Julie C. Martin DNP, AOCN, FNP-BC, discusses best practices to approaching conversations on clinically actionable genomic results with patients.
Despite the importance of biomarker testing, many patients with cancer are not undergoing guideline-indicated testing of their tumors. Several tools and resources are available to facilitate conversations with patients and develop a more comprehensive understanding of the role unique tumor variants play in treatment decision-making, according to Julie C. Martin, DNP, AOCN, FNP-BC.1
In a presentation at the 48th Oncology Nursing Society (ONS) Annual Congress, Martin, director of cancer research at Prisma Health, highlighted the clinical significance of biomarker testing, what is important for nurses to know when interpreting results, and how to counsel patients through complex conversations.1
Benefits, Methods, and Results of Testing
“Our present view focuses on the molecular pathology of the tumor to personalize cancer [based on] variants,” Martin said. “Biomarker testing can improve outcomes by aiding in the diagnosis [and] monitoring of disease, [as well as] predicting response to therapy.”
Martin cited the recent influx of FDA approvals for novel, targeted molecular entities, which have dramatically increased since 2005.1,2 “To that end, NCCN [National Comprehensive Cancer Network] guidelines reflect the importance of biomarker testing,” she said. Using non–small cell lung cancer (NSCLC) as an example, for patients with advanced or metastatic disease, during the establishment of the histologic type, it is important to ensure adequate tissue is collected for molecular testing. For example, the NSCLC guidelines suggest biopsy of tissue or perhaps the use of liquid biopsy if an initial biopsy or the tissue is inadequate.
The guidelines also elaborate on what to include in molecular testing, including EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and HER2, in NSCLC. “[The footnote in the guideline] says that if there’s insufficient testing for you to at least look at EGFR, KRAS or ROS1, repetition of the tissue biopsy or plasma/liquid biopsy is recommended. If you can’t do that, then patients are typically treated as though they do not have a driver oncogene,” Martin said, adding that they would then proceed to standard therapies.
Tissue-based and liquid biopsy are the most prevalent testing methods for tumor variants, and each have their advantages. For example, liquid biopsy is minimally invasive and generally has a faster turnaround time. However, during a discussion, the audience noted that turnaround times with both tissue and liquid biopsies have been exceeding 3 weeks or longer in their practice.1
Once reports return, Martin noted that resources are available for nurses to help interpret the data. One such resource is the somatic biomarker test report checklist provided by ONS. This contains items such as, genes tests, associated FDA-approved therapies and their clinical benefit, as well as available clinical trials, all of which may be included on the readout.1,4
“The reports typically begin with the results of variants that are considered clinically significant,” Martin explained. “These variants are associated with either sensitivity or resistance to a targeted therapy. This section typically includes markers such as PD-L1 expression that may indicate the sensitivity to immunotherapy. Tumor mutational burden and microsatellite instability are often recorded in this section as well.”
Delivering Information to Biomarker Information to Patients and Caregivers
“As nurses and/or advanced practice providers, we have big role in patient and family education,” Martin said. “Therefore, we need to be able to describe and define what we’re testing for patients, what needs to be performed, what is involved in the testing, and what might the results tell us.” Additionally, cost to the patient and insurance barriers are also topics that nurses may need to discuss with patients and their families. “Prior authorization is important,” Martin said. She added that it is important to remind patients, especially the under or uninsured, that most companies have financial assistance programs.
“It’s also important to offer other names for biomarker testing,” Martin said. “We have lots of terms to describe profiling—tumor genetic testing, genomic profiling, molecular profiling, molecular testing—all those refer to and mean the same thing. Educating your patients that a planned marker testing typically occurs before beginning treatment, so that we have that information to assist in diagnosis and prognosis and that it can help direct individualized treatment plans for patients based on the specific characteristics of their tumor.”
Additionally, patients may be counseled on the available options and undergo testing only to discover there are no actionable variants in their report. “Remember to offer emotional support to patients who have testing which doesn’t reveal an actual biomarker,” Martin said. “They may feel disadvantaged, so we need to emphasize the appropriateness of the treatment plan outlined by their oncologist, and the standard of care that they will be getting. Also remember that new treatments are constantly being studied and [can] become available for that patient.”
Finally, conversations around testing are crucial to closing the disparity gap in testing patterns. “Disparities have been noted despite the evidence demonstrating the importance of testing,” Martin said. “These disparities include racial, ethnic, and socioeconomic disparities related to access to task equalization of the testing.”5
In a retrospective analysis of patients with advanced or metastatic NSCLC, colorectal cancer (CRC), or breast cancer (N = 23,488), 76.5% had at testing for at least 1 biomarker and 48.7% underwent next-generation sequencing (NGS). Among Black patients with NSCLC (n = 1288), rates of NGS were significantly lower compared with White patients with NSCLC (n = 9793) at any time during their care in the NSCLC group (39.8% vs 50.1%; P < .0001). This was also observed for Black patients with CRC (n = 838) vs White patients with CRC (n = 4803; 41.8% vs 51.6%; P < .0001).6 No differences were observed in the breast cancer cohort.6
“Targeted therapies have improved patient outcomes and quality of life across multiple tumor types, Martin said. “Therefore, testing is integral…. Unfortunately, not all patients are receiving biomarker testing, and we can [play a role] to improve testing rates.”