Aaron Scholnik, M.D., P.K. Pathak, Ph.D., Principal Investigators

1. Michigan Basic Pathology Lexicon Project and Reporting Formats for Cancer Aaron Scholnik, M.D., P.K. Pathak, Ph.D., Principal Investigators John McPhail, (Project Manager), Renu Pandit, M.D., Asif Masood, M.D., Department of EpidemiologyMichigan State University • East Lansing, MI

2. Vision Develop a format which: • Is scientifically validated, clinically useable, and user friendly • Is a common format for hospitals across Michigan • Concept to be extended to other anatomical sites and pathology specimens (biopsies, excisions)

3. Early 2005 Priority Objective Goal for Standardized (Basic) Lexicon: • (Pages 4-5)By 2006, develop and disseminate basic pathology protocols and reporting formats for examination of cancerous tissue specimens and determine the need for similar surgical pathology reporting formats that include data important in making breast and prostate (including core biopsies), cervical, colorectal (including polypectomies that contain cancer), and lung cancer treatment and prognostic decisions. *Note: This will now include breast and prostate needle biopsies, colorectal polypectomies, and other endoscopic biopsies.

4. Updated Priority Objective Goal: • “By 2006, finalize, disseminate, and evaluate basic pathology lexicons for breast, prostate, and colorectal, cervix and lung cancers to include information for making prognostic and treatment decisions. Further expand the number of pathology lexicons to include all common cancer types to enhance their adoption as a reporting system.”

5. Pathology LEXICON • Is a collaborative effort of MDCH, MSU, and other institutions to generate a consensus format for the reporting of breast, colorectal, and prostate cancers.

6. Cooperating Organizations • Michigan Department of Community Health • Michigan Society of Tumor Registrars (page 16) • Michigan Society of Pathologists (pages 17-19) • American College of Surgeons • Michigan Public Health Institute – Cancer Control Services Project • Michigan Society of Hematology and Oncology

7. A “Call to Action”Implications for MCC Member Organizations over the next 2 years: • FOCUS- Lab Facilities/Health Care Systems • Educate health care professionals regarding the methodology and benefit of incorporating a basic lexicon to improve cancer diagnosis and treatment. • Encourage participation in the pilot/evaluation phase of the draft template of the basic lexicon within your facility/organization. • Support use of the finalized product (template) within all MI facilities/organizations.

8. ACOS-CoC Guidelines for Cancer Reporting • (Page 6) The Cancer Program Standards 2004 publication specifies that the CoC requires 90 percent of pathology reports which include a cancer diagnosis will contain the scientifically validated data elements outlined on the surgical case summary checklist of the College of American Pathologists (CAP) publication, Reporting on Cancer Specimens.

9. ACOS-CoC Guidelines for Cancer Reporting 1) A specific style of report is not required. Both synoptic or narrative reporting are acceptable, however, synoptic reporting is preferred. 2) There is no set orderin which the elements must appear.

10. ACOS-CoC Guidelines for Cancer Reporting 3) No specific location for the scientifically validated elements within the pathology report has been set. For example, the scientifically validateddata elements may be reported in either the Macroscopic [gross] description, the Microscopic description, the Pathologic Diagnosis, or the Special Studies section of the report.

11. Steering Committeeand Expert Panel • Please see pages 7, 8, 9, and 10

12. LEXICON in the Making • Gathered data from 52 facilities across MI, which report at least 250 cases/year • Hospitals were requested to submit their formats/checklists to identify their cancer reporting practices • Each institution was expected to submit only one format for each cancer site, independent of the # of pathologists/institution • No actual pathology reports were required

22. Pathology LEXICON Template (pages 12-15) _____ COLON RESECTION SPECIMEN: _____________________ 6TH ADDITION AJCC STAGING: pT__ pN__ pM__ ---------------------------------------------------------------------------------------------------------------- HISTOLOGY Histologic Type: _______ Histologic Grade: _______ Deepest bowel layer invasion: _______ MARGINS (yes,no) Proximal and distal: _______ for tumor cm from tumor to margin: _______ Radial: _______ cm from tumor to margin: _______ for tumor VISCERAL PERITONEUM: ______ for tumor VASCULAR / LYMPHATIC STATUS (yes,no) Large vessel: _______ for tumor Small vessel: _______ for tumor Lymphatics: _______ for tumor LYMPH NODES: ______ of _____ nodes contain tumor ADDITIONAL PATHOLOGY: ______ COMMENTS: ______

23. ____ PROSTECTOMY SPECIMEN: ADENOCARCINOMA AJCC 6TH EDITION STAGING: pT __ pN__ pM __ ------------------------------------------------------------------------------------------------------ HISTOLOGIC PATTERN / SCORE Primary: _____ of 5 Secondary: _____ of 5 Tertiary: _____ of 5 Total Gleason Score: _____ of10 EXTENT OF SPREAD *Right gland replaced: _____ % *Left gland replaced: _____ % Portion of total gland replaced: _____ % Margins of excision: _____ If present, location(s): _____ Involvement of apex margins: _____ Extracapsular extension: _____ If present, location(s): _____ Seminal Vesicle Invasion: _____ If present, location(s): _____ Other pelvic tissue: _____ If present, location(s): _____ *Perineural: _____ *Venous: _____

24. __________ BREAST SPECIMEN: __________ carcinomaAJCC 6TH EDITION PATHOLOGIC STAGING: pT__ pN__ pM__ ---------------------------------------------------------------------------------------------------------------------- HISTOLOGY, INVASIVE Nottingham grade (specify if other): _______ of 3 Greatest dimension: _______ cm HISTOLOGY, IN SITU Type: _______ Grade: _______ of 3 Extent (> or < than 25% of mass): _______ PROGNOSTIC MARKERS / RECEPTORS Estrogen : _______ Progesterone: _______ Her2-neu: _______ LOCAL EXTENT OF SPREAD Lymph nodes, Macro-metastasis ( > 2.0 mm): ___ of ___ nodes positive for tumor Lymph nodes, Micro-metastasis (> 0.2 but < 2.0 mm): ___ of ___ nodes positive for tumor Lymph nodes, Isolated tumor cells/clusters (< 0.2 mm): ___ of ___ nodes positive for tumor Margin analysis Invasive carcinoma: _______ for invasive carcinoma If positive extent: _______ If neg., cm to margin: ___ cm. In situ carcinoma: _______ for in situ carcinoma If positive, extent: _______ If neg., cm to margin: ___ cm. Lymphatic invasion: _______ Vascular invasion: _______ Microcalcifications: _______ Skin ulceration: _______ Satellite skin nodules: _______ OTHER: _______

25. LEXICON on the Road Lexicon was presented at: • MCC Annual Meeting 2003 and received “Spirit of Collaboration” award • MICRA Annual Meeting, Sept. 2003 • MSP Meeting, 2004 • MCC Priority Review, June 16, 2004

26. Collaborative Efforts • Identified similar projects in Ohio and California • Held teleconferences and learned from their experiences

27. Piloting LEXICON • Lexicon has been tried at participating institutions: Ingham Regional Medical Center, Marquette General Hospital, and Wayne State/Karmanos Cancer Institute

28. Evaluation Instrument • An evaluation instrument has been developed (please see page 20) • This could be completed on paper or on the web

29. LEXICON – An Evolving Concept • LEXICON is all about sharing knowledge and developing grounds for mutual understanding and agreement. We are looking forward to learning from you, your thoughts, and your feedback.

30. LEXICON Agreement (Page 30) • Templates designed so far are in a DRAFT form only. • Please disseminate only once they are finalized.

31. A Review of the Priorities and Recommendation to MCC Board Early 2005 Priority Updated Priority Objective Goal By 2005, develop and disseminate basic pathology protocols and reporting formats for examination of cancer tissue specimens and determine the need for similar surgical reporting formats that include data important in making breast, cervical, colorectal, lung, and prostate cancer treatment and prognostic decisions. *Note: This will now include breast and prostate needle biopsies, colorectal polypectomies, and other endoscopic biopsies. “By 2006, finalize, disseminate, and evaluate basic pathology lexicons for breast, prostate, and colorectal, cervix and lung cancers to include information for making prognostic and treatment decisions. Further expand the number of pathology lexicons to include all common cancer types to enhance their adoption as a reporting system.”

32. Recommendation from the Board (continued…) Change the name of the project from: The Michigan Common (or Standardized) Pathology Lexicon Project to: The Michigan Basic Pathology Lexicon Project