Generali Daniele, Rocca Andrea, Strina Carla, Milani Manuela, Fiorino Enrico, Cervoni Valeria, Azzini Carlo, Saracino Antonella, Ciliberto Ingnazio, Ziglioli Nicoletta, Alberio Marzia, Giudici Fabiola, Dester Martina, Ciani Oriana, Fornaro Giulia, Aguggini Sergio, Dreezen Christa, Pronin Darina, Ende Stefanie
Multidisciplinary Unit of Breast Cancer, ASST of Cremona, Cremona, Italy.
Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.
Heliyon. 2024 Oct 26;10(21):e39485. doi: 10.1016/j.heliyon.2024.e39485. eCollection 2024 Nov 15.
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.
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.
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.
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.
本研究旨在评估70基因标志物MammaPrint在意大利单中心前瞻性队列的早期中度风险乳腺癌（BC）患者中的预后性能。
2006年至2013年间，共对195例符合条件的早期BC病例进行了基因组风险检测。在这项回顾性分析中，使用Cox回归模型评估基因组风险与无远处转移生存期（DMFS）和总生存期（OS）的关联，并对临床和病理肿瘤特征进行校正。
MammaPrint鉴定出118例（60.5%）基因组低风险肿瘤患者和77例（39.5%）基因组高风险肿瘤患者。MammaPrint风险类别之间的年龄、绝经状态、肿瘤大小、受体状态和淋巴结状态具有可比性。DMFS的中位随访时间为8.4年，OS为9.3年；两个终点均报告了8年随访情况。MammaPrint低风险肿瘤患者的8年DMFS为90.4%（95%CI 84.9 - 95.9），而高风险肿瘤患者为60.8%（95%CI 49.8 - 71.8）。与MammaPrint高风险肿瘤（89.5%；95%CI 82.6 - 96.4；p = 0.028）相比，MammaPrint低风险肿瘤患者的8年OS显著更高（97.3%；95%CI 94.4 - 100）。多变量分析确定MammaPrint与8年DMFS显著相关，MammaPrint与孕激素受体阳性与8年OS显著相关。
MammaPrint的预后性能在早期临床中度至高度风险的BC患者中得到了证实。此外，MammaPrint低风险肿瘤患者无论治疗方案如何都有良好的预后，从而支持个性化的治疗选择。
