Streamlining the Precision Medicine Process: It's Possible, Necessary, and Improves Care

Jonathan C. Trent, MD, PhD

Director, Sarcoma Program

Associate Director, Clinical Research Sylvester Comprehensive Cancer Center

This scenario is familiar to oncologists at cancer centers around the world: A patient with advanced cancer requires a precision medicine test, such as next-generation sequencing (NGS), for optimal management. The physician fills out a paper form, which is then faxed to a vendor. After receiving the fax and routing it to the right individual, requesting tissue, obtaining tissue, and performing NGS, the vendor faxes or e-mails the results to the doctor’s office. The fax or the printed e-mail is often scanned into the patient’s electronic medical record (EMR) or placed in the paper record.

Needless to say, this approach is slow, inefficient, and archaic. The EMR folder is already overflowing with other data that are often not organized in an easily searchable format. At times, tracking down the NGS results is a test of endurance. This entire process is laden with manual exchanges and time-consuming printing and scanning that substantially delay care for patients with cancer, who clearly do not have time to waste.

Improving Processes

To better manage this challenge, Sylvester Comprehensive Cancer Center, part of the University of Miami Health System, initiated a partnership with Syapse, a company that specializes in precision oncology solutions. With Syapse, we have been able to streamline the precision medicine process and organize the data to improve care for our patients with cancer.The most obvious benefit from this partnership with Syapse is easy access to critical precision medicine data. Syapse has created a secure electronic portal between vendors and our EMR that is compliant with the Health Insurance Portability and Accountability Act. Our updated version of the precision medicine workflow is not only more efficient, it improves turnaround time for test results.

Physicians and patients decide to pursue NGS. The physician enters the patient’s chart in the EMR and not only chooses specific tests but also selects the vendor to perform testing from user-friendly dropdown menus. The system automatically notifies our pathology laboratory to obtain the patient’s archival tumor samples and provides the tissue to the testing vendor in a timely fashion.

After the testing is complete, the vendor sends the results through an electronic portal directly to the patient’s chart in the EMR. An automated, electronic notification is sent to the physician or designee when the test results are available. When the patient returns, the provider can open the patient’s record and easily find the new testing data, which are searchable and annotated by vendor and test type.

The Big Payoffs

This approach eliminates a number of barriers that often unacceptably delay patient care. By placing all the test data in the patient’s EMR, physicians no longer need to access multiple vendor sites, with multiple passwords. Also, removing the manual handling associated with faxes and e-mails enhances speed and reduces human error.Rapid access to precision medicine data is necessary for optimal patient care and drives important opportunities that could potentially advance our understanding of cancer.

This new, digital process supports a wide range of clinical investigations. Discrete precision medicine results enhance data mining so that we can identify patients within the EMR whose tumors harbor specific mutations. This allows for seamless collection and analysis of clinical outcomes and fosters the development of biomarkers that allow continuous improvement in patient care.

The Syapse platform ensures our ability to rapidly and easily study patients who have received precision medicine tests. Early results from these types of investigations have been quite positive.

In our experience, approximately 30% of patients had their treatment modified or a new therapy recommended because of precision medicine results. In some cases, patients with no other options were enrolled in clinical trials. Fast access to precision medicine results made these care improvements possible. The platform also gives us important data to drive clinical trials. We are able to prospectively identify patients in our health system who are likely to benefit from a therapy that matches their specific molecular abnormality.

Tumor Boards Reimagined

Sylvester Comprehensive Cancer Center is a tertiary referral center, which means we treat patients from the southeastern United States, Latin America, and the world. As a result, our clinicians see quite a few patients with gastrointestinal stromal tumors (GISTs). The majority of these patients have mutations in the KIT gene. However, a small percentage have RAF mutations. Because we have so much granular data on this mutation in these tumors, we are able to treat patients with RAF-mutant GISTs with RAF inhibitors rather than the more commonly prescribed imatinib, which is only active against KIT-mutant GISTs. This is such a tiny subgroup, we never could have designed a full-fledged clinical trial.The partnership with Syapse is only one aspect of the investment Sylvester has made in upgrading our infrastructure. Another example is our precision medicine tumor board.

In many ways, the tumor board provides the multidisciplinary processing so necessary for excellent cancer care. Precision medicine test results, medical history, treatment history, pathology, radiology, and many other factors are evaluated by the group’s combined expertise. Molecular pathologists join medical, radiological, surgical, gynecological oncologists, and others to fully analyze an individual patient’s data to determine the best therapeutic approach for each patient.

These meetings guide treatment and compile evidence to help patients into clinical trials or off-label therapy, or petition a drug company for a compassionate-use waiver.

Even more exciting is the precision medicine clinic that was created to help patients understand their disease and how its unique molecular fingerprints can guide therapy. By introducing patients to the strange new language of precision medicine, we increase their comfort levels and help them make informed decisions about their own care.

We have entered a promising new era of precision medicine, but we have to move beyond theoretical constructs to proven approaches. The only way we can do that effectively is to have access to the data.

Our recent partnership with Syapse, and other refinements, have made that a reality, and early results have been encouraging. Finally, we are leveraging NGS and other molecular data to design trials that target the aberrant proteins found in the tumors that are prevalent in our patient population.