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Seattle Cancer Care Alliance Aims to Improve Molecular Profiling Access for Thyroid Cancer Patients


NEW YORK – Researchers at the University of Washington and Seattle Cancer Care Alliance are exploring ways to standardize and increase the use of in-house multigene molecular testing among thyroid cancer patients treated at community oncology clinics across five states.

Project leads Cristina Rodriguez, an associate professor at the UW School of Medicine and a medical oncologist at SCCA, and Perrin Romine, a hematology-oncology fellow at UW, wish to address barriers to molecular profiling and develop processes that streamline test ordering for community oncologists who practice at SCCA-affiliated clinics.

The project received grant funding from the National Comprehensive Cancer Network's Oncology Research Program, which this month funded several projects focused on improving care for lung and thyroid cancer patients by optimizing the workflow for providers.

SCCA is a National Cancer Institute-designated comprehensive cancer center that treats patients and works with researchers and physicians at Fred Hutchinson Cancer Research CenterSeattle Children's, and UW Medicine as part of the Fred Hutch/UW Cancer Consortium. SCCA also partners with nine regional hospitals throughout Washington, Idaho, Montana, Alaska, and Hawaii.

In the first stage of the project, researchers will assess the needs of these community clinics and identify barriers to molecular profiling. Rodriguez noted that despite the differences among the communities that the SCCA affiliates serve in the five states, there are common barriers that make standardizing molecular profiling a challenge for oncologists.

Community oncologists are more likely to see patients with the most common cancers, like breast and lung tumors, and therefore may be better educated on when to conduct molecular profiling and which markers are therapeutically relevant. Rodriguez's project focuses on thyroid cancer, because she recognized that community oncologists needed help with personalizing treatment for patients with less-common tumor types.

The American Thyroid Association's 2021 guidelines state that targeted next-generation sequencing panels, whether they are pan-cancer or specific for thyroid cancer, "are preferable" when conducting the initial molecular profiling for advanced patients, because such testing offers a better chance of identifying markers associated with US Food and Drug Administration-approved treatments, particularly when patients have limited tissue samples.

For example, patients with RET fusion-positive advanced or metastatic medullary thyroid cancer can be treated with either Eli Lilly's Retevmo (selpercatinib) or Blueprint Medicines/Genentech's Gavreto (pralsetinib). For patients with BRAF V600E-mutant advanced or metastatic anaplastic thyroid cancer, the available treatment is the combination of Novartis' Tafinlar (dabrafenib) and Mekinist (trametinib).

Two NTRK inhibitors, Bayer's Vitrakvi (larotrectinib) and Genentech's Rozlytrek (entrectinib), are also used to treat advanced thyroid cancer patients with an NTRK gene fusion who are out of treatment options. Both drugs are approved for NTRK fusion-positive refractory solid tumors.

Within the main SCCA campus in Seattle, which includes about 75 oncologists, the molecular profiling process is inconsistent. Rodriguez knew anecdotally that doctors currently order testing from both UW's in-house lab and commercial testing companies, and that signaled to her that a uniform and streamlined process may help ensure thyroid cancer patients across clinics will receive equitable care.

Through this project, Rodriguez aims to funnel testing at SCCA-affiliated clinics through UW's Department of Laboratory Medicine and Pathology, rather than through commercial labs.

"As we grew, we realized the community and our group would benefit from a uniform process of ordering that was easy for the provider, and that would allow a central process of procuring the tissue and testing using the methods that are adequate for defining actionable mutations," Rodriguez said. "It was a process that was in terrible need of streamlining."

The NCCN funding came at a time when SCCA is also overhauling its electronic medical records, or EMR, system. This gives Rodriguez an opportunity to ensure not only that thyroid cancer patients are receiving molecular testing but that the results can be easily integrated into a patient's medical record.

Currently, even if a patient has had molecular testing, the results are hard to find in the EMR and are not automatically tied to FDA-approved treatments or clinical trial options. By using an in-house lab, Rodriguez also hopes to eliminate the need to upload results from external lab reports in the EMR, which can delay care.

Another aim within the project is to help community oncologists stay on top of the latest testing guidelines for thyroid cancer. Rodriguez hopes to build a system that will flag thyroid cancer patients who may be eligible for molecular profiling. Ideally, the system will automatically schedule tissue procurement and order testing for thyroid cancer patients who meet the criteria for FDA-approved targeted therapies. These treatments are available for patients who have advanced or metastatic disease and are ineligible for surgery; patients with less advanced disease are more likely to undergo surgery, chemotherapy, or radiation therapy before trying a targeted therapy.

This process, Rodriguez hopes, will reduce the burden on busy community doctors, streamline the test ordering process, and ensure patients seen at affiliate clinics are getting tested.

The process improvements Rodriguez has planned will also ensure that doctors are ordering tests that make the best use of available tissue and have a good chance of being covered by patients' insurance. Within SCCA clinics, it's not uncommon for patients to get unexpected bills for molecular tests that their doctors ordered for them. Currently, Rodriguez doesn't have a good sense of how extensive this problem is and therefore wants to investigate the number of surprise bills patients receive from testing in this project. "That's something that we want to eliminate through an easy ordering process," she said.

Although the Centers for Medicare & Medicaid Services has national coverage for NGS-based multigene panels for advanced cancer patients, commercial payor coverage is more unpredictable for large panels. "We've been running into issues [and] getting pushback on coverage for comprehensive genomic profiling," Rodriguez said. "We know that these molecular aberrations tend to be mutually exclusive for thyroid cancers, so that's one of the reasons why we are not advocating for comprehensive genome sequencing in this project. We want use tests that identify the actionable mutations that have FDA-approved indications."

UW has an institutional cancer gene panel, called UW OncoPlex, which can assess mutations in more than 350 genes or be tailored to evaluate specific genes in different tumor types. Some SCCA oncologists already use UW OncoPlex, Rodriguez said, adding that through this project oncologists treating advanced thyroid cancer patients will be encouraged to order in-house testing on this platform to gauge alterations in genes therapeutically relevant in this type of cancer, such as RET, BRAF, and NTRK.

The benefits of more tailored NGS panels are that they can provide results faster than comprehensive genome sequencing. Panels assessing hundreds of genes can take weeks or even longer than a month to return results and can identify more investigational biomarkers that may not be actionable at all or have limited evidence on therapeutic actionability.

Commercial payors are less likely to cover large panels for this reason and may be more likely to cover testing that has a chance of identifying candidates for FDA-approved, standard-of-care drugs. However, Rodriguez noted that the project is not leaving out the larger NGS panels entirely. It will focus on testing patients for BRAF, NTRK, and RET alterations for now, but if patients do not carry these mutations, then the group will push for comprehensive genomic profiling to potentially match them to mutation-specific, tumor-agnostic clinical trials at SCCA.

Once the ordering system is developed based on the needs of community oncologists and their patients, SCCA will begin implementing the process, first at SCCA's main campus, then throughout its affiliate clinics.

The entirety of the three-stage project, including information gathering, developing the workflow, and implementing the process throughout SCCA, will take two years, Rodriguez estimated. She hopes to create a streamlined workflow that is scalable, but that can also be easily adjusted as guidelines recommend testing for new genetic alterations and the FDA approves new biomarker-indicated drugs.

If successful, she also hopes to expand the workflow to other head and neck cancers, like salivary gland tumors, that researchers are only beginning to explore treating with targeted therapies with the help of molecular profiling.

"The vision that many large cancer networks have when they take on affiliates or community sites is they want to reassure the patient that when you come to an affiliate, you're getting the standard of care that we practice throughout the system," Rodriguez said. "This effort speaks to that goal. We want patients to get molecular testing in a timely fashion wherever they enter our system. That's key in this era of inclusion and access."