Il controllo di qualità nei programmi di screening, impatto sul trattamento e controllo di qualità in istologia

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1 Il controllo di qualità in Anatomia Patologica e negli Screening Oncologici Torino, 10 giugno 2008 Il controllo di qualità nei programmi di screening, impatto sul trattamento e controllo di qualità in istologia Nereo Segnan CPO Piemonte e AUO S.Giovanni Battista Torino N. Segnan CPO 2008

2 European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis N. Segnan CPO 2008

3 European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis Table of contents for pathology (1) N. Segnan CPO 2008

4 European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis Table of contents for pathology (2) N. Segnan CPO 2008

5 European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis Table of contents for pathology (3) N. Segnan CPO 2008

6 European Guidelines for Quality Assurance in Cervical Cancer Screening N. Segnan CPO 2008

7 European Guidelines for Quality Assurance in Cervical Cancer Screening Table of contents for pathology N. Segnan CPO 2008

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9 Section 3 Assessment and Management

10 Adenomi e Polipi cancerizzati - Screening del Carcinoma del Colon Retto CDIS Screening del carcinoma mammario CIN - Screening della Cervice Uterina lesioni diagnosticate dallo screening N. Segnan CPO 2008

11 Longitudinal Evaluation of Interobserver and Intraobserver Agreement of Cervical Intraepithelial Neoplasia Diagnosis Among an Experienced Panel of Gynecologic Pathologists Cai B et al Am J Surg Pathol 2007;31: N. Segnan CPO 2008

12 A. Malpica et al. / Gynecologic Oncology 99 (2005) S38 S52 N. Segnan CPO 2008

13 Interlaboratory Reproducibility of Liquid-Based Equivocal Cervical Cytology Within a Randomized Controlled Trial Framework M. Confortini et al Diagn. Cytopathol. 2007; 35: N. Segnan CPO 2008

14 Interlaboratory Reproducibility of Liquid-Based Equivocal Cervical Cytology Within a Randomized Controlled Trial Framework M. Confortini et al Diagn. Cytopathol. 2007; 35: N. Segnan CPO 2008

15 Interobserver Reproducibility of Cervical Cytologic and Histologic Interpretations Realistic Estimates From the ASCUS-LSIL Triage Study Stoler MH et al JAMA. 2001;285: N. Segnan CPO 2008

16 Interobserver Reproducibility of Cervical Cytologic and Histologic Interpretations Realistic Estimates From the ASCUS-LSIL Triage Study Stoler MH et al JAMA. 2001;285: N. Segnan CPO 2008

17 TOTALE ALTRO % 2.0% 0.0% 2.0% 0.0% 0.0% 2.0% 8.0% 2.0% 2.0% POLIPO IPERPLASTICO 6 ADENOMA TUBULARE DISPLASIA BASSO GRADO ADENOMA TUBULARE DISPLASIA ALTO GRADO ADENOMA T. VILLOSO DISPLASIA BASSO GRADO ADENOMA T. VILLOSO DISPLASIA ALTO GRADO ADENOMA VILLOSO DISPLASIA BASSO GRADO ADENOMA VILLOSO DISPLASIA ALTO GRADO 12.0% % 3 6.0% % 3 6.0% % 3 6.0% ADENOMA SERRATO 2 4.0% CANCRO % % 3 6.0% 0 0.0% % % % 3 6.0% 0 0.0% % % % 4 8.0% % 2 4.0% % 3 6.0% 2 4.0% % % % 3 6.0% 3 6.0% 2 4.0% % % 2 4.0% % % % 1 2.0% % 2 4.0% % % 2 4.0% % % % 2 4.0% % 3 6.0% % 2 4.0% 0 0.0% % % % 0 0.0% % 2 4.0% % % 0 0.0% 4 8.0% % % 2 4.0% % % % 1 2.0% 0 0.0% 4 8.0% % % 0 0.0% % % 4 8.0% 1 2.0% 0 0.0% % % % 3 6.0% 4 8.0% 1 2.0% % 4 8.0% 2 4.0% %

18 CONCORDANZA CON LA DIAGNOSI DI RIFERIMENTO (R) adenoma vs altro polipo adenoma tubulare vs altro adenoma displasia hg vs lg adenoma hr vs altro adenoma R R R R

19 Journal of the National Cancer Institute, Vol. 94, No. 23, December 4, 2002

20 DR CCR: 5.4 x 1000 CANCRI DISTALI 47 CANCRI PROSSIMALI 7 TOTALE 54 ADENOMI CANCERIZZATI : 26 (48.1%) TRATTAMENTO LIMITATO ALL ESCISSIONE DEL POLIPO IN 11 CASI SU 26 (20.3%)

21 Revisione istologica 57 casi diagnosticati inizialmente come CCR 51 casi confermati in revisione (6 adenomi cancerizzati riclassificati come adenomi HR) 3 casi di adenomi HR riclassificati come CCR (adenoma cancerizzato) su un campione di 48 casi di adenomi HR inviati in revisione

22 TRATTAMENTO ADENOMA CANCERIZZATO NON INDICATA RESEZIONE SE: TUMORE: BEN DIFFERENZIATO MARGINE DI RESEZIONE: LIBERO EMBOLIZZAZIONE NEOPLASTICA: ASSENTE VETRINI RIVISTI DA DUE PATOLOGI

23 PROGETTO DIMOSTRATIVO TORINO - CONCORDANZA TRA LABORATORI CONCORDANZA TRA LABORATORI (kappa - Il lettore 1 e' il riferimento) adenoma tubulare vs altro tipo di adenoma

24 PROGETTO DIMOSTRATIVO TORINO - CONCORDANZA TRA LABORATORI CONCORDANZA TRA LABORATORI (kappa - Il lettore 1 e' il riferimento) diagnosi di adenoma vs altro polipo diagnosi di adenoma a "alto rischio" vs altro

25 First reading (9 pathologists) Individual Majority diagnosis diagnosis Ben. Mal. Ben. 92% 1% Mal. 8% 99% N Second reading Individual Majority diagnosis diagnosis Ben. Mal. Ben. 95% 8% Mal. 5% 92% N J. Swanson Beck et al J Clin Pathol 1986

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28 SOVRADIAGNOSI? La prevalenza dei carcinomi duttali in situ in serie autoptiche medicolegali è decisamente più elevata rispetto all incidenza clinica dei tumori invasivi. Il follow up di biopsie mammarie originariamente ed erroneamente interpretate come benigne, con conseguente mancanza di trattamento della lesione, rivela che la maggior parte di esse non progredisce in carcinomi invasivi. D altra parte i fattori di rischio associati all insorgenza dei CDIS sono del tutto simili a quelli per il carcinoma invasivo e da analisi condotte in serie di screening non è stata trovata sovradiagnosi significativa.

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31 At prevalence screen, 37% of DCIS were estimated to be non-progressive. At incidence screen only 4% (Yen MF et al 2003)

32 Created by statecancerprofiles.cancer.gov on May 31, Rates are age-adjusted to the 2000 US standard population by 5-year age groups.

33 Created by statecancerprofiles.cancer.gov on May 31, Rates are age-adjusted to the 2000 US standard population by 5-year age groups.

34 CDIS, tassi standardizzati (per ) sulla popolazione europea a Torino Periodo Tutte le età (dati Registro Tumori Piemonte)

35 Carcinomi duttali in situ della mammella nelle donne residenti a Torino (50-69 anni) Modalità di diagnosi Screen detected Altro Totale n. % n. % n. % (dati Registro Tumori Piemonte)

36 Percentuale di mastectomie e dissezioni ascellari per modalità diagnostica SD (1 test) SD (test ripet) NSD non rispondenti NSD non invitate % mastec. % dissez. % mastec. % dissez. % mastec. % dissez. % mastec. % dissez. ptis 13,9 15,1 13,6 14,6 18,0 17,5 17,7 19,5 ptmicr 40,8 68,9 32,1 75,0 41,5 66,0 44,7 76,6 pt1a 17,5 61,7 13,3 47,9 29,4 58,7 23,4 66,6 17,6 34,0 15,5 31,4 24,9 36,5 21,9 37,4

37 Do women 50 years of age need as much screening as women <50 years after they have had negative screening results? ASSUMPTIONS: One critical point in cervical screening is the specificity of cyto-histological diagnosis. In this study the joint probability of a false positive CIN2+ diagnosis within a screening episode was estimated, as it depends on the probability of being a false positive case at both the primary and the assessment test. Histological diagnosis reproducibility might be as questionable as cytological diagnosis. Studies of cervical biopsies have shown fair to poor interobserver and intraobserver agreement in reporting (Robertson et al, 1989). P Armaroli et al. British Journal of Cancer 2008 N. Segnan CPO 2008

38 Do women 50 years of age need as much screening as women <50 years after they have had negative screening results? N. screening episodes CR (per 10000) False positive (per 10000) True positive (per 10000) True positive/false positive Positive/false positive Cytological specificity: 0.97 Histological specificity: 0.94 OR Cytological specificity: 0.94 Histological specificity: Cytological specificity: 0.96 Histological specificity: 0.95 OR Cytological specificity: 0.95 Histological specificity: P Armaroli et al. British Journal of Cancer 2008 N. Segnan CPO 2008

39 Do women 50 years of age need as much screening as women <50 years after they have had negative screening results? N. screening episodes CR (per 10000) False positive (per 10000) True positive (per 10000) True positive/false positive Positive/false positive Cytological specificity: 0.97 Histological specificity: 0.94 OR Cytological specificity: 0.94 Histological specificity: P Armaroli et al. British Journal of Cancer 2008 N. Segnan CPO 2008

40 Do women 50 years of age need as much screening as women <50 years after they have had negative screening results? CONCLUSIONS: The ratio between true positive and false positive results is almost above 10 under 50 years of age, while among older women for each real case identified one false positive is also diagnosed. After four tests at least 3 false positive cases are diagnosed every true positive. These results show that the screening benefits over 50 years is uncertain. False positive results are associated with unnecessary assessment and its complications, adverse effects of treatment, unnecessary treatment, adverse effects of labelling or early diagnosis, anxiety and costs generated by investigations and treatment (International Agency for Research on Cancer, 2005). Hence an effort to increase specificity is needed, especially in older age groups. P Armaroli et al. British Journal of Cancer 2008 N. Segnan CPO 2008

41 TRIAL SCORE - CONCORDANZA TRA PATOLOGI diagnosi di adenoma basso rischio vs alto rischio CONCORDANZA GLOBALE : 0.59

42 DISTRIBUZIONE PER STADIO DEI CANCRI SCREEN DETECTED A 52.7% (N=29) B 16.4% (N= 9) C 29.1% (N=15) D 1.8% (N= 1)

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