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Adoption Quickening for Genomic Cancer Testing in Community Settings

by | Sep 16, 2019 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Top of the News-dtet

From - Diagnostic Testing & Emerging Technologies Clinicians are increasingly using genomic cancer testing in community health care settings, although there are… . . . read more

Clinicians are increasingly using genomic cancer testing in community health care settings, although there are lingering questions about the utility of results. These are the findings of several presentations made at American Society of Clinical Oncology’s annual meeting (May 31 to June 4, Chicago)

Trend Toward Increased Utilization
Medical Oncologists in the Sarah Cannon Research Institute network (Nashville, Tenn.) ordered commercially available next generation sequencing-based molecular profiling for patients as the standard of care. Data use agreements between the institute, affiliated medical oncology practices, and commercial test providers enabled analysis of patient data from 2012 to 2018.

The researchers report that NGS-based tumor testing utilization increased in the community-setting between 2012 and 2018. Community-based NGS testing rates within the Sarah Cannon network were 5.75 per month in 2012 versus 440 per month in 2018. The number of oncologists ordering molecular profiles increased from 11 to 269 over the same time period. Physician test utilization grew from an average of six tests per physician in 2012 to 22 tests per physician in 2018.

Plasma-based NGS testing grew from 4.9 percent of total testing in 2014, when it was initiated, to 40.1 percent in 2018. NGS tests were performed on 34 different tumor types and biopsies taken from both primary (~40 percent) and metastatic (~60 percent) sites. Tissue-based tests averaged 14 mutations percent sample, while plasma-based tests averaged four mutations per sample. From 2012 to 2018, there was a 74 percent decrease in median time between biopsy collection and NGS test results (131 and 34 days, respectively), indicating a shift toward the use of fresh, non-archival tissue, the authors say.

Test Result Utility Affected by Geography
Analysis included 360 patients with advanced solid tumors who had progressed on standard treatment regimens and had an available test results from Foundation Medicine’s multiplex genomic test. Patients had solid tumors and were treated at two community hospital-based oncology practices in central rural Nebraska between 2014 and 2018. Treating community oncologists directed treatment choices based on MGT results.

The researchers report that the average turn-around time from order to reporting was 20.19 days. Reimbursements were through commercial insurance (27 percent), Medicare (66 percent), Medicaid (3 percent), self-pay (2 percent), and financial assistance by company (2 percent). Most common cancer types were non-small cell lung (27 percent), pancreas (9 percent), colon (8 percent), unknown primary (4 percent), sarcoma (4 percent), breast (4 percent), gastro-esophageal (2 percent), and kidney (1 percent).

The vast majority of samples (79 percent) of samples had at least one actionable alteration. Nearly one in five of these patients (19 percent) alterations were matched to one or more on- or off-label targeted therapies approved by the U.S. Food and Drug Administration (FDA) and/or professional guidelines. Just over one-third of patients (26 of 69) with actionable alterations were able to have a new therapy and 12 percent of patients were qualified to participate in locally available clinical trials (MATCH, LUNG-MAP and TAPUR).

“In addition to established barriers of cost, long turnaround time, adequate tissue, the low yield of new FDA- and/or guideline-approved treatments decreases the utility of multiplex genomic testing,” write the authors led by Mehmet Sitki Copur, from Mary Lanning Healthcare in Hastings, Nebraska. “Increased variety and availability of precision medicine clinical trials with improved patient access in the rural setting may improve this shortcoming.”

Clinicians Report Confidence Using Tumor Genomic Testing
Researchers led by Suanna S. Bruinooge form the American Society of Clinical Oncology (Alexandria, Virginia) surveyed physicians seeing patients as part of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a multibasket study of marketed agents targeting tumor genomics. Analysis included 112 physician respondents at 54 TAPUR sites, including community oncology practices. Questions assessed use of tumor genomic testing, barriers to ordering testing, and genomic confidence. Surveys included 3 scenarios for test ordering 1) pretreated advanced cancer patients without options, 2) newly diagnosed, untreated, metastatic patients and 3) early-stage, potentially curable patients with standard options.

Respondents reported that a median of 25 percent of their pts had tumor genomic testing in past 12 months for trials or routine care (range 0 to 85 percent). Barriers to testing primarily included access to tumor specimen (86 percent), insurance coverage (67 percent), concerns that results will not be actionable (55 percent), and test issues (wait time, unsure which test or lab to use, and test accuracy; 54 percent).

TGT was ordered most often for scenarios 1 (96 percent) and 2 (70 percent), but one-third of physicians said they would order testing in scenario 3. For clinicians reporting ordering testing for scenarios 1 and 2, most explained to patients that results could inform treatment, prognosis, and access trials (97 percent), but may be uninformative (84 percent). Clinicians said that for scenarios, they discussed patients’ expectations of test results prior to testing. More than one-third of respondents reported frequently telling patients in advance that results could inform heritable cancer susceptibility (37 percent), despite growing evidence of germline findings in somatic testing.

Confidence in using tumor genomic testing was high with more than 95 percent saying they are somewhat or very confident in their ability to recommend treatment based on test results and their ability to explain test results to patients. However, confidence drops to 66 percent in providers practicing for than 15 years.

Takeaway: While it is encouraging that genomic oncology test ordering and confidence in interpretation of test results is growing among community-practicing oncologists, there is concern that geography may hamper the utility of results by limiting access to clinical trials.

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