Lo screening (di massa) del tumore della prostata

Giovanni L. Pappagallo

(Dipartimento di Scienze Mediche, Azienda ULSS 13 - Mirano)

Rilevanza del problema

per la salute pubblica

Esistenza di un trattamento di

provata efficacia per la

malattia oggetto di screening ?

Accordo su quali “soggetti”

sottoporre a trattamento

• Analytical validation

– Pre-analytical and post-analytical robustness

• Clinical validation

– Does the biomarker predict what its supposed

to predict for independent data

• Clinical utility – Does use of the biomarker result in patient

benefit

Types of Validation for Prognostic and Predictive Biomarkers

Levels of Evidence for Biomarker Studies

Level Definition

I. Prospective, Marker Primary Objective, well-powered OR meta-analysis

II. Prospective, Marker Secondary Objective

III. Retrospective, Outcomes, Multivariate Analysis

IV. Retrospective, Outcomes, Univariate

V. Retrospective, Correlation with Other Marker, No Outcome

Hayes, et al; J Nat Cancer Institute 88:1456, 1996 - Simon R.M., Paik S., Hayes D.F. J Natl Cancer Inst. 2009

Disponibilità di un test

diagnostico attendibile

There is no cutpoint of

PSA with simultaneous

high sensitivity and high

specificity for monitoring

healthy men for prostate

cancer, but rather a

continuum of prostate

cancer risk at all values

of PSA

[TITLE]

Presented By Phillip G. Febbo, MD at 2013 ASCO Annual Meeting

Bilancio positivo tra

benefici e “danni”

modified from M. Robool, Erice 2013

Sostenibilità economica

Lo screening (di massa) del tumore della prostata

Giovanni L. Pappagallo

(Dipartimento di Scienze Mediche, Azienda ULSS 13 - Mirano)