Majić Ana, Bajić Žarko, Ban Marija, Tica Sedlar Ivana, Čerina Pavlinović Dora, Petrić Miše Branka, Strikić Ante, Tomić Snježana, Vrdoljak Eduard
Department of Oncology, University Hospital Center Split, School of Medicine, University of Split, 21000 Split, Croatia.
Research Unit "Dr. Mirko Grmek", Psychiatric Clinic Sveti Ivan, 10090 Zagreb, Croatia.
Cancers (Basel). 2025 Jun 21;17(13):2083. doi: 10.3390/cancers17132083.
: The role of neoadjuvant endocrine therapy (NET) in patients with luminal tumors is still not well defined in everyday clinical practice. To assess the efficacy of combination NET, we analyzed the outcomes of fulvestrant and aromatase inhibitors (AI) in combination in a real-world population. : This was a single-arm, retrospective longitudinal study of the total population of patients diagnosed with locoregionally advanced, clinical stage II-III, HR+ HER2-, luminal-type eBC, who were treated with the neoadjuvant combination of fulvestrant and AI between 2019 and 2024 at the Clinical University Hospital of Split, Croatia. : We enrolled 44 patients in the intention-to-treat (ITT) population, while 34 completed NET and surgery (per-protocol population; PPP). The median duration of NET was 11 months (interquartile range [IQR] of 9-16 months). The best radiological objective response rate (partial or complete response) was achieved by 30 (68.2%) in ITT, and 26 (76.5%) in PPP, defined by radiological examination, breast ultrasound, or MR. In the PPP, the minimal or moderate pathological response according to residual cancer burden (I or II) was observed in 29 (85.3%) patients. The median of absolute changes in Ki-67 was -5 (95% CI: -9 to 0), and the median of relative Ki67 changes was -40% (95% CI: -72% to 0%). Post-surgical Ki-67 was significantly predicted by initial Ki-67, positive lymph nodes, and time from diagnosis to the initiation of NET. Treatment was well tolerated, with no therapy discontinuation or dose reductions needed due to toxicity. The most commonly reported side effects included musculoskeletal pain (45.5%), asthenia (34.1%), and hot flashes (29.5%). : Dual hormonal therapy with fulvestrant and AI is an active, easily given, non-toxic, promising neoadjuvant treatment in real-world patients with locally advanced luminal-type eBC who are not candidates for chemotherapy.
在日常临床实践中，新辅助内分泌治疗（NET）在管腔型肿瘤患者中的作用仍未明确界定。为评估联合NET的疗效，我们分析了氟维司群和芳香化酶抑制剂（AI）联合应用于真实世界人群的治疗结果。
这是一项单臂回顾性纵向研究，研究对象为2019年至2024年期间在克罗地亚斯普利特临床大学医院接受氟维司群和AI新辅助联合治疗的局部晚期、临床II - III期、HR + HER2 - 、管腔型早期乳腺癌（eBC）患者的总体人群。
我们将44例患者纳入意向性分析（ITT）人群，其中34例完成了NET及手术（符合方案人群；PPP）。NET的中位持续时间为11个月（四分位间距[IQR]为9 - 16个月）。ITT人群中30例（68.2%）、PPP人群中26例（76.5%）达到最佳影像学客观缓解率（部分或完全缓解），通过影像学检查、乳腺超声或磁共振成像确定。在PPP人群中，29例（85.3%）患者根据残余癌负担观察到最小或中度病理缓解（I或II级）。Ki - 67的绝对变化中位数为 - 5（95%CI： - 9至0），相对Ki67变化中位数为 - 40%（95%CI： - 72%至0%）。术后Ki - 67可由初始Ki - 67、阳性淋巴结以及从诊断到开始NET的时间显著预测。治疗耐受性良好，未因毒性而中断治疗或减少剂量。最常报告的副作用包括肌肉骨骼疼痛（45.5%）、乏力（34.1%）和潮热（29.5%）。
对于不适合化疗的局部晚期管腔型eBC真实世界患者，氟维司群和AI的双重激素治疗是一种积极、易于给药、无毒且有前景的新辅助治疗方法。
