Dedic Vedad, Pusina Sadat, Salibasic Mirhan, Bicakcic-Filipovic Emina, Bicakcic Emir, Herenda Naida, Karup Nidzara
Department of General, Abdominal and Glandular Surgery, University Clinical Center of Sarajevo, Sarajevo, BIH.
Department of Oncology, University Clinical Center of Sarajevo, Sarajevo, BIH.
Cureus. 2025 Apr 23;17(4):e82825. doi: 10.7759/cureus.82825. eCollection 2025 Apr.
Background Adjuvant chemotherapy decisions in early-stage, hormone receptor-positive, HER2-negative breast cancer traditionally rely on clinicopathological features such as tumor size, grade, and lymph node status. However, multigene expression assays like MammaPrint offer additional prognostic information that may alter treatment recommendations. This study aimed to assess the level of agreement between MammaPrint-based genomic risk classification and chemotherapy recommendations derived from National Comprehensive Cancer Network (NCCN)-based clinical criteria in a cohort of Bosnia and Herzegovina breast cancer patients. Methods We retrospectively analyzed 66 patients with HR+/HER2-, node-negative early breast cancer treated between 2023 and 2024. All patients underwent MammaPrint testing, which classified tumors as either low risk or high risk for distant recurrence. Clinical risk was assessed using a simplified NCCN-guided algorithm, in which chemotherapy was recommended for tumors >2 cm and/or grade three histology. The primary outcome was the rate of concordance between genomic and clinical risk classifications. Statistical analysis included descriptive summaries, cross-tabulation, and Cohen's kappa to evaluate agreement. Results Of the 66 patients analyzed, MammaPrint classified 27 (40.9%) as high risk and 39 (59.1%) as low risk. Based on NCCN criteria, 36 patients (54.5%) were considered clinically high-risk and recommended for chemotherapy, while 30 (45.5%) were not. Concordance between genomic and clinical classifications was observed in 37 patients (56.1%), while 29 patients (43.9%) showed discordant results. The most common discordance pattern was a clinically high-risk but genomically low-risk classification, observed in 19 cases (65.5% of discordant pairs). Cohen's kappa for agreement between methods was 0.136, indicating slight agreement beyond chance. McNemar's test yielded a χ² value of 10.0 (p = 0.036), suggesting significant asymmetry in discordance patterns. Conclusion This study highlights a substantial rate of discordance between MammaPrint genomic risk and NCCN-based clinical risk assessment. In our cohort, reliance on clinicopathological features alone would have led to different chemotherapy recommendations in over half of the cases. These findings support the clinical utility of multigene assays in refining adjuvant treatment decisions and reducing potential overtreatment in early breast cancer.
背景 在早期、激素受体阳性、人表皮生长因子受体2阴性乳腺癌中,辅助化疗决策传统上依赖于肿瘤大小、分级和淋巴结状态等临床病理特征。然而,像MammaPrint这样的多基因表达检测可提供额外的预后信息,这可能会改变治疗建议。本研究旨在评估在波斯尼亚和黑塞哥维那乳腺癌患者队列中,基于MammaPrint的基因组风险分类与源自基于美国国立综合癌症网络(NCCN)临床标准的化疗建议之间的一致程度。方法 我们回顾性分析了2023年至2024年期间接受治疗的66例激素受体阳性/人表皮生长因子受体2阴性、淋巴结阴性的早期乳腺癌患者。所有患者均接受了MammaPrint检测,该检测将肿瘤分为远处复发低风险或高风险。使用简化的NCCN指导算法评估临床风险,对于肿瘤直径>2 cm和/或组织学分级为三级的肿瘤推荐进行化疗。主要结局是基因组和临床风险分类之间的一致率。统计分析包括描述性总结、交叉表分析以及用于评估一致性的Cohen's kappa检验。结果 在分析的66例患者中,MammaPrint将27例(40.9%)分类为高风险,39例(59.1%)分类为低风险。根据NCCN标准,36例患者(54.5%)被认为临床高风险并推荐化疗,而30例(45.5%)则不推荐。37例患者(56.1%)观察到基因组和临床分类之间的一致性,而29例患者(43.9%)结果不一致。最常见的不一致模式是临床高风险但基因组低风险分类,在19例中观察到(占不一致对的65.5%)。两种方法之间一致性的Cohen's kappa为0.136,表明一致性略高于偶然。McNemar检验得出χ²值为10.0(p = 0.036),表明不一致模式存在显著不对称性。结论 本研究强调了MammaPrint基因组风险与基于NCCN的临床风险评估之间存在相当高的不一致率。在我们的队列中,仅依赖临床病理特征会导致超过半数的病例出现不同的化疗建议。这些发现支持了多基因检测在优化辅助治疗决策和减少早期乳腺癌潜在过度治疗方面的临床实用性。