Financial Disclosure. Learning Objectives. Use of Genomics in the NCDB, Early Data Analysis. I have no financial disclosures

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1 Use of Genomics in the NCDB, Early Data Analysis Katharine Yao, MD Chief, Division of Surgical Oncology NorthShore University HealthSystem Chair, QI Committee, NAPBC Financial Disclosure I have no financial disclosures Learning Objectives To learn what genomic testing information is available in the NCDB Oncotype vs test not done Genomic testing utilization NAPBC vs. non-napbc facilities Genomic testing and AJCC 8 th edition

2 Multigene Panels Oncotype Mammaprint Multigene Panels Started in 2010 Variable Oncotype Dx Mammaprint Other testing Test performed, type unknown Test not done, not performed Unknown Total Oncotype Utilization Of 143, 000 patients, % had Oncotype scores Lower use of Oncotype associated with Older age Black and non white races Governmental health insurance compared to private insurance Jasem JCO 2016;34:1995

3 NCDB Study Jasem JCO 2016;34:1995 Jasem JCO 2016;34:1995 NCCN Criteria for Oncotype NCDB PUF NCCN criteria pt1 or T2 tumor ER positive Node negative (did not include N1mi) HER2neu negative

4 Percent Frequency in Patient Fulfilling NCCN Criteria, Variable Proportion of Patients Oncotype Dx 87,041 (40.9%) Mammaprint 2167 (1.0%) Other testing 786 (0.4%) Test performed, type unknown 333 (0.2%) Test not done 86,081 (40.5%) Unknown 36,204 (17.0%) Total 212,612 patients Oncotype Scores Original criteria Percentage of Patients Low risk (0-17) 59% Intermediate risk (18-30) 31% High risk (>=31) 10% Proportion of Patients Not Undergoing Chemotherapy, Variable No chemotherapy p value Oncotype Dx 78.0% p<0.001 Test not done 69.0% p<0.001 Mammaprint 62.0%

5 Patient Characteristics of Oncotype vs. Test Not Done Variable Oncotype Test not done Age <50yo 51-70yo >70yo Race Caucasian African American Hispanic Asian Pacific Islander Other 25.9% 62.3% 11.8% 84.5% 7.4% 4.3% 3.2% 0.6% 14.2% 50.5% 35.3% 84.3% 7.9% 4.5% 2.8% 0.5% Patient Characteristics of Oncotype vs. Test Not Done Variable Oncotype Test not done Insurance No insurance Private/managed care Medicaid Medicare Other/unknown 1.4% 63.8% 5.1% 27.7% 2.0% 1.3% 43.8% 4.3% 48.7% 1.9% Facility Characteristics of Oncotype vs. Test Not Done Variable Oncotype Test not done Facility type Community Comprehensive community Academic Integrated network 9.5% 47.3% 32.1% 11.0% 11.3% 49.8% 27.7% 11.1%

6 Regional Location of Oncotype vs. Test Not Done 9.3% 12.2% 5.3% 5.0% 8.4% 9.0% 4.5% 6.1% 20.5% 19.4% 5.4% 5.2% 17.5% 13.5% 22.6% 22.1% 6.5% 7.5% Oncotype Test not done Oncotype Score NCDB PUF Approximately a fifth of eligible patients unknown if Oncotype done or not Oncotype test associated with less utilization of chemotherapy Disparity in Oncotype test Race, location, insurance, age Oncotype Utilization NAPBC Database 2013

7 Comparison of non-napbc and NAPBC Facilities, 2013 Variable Non-NAPBC Facilities NAPBC Facilities Oncotype Dx 32.5% 36.9% Mammaprint 1.2% 1.2% Other testing 0.5% 0.5% Test performed, type unknown 0.1% 0.1% Test not done 44.3% 44.9% Unknown 21.4% 16.4% Comparison of non-napbc and NAPBC Facilities, Within NCCN Criteria (pn0), 2013 Oncotype within criteria Non-NAPBC NAPBC p value 95.3% 96.5% <0.001 Total # of pts 9, 413 9, 867 Proportion Receiving Chemotherapy Stratified by Oncotype Recurrence Risk, 2013 Oncotype Recurrence Score Non-NAPBC Facility NAPBC Facility Low (0-17) 3.1% 2.8% Intermediate (18-30) 34.6% 36.3% High (>=31) 85.7% 85.7%

8 % Receiving CT % Receiving CT % Receiving CT Non-NAPBC vs. NAPBC: Tumor Size Tumors <1cm Tumors 1-2cm Non NAPBC NAPBC 60 Non NAPBC NAPBC OncoType Score OncoType Score Non-NAPBC vs. NAPBC: Tumor Size 120 Tumors 2-3cm Non NAPBC NAPBC OncoType Score Non-NAPBC vs. NAPBC: Tumor Grade

9 Comparison of non-napbc and NAPBC Facilities, Node Positive Patients Oncotype within criteria Non-NAPBC NAPBC p value 88.0% 91.0% <0.001 Total # of pts 1, 352 1,416 Proportion Receiving Chemotherapy Stratified by Oncotype Recurrence Risk, Node Positive Patients, 2013 Non-NAPBC Facilities NAPBC Facilities Low Risk (0-17) 29.5% 27.5% Intermediate Risk (18-30) 57.5% 59.4% High Risk (>=31) 88.5% 87.5% NAPBC vs. non-napbc Slightly higher use of Oncotype at NAPBC facilities Utilization of chemotherapy not different Tumor size, grade Node negative vs node positive

10 AJCC 8 th Edition New AJCC staging manual includes Oncotype score Prognostic group-favorable ER positive Her2neu negative Node negative Any tumor size Oncotype score <= 11 Prospective Validation of Oncotype Prospective study 15.9% of women had Oncotype score of 0-10 OS 98.0% Sparano JA et al, NEJM 2015 Low Risk Oncotype in NCDB NCDB ,103,681 pts Noninvasive disease Stage IV disease ER negative PR negative Her2neu positive Node positive disease 220, 561 Patients ER+/PR+/HER2neu No tumor size Node negative

11 Low Risk Oncotype in NCDB 220, 561 pts Favorable prognostic group AJCC 8 th edition 87,219 (40%) had Oncotype 22,609 (26%) had an Oncotype score <11 Oncotype <11 Factor % Tumor size 0-0.5cm cm cm >2.0cm Tumor grade I II III Age <50yo 51-70yo >70yo Tumor histology Ductal Lobular 3% 24% 52% 21% 38% 56% 6% 23% 63% 14% 89% 11% Summary Oncotype underutilized? Age? Socioeconomic? Low risk Non NAPBC and NAPBC similar Under-reporting of Oncotype

12 Conclusions NCDB powerful tool to measure Oncotype Trends Patterns of utilization Decrease unknown values Oncotype variable in the NCDB Thank You