Breast Center, University Hospital Basel, Basel, Switzerland.
Faculty of Medicine, University of Basel, Basel, Switzerland.
JAMA Surg. 2023 Oct 1;158(10):1013-1021. doi: 10.1001/jamasurg.2023.2840.
The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive breast cancer (BC) is currently unknown.
To address the association of ALND with systemic therapy in cN-positive BC in the upfront surgery setting and after neoadjuvant chemotherapy (NACT).
DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, observational, cohort study conducted from August 2018 to June 2022. This was a preplanned study within the phase 3 randomized clinical OPBC-03/TAXIS trial. Included were patients with confirmed cN-positive BC from 44 private, public, and academic breast centers in 6 European countries. After NACT, residual nodal disease was mandatory, and a minimum follow-up of 2 months was required.
All patients underwent tailored axillary surgery (TAS) followed by ALND or axillary radiotherapy (ART) according to TAXIS randomization. TAS removed suspicious palpable and sentinel nodes, whereas imaging-guidance was optional. Systemic therapy recommendations were at the discretion of the local investigators.
A total of 500 patients (median [IQR] age, 57 [48-69] years; 487 female [97.4%]) were included in the study. In the upfront surgery setting, 296 of 335 patients (88.4%) had hormone receptor (HR)-positive and Erb-B2 receptor tyrosine kinase 2 (ERBB2; formerly HER2 or HER2/neu)-negative disease: 145 (49.0%) underwent ART, and 151 (51.0%) underwent ALND. The median (IQR) number of removed positive lymph nodes without ALND was 3 (1-4) nodes compared with 4 (2-9) nodes with ALND. There was no association of ALND with the proportion of patients undergoing adjuvant chemotherapy (81 of 145 [55.9%] vs 91 of 151 [60.3%]; adjusted odds ratio [aOR], 0.72; 95% CI, 0.19-2.67) and type of systemic therapy. Of 151 patients with NACT, 74 (51.0%) underwent ART, and 77 (49.0%) underwent ALND. The ratio of removed to positive nodes was a median (IQR) of 4 (3-7) nodes to 2 (1-3) nodes and 15 (12-19) nodes to 2 (1-5) nodes in the ART and ALND groups, respectively. There was no observed association of ALND with the proportion of patients undergoing postneoadjuvant systemic therapy (57 of 74 [77.0%] vs 55 of 77 [71.4%]; aOR, 0.86; 95% CI, 0.43-1.70), type of postneoadjuvant chemotherapy (eg, capecitabine: 10 of 74 [13.5%] vs 10 of 77 [13.0%]; trastuzumab emtansine-DM1: 9 of 74 [12.2%] vs 11 of 77 [14.3%]), or endocrine therapy (eg, aromatase inhibitors: 41 of 74 [55.4%] vs 36 of 77 [46.8%]; tamoxifen: 8 of 74 [10.8%] vs 6 of 77 [7.8%]).
Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.
重要性：目前尚不清楚腋窝淋巴结清扫术（ALND）在临床淋巴结阳性（cN）乳腺癌（BC）患者中确定淋巴结负担以告知系统治疗建议的作用。
目的：在新辅助化疗（NACT）前后的 upfront 手术环境中，解决 ALND 与 cN 阳性 BC 中的系统治疗的关联。
设计、设置和参与者：这是一项前瞻性、观察性队列研究，于 2018 年 8 月至 2022 年 6 月进行。这是一项在 3 期随机临床试验 OPBC-03/TAXIS 内的预先计划的研究。纳入了来自欧洲 6 个国家的 44 家私人、公共和学术乳房中心的确诊 cN 阳性 BC 患者。在 NACT 后，必须有残留的淋巴结疾病，并且需要至少 2 个月的随访。
暴露：所有患者均接受了定制的腋窝手术（TAS），然后根据 TAXIS 随机分组进行 ALND 或腋窝放疗（ART）。TAS 切除可疑的可触及和前哨淋巴结，而影像学引导是可选的。系统治疗建议由当地研究者自行决定。
结果：共纳入 500 名患者（中位数[IQR]年龄，57 [48-69] 岁；487 名女性[97.4%]）。在 upfront 手术环境中，335 名患者中有 296 名（88.4%）患有激素受体（HR）阳性和 Erb-B2 受体酪氨酸激酶 2（ERBB2；以前称为 HER2 或 HER2/neu）阴性疾病：145 名（49.0%）接受 ART，151 名（51.0%）接受 ALND。无 ALND 时移除的阳性淋巴结中位数（IQR）为 3（1-4）个淋巴结，而有 ALND 时为 4（2-9）个淋巴结。ALND 与接受辅助化疗的患者比例（145 名中的 81 名[55.9%]与 151 名中的 91 名[60.3%]；调整后的优势比[aOR]，0.72；95%CI，0.19-2.67）和系统治疗类型无关。在 151 名接受 NACT 的患者中，74 名（51.0%）接受 ART，77 名（49.0%）接受 ALND。ART 和 ALND 组中，移除的淋巴结与阳性淋巴结的比值中位数（IQR）分别为 4（3-7）个与 2（1-3）个，15（12-19）个与 2（1-5）个。在接受 postneoadjuvant 系统治疗的患者比例（74 名中的 57 名[77.0%]与 77 名中的 55 名[71.4%]；aOR，0.86；95%CI，0.43-1.70）、postneoadjuvant 化疗类型（例如卡培他滨：74 名中的 10 名[13.5%]与 77 名中的 10 名[13.0%]；曲妥珠单抗 emtansine-DM1：74 名中的 9 名[12.2%]与 77 名中的 11 名[14.3%]）或内分泌治疗（例如芳香酶抑制剂：74 名中的 41 名[55.4%]与 77 名中的 36 名[46.8%]；他莫昔芬：74 名中的 8 名[10.8%]与 77 名中的 6 名[7.8%]）之间，没有观察到 ALND 的关联。
结论：该队列研究的结果表明，未行 ALND 的患者明显分期不足。然而，ALND 并没有告知系统治疗建议。
