Original Title: Plataformas genómicas de carácter pronóstico-predictivo en el cáncer de mama: actualización de la evidencia. Revisión sistemática

Authors' objectives: The aim of this report was to update the evidence on the validity and clinical utility of the genetic tests (MammaPrint®, Oncotype DX ™, EndoPredict® and Prosigna ™) as prognostic tests in early breast cancer.

Authors' results and conclusions: Clinical validity • EndoPredict® seems to be an independent prognostic factor for 10-year local recurrence in postmenopausal patients with early breast cancer ER+, HER2- although it may be not suitable for tailoring local therapy.· ROR index (Prosigna) seems to be an independent prognostic factor for 10-year distant recurrence in postmenopausal HR+ patients early breast cancer with 1-3 positive nodes, although it provided less prognostic information in this subgroup than in nodenegatives patients. Clinical utility · A 5-year follow-up MammaPrint identifies those patients with breast cancer in early stages with and without lymph node involvement who present low risk of recurrence and who could avoid chemotherapy. These results are promising, but a longer follow-up time is necessary for confirmation, the possible long-term chemotherapy benefit in these patients is unknown. · Oncotype seems to identify early breast cancer patients ER+, HER2- and negative-nodes with low risk that could avoid chemotherapy, although the definitive results of the clinical trial on its usefulness are not yet available. · Gene expression tests impact on decision making by modifying the therapeutic recommendation and generally reducing the adjuvant chemotherapy.

Authors' methods: A systematic review of the literature was performed. A bibliographic search to compile the scientific evidence published with date subsequent to 2013 and 2015 until December 2017 was carried out. In addition, the major national and international agencies and units of Health Technology Assessment were consulted. A critical appraisal of selected studies was performed to identify the methodological problems that could influence their validity, and a qualitative and, when possible, quantitative synthesis (meta-analysis) of the results was done.

Project Status: Completed

Year Published: 2018

URL for published report: https://www.aetsa.org/publicacion/plataformas-genomicas-de-caracter-pronostico-predictivo-en-el-cancer-de-mama-actualizacion-de-la-evidencia-revision-sistematica/

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: AETSA, Andalusian Health Technology Assessment Area