Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
Ann Surg Oncol. 2024 Dec;31(13):8776-8785. doi: 10.1245/s10434-024-16354-x. Epub 2024 Oct 14.
The SOUND trial demonstrated that omission of sentinel lymph node biopsy (SLNB) is noninferior to axillary staging in patients with early-stage breast cancer (BC) and negative axillary ultrasound (AxUS). We examined the generalizability of these findings in patients with hormone receptor (HR)+HER2- disease.
Patients with cT1N0M0, HR+HER2- BC and negative AxUS undergoing breast conservation with SLNB from 2016 to 2023 were identified from a prospectively maintained database. Clinicopathologic characteristics, disease burden, adjuvant treatment, and oncologic outcomes were examined and compared with the SLNB arm of the SOUND trial. In postmenopausal patients, the impact of nodal status and 21-gene recurrence score on chemotherapy recommendations were also examined.
Of 3972 patients with cT1N0M0 HR+HER2- breast cancer, 544 underwent AxUS; 312 met SOUND eligibility criteria. Median age was 57 (interquartile range [IQR] 48-64) years, and 199 (63.8%) were postmenopausal. Median (IQR) tumor size was 1.3 (0.9-1.7) cm, and 260 (83.3%) tumors were grade 1 or 2. Sentinel lymph node biopsy was positive in 38 (12.2%) patients. Only three (0.4%) had ≥ 4 positive lymph nodes. At a median follow-up of 26.2 (IQR 10.8-38.2) months, there were no axillary recurrences and one (0.3%) distant recurrence. Among postmenopausal women with recurrence score ≤ 25, chemotherapy recommendations were not associated with nodal status.
Examination of our real-world HR+ HER2- "SOUND-eligible" population suggests that nodal disease burden and oncologic outcomes are similar to the SOUND trial population, supporting careful implementation of trial results into multidisciplinary practice. In postmenopausal patients, omission of SLNB does not appear to impact adjuvant chemotherapy recommendations.
SOUND 试验表明，对于早期乳腺癌（BC）且腋窝超声（AxUS）阴性的患者，省略前哨淋巴结活检（SLNB）与腋窝分期非劣效。我们在激素受体（HR）+HER2-疾病患者中检验了这些发现的普遍性。
从 2016 年至 2023 年，从一个前瞻性维护的数据库中确定了接受保乳手术且 SLNB 的 cT1N0M0、HR+HER2-BC 且 AxUS 阴性的患者。检查了临床病理特征、疾病负担、辅助治疗和肿瘤学结局，并与 SOUND 试验的 SLNB 组进行了比较。在绝经后患者中，还检查了淋巴结状态和 21 基因复发评分对化疗建议的影响。
在 3972 例 cT1N0M0 HR+HER2-BC 患者中，544 例行 AxUS；312 例符合 SOUND 入选标准。中位年龄为 57 岁（四分位距 [IQR] 48-64 岁），199 例（63.8%）为绝经后患者。中位（IQR）肿瘤大小为 1.3（0.9-1.7）cm，260 例（83.3%）肿瘤为 1 级或 2 级。38 例（12.2%）患者的 SLNB 阳性。仅 3 例（0.4%）有≥4 个阳性淋巴结。中位随访 26.2（IQR 10.8-38.2）个月，无腋窝复发，1 例（0.3%）远处复发。在复发评分≤25 的绝经后妇女中，化疗建议与淋巴结状态无关。
对我们的真实世界 HR+HER2-“SOUND 合格”人群的检查表明，淋巴结疾病负担和肿瘤学结局与 SOUND 试验人群相似，支持将试验结果谨慎应用于多学科实践。在绝经后患者中，省略 SLNB 似乎不会影响辅助化疗建议。
