CENTRALIZED PROGRAMS OF THE BIOPSY DIAGNOSIS

OF SELECTED ONCOLOGICAL DISEASE SIN SLOVAKIA

Lukáš Plank

Department of Pathology Comenius University Jessenius Faculty of Medicine a nd University Hospital

and

Martin´s Biopsy Center, Ltd.

Martin, Slovakia

Siofok, 18. 05. 2012

2000 2004

2009

The pathology in Slovakia

� population 5,5 mil� < 100 active pathologists� approx. 40 labs/depts (3 university depts)

2000 2004

2009

The pathology in Slovakia

� population 5,5 mil� < 100 active pathologists� approx. 40 labs/depts (3 university depts)

� the whole autopsy/necropsy program from depts of Pa thol to aspecialized institution: The Healthcare Surveillance Authority

� clinical/surgical pathology only

� partial privatization

� Principle regulatory changes in 2004:

2000 2004

2009

Institutes of quality control (IQC) - pathology

� SWOT analysis - the weak point of the IQC:

� absence of a body/authority in the Slovak Republic p roviding the EQA

� Health care insurance companies:

� calls for IQC/ EQA

2000 2004

2009

Institutes of quality control (IQC) – pathology I.

� SWOT analysis - the weak point of the IQC:

� possible mechanisms and regulations – formal/legal i nstitutions

� absence of a body/authority in the Slovak Republic p roviding the EQA

� The Slovak National Accreditation Service - accredit ation of medical labs

� Certification Services:- Systems of Managment´s Quality (EN ISO 9001: 2000) and - Certification of Medical Laboratories (STN EN ISO 15 189: 2007)

� a real assessment of the quality ?

� Health care insurance companies:

� calls for IQC/ EQA

2000 2004

2009

Institutes of quality control (IQC) – pathology II.

� “home-made” internal QCs within individual labs / dep ts

� internal QC controls into the lab / analytical protoc ols, provided by producers of dg assays and/or analysator s

� informal institutes:

HercepTest

IHC

2000 2004

2009

Institutes of quality control (IQC) – pathology II.

� „home-made” internal QCs within individual labs / dep ts

� internal QC controls into the lab / analytical protoc ols, provided by producers of dg assays and/or analysator s

� 2nd look opinion / consultation centers:

- by larger / regional / Univ. Depts- based mostly on the natural respect / authority of the individual pathologists and/or

- by the agreement of Slovak pathologists /oncologist s, event. the Slovak Society of Pathology / SD-IAP

- by the Ministery of Health of the Slovak Republic

� informal institutes:

2000 2004

2009

� WHY ?:

� centralization of less common /rare oncol. disorders

� experiences or special dg. (costs / benefits)

� „2nd look opinion“ = confirmation / exclusion / finalizat ion of the dg

� if confirmation „only“, then + „added value“:

- typing, grading, etc,

- predictive / prognostic parameters

- molecular-biologic analyses and identification of the „t argets“

Programs of the centralized Dx of the oncol. disorde rs

Programs of the centralized Dx of the oncol. disorde rs

2000 2004

2009

� Hematooncology: ML, myeloid tumors (MPN, MDS, AML) + dif. Dx (MT)

� National centralized programs: network of depts + coordination / verification cent er in MT:

� HER2 (Ca mammae, ventriculi)

� rare GIT tumors (GISTs + NETs)

� RCC

� coordinated programs of specialized Dx:interdisciplinary + interinstitutional cooperation

� K-RAS (+ B-RAF) in CRC

� EGFR (+ ALK1) in NSCLC

� B-RAF in malignant melanoma etc.

� other „experts“: pediatric tumors, melanoma, CNS tumors etc.

� REGISTERS

Lymphomas

Leukemias/MDS

HER2

GIST

NET

RCC

NSCLC

etc...

2000 2004

since 2009

Centralized programs: Lymphomas and leukemias

� The Slovak Lymphoma Study Groupwww.lymphoma.sk

� standardization of the Dx and treatment of lymphoma patients

� clinical studies (incl. EORTC etc.)� international activities and cooperation, EAHP

� MPN

� Dx of MPN, incl. genetical markers of MPNs

2000 2004

Centralized programs: rare GIT tumors:GISTs + NETs

� central register of GIST: database of > 500 GISTs� mutations in C-KIT exon 9, 11, 13, 17 and PDGFRA exon 12, 14, 18� experimentally exon 8, B-RAF, SDH, etc

2000 2004

2009

Centralized programs: rare GIT tumors:GISTs + NETs

The Lancet Oncology, Published online December 7, 2 011 DOI:10.1016/S1470-2045(11)70299-6

2000 2004

2009

Centralized programs: HER2 testing in Slovakia

� approx. 2300 new cases of Ca mammae

� 9-12 centers - standardizedIHC testing (HercepTest DAKOCytomation)

� 1 center (Martin): CISH / FISH / ddISH

� start 01/2003 ,

in 2003-2011 > 20 000 patients tested

� 2011 + testing Ca ventriculi

� testing support by Roche Slovakia up to 08/2011

2000 2004

2009

Centralized program of HER2 testing in Slovakia

2000 2004

2009

Centralized program of HER2 testing in Slovakia

2000 2004

2009

Centralized program of HER2 testing in Slovakia

in Martin:since 2012 BenchMark ULTRA based:

�IHC testing�ddISH testing

2000 2004

2009

Reports on the HER2 program:national / international / european congresses, e.g.:

ESP Istanbul 2007

Visegrad 2008

2000 2004

2009

Quality control mechanisms of the HER2 program:

� incl. in DAKO HercepTest kit

� internal controlsnegat. versus posit.

� 3x „internal“ quality control in the program

(2005-2007)

• annual reports

• Nr of centers involved

• meetings, seminars• training courses

• HER2 Academy 2010

2000 2004

2009

1st EQA of HER2 IHC testing (Nov 2011)

to stain and to interpret...

2000 2004

2009

1st EQA of HER2 IHC testing – RESULTS (Nov 2011)

� 9/11 centers participated - correct „staining“ > interpret ation

��

2000 2004

2009

1st EQA of HER2 IHC testing – RESULTS (Nov 2011)

� 2nd run: April/May 2012

2000 2004

2009

Centralized programs: CRC and K-RAS

2000 2004

2009

Centralized programs: CRC and K-RAS

National guidelines (Min. of Health)

2000 2004

2009

Centralized programs: NSCLC and EGFR / ALK

National guidelines

(similar to KRAS testing)

„from histology based to biomarker based“ (?)

2000 2004

2009

Centralized programs: NSCLC and EGFR / ALK

2011

IHC: ALK protein

2000 2004

2009

THANK YOU

Supported by project Center of excellence at JLF UK Martin:CEPV II (IMTS 26220120036) and MBRKM (IMTS 26220220 113),

co-financed by EU

☺☺☺☺

Thanks

� to all my co-workers in Martin, pathologists + biologi sts� to all cooperating pathologists+� inspirations by oncologists� grant supports