Aaron Scholnik, M.D.Asif Masood, M.D.

Department of MedicineDivision of Hematology/Oncology

Michigan State UniversityEast Lansing, MI

Michigan Common Pathology Lexicon Project

and Reporting Formats for Cancer:

An MCC Priority Review

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)

The Current Priority Objective Goal for a Common Lexicon:

• By 2005, develop and disseminate standardized pathology protocols and reporting formats for examination of cancerous 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 did not specify breast and prostate core biopsies and colorectal polypectomies.

Recommendation for Updated Priority Objective Goal:

• By 2006, develop and disseminate common 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.

A Focus for the Future – after 2006:

• Expand the pathology protocols and reporting formats to include ALL the common tumor sites and tissue samples.

Pathology LEXICON

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

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 common lexicon to improve cancer diagnosis and treatment.

• Encourage participation in the pilot/evaluation phase of the draft template of the common lexicon within your facility/organization.

• Support use of the finalized product (template) within all MI facilities/organizations.

ACOS-CoC Guidelines for Cancer Reporting

• 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.

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 order in which the elements must appear.

ACOS-CoC Guidelines for Cancer Reporting

3) No specific location for the scientificallyvalidated elements within the pathologyreport has been set.

For example, the scientifically validateddata elements may be reported in eitherthe Macroscopic [gross] description theMicroscopic description, the PathologicDiagnosis, or the Special Studies sectionof the report.

Steering Committeeand Expert Panel

• A steering committee and expert panel was convened to provide direction and advice for this important project.

• For more information contact Dr. Aaron Scholnik at ascholnik@mgh.org

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

Breast Cancer Check List

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Pathology LEXICON Template (pages 12-15)

@ COLON RESECTION SPECIMEN: @

6TH ADDITION AJCC STAGING: pT@ pN@ pM@

----------------------------------------------------------------------------------------------------

HISTOLOGY

Histologic Type: @ Histologic Grade: @ of

Deepest bowel layer invasion: @

MARGINS (yes,no)

Proximal and distal: @ cm from tumor to proximal/distal margin: Radial: @ cm from tumor to radial margin:

VISCERAL PERITONEUM: @ for tumor

VASCULAR / LYMPHATIC STATUS (yes,no)

Large vessel: @ Small vessel: @ Lymphatics: @

LYMPH NODES: @ of @ nodes contain tumor

ADDITIONAL PATHOLOGY: @

COMMENTS: @

@ PROSTECTOMY SPECIMEN: @ ADENOCARCINOMA

AJCC 6TH EDITION: pT@ pN@ pM@

 HISTOLOGIC PATTERN / SCOREPrimary: @/5 Secondary: @/5 Tertiary: @/5Total Gleason Score: @/10

EXTENT OF SPREAD *Right gland replaced: @ %

*Left gland replaced: @ % Portion of total gland replaced: @ %

Margins of excision: @ If present, location(s): @Involvement of Apex:Extracapsular extension: @ If present, location(s): @Seminal Vesicle Invasion: @ If present, location(s): @Other pelvic tissue: @ If present, location(s): @*Perineural: @*Venous: @

BREAST TISSUE, @ SPECIMEN: @ carcinomaAJCC 6TH EDITION PATHOLOGIC STAGING: pT@ pN@ pM@-------------------------------------------------------------------------------------------------------------HISTOLOGY, INVASIVE

Nottingham grade/other (specify): @ of 3 Greatest dimension: @ cmHISTOLOGY, IN SITU

Type: @ Grade: @ Extent: @LYMPH NODES

Macro-metastasis ( > 2.0 mm): @ of @ nodes positive for tumorMicro-metastasis (> 0.2 but < 2.0 mm): @ of @ nodes positive for tumorIsolated Tumor cells/clusters ( < 0.2 mm): @ of @ nodes positive

MARGIN ANALYSIS In situ carcinoma: @ Extent: @ If neg., cm to margin: @ cm.

Invasive carcinoma: @ Extent: @ If neg., cm to margin: @ cm.PROGNOSTIC MARKERS / RECEPTORS

Estrogen : @ Progesterone: @ Her2-neu: @ADDITIONAL MICROSCOPIC

Lymphatic invasion: @Vascular invasion: @

Microcalcifications: @ Skin ulceration: @ Satellite skin nodules: @

Other: @

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

Collaborative Efforts

• Identified similar projects in Ohio and California

• Held teleconferences and learned from their experiences

Cooperating Organizations

• Michigan Department of Community Health

• Michigan Society of Tumor Registrars

• Michigan Society of Pathologists

• American College of Surgeons

• Michigan Public Health Institute – Cancer Control Services Project

Piloting LEXICON

• Lexicon has been tried at participating institutions:

Ingham Regional Medical Center, Marquette General Hospital, and Wayne State/Karmanos Cancer

Institute

Evaluation Instrument

• An evaluation instrument has been developed

• This could be completed on paper or on the web

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.

LEXICON Agreement

• Templates designed so far are in a DRAFT form only.

• Please disseminate only once they are finalized.

A Review of the Priorities and Recommendation from the Board

By 2005, develop and disseminate standardized 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, cervical, colorectal, lung, and prostate cancer treatment and prognostic decisions.*Note: This did not specify breast and prostate core biopsies and colorectal polypectomies.)

By 2006, develop and disseminate standardized 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.

Current Priority Recommendation for Update

Basic Lexicon Priority

After final revisions, the following updated Lexicon

Priority was approved by the MCC Board:• By 2006, finalize, disseminate, and evaluate basic

pathology lexicons for breast, prostate, 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.