognize patient and physician autonomy so that providers and their patients are still able to communicate about treatment goals and plan accordingly. Lastly, pathways should support reimbursement for biomarker tests with proven evidence and employ rigorous and transparent evidence-based approaches that are regularly updated.
Clinical pathways are an effective method of reducing variability and managing costs, concluded Dr Schilsky, but it is only when they are combined with precision medicine, physician judgment, and patient preferences that they truly optimize care.