Assessing the long-term prognostic ability of the 70 gene expression signature MammaPrint in an Italian single-center prospective cohort study of early-stage intermediate-risk breast cancer patients
Daniele Generali,
Andrea Rocca,
Carla Strina,
Manuela Milani,
Enrico Fiorino,
Valeria Cervoni,
Carlo Azzini,
Antonella Saracino,
Ingnazio Ciliberto,
Nicoletta Ziglioli,
Marzia Alberio,
Fabiola Giudici,
Martina Dester,
Oriana Ciani,
Giulia Fornaro,
Sergio Aguggini,
Christa Dreezen,
Darina Pronin,
Stefanie Ende
Affiliations
Daniele Generali
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy; Corresponding author. Breast Cancer Unit - Azienda Socio-Sanitaria di Cremona, Italy, Department of Medicine, Surgery and Health Sciences - University of Trieste Strada di Fiume 447, 34149, Trieste, Italy.
Andrea Rocca
Department of Medical, Surgical and Health Sciences, University of Trieste, Italy
Carla Strina
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Manuela Milani
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Enrico Fiorino
Department of Medical, Surgical and Health Sciences, University of Trieste, Italy
Valeria Cervoni
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Carlo Azzini
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Antonella Saracino
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Ingnazio Ciliberto
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Nicoletta Ziglioli
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Marzia Alberio
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Fabiola Giudici
Cancer Epidemiology Unit, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy
Martina Dester
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Oriana Ciani
Centre for Research on Health and Social Care Management, SDA Bocconi, Milan, Italy
Giulia Fornaro
Centre for Research on Health and Social Care Management, SDA Bocconi, Milan, Italy
Sergio Aguggini
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy
Purpose: The aim of this study was to assess the prognostic performance of the 70-gene signature, MammaPrint, in an Italian single-center prospective cohort of early-stage intermediate-risk breast cancer (BC) patients. Methods: A total of 195 eligible early BC cases were tested for genomic risk between 2006 and 2013. In this retrospective analysis, the association of genomic risk with distant metastasis-free survival (DMFS) and overall survival (OS) were assessed using Cox regression models, adjusting for clinical and pathological tumor characteristics. Results: MammaPrint identified 118 (60.5 %) patients with genomically Low Risk tumors and 77 (39.5 %) patients with genomically High Risk tumors. Age, menopausal status, tumor size, receptor status, and nodal status were comparable between MammaPrint Risk categories. The median follow-up was 8.4 years for DMFS and 9.3 years for OS; 8-year follow-up was reported for both endpoints. The 8-year DMFS was 90.4 % (95 % CI 84.9–95.9) in patients with MammaPrint Low Risk tumors compared to 60.8 % (95 % CI 49.8–71.8) for patients with High Risk tumors. Patients with MammaPrint Low Risk tumors exhibited significantly superior 8-year OS (97.3 %; 95 % CI 94.4–100) compared with MammaPrint High Risk tumors (89.5 %; 95 % CI 82.6–96.4; p = 0.028). Multivariate analyses identified MammaPrint as significantly associated with 8-year DMFS and MammaPrint together with Progesterone Receptor positivity with 8-year OS. Conclusion: The prognostic performance of MammaPrint was demonstrated in early-stage clinically intermediate to high-risk BC patients. Moreover, patients with MammaPrint Low Risk tumors had good outcome regardless of treatment regimen, thus supporting personalized treatment choices.