Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting

Defined as standing protocols that do not require an oncologist order for each of the following: 1) EGFR and ALK testing in lung cancer; 2) KRAS testing in colorectal cancer; 3) BRAF testing in melanoma; and 4) HER2 testing in breast cancer. Will itemize each guideline recommendation and determine whether each pathology practice has reflexive testing protocols through self-report on the assessment. The proportion of pathology practices and exact 95% two-sided confidence intervals with reflexive-testing protocols will be calculated.

The pathology practices will indicate the average number of business days between the day the tumor tissue is available and the day that all the test results are reported to the physician. Pathology practices will be considered meeting guidelines if the average is less than or equal to 10 days. The proportion of pathology practices and exact 95% two-sided confidence intervals with average turnaround time within 10 business days will be calculated.

For each biomarker-cancer combination being investigated, univariate and multivariate logistic regression modelling will be performed. There will be variables collected at the oncology component/subcomponent level and variables collected at the pathology practice level. The analysis will be completed at the level of the pathology practice, so characteristics of the oncology component/subcomponent will have to be adapted to that of the pathology practice: repeated for all of pathology practices used by one oncology component/subcomponent, or consolidated for pathology practices that service multiple oncology component/subcomponent. Variables used to assess heterogeneity will be (a) component/subcomponent characteristics: geography (census region), size (number of adult oncology beds), safety-net hospital, minority/underserved National Cancer Institute (NCI) Community Oncology Research Program (NCORP) component/subcomponent, academic hospital, public-ownership type.

Will determine whether each pathology practice is using genotyping or broad molecular profiling / next-generation tumor sequencing through self reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.

For colorectal cancer, will determine whether each pathology practice is using MMR protein expression testing by IHC or MSI through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.

Will determine whether each pathology practice has the capacity to test for cMET or PTEN through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.

For colorectal cancer, will determine whether each pathology practice has the capacity to test for HRAS, AKT1, PTEN or PIK3CA through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.

For novel biomarkers, will determine whether each pathology practice tests for novel biomarkers to be used for clinical care, clinical trials, or both through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each time point will be calculated.

Each pathology practice will report the number of days until all biomarkers tested are completed. The average number of days across all pathology practices and 95% two-sided confidence intervals will be calculated.

Will determine whether each pathology practice tests for novel biomarkers using a standard reflexive testing protocol through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each characteristic will be calculated.