Background: 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.Methods: 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.Results: 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%).Conclusions: 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.
背景：在新辅助内分泌治疗（NET）对于管腔型肿瘤患者的作用，在日常临床实践中仍未得到明确定义。为评估联合NET的疗效，我们在真实世界人群中分析了氟维司群与芳香化酶抑制剂（AI）联合治疗的效果。 方法：本研究为单臂回顾性纵向研究，纳入2019年至2024年间在克罗地亚斯普利特大学临床医院接受氟维司群联合AI新辅助治疗的全部局部晚期、临床II-III期、HR+ HER2-管腔型早期乳腺癌患者。 结果：意向治疗（ITT）人群共纳入44例患者，其中34例完成NET及手术治疗（符合方案集人群；PPP）。NET中位持续时间为11个月（四分位距[IQR]为9-16个月）。通过影像学检查、乳腺超声或磁共振评估，ITT人群中最佳影像学客观缓解率（部分或完全缓解）为68.2%（30例），PPP人群中为76.5%（26例）。在PPP人群中，根据残留肿瘤负荷评估为轻度或中度病理缓解（I级或II级）的患者占85.3%（29例）。Ki-67绝对变化值中位数为-5（95% CI：-9至0），相对变化中位数为-40%（95% CI：-72%至0%）。术后Ki-67水平可通过初始Ki-67值、淋巴结阳性状态及从确诊到开始NET的时间进行显著预测。治疗耐受性良好，未出现因毒性需要终止治疗或降低剂量的情况。最常见报告的不良反应包括肌肉骨骼疼痛（45.5%）、乏力（34.1%）和潮热（29.5%）。 结论：对于不适合化疗的局部晚期管腔型早期乳腺癌真实世界患者，氟维司群联合AI的双重激素治疗是一种有效、易于实施、无毒性的新辅助治疗方案，具有良好应用前景。
肿瘤(癌症)患者之家