研究动态
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声音试验的现实世界意义。

Real-World Implications of the SOUND Trial.

发表日期:2024 Oct 14
作者: Andreas Giannakou, Olga Kantor, Ko Un Park, Adrienne G Waks, Rinaa S Punglia, Laura S Dominici, Faina Nakhlis, Elizabeth A Mittendorf, Tari A King
来源: ANNALS OF SURGICAL ONCOLOGY

摘要:

SOUND 试验表明,对于早期乳腺癌 (BC) 和腋窝超声 (AxUS) 阴性的患者,省略前哨淋巴结活检 (SLNB) 并不劣于腋窝分期。我们检查了这些研究结果在激素受体 (HR) HER2- 疾病患者中的普遍性。从前瞻性维护的数据库中确定了 2016 年至 2023 年接受 SLNB 保乳的 cT1N0M0、HR HER2- BC 和阴性 AxUS 患者。检查临床病理特征、疾病负担、辅助治疗和肿瘤学结果,并与 SOUND 试验的 SLNB 组进行比较。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 名 cT1N0M0 HR HER2- 乳腺癌患者中,544 名接受了 AxUS;其中 544 名接受了 AxUS 治疗。 312 人符合 SOUND 资格标准。中位年龄为 57 岁(四分位距 [IQR] 48-64)岁,其中 199 岁 (63.8%) 已绝经。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%) 患者前哨淋巴结活检呈阳性。只有 3 名(0.4%)有 ≥ 4 个阳性淋巴结。中位随访时间为 26.2 (IQR 10.8-38.2) 个月,没有腋窝复发,只有 1 例 (0.3%) 远处复发。在复发评分 ≤ 25 的绝经后女性中,化疗建议与淋巴结状态无关。对我们真实世界 HR HER2-“SOUND 合格”人群的检查表明,淋巴结疾病负担和肿瘤学结果与 SOUND 试验人群相似,支持将试验结果认真落实到多学科实践中。在绝经后患者中,省略前哨淋巴结活检似乎不会影响辅助化疗建议。© 2024。外科肿瘤学会。
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.© 2024. Society of Surgical Oncology.