Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Breast Center St. Anna, Lucerne, Switzerland.
Helen Diller Family Comprehensive Cancer Center, University California San Francisco, San Francisco, USA.
ESMO Open. 2021 Feb;6(1):100006. doi: 10.1016/j.esmoop.2020.100006. Epub 2020 Dec 31.
MammaPrint is a prognostic assay based on gene expression in tumors from patients with early breast cancer. MammaPrint has been extensively validated and Food and Drug Administration cleared in fresh and formalin-fixed and paraffin-embedded (FFPE) tissue. We aimed to assess its prognostic performance in the biomarker cohort of the Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG-8) patient population, and to obtain a higher level of evidence with regard to its clinical validity after RNA extraction from FFPE biobank tissue.
A prespecified retrospective analysis to test the prognostic performance of the MammaPrint test to predict distant recurrence-free survival at 5 and 10 years as primary end point was carried out. MammaPrint risk, clinicopathological factors (after central pathological review), and clinical risk (using a modified version of Adjuvant! Online) were evaluated by Cox regression analyses.
From 1347 available samples, 607 (45%) failed quality control after RNA extraction. In total, 658 (49%) patients were included in survival analyses: MammaPrint low risk versus high risk is a significant prognostic factor for distant recurrence-free survival at 5 years (94.0% versus 91.6%) with a significant risk reduction of 6.5% at 10 years (log-rank P value = 0.017, low risk 91.3% versus high risk 84.8%). The multivariable models suggest that hazard ratio (HR) is primarily driven by tumor stage (5-year HR 3.89; confidence interval 1.97-7.71) and nodal status (5-year HR 1.73; confidence interval 0.91-3.21). After adjustment for clinical risk groups, MammaPrint HRs remain stable with values just below 2.0 after the first 3 years.
The MammaPrint test showed significant prognostic performance at 5 and 10 years of follow-up. In the particular cohort of ABCSG-8, the statistical independence from clinically assessed covariates remains unclear, and no conclusions concerning the clinical validity of the test can be drawn.
MammaPrint 是一种基于早期乳腺癌患者肿瘤基因表达的预后检测方法。MammaPrint 已得到广泛验证，并获得美国食品和药物管理局在新鲜和福尔马林固定及石蜡包埋（FFPE）组织中的批准。我们旨在评估其在奥地利乳腺癌和结直肠癌研究组 8（ABCSG-8）患者人群的生物标志物队列中的预后性能，并在从 FFPE 生物库组织中提取 RNA 后获得其临床有效性的更高水平证据。
进行了一项预设的回顾性分析，以测试 MammaPrint 检测对预测 5 年和 10 年无远处复发的预后性能作为主要终点。使用 Cox 回归分析评估 MammaPrint 风险、临床病理因素（经中心病理复查）和临床风险（使用改良版 Adjuvant! Online）。
在 1347 个可用样本中，有 607 个（45%）在 RNA 提取后质量控制失败。共有 658 例患者纳入生存分析：MammaPrint 低风险与高风险是 5 年无远处复发的显著预后因素（94.0%与 91.6%），10 年时风险降低 6.5%（对数秩 P 值=0.017，低风险 91.3%与高风险 84.8%）。多变量模型表明，风险比（HR）主要由肿瘤分期（5 年 HR 3.89；置信区间 1.97-7.71）和淋巴结状态（5 年 HR 1.73；置信区间 0.91-3.21）驱动。在调整临床风险组后，MammaPrint HR 在最初 3 年后仍保持稳定，略低于 2.0。
MammaPrint 检测在 5 年和 10 年随访时表现出显著的预后性能。在 ABCSG-8 的特定队列中，其与临床评估协变量的统计独立性仍不清楚，并且不能得出关于该检测临床有效性的结论。
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