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Confronto Interistituzionale in Patologia Mammaria: determinazione immunofenotipica di ER/PR Licia Laurino and Angelo P. Dei Tos Dipartimenti di Patologia.

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Presentazione sul tema: "Confronto Interistituzionale in Patologia Mammaria: determinazione immunofenotipica di ER/PR Licia Laurino and Angelo P. Dei Tos Dipartimenti di Patologia."— Transcript della presentazione:

1 Confronto Interistituzionale in Patologia Mammaria: determinazione immunofenotipica di ER/PR Licia Laurino and Angelo P. Dei Tos Dipartimenti di Patologia ed Oncologia Treviso

2 Breast Cancer Diagnosis NecessaryNecessary DifficultDifficult Insufficient for planning the adjuvant treatmentInsufficient for planning the adjuvant treatment

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4 St. Gallen Conference Absolute importance of timely, accurate and reliable histopathologic assessmentAbsolute importance of timely, accurate and reliable histopathologic assessment Target identification and quantitationTarget identification and quantitation Enhanced partnership between clinician and pathologists substantially improved outcomes.Enhanced partnership between clinician and pathologists substantially improved outcomes.

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6 Treatment Options Endocrine therapyEndocrine therapy –Any detectable ER Anti HER2 therapyAnti HER2 therapy –HER2 + (ASCO/CAP) ChemotherapyChemotherapy

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8 Gene Epression Signatures …after a long debate, the Panel supported the use of a validated multigene-profiling assay, as an adjunct to high quality phenotyping of breast cancer in cases in which the indication for adj chemo remained uncertain

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10 Currently accepted prognostic/predictive parameters Patient AgePatient Age characteristics(Race) DiseaseTumor sizeDiseaseTumor size characteristicsTumor type Axillary status Tumor grade Peritum. vascular invasion BiomarkersReceptor statusBiomarkersReceptor status HER2/neu expression Ki-67 labeling index

11 The histopathologic report Invasive ductal ca, NOS, G2, negative margins, with 2 lymph node mets in post-meno patient.Invasive ductal ca, NOS, G2, negative margins, with 2 lymph node mets in post-meno patient. ER: 90%; PgR 90%, HER2 negative, Ki67: 12%ER: 90%; PgR 90%, HER2 negative, Ki67: 12% Endocrine-responsive tumor with an intermediate risk. Adjuvant Tamoxifen for 2 yrs, followed by AI for additional 3 yrs. Then wait for the results of current trials of extended endocrine treatmentEndocrine-responsive tumor with an intermediate risk. Adjuvant Tamoxifen for 2 yrs, followed by AI for additional 3 yrs. Then wait for the results of current trials of extended endocrine treatment

12 The histopathologic report Invasive ductal ca, NOS, G2, negative margins, with 2 lymph node mets in post-meno patient.Invasive ductal ca, NOS, G2, negative margins, with 2 lymph node mets in post-meno patient. ER: 90%; PgR 90%, HER2 negative, Ki67: 12%ER: 90%; PgR 90%, HER2 negative, Ki67: 12% Endocrine-responsive tumor with an intermediate risk. Adjuvant Tamoxifen for 2 yrs, followed by AI for additional 3 yrs. Then wait for the results of current trials of extended endocrine treatmentEndocrine-responsive tumor with an intermediate risk. Adjuvant Tamoxifen for 2 yrs, followed by AI for additional 3 yrs. Then wait for the results of current trials of extended endocrine treatment

13 Taxane most effective on endocrine Non or INCOMPLETELY responsive tumorsTaxane most effective on endocrine Non or INCOMPLETELY responsive tumors – Optimal ER/PgR/HER2 assessment Microtubule binding protein TAU predicts response to PaclitaxelMicrotubule binding protein TAU predicts response to Paclitaxel Topoisomerase II alpha amplification and protein overxpression predict response to anthracyclins (?)Topoisomerase II alpha amplification and protein overxpression predict response to anthracyclins (?) Basal –like tumors (often associated with BRCA1) more responsive to DNA damaging agents (platinum)Basal –like tumors (often associated with BRCA1) more responsive to DNA damaging agents (platinum) Increasing Roles for Pathologist

14 External quality controls for ER UK-NEQAS (round #53) (#54)UK-NEQAS (round #53) (#54) –Score >12/20 49%69% –Score %16% –Score <10/20 24%15% German Q.A.:German Q.A.: –False-negative rate= 11-24% (Am J Surg Pathol 2002)

15 J Nat Cancer Inst 2008, 100:836.

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18 CQ Veneto 09 Inviate sezioni di mammella normale, carcinoma papillare, (+vo) carcinoma adenoidocistico (-vo), carcinoma lobulare pleomorfo (debolmente +vo) 14 centri

19 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVOK 100% 002% SP1 / 636 Polimero DAKO AOK-100% disomog 100% ++ 0Deb pos ? 2% deb 100% deb ? SP1/Ab8 ultravision COK 100% disomog 100% % ? 0?0? Vector Polimero DAKO DDeb 50% disomog 100%0 Contr. Ins. 00 Contr. Ins. 0 Contr. Ins. SP1/Ab8 Bond-max EDeb-90% disomog 100%00<5%06F11/1A6 Bond-max FOK 100% disomog 002%0 Contr. Ins. SP1/ 1E2 Ventana G--100%90% debole 002%0SP1/ 1E2 Ventana

20 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVTV OK 100% 002% SP1 / 636 Polimero DAKO HOK 100% disomog 002%0SP1 /1E2 Ventana IDebOK100% disomog 100% 00 0 Contr. Ins. 0 Contr. Ins. SP1 / 636 Polimero LOKnp100% disomog 100% disomog 002%0 Contr. Ins. 6F11 / 636 Bondmax NDebOK100% 002%0 Contr. Ins. SP1/1E2 ? OOK 100% 002%0 Contr. Ins. SP1/1E2 Ventana POK 100%np2%0 0 Contr. Ins. ???? RDeb 60% disomog 60% disomog 000 Contr. Ins. 0 Contr. Ins. ???? SOK 100% 002%0 Contr. Ins. ? BondMax

21 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVOK 100% 002% SP1 / 636 Polimero DAKO AOK-100% disomog 100% ++ 0Deb pos ? 2% deb 100% deb ? SP1/Ab8 ultravision COK 100% disomog 100% % ? 0?0? Vector Polimero DAKO DDeb 50% disomog 100%0 Contr. Ins. 00 Contr. Ins. 0 Contr. Ins. SP1/Ab8 Bond-max EDeb-90% disomog 100%00<5%06F11/1A6 Bond-max FOK 100% disomog 002%0 Contr. Ins. SP1/ 1E2 Ventana G--100%90% debole 002%0SP1/ 1E2 Ventana

22 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVTV OK 100% 002% SP1 / 636 Polimero DAKO HOK 100% disomog 002%0SP1 /1E2 Ventana IDebOK100% disomog 100% 00 0 Contr. Ins. 0 Contr. Ins. SP1 / 636 Polimero LOKnp100% disomog 100% disomog 002%0 Contr. Ins. 6F11 / 636 Bondmax NDebOK100% 002%0 Contr. Ins. SP1/1E2 ? OOK 100% 002%0 Contr. Ins. SP1/1E2 Ventana POK 100%np2%0 0 Contr. Ins. ???? RDeb 60% disomog 60% disomog 000 Contr. Ins. 0 Contr. Ins. ???? SOK 100% 002%0 Contr. Ins. ? BondMax

23 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVOK 100% 002% SP1 / 636 Polimero DAKO AOK-100% disomog 100% ++ 0Deb pos ? 2% deb 100% deb ? SP1/Ab8 ultravision COK 100% disomog 100% % ? 0?0? Vector Polimero DAKO DDeb 50% disomog 100%0 Contr. Ins. 00 Contr. Ins. 0 Contr. Ins. SP1/Ab8 Bond-max EDeb-90% disomog 100%00<5%06F11/1A6 Bond-max FOK 100% disomog 002%0 Contr. Ins. SP1/ 1E2 Ventana G--100%90% debole 002%0SP1/ 1E2 Ventana

24 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVTV OK 100% 002% SP1 / 636 Polimero DAKO HOK 100% disomog 002%0SP1 /1E2 Ventana IDebOK100% disomog 100% 00 0 Contr. Ins. 0 Contr. Ins. SP1 / 636 Polimero LOKnp100% disomog 100% disomog 002%0 Contr. Ins. 6F11 / 636 Bondmax NDebOK100% 002%0 Contr. Ins. SP1/1E2 ? OOK 100% 002%0 Contr. Ins. SP1/1E2 Ventana POK 100%np2%0 0 Contr. Ins. ???? RDeb 60% disomog 60% disomog 000 Contr. Ins. 0 Contr. Ins. ???? SOK 100% 002%0 Contr. Ins. ? BondMax

25 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVOK 100% 002% SP1 / 636 Polimero DAKO AOK-100% disomog 100% ++ 0Deb pos ? 2% deb 100% deb ? SP1/Ab8 ultravision COK 100% disomog 100% % ? 0?0? Vector Polimero DAKO DDeb 50% disomog 100%0 Contr. Ins. 00 Contr. Ins. 0 Contr. Ins. SP1/Ab8 Bond-max EDeb-90% disomog 100%00<5%06F11/1A6 Bond-max FOK 100% disomog 002%0 Contr. Ins. SP1/ 1E2 Ventana G--100%90% debole 002%0SP1/ 1E2 Ventana

26 Nor ER Nor PR Pos ER Pos PR Neg ER Neg PR Deb ER Deb PR Metodica TVTV OK 100% 002% SP1 / 636 Polimero DAKO HOK 100% disomog 002%0SP1 /1E2 Ventana IDebOK100% disomog 100% 00 0 Contr. Ins. 0 Contr. Ins. SP1 / 636 Polimero LOKnp100% disomog 100% disomog 002%0 Contr. Ins. 6F11 / 636 Bondmax NDebOK100% 002%0 Contr. Ins. SP1/1E2 ? OOK 100% 002%0 Contr. Ins. SP1/1E2 Ventana POK 100%np2%0 0 Contr. Ins. ???? RDeb 60% disomog 60% disomog 000 Contr. Ins. 0 Contr. Ins. ???? SOK 100% 002%0 Contr. Ins. ? BondMax

27 PR normal breast

28 ER normal breast

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30 ER

31 PR

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33 ER

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35 ER Low expressing

36 PR +ve ?

37 ER

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39 PR-ve

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41 E necessario che l inclusione scelta per la determinazione dei parametri biologici includa anche parenchima mammario non neoplastico in tutti i casi in cui ciò sia possibile. Statement 14. Scelta del campione per la determinazione dei fattori prognostico predittivi

42 Statement 15. Scelta del campione per la determinazione dei fattori prognostico predittivi La valutazione dei parametri biologici (assetto recettoriale, stato di HER2 e Ki-67) deve essere effettuata anche sulle biopsie pre- operatorie se è prevista terapia neo-adiuvante e sulle biopsie di recidive e metastasi

43 Nel caso di neoplasie multiple, la determinazione dei parametri biologici va effettuata su tutte le lesioni solo se di diverso istotipo o grado Statement 16. Scelta del campione per la determinazione dei fattori prognostico predittivi

44 La determinazione dellassetto recettoriale (ER/PR) deve essere effettuata anche su neoplasie intraduttali Statement 17. Determinazione sulle neoplasie in situ di fattori prognostico predittivi

45 La valutazione dellassetto dei recettori ormonali deve essere espressa in valori percentuali indipendentemente dalla intensità di colorazione Statement 18. Determinazione dei recettori ormonali Il referto deve riportare il clone utilizzato per la determinazione immunocitochimica dei recettori

46 La valutazione dellassetto recettoriale deve corrispondere alla espressione media di recettori dell intera sezione esaminata Statement 19. Determinazione dei recettori ormonali

47 Il controllo positivo interno deve mostrare una colorazione eterogenea delle cellule luminali normali, con cellule non colorate accanto a cellule debolmente colorate e a cellule intensamente colorate. Una colorazione limitata a poche cellule e di uguale intensità può essere dovuta ad una scarsa sensibilità della reazione. Le cellule mioepiteliali e i fibroblasti rappresentano un utile controllo negativo interno: una loro colorazione per quanto debole è segno di aspecificità della reazione Statement 20. Determinazione dei recettori ormonali

48 Conclusions The pathology report of breast cancer is the choice of adjuvant therapyThe pathology report of breast cancer is the choice of adjuvant therapy The report must be complete and accurate – in the diagnosis and in the assessment of prognostic/predictive parametersThe report must be complete and accurate – in the diagnosis and in the assessment of prognostic/predictive parameters Pathologists should be more and more aware of their role in the management of patients with breast carcinomaPathologists should be more and more aware of their role in the management of patients with breast carcinoma

49 Conclusions Good laboratory practiceGood laboratory practice Technical validationTechnical validation Clinical validationClinical validation –Correlation with outcome Internal and external quality control programsInternal and external quality control programs

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