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

Michigan Basic Pathology Lexicon Project

and Reporting Formats for Cancer

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)

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.

•

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.”

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.

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

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.

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.

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

• Please see pages 7, 8, 9, and 10

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: _______ 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 tumorSmall vessel: _______ for tumorLymphatics: _______ for tumor

LYMPH NODES: ______ of _____ nodes contain tumor

ADDITIONAL PATHOLOGY: ______COMMENTS: ______

____ PROSTECTOMY SPECIMEN: ADENOCARCINOMA

AJCC 6TH EDITION STAGING: pT __ pN__ pM __------------------------------------------------------------------------------------------------------

HISTOLOGIC PATTERN / SCOREPrimary: _____ of 5Secondary: _____ of 5Tertiary: _____ of 5Total Gleason Score: _____ of 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 margins: _____ Extracapsular extension: _____ If present, location(s): _____

Seminal Vesicle Invasion: _____ If present, location(s): _____

Other pelvic tissue: _____ If present, location(s): _____*Perineural: _____*Venous: _____

__________ BREAST SPECIMEN: __________ carcinomaAJCC 6TH EDITION PATHOLOGIC STAGING: pT__ pN__ pM__----------------------------------------------------------------------------------------------------------------------

HISTOLOGY, INVASIVENottingham 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 SPREADLymph nodes, Macro-metastasis ( > 2.0 mm): ___ of ___ nodes positive for tumorLymph nodes, Micro-metastasis (> 0.2 but < 2.0 mm): ___ of ___ nodes positive for tumorLymph nodes, Isolated tumor cells/clusters (< 0.2 mm): ___ of ___ nodes positive for tumorMargin analysis

Invasive carcinoma: _______ for invasive carcinoma If positive extent: _______If neg., cm to margin: ___ cm.

In situ carcinoma: _______ for in situ carcinomaIf positive, extent: _______ If neg., cm to margin: ___ cm.

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

• MCC Priority Review, June 16, 2004

Collaborative Efforts

• Identified similar projects in Ohio and California

• Held teleconferences and learned from their experiences

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 (please see page 20)

• 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 (Page 30)

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

• Please disseminate only once they are finalized.

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.”

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