Despite the OlympiA trial demonstrating that early-stage, high-risk, HER2- germline BRCA1 and BRCA2 mutation (gBRCAm) positive breast cancer patients can benefit from PARPi in the adjuvant setting, the gBRCA testing rate in early-stage HR+/HER2− patients remains suboptimal compared to that in early-stage TNBC patients. To better understand the perceived barriers associated with gBRCA testing in HR+/HER2− disease, a quantitative survey was conducted across stakeholders (n = 430) including medical oncologists, surgeons, nurses, physician assistants, payers, and patients. This study revealed that while payers claim to cover gBRCA testing, poor clinician documentation and overutilization are key challenges. Therefore, payers place utilization management controls on gBRCA testing due to their impression that clinicians overtest. These controls have led to healthcare professionals experiencing payer pushback in the form of reimbursement limitations and denials. The perceived challenges to gBRCA testing stem from the lack of consensus dictating which patients are high risk and should be tested. While payers define high risk based on the CPS + EG score from the OlympiA trial, HCPs adopt a broader definition including genomic risk scores, lymph node involvement, and tumor grade and size. A dialogue to harmonize risk classification and testing eligibility across stakeholders is critical to address this disconnect and increase gBRCA testing in appropriate patients.

BACKGROUND:National Comprehensive Cancer Network (NCCN) guidelines recommend biomarker testing as the first step in the management of patients with advanced non-small cell lung cancer (aNSCLC). We assessed anaplastic lymphoma kinase (ALK) testing rates and factors related to underuse in community medical systems between 2012 and 2019 to understand guideline adoption. METHODS:A retrospective observational study using a nationwide electronic health record (EHR)-derived deidentified database was conducted. Patients with aNSCLC diagnosed in community medical centers from January 2012 to May 2019 were included to describe the ALK testing trend. This cohort was further restricted to patients diagnosed after 2015 to understand factors associated with testing underuse using mixed-effects multivariable logistic regression models. RESULTS:Trends for increased ALK testing rates by year were observed in both NCCN guideline-eligible patients (59.5% in 2012 to 84.1% in 2019) and -ineligible patients (15.6% to 50.8%) in a cohort of 41,728 patients. Histology type and smoking status had the greatest impact on test use. Compared with patients with nonsquamous histology and no smoking history, patients with squamous histology and no smoking history (adjusted odds ratio [aOR], 7.6; 95% confidence interval [CI], 5.6-10.4), NSCLC histology not otherwise specified (NOS) with smoking history (aOR, 3.4; 95% CI, 2.8-4.2); NSCLC NOS/nonsmoker (aOR, 1.8; 95% CI, 1.1-3.2), and nonsquamous/smoker (aOR, 1.5; 95% CI, 1.3-1.7) were less likely to be tested. Factors related to underuse also included Eastern Cooperative Oncology Group performance status, stage at initial diagnosis, and demographics. CONCLUSION:This analysis of real-world data shows increasing test use by year; however, one fifth of patients eligible for ALK testing still remain untested and potentially missing therapeutic options. IMPLICATIONS FOR PRACTICE:Advancement in treatment of lung cancer is accompanied by an increasing number of tests that should be run to determine potential therapy options for each patient. This study assessed adoption of testing recommendations for anaplastic lymphoma kinase rearrangements in a national database. Although test use increased over the time period studied (2012-2019), there is still room for improvement. Efforts are needed to increase test use in undertested groups, thus enabling eligible patients to benefit from novel lung cancer therapies.

Context.-With multiple therapeutic options available for patients with advanced non-small cell lung cancer, the timely ordering and return of results to determine therapy are of critical importance. Objective.-To assess factors impacting anaplastic lymphoma kinase (ALK) test ordering and time to result delivery. Design.-A retrospective study using a de-identified electronic health record database was performed. Post-diagnosis ALK tests (n = 14 657) were analyzed from 14 197 patients with advanced non-small cell lung cancer diagnosed between January 2015 and May 2019. Time from non-small cell lung cancer diagnosis to ALK sample receipt in the laboratory was a surrogate for test order time. Test ordering was considered delayed if order time was more than 20 days. Turnaround time from sample received to test result was calculated and considered delayed if more than 10 days. Multivariable logistic regression was used to assess factors associated with order time and turnaround time delays. Results.-Median ALK test order time was 15 days, and 36.4% (5342) of all 14 657 orders were delayed. Factors associated with delays were non-fluorescence in situ hybridization testing, send-out laboratories, testing prior to 2018, nonadenocarcinoma histology, and smoking history. Median turnaround time was 9 days, and 40.3% (5906) of all 14 657 test results were delayed. Non-fluorescence in situ hybridization testing, tissue sample, and orders combining ALK with other biomarkers were associated with delayed ALK result reporting. Conclusions.-This study provides a snapshot of realworld ALK test ordering and reporting time in US community practices. Multiple factors impacted both test ordering time and return of results, revealing opportunities for improvement. It is imperative that patients eligible for targeted therapy be identified in a timely fashion.

Background NCCN guidelines recommend biomarker testing as the first step in the management of patients with advanced non-small cell lung cancer (aNSCLC). We assessed ALK testing rates and factors related to underutilization in community medical systems between 2012 and 2019 to understand guideline adoption. Methods A retrospective observational study utilizing a nationwide electronic health record (EHR)-derived de-identified database was conducted. Patients with aNSCLC diagnosed in community medical centers from January 2012 to May 2019 were included to describe the ALK testing trend. This cohort was further restricted to patients diagnosed after 2015 to understand factors associated with testing underutilization, using mixed-effects multivariable logistic regression models. Results Trends for increased ALK testing rates by year were observed in both NCCN guideline eligible patients (59.5% in 2012 to 84.1% in 2019) and ineligible patients (15.6% to 50.8%) in a cohort of 41,728 patients. Histology type and smoking status had the greatest impact on test utilization. Compared to patients with non-squamous histology and no smoking history, patients with squamous histology and no smoking history (adjusted odds ratio (aOR), 95% confidence interval (95%CI): 7.6, 5.6-10.4), NSCLC histology not otherwise specified (NOS) with smoking history (3.4, 2.8-4.2); NSCLC NOS/nonsmoker (1.8, 1.1-3.2), and non-squamous/smoker (1.5, 1.3-1.7) were less likely to be tested. Factors related to underutilization also included ECOG performance status, stage at initial diagnosis and demographics. Conclusions This analysis of real-world data shows increasing test utilization by year; however, one fifth of patients eligible for ALK testing still remain untested and potentially missing therapeutic options. Implications for practice Advancement in treatment of lung cancer is accompanied by an increasing number of tests that should be run to determine potential therapy options for each patient. We assessed adoption of testing recommendations for ALK rearrangements in a national database. While test utilization increased over the time period studied (2012-2019), there is still room for improvement. Efforts are needed to increase test utilization in under-tested groups, thus enabling eligible patients to benefit from novel lung cancer therapies.

Objective: This study assessed the prevalence of anaplastic lymphoma kinase (ALK) rearrangements in US oncology practices. Materials and Methods: Using a nationwide real-world database, we included adults with advanced non-small cell lung cancer (aNSCLC, stage IIIB- IV) diagnosed January 2015 – May 2019, with documented ALK testing results and smoking status. Rearrangement prevalence was assessed overall and then stratified by patient characteristics. Results: The cohort included 19,895 eligible patients with a mean age 68.5 years, majority ever-smokers (85.5%) and from community centers (92.2%). The overall ALK rearrangement prevalence was 2.6%. Positivity rate varied by histology and smoking status; it was the highest among non-smoking patients with non-squamous histology (9.3%). Differences in ALK status also varied by age and race, with young patients (18–39 years) having a higher prevalence (21.6%) vs. older patients (age ≥55 = 2.2%); Asian patients had a prevalence of 6.3%. Patients that were positive for other mutations or rearrangements had a lower ALK positivity rate (0.5%) and patients positive for PD-L1 had a rate of 3.0%. Conclusions: The likelihood of finding an ALK translocation was highest in younger patients and nonsmokers; however, age and smoking history were not discriminative enough to exclude testing based on clinical variables.

e21592 Background: Over the last 10 years, guideline recommendations for testing advanced non-small cell lung carcinomas (aNSCLC) have rapidly evolved with the identification of driver mutations and associated therapies. A retrospective study of the testing rates for ALK was initiated to understand real world adherence to guidelines. Methods: A retrospective study of the testing rates (negative category = not tested/unknown testing status) for ALK utilizing the nationwide Flatiron Health electronic record-derived de-identified database was initiated. Patients diagnosed with NSCLC (Stage IIIB-IV) were initially included (41,728 patients from Jan 2012 to May 2019) to describe the trend of ALK testing in community setting. An increase in ALK testing was seen from 59.5% to 84.1% of NCCN guideline eligible patients from 2012-2019. There was also an increase in the number of ineligible patients (smokers with squamous histology) tested (15.6% in 2012 to 50.8% in 2019). This 2012-2019 patient population was then limited to diagnosis from Jan 2015 to May 2019 to assess factors related to test utilization. In 26,617 aNSCLC patients, 75% were ALK testing eligible (by NCCN guidelines) with one quarter ineligible. Multivariable logistic regression analysis was used to assess clinical and demographic factors for impact on testing rates. Results: Both histology type and smoking status played an important role impacting ALK testing rate. Compared to non-squamous non-smokers (9.3% ALK-positive, 87.9% testing rate), non-smokers with squamous cell histology had a relatively high rate of ALK mutation (3.3%) but a low testing rate (55.03%) (Odds ratio (OR) 7.6, 95% CI 5.6-10.4). Other histology type and smoking status also had lower testing rate, including non-smoker with NSCLC non-specific type (OR 1.8, 95% CI 1.1-3.2), and smoker with non-squamous type (OR 1.5, 95% CI 1.3-1.7). Additional factors related to underutilization were patients with poorer ECOG scores and earlier stage at diagnosis. Demographic characteristics that also played a role in underutilization were older age ( > 50 yrs), non-commercial insurance, male, and patients diagnosed before 2017. Conclusions: This analysis of real world data shows that test utilization has increased but there remains room for improvement. While testing ineligible patients is an inefficient use of resources (smokers with squamous histology), smokers with a small biopsy should be tested as they might be harboring an actionable driver mutation. Eligible patients still remain untested and potentially missing therapeutic options.

e21586 Background: ALK mutation rate is widely reported to be 3-7% of advanced non-small cell lung carcinoma (aNSCLC) patients. A cross-sectional study to assess the prevalence of ALK mutations in the real world was performed on the nationwide Flatiron Health electronic record-derived de-identified database. Methods: Patients with aNSCLC (stage IIIB-IV) diagnosed between 1 Jan 2015 – 31 May 2019, age ≥18 at the time of aNSCLC diagnosis, known ALK result and smoking status were included in the analysis. The included patient cohort had 19,895 eligible patients, with a mean age of 68.5 (Standard deviation = 10.0), most of them were ever-smokers (85.5%) and from community centers (92.2%). Results: The overall ALK mutation prevalence was 2.6%. Prevalence of ALK mutation was calculated by age, gender, race, ECOG status and cancer type. Non-smokers had the greatest mutation rate (9.3% non-squamous histology, 6.3% NSCLC histology not otherwise specified [NOS], 3.3% squamous) vs smokers (1.7% non-squamous, 1.4% NSCLC NOS, 0.7% squamous). Differences in ALK status varied by age and race with young patients (18-44 yrs) having a greater mutation rate (16.2%) vs older patients (age 45-64 = 4.5%, age ≥ 65 = 2.2%) and Asian patients having a mutation prevalence of 6.3%. Patients that were positive for other biomarkers (EGFR, ROS1, KRAS or BRAF) had a lower ALK positivity rate (0.5%) while patients reported to be positive for PD-L1 had an ALK mutation rate of 3.0%. Conclusions: While this data overwhelmingly represented testing in the community setting vs academic medical centers, it provides insight into the ALK mutation prevalence across the US. The prevalence of ALK mutations in smokers suggests that a smoking patient (with non-squamous, mixed histology or small biopsy) should not be excluded from testing. This also highlights the need to capture smoking histories as accurate pack-year histories