Learning Objectives. Financial Disclosure. Breast Cancer Quality Improvement Project with Oncotype DX. Nothing to disclose

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1 Breast Cancer Quality Improvement Project with Oncotype DX Denise Johnson Miller, MD, FACS Medical Director Breast Surgery Hackensack Meridian Health Legacy Meridian (Jersey Shore University Medical Center, Riverview Medical Center, Bayshore Hospital, Ocean Medical Center) Neptune City, NJ Nothing to disclose Financial Disclosure Learning Objectives Discuss role of genomic testing in staging and adjuvant treatment of breast cancer Identify best practice guidelines for patients with early stage breast cancer Discuss data on patients with 1-3 positive lymph nodes and role of genomic testing

2 Benefits of Standardization SURGEON SATISFACTION Consistent standard ordering process for all eligible patients at time of diagnosis MED ONC SATISFACTION Recurrence Score results are available to guide treatment decisions prior to initial patient visit More Clarity Amongst All Stakeholders PATIENT SATISFACTION Reduced anxiety and decreased time to treatment due to a seamless and well-coordinated process Impact of Standardization on Performance to NAPBC/COC Metrics Compliance with Guidelines (Standard 1.3) Oncotype DX is incorporated into the NCCN (node negative and node positive; 2A level of evidence) and ASCO guidelines Responsibility & Accountability (Standards 1.1, 1.2) Quality & Outcomes (Standards 6.1, 6.2) Timing of Care (Standards 2.12, 2.13) Monitoring & Compliance with Evidence-Based Guidelines (Standard 4.6) Quality Improvements (Standard 4.8) Studies of Quality (Standard 4.7) Potential Impact of Standardization on Performance to NAPBC Metrics NAPBC accreditation requires compliance with evidence-based guidelines (Standard 1.3) Oncotype DX is incorporated into the NCCN and ASCO guidelines Medical Oncology (Standard 2.13) Chemotherapy and/or hormonal therapy is delivered in a timely manner Radiation Oncology (Standard 2.12) Radiation therapy is administered within one year of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer Quality Improvement (Standard 6.2 ) Annual performance rates are reported for each of the measures identified by the NAPBC, and performance is evaluated annually by the Breast Program Leadership (BPL) Quality and Outcomes (Standard 6.1) Each year, the breast program leadership conducts or participates in two or more studies that measure quality and/or outcomes

3 Bayt et al. St. Gallen Markopoulos et al. Eur J Oncol Filipits et al. Clin Cancer Res Martin et al. Breast Cancer Research Sgroi et al. Lancet Oncol Zhang et al. Clin Cancer Res NCCN Clinical Practice Guidelines in Oncology. V NICE Diagnostics Guidance Harris et al. J Clin Oncol Senkus et al. Ann Oncol Coates et al. Ann Oncol Guidelines Breast Cancer Version Sparano et al. N Engl J Med Petkov et al. npg Breast Cancer Shak et al. ASCO QCS Gluz et al. J Clin Oncol Stemmer et al. SABCS Stemmer et al. ESMO Miller et al. ESMO Shak et al. ESMO Cardoso et al. N Engl J Med Drukker et al. Int J Cancer van de Vijver et al. N Engl J Med Buyse et al. J Natl Cancer Inst AJCC Cancer Staging Manual 8 th edition 2017 Inclusion of Oncotype DX into AJCC 8 th Edition Staging Manual the Expert Panel determined that it was appropriate to incorporate multigene molecular profiling to incorporate the Oncotype DX score into staging for the subgroup of patients defined by Arm A of the TAILORx study (including Oncotype DX Recurrence Score less than or equal to 10). (Emphasis added.) When T When N When M And G And HER2 And ER And PR The Prognostic is is is is Status Status Status Stage Group is is is is MultiGene Panel** - Oncotype DX Recurrence Score Results Less Than 11 T1-T2 N0 M0 1-3 Negative Positive Any IA **If Available Oncotype DX is the only multigene test supported by prospective Level 1 evidence included in the new Prognostic Stage Group table Adapted from Amin MB, Edge S, Greene F, et al, eds. AJCC Cancer Staging Manual. 8th ed. New York, NY; Springer Publishing; Comparison of Genomic Breast Cancer Tests Genomic Health Oncotype DX NanoString Prosigna Agendia MammaPrint biotheranostics Breast Cancer Index Myriad EndoPredict Validated for Node Negative and Node Positive Prognosis 1-6 Pre-Menopausal Post-Menopausal Homogenous Populations Validated for Prediction of Chemotherapy Benefit 1 Inclusion in Major International Guidelines NCCN Algorithm 7 and NICE (UK) 8 NCCN Discussion Section 7 ASCO 9 ESMO 10, St. Gallen 11 and AGO 12 Prospective Outcomes Evidence >63,000 patients13-20 >7, Inclusion in AJCC 8 th Edition Cancer Staging Manual for assignment of Prognostic Stage Group 1A 25 Additional Clinical Evidence DCIS, Neoadjuvant, Late Neoadjuvant, Late Recurrence, Adjuvant Recurrence Hormonal Therapy Benefit Neoadjuvant Late Recurrence, Extended Hormonal Therapy Benefit Late Recurrence NCCN and NCCN Guidelines are trademarks of the National Comprehensive Cancer Network. ASCO is a trademark of the American Society of Clinical Oncology. AJCC is a trademark of the American College of Surgeons. NCCN, ASCO, ESMO, St. Gallen, NICE, AGO and AJCC do not endorse any product or therapy. The Only Multigene Assay Incorporated Into All 4 Major Guidelines to Predict Adjuvant Chemotherapy Benefit in ER+, HER2 Early-Stage Breast Cancer NCCN Guidelines > 0.5 cm, node-negative, N1mi Quantifies the risk of recurrence as a continuous variable Predicts responsiveness to tamoxifen and chemotherapy 1 ASCO Guidelines Node-negative Predicts the risk of recurrence in tamoxifen-treated patients May be used to identifies patients likely to benefit from chemotherapy 2 St Gallen Consensus Node-negative, node-positive Provides prognostic AND predictive information on the utility of cytotoxic therapy in addition to endocrine therapy 3 NICE Node-negative Recommended for guidance of chemotherapy decisions in patients at intermediate risk * of distant recurrence 4 1. NCCN Practice Guidelines in Oncology. V Harris L, et al. J Clin Oncol Goldhirsch A, et al. Ann Oncol NICE Diagnostics Guidance ASCO is a trademark of the American Society of Clinical Oncology. NCCN and NCCN Guidelines are trademarks of the National Comprehensive Cancer Network. The guidelines do not endorse products or therapies. *Intermediate risk of distant recurrence is defined as Nottingham Prognostic Index score above 3.4 or being at intermediate risk by other decision making tools or protocols

4 Genomic Health Pathology Surgery Increase Value through Evidence-Based, Guideline Supported Pathways How can information that is critical to treatment decision making be reliably delivered within three weeks of breast surgery? What impact will this have on the patient experience? What impact will this have on patient flow within the cancer center? Can this information be utilized as part of quality metrics? Legacy Meridian Quality Initiative (QI) Schedule Pre-QI Program (September 1, 2014 August 31, 2015) QI Program (September 1, 2015 August 31, 2016) Post-QI Program (September 1, 2016 August 31, 2017) Standardized Workflow (PATHOLOGY) Patient Undergoes Surgery Steps: 3 TAT: 8-9 days Staff Time: 1 Hour END Pathologist reviews resection No Specimen meets Standing Order Criteria Yes Lab Personnel Orders ODX in Portal and Block Fed-exed to GHI Cycle Time: minutes Invasive BC, ER+, HER2(-), N0-Nmic, T1-T2, <80yrs, Exclusion of certain patients based on tumor board discussion GHI receives Block and Report available in 7-10 days

5 Impact of Standardization Time from Surgery to Oncotype DX Report Pre-Standardization Post-Standardization % Reduction (10 days) Surgery Order Tissue Report Greatest Impact Consistent Patient Management Reduced Variability Consistent Patient Management Reduce variability in care Increase compliance to guidelines Receive Recurrence Score report for personalized decision making % of Eligible Patients for Oncotype DX 56% 65% National Average: SEER Data Review: 1 (n=22,971 Elig Pts) = 41% NCDB Review: 2 (n=158,235 Elig Pts) = 36% npj Breast Cancer 2, Article number: (2016) doi: /npjbcancer SEER San Antonio Breast Cancer Symposium Presentation, Dec Am J Surg Jun0. pii:s (17) doi: /j.amjsurg [Epub ahead of print] Turnaround Times (reported IBC orders only) Legacy Meridian (September 1, 2014 August 31, 2017) Pre-QI Program (average calendar days) QI Program (average calendar days) Post-QI Program (average calendar days) Order Start Date to Specimen Received TAT 5.7 Order Start Date to Specimen Received TAT 3.4 Order Start Date to Specimen Received TAT 3 Specimen Receipt Date to Report 6.5 Specimen Receipt Date to Report 8.4 Specimen Receipt Date to Report 7.4 Order Start Date to Report 12.2 Order Start Date to Report 11.8 Order Start Date to Report 10.4 Surgery Date to Order Start 28.8 Surgery Date to Order Start 19.3 Surgery Date to Order Start 17.2 Surgery Date to Report 41.1 Surgery Date to Report 31.2 Surgery Date to Report 27.7

6 Invasive Breast Cancer Order Volume by Physician (Top 5) Legacy Meridian (September 1, 2014 August 31, 2017) Pre-QI Program QI Program % 14 7% 9% % 12% % 30 19% 43% 30% 34 22% Debra Ellen Physician Camal A Denise J. Physician Miller B Kenneth Physician David Nahum C Apurv Agrawal Physician D Michael Physician Joshua Levitt E Debra Camal Physician A Denise Johnson Physician Miller B Catherine Physician Campo C William Physician Adams D Namita Physician Gupta E Total Invasive Breast Cancer Order Volume by Patient Age Legacy Meridian (September 1, 2014 August 31, 2017) Pre-QI Program QI Program 1 0% 45 20% 86 38% 4 2% 40 18% 49 22% 67 28% 5 2% 72 30% 7 3% 29 12% 59 25% Total Invasive Breast Cancer Risk Distribution Legacy Meridian (September 1, 2014 August 31, 2017) QI Program 15 6% National Average 8% 69 29% % 38% 54% Low Intermediate High Low Intermediate High

7 Key Findings Standardization of Oncotype DX Utilization and Ordering: Compliance to National Guidelines increased from 56% to 65% in NCCN eligible patients Implementing standardization shortened Time to Report by 10 days (Post QI is now 13 days) Standardization increased pathology efficiency Improved performance and measurement to key quality metrics Used as quality improvement project to meet NAPBC accreditation requirement Summary Oncotype DX utilization and ordering is feasible in a large, multiinstitutional organization Standardization increases process efficiency leading to measurable and meaningful improvements in quality of care Standardization allows for Identification of sources of delays and inefficiency within the process thereby improving consistency/quality of care QI workflow has a favorable effect on consistency of patient management across the organization Extras

8 Turn Around Time Definitions Surgery to Order Order to Tissue Tissue to Report Surgery to Order TAT: The average turn around time from the surgery date (of the specimen tested) to placing the Oncotype DX order Order to Tissue TAT: The average turn around time from the Oncotype DX order to the tissue received at Genomic Health. Tissue to Report TAT: The average turn around time from the tissue receipt at Genomic Health to the date the Oncotype DX report is available on the portal. Surgery Order Tissue Report TOTAL TAT: The total turn around time from Surgery to Report. TOTAL TAT