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Reconciling Precision Medicine and Clinical Pathways in Oncology

October 01, 2016

Richard Schilsky, MD, senior vice president and chief medical officer of the ASCO kicked off the meeting on Friday night with his Keynote Address on the relationship between clinical pathways development and the emergence of precision medicine.

To begin, Dr Schilsky offered a general definition of clinical pathways 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 practices for different disease types. They also aim to standardize care for a specific clinical problem, procedure, or episode of care in a specific population.

Successful pathways, Dr Schilsky said, can reduce variations in care, improve team-based care, demonstrate quality in care delivery, and improve patient confidence in the care they receive. Additionally, all pathways can and should encourage clinical trial enrollment. However, while pathways have been lauded for their ability to improve care quality, 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 to determine the optimal care for that patient.

One of the most important results of precision medicine research in cancer has been targeted therapeutics. Research into the cancer genome revealing specific mechanisms that stimulate cancer growth and progression has led to the identification of unique targets for cancer therapies in specific patient populations. As a result, rather than treating a given cancer type as a single disease, genetic testing can be used to identify targetable mutations in patients in order to guide treatment decisions. The outcomes of such approaches have far surpassed those of more traditional cancer therapies.

However, these advancements have been a source of 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, comprehensive, transparent, and easily modifiable in the event that new evidence becomes available.

One way in which clinical pathways could better incorporate the benefits of precision medicine is through the inclusion of biomarker testing, 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. Tests such as the OncotypeDx 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. However, while this approach to treatment is effective in most patients, Dr Schilsky cautioned that 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, liquid biopsies are available for patients with non-small cell lung cancer to track treatment response. While these tests are not yet widely used, their incorporation into pathways could provide a better means of tracking how well treatments are performing than standard biopsies.

Dr Schilsky offered some further suggestions for easing the tension between pathways and precision medicine. First, he said, oncology pathways should always include precision medicine approaches when they are supported by high-level evidence. 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.

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