Jilderda Marie-France, Zhang Yi, Rebattu Valerie, Salunga Ranelle, Mesker Wilma, Wong Jenna, de Munck Linda, Fornander Tommy, Nordenskjöld Bo, Stål Olle, Anderson Amanda K L, Bastiaannet Esther, Treuner Kai, Liefers Gerrit-Jan
Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.
Biotheranostics Inc., A Hologic Company, San Diego, California.
Clin Cancer Res. 2025 Jun 3;31(11):2222-2229. doi: 10.1158/1078-0432.CCR-24-3836.
This study assessed the prognostic ability of the breast cancer index (BCI) to identify patients at a minimal risk (<5%) of 10-year distant recurrence (DR) who are unlikely to benefit from adjuvant endocrine therapy.
This prospective translational study included postmenopausal patients with early-stage, hormone receptor-positive N0 breast cancer from the Stockholm (STO-3) trial who underwent surgery alone ("untreated") or surgery plus adjuvant tamoxifen ("treated") and from the Netherlands Cancer Registry (surgery alone). The primary endpoint was time to DR. An adjusted BCI model with an additional cutpoint was developed, which stratified patients into four prognostic risk groups.
Across cohorts, 16% to 22% of patients were classified as minimal risk of 10-year DR. In the Stockholm untreated cohort (n = 283), risks in the minimal-, low-, intermediate-, and high-risk groups were 2.3%, 15.5% [hazard ratio, 4.71 (95% confidence interval, 1.09-20.29) vs. minimal risk], 19.8% [6.97 (1.61-30.18)], and 35.9% [13.21 (3.07-56.76)], respectively (P < 0.001). In the Stockholm treated cohort (n = 317), risks were 4.3%, 5.0% [1.16 (0.35-3.85)], 11.7% [2.45 (0.74-8.14)], and 21.1% [5.27 (1.72-16.16); P < 0.001]. In the Netherlands Cancer Registry cohort (n = 1245), risks were 4.5%, 7.5% [subdistribution hazard ratio, 1.67 (95% confidence interval, 0.81-3.45)], 10.3% [2.40 (1.14-5.03)], and 13.1% [3.13 (1.50-6.55); P = 0.005]. BCI risk scores provided additional independent information over standard prognostic factors (likelihood ratio, χ2 = 7.98; P = 0.004).
The adjusted BCI model identified women with early-stage, hormone receptor-positive N0 breast cancer at a minimal risk of DR who may consider de-escalating adjuvant endocrine therapy.
本研究评估了乳腺癌指数（BCI）识别10年远处复发（DR）风险最低（<5%）且不太可能从辅助内分泌治疗中获益的患者的预后能力。
这项前瞻性转化研究纳入了来自斯德哥尔摩（STO-3）试验的绝经后早期激素受体阳性N0乳腺癌患者，这些患者单独接受手术（“未治疗”）或手术加辅助他莫昔芬（“治疗”），以及来自荷兰癌症登记处的患者（单独手术）。主要终点是至DR的时间。开发了一个带有额外切点的调整后BCI模型，该模型将患者分为四个预后风险组。
在各个队列中，16%至22%的患者被归类为10年DR风险最低。在斯德哥尔摩未治疗队列（n = 283）中，极低、低、中、高风险组的风险分别为2.3%、15.5%[风险比，4.71（95%置信区间，1.09 - 20.29）对比极低风险]、19.8%[6.97（1.61 - 30.18）]和35.9%[13.21（3.07 - 56.76）]（P < 0.001）。在斯德哥尔摩治疗队列（n = 317）中，风险分别为4.3%、5.0%[1.16（0.35 - 3.85）]、11.7%[2.45（0.74 - 8.14）]和21.1%[5.27（1.72 - 16.16）；P < 0.001]。在荷兰癌症登记处队列（n = 1245）中，风险分别为4.5%、7.5%[亚分布风险比，1.67（95%置信区间，0.81 - 3.45）]、10.3%[2.40（1.14 - 5.03）]和13.1%[3.13（1.50 - 6.55）；P = 0.005]。BCI风险评分提供了超过标准预后因素的额外独立信息（似然比，χ2 = 7.98；P = 0.004）。
调整后的BCI模型识别出了早期激素受体阳性N0乳腺癌且DR风险最低的女性，这些女性可能考虑降低辅助内分泌治疗强度。
