临床淋巴结阳性乳腺癌患者腋窝清扫术与全身治疗的相关性。

Association of Axillary Dissection With Systemic Therapy in Patients With Clinically Node-Positive Breast Cancer.

机构信息

Breast Center, University Hospital Basel, Basel, Switzerland.

Faculty of Medicine, University of Basel, Basel, Switzerland.

出版信息

JAMA Surg. 2023 Oct 1;158(10):1013-1021. doi: 10.1001/jamasurg.2023.2840.

DOI:10.1001/jamasurg.2023.2840

PMID:37466971

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10357358/

Abstract

IMPORTANCE

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.

OBJECTIVE

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.

EXPOSURES

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.

RESULTS

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%]).

CONCLUSION

Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.

摘要

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。