Original Title: Test genómicos pronósticos para el cáncer de próstata localizado

Authors' objectives: To systematically review the available scientific literature on the clinical validity, clinical utility and cost-effectiveness of the prognostic genomic multimarker tumour tissue based tests, for localised organ-confined prostate cancer.

Authors' results and conclusions: RESULTS: In this review, we identified a total number of 18 articles: 4 secondary studies and 14 articles related to primary studies. Of the latter, two informed about the clinical validity of Oncotype Dx® and other two about clinical utility. Regarding the panel Prolaris®, numbers were two and six respectively. For the newer test Promark®, we found only one study about clinical validity and one economic evaluation. Oncotype Dx® presents some evidence supporting this panel could be a predictive factor of adverse pathology and biochemical recurrence (BCR) in prostatectomy patients, and also could be valid for predicting disease progression in low and intermediate risk men who have to decide between AS and radical treatment. In this case, extrapolating this evidence to other groups of patients eligible for AS is nor straightforward, as 100% of participants in the study chose RP within the first 6 months after diagnosis. The cell cycle progression (CCP) score in which Prolaris® is based, has been studied in different cohorts (RP, transurethral resection of the prostate, external beam radiotherapy or conservative managed patients) resulting to be in correlation with outcomes like BCR, PCa-specific mortality, metastasis and clinical utility variables like change in treatment option, change in final treatment and in therapeutic burden. Some of this evidences lack enough validity because of the small sample the correlations are based on. CONCLUSIONS: Although there exist some evidence about the clinical validity and utility of Oncotype Dx® and Prolaris® as prognostic markers for localised PCa, for low and intermediate risk groups, the scientific information supporting it is heterogeneous and comes from studies with several design limitations, therefore with a compromised external validity. Beyond, there not exist enough published evidence on the efficiency of these panels. Thus, at the time of writing this report, the technologies do not fulfil the requirements to be included in the he Basic Services Portfolio of the NHS, according to the Guía para la toma de decisiones sobre incorporación de nuevas pruebas genéticas en el Sistema Nacional de Salud (Guía GEN) of 2007, updated in 2015. The new test Promark®, is not supported with enough published evidence, therefore must be further validated in well-designed future studies. Prospective studies are needed to prove the clinical utility of these tests in the context of real clinical settings. One possibility is to establish prospective registries within the NHS services (validation and utility studies), as is the case for Prolaris® in some hospitals in Madrid. It is important as well to perform economic evaluations in order to establish the efficiency of these technologies.

Authors' recommendations: • Although there exist some evidence about the clinical validity and utility of Oncotype Dx® and Prolaris®, which could apply for PCa low and intermediate risk groups, it is heterogeneous and not robust enough, so at the time of writing this report, a recommendation cannot be formulated for or against its inclusion in the NHS services. • Prospective studies are needed to prove the clinical utility of these tests in the context of real clinical settings. One possibility is to establish prospective registries within the NHS services (validation and utility studies), as is the case for Prolaris® in some hospitals in Madrid. • The new test Promark® is not supported with enough published evidence, therefore it must be validated in high quality future studies, with a sufficient follow-up period and a proper sample size, before considering to include it in the NHS services. • Besides, it is important as well to perform robust studies on the efficiency of these technologies before giving any recommendation for them.

Authors' methods: We conducted a systematic search for articles in the electronic databases The Cochrane Library Plus (CENTRAL, Cochrane Systematic Reviews Database), MEDLINE, PREMEDLINE, SCOPUS, EMBASE up to April 2016. We also hand searched in the references of the included articles and identified systematic reviews. We also searched in the websites of the main health technology assessment agencies national and internationally and in clinicaltrials.gov, and contacted the authors of the studies when needed. We included studies researching the clinical validity and utility of genomic panels aimed to provide with prognostic information of value for deciding the better treatment after diagnosis of men of any ethnic origin with localised PCa. Two independent reviewers selected the studies. Data extraction of the included studies was carried out by one reviewer and verified by a second one. Both reviewers discussed their decisions and in the event of any differences, they were resolved through discussion with a third member of the team until consensus was reached. We collected the data in electronic forms designed ad hoc. Methodological quality of the studies was assessed using different tools depending on the design. The information gathered was summarized through a narrative synthesis and the results were shown in tables. The information gathered was summarized through a narrative synthesis and the results were shown in tables. Quality of the evidence and strength of recommendations was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Project Status: Completed

Year Published: 2016

URL for published report: https://sescs.es/test-genomicos-pronosticos-para-el-cancer-de-prostata-localizado/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es