Han Wonshik, Kang Eunhye, Jung Ji Gwang, Kim Hong-Kyu, Lee Han-Byoel, Kim Jisun, Lee Sae Byul, Shin Hee-Chul, Park Chan Sub, Seong Min-Ki, Kim Hyun-Ah, Kim Eun-Kyu, Son Byung Ho
Department of Surgery, Seoul National University Hospital and Seoul National University College of Medicine, Seoul, South Korea.
Cancer Research Institute, Seoul National University, Seoul, South Korea.
NPJ Breast Cancer. 2025 Jun 20;11(1):57. doi: 10.1038/s41523-025-00772-5.
We investigated whether tailored neoadjuvant therapy (chemotherapy [NCT] or endocrine therapy [NET]) guided by a 70-gene assay could improve breast-conserving surgery (BCS) rates among patients with ER-positive/HER2-negative breast cancer initially deemed ineligible for BCS. Of 130 prospectively enrolled patients (stage II-IIIA, across four Korean centers), 92 were analyzed. Patients classified as high genomic risk received NCT, while low-risk patients underwent NET (letrozole ± leuprolide for premenopausal women) for 16-24 weeks. The primary endpoint-achieving the surgeon-defined target tumor size for BCS-was reached in 69.6% (95% CI: 59.1-78.7%), significantly surpassing the predefined goal of 50.8% (p < 0.05). The actual overall BCS rate was 59.8% (64.7% NCT, 45.8% NET). Pathologic complete response occurred in 2.2%, exclusively in the NCT group. Thus, pretreatment genomic profiling effectively guided therapy selection, substantially increasing BCS eligibility while sparing low-risk patients unnecessary chemotherapy toxicity.
我们研究了由70基因检测指导的个体化新辅助治疗(化疗[NCT]或内分泌治疗[NET])是否能提高最初被认为不适合保乳手术(BCS)的雌激素受体阳性/人表皮生长因子受体2阴性乳腺癌患者的保乳手术率。在130例前瞻性入组患者(来自韩国四个中心的II-IIIA期患者)中,对92例进行了分析。被分类为高基因组风险的患者接受NCT,而低风险患者接受NET(绝经前女性使用来曲唑±亮丙瑞林)治疗16-24周。达到外科医生定义的BCS目标肿瘤大小这一主要终点的患者比例为69.6%(95%CI:59.1-78.7%),显著超过了预先设定的50.8%的目标(p<0.05)。实际的总体BCS率为59.8%(NCT组为64.7%,NET组为45.8%)。病理完全缓解率为2.2%,仅出现在NCT组。因此,治疗前的基因组分析有效地指导了治疗选择,大幅提高了BCS的适宜性,同时使低风险患者免受不必要的化疗毒性。