Getting Tissue for Molecular Testing: An NSCLC Strategic Initiative Activity Summary Date: Jan, 2015 CME Credit Provider: Temple University School of Medicine Collaborators: Association of Community Cancer Centers (ACCC), Fox Chase Cancer Center, and MCM Education Grant Supporter: Pfizer Start Date: March, 2013 End Date: Jan, 2015 Table of Contents Executive Summary ....................................................................................................................................... 1 Introduction .................................................................................................................................................. 2 Planning Committee: .................................................................................................................................... 3 Learning Objectives ....................................................................................................................................... 3 Participating Cancer Centers ......................................................................................................................... 3 QI Initiative Design ........................................................................................................................................ 5 Molecular Testing Rates: Pre (Baseline) vs. Post (Follow-Up) ...................................................................... 5 QI Summary of Centers ................................................................................................................................. 6 Remaining Educational Gaps ...................................................................................................................... 12 Future Opportunities for QI ........................................................................................................................ 13 Conclusion ................................................................................................................................................... 13 Appendix ..................................................................................................................................................... 15 Executive Summary 1 Getting Tissue for Molecular Testing: An NSCLC Strategic Initiative was a systems-based quality improvement (QI) initiative developed for medical oncologists, pathologists, pulmonologists, radiologists, surgeons, nurses, cancer registrars, and other health care professionals involved in the treatment of patients with non-small cell lung cancer (NSCLC). This initiative was implemented through a multifaceted collaboration among Temple University, Fox Chase Cancer Center, the Association of Community Cancer Centers (ACCC), and MCM Education. This initiative was focused on guiding five community cancer centers through quality improvement methodologies designed to help them improve molecular testing in patients with advanced NSCLC. ACCC invited member centers to participate in this QI initiative and recruited five centers around the country. Each of the participating centers collected baseline data on their molecular testing rates for EGFR and/or ALK and processes for patients with advanced NSCLC. Working through a series of focus groups, workshops, and educational sessions, each cancer center identified key opportunities for process improvement and implemented them over the course of a year using Plan-Do-Study-Act (PDSA) cycles for process improvement. Follow-up data on molecular testing rates and processes reveal that each of the centers made significant process changes and educated their clinicians about the importance of properly identifying and targeting molecular pathways of tumor progression in advanced NSCLC. The average baseline molecular testing rate for advanced NSCLC was 68% when the initiative began in mid-2013 and the average follow- up molecular testing rate for advanced NSCLC improved to 89% at the end of 2014. Clinicians and administrators at each participating center acknowledged the value that this initiative provided at their centers and stated that they would continue to identify key opportunities to make ongoing quality improvements in the area of molecular testing in advanced NSCLC. This activity summary provides an analysis of key outcomes data, with complete outcomes data (to date) found in the Appendix at the end of this document. Introduction Recently, treatment for advanced NSCLC has expanded beyond chemotherapy as the cornerstone of treatment to include a new generation of targeted therapies that interfere with the cellular pathways involved in tumor growth, progression, and cell death. The use of molecularly targeted therapies represents a significant advance in the treatment of patients with advanced NSCLC. However, there remains a major gap between the optimal management of advanced NSCLC and current clinical practice because molecular testing is often not being performed in patients who may benefit from molecularly targeted therapies. Furthermore, many oncologists in the community remain unaware of how best to apply the latest clinical evidence when managing complex patients with advanced NSCLC. However, there remain significant gaps between the optimal management of patients with advanced NSCLC and current clinical practice in the community setting. Clinicians often remain unaware of new 2 and emerging clinical evidence and how best to apply these advances to their clinical practice. The goal of this QI initiative was to bring members of the interdisciplinary care team together to identify, discuss, and implement changes designed to improve their molecular testing process for patients with advanced NSCLC. Planning Committee: Hossein Borghaei, MS, DO (Chair) Director, Thoracic Medical Oncology Co-Leader, Thoracic Cancer Service Line Fox Chase Cancer Center Philadelphia, PA David Feller-Kopman, MD Luis H Camacho, MD Director, Bronchoscopy and Interventional Director, St Luke’s Cancer Center Pulmonology St. Luke’s Kirby Glen Outpatient Center Associate Professor of Medicine Houston, TX Johns Hopkins Hospital Baltimore, MD Ritu Randhawa Gill, MD Fred R. Hirsch, MD, PhD Assistant Professor Professor of Medicine and Pathology Department of Radiology Associate Director for International Programs Brigham and Women's Hospital University of Colorado Cancer Center Boston, MA Aurora, CO Learning Objectives Upon completion of this educational activity, the participant should be able to: 1. Discuss the importance of obtaining adequate tissue samples at biopsy of patients with NSCLC in order to do molecular testing. 2. Discuss the impact of an inadequate tissue sample on patient treatment and outcomes. 3. Explain the challenges that may arise in obtaining an adequate tissue sample and strategies to overcome these challenges. 4. Identify targeted treatments that would be indicated for patients with advanced NSCLC with positive biomarker findings. 5. Develop strategies to improve communication across all NSCLC team members. Participating Cancer Centers 3 Fox Chase Cancer Center 333 Cottman Avenue Philadelphia, PA. 19111 Harbin Clinic Tony E. Warren, MD Cancer Center 255 West Fifth Street Rome, GA 30165 Holy Cross Hospital 1500 Forest Glen Road Silver Spring, MD 20910 Lancaster General Hospital Ann B. Barshinger Cancer Institute 2102 Harrisburg Pike Lancaster, PA 17604 Skagit Valley Hospital 307 South 13th Street Mount Vernon, WA 98273 4 QI Initiative Design Getting Tissue for Molecular Testing: A NSCLC Strategic Initiative Gather and Initial Focused Lecture Interdisciplinary Interdisciplinary and Workshop Concluding Review Baseline Tumor Board Interdisciplinary Data Workshop (#1) Specifically for: - Case discussions Workshop (#2) - Review data and - Determine % of Interventional around NSCLC - Review molecular testing in current process Radiologists, patients (2- 3 NSCLC patients for molecular processes for Pulmonologists, Cases) molecular testing -- Utilize available testing Surgeons - Discuss the registries - Identify barriers - Share application of outcomes/ results -Conduct focus and strategies to molecular testing groups and surveys Medical overcome results - Discuss future within the center to barriers oncologists startegies for identify key barriers continuing -Plan for - Determine key improvement strategies for improvement improvement Pathologists Molecular Testing Rates: Pre (Baseline) vs. Post (Follow-Up) Fox Chase Lancaster Harbin Clinic Skagit Valley Holy Cross Average Cancer General Hospital Hospital Center Hospital Baseline data time Jan 2011- Jan 2011 – Jan 2011 – Jan – Dec Jan – Dec period Dec 2012 (24 Dec 2012 (24 June 2012 2012 (12 2012 (12 months) months) (18 months) months) months) NSCLC total 259 303 81 52 79 NSCLC per year 129 151 54 52 79 93 Stage IV lung 84 68 37 8 19 43.2 adenocarcinoma Molecular testing 84% 65% 76% 62% 53% 68% rate (Stage IV lung adenocarcinoma) Follow-up data Jan 2013 – Jan 2013 – June 2013- Nov 2013 – Jan 2014 – time period Oct 2014 (22 August 2014 June 2014 May 2014 (7 May 2014 (5 months) (20 months) (13 months) months) months) Stage IV lung 117 37 16 11 32 adenocarcinoma Molecular testing 100% 81% 75% 91% 100% 89% rate (Stage IV lung adenocarcinoma) 5 QI Summary of Centers Fox Chase Cancer Center Fox Chase Cancer Center in Philadelphia, PA is accredited by the Commission on Cancer as an NCI Designated Comprehensive Cancer Program. Founded in 1904 in Philadelphia as American Oncologic Hospital – one of the nation's first cancer hospitals—Fox Chase Cancer Center (FCCC) was also