Breast Center, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
Breast Center Eastern Switzerland, St. Gallen, Switzerland.
Breast. 2023 Jun;69:281-289. doi: 10.1016/j.breast.2023.03.005. Epub 2023 Mar 8.
Axillary surgery in patients with breast cancer has been a history of de-escalation; however, surgery for clinically node-positive breast cancer remained at the dogmatic level of axillary lymph node dissection (ALND). In these patients, currently the only way to avoid ALND is neoadjuvant systemic treatment (NST) with nodal pathologic complete response (pCR) as diagnosed by selective lymph node removal. However, pCR rates are highly dependent on tumor biology, with luminal tumors being most present yet showing the lowest pCR rates. Therefore, the TAXIS trial is investigating whether in clinically node-positive patients, either with residual disease after NST or in the upfront surgical setting, ALND can be safely omitted. All patients undergo tailored axillary surgery (TAS), which includes removal of the biopsied and clipped node, the sentinel lymph nodes as well as all palpably suspicious nodes, turning a clinically positive axilla into a clinically negative. Feasibility of TAS was recently confirmed in the first pre-specified TAXIS substudy. TAS is followed by axillary radiotherapy to treat any remaining nodal disease. Disease-free survival is the primary endpoint of this non-inferiority trial, and morbidity as well as quality of life are the main secondary endpoints, with ALND being known for having a relevant negative impact on both. Currently, 663 of 1500 patients were randomized; accrual completion is projected for 2025. The TAXIS trial stands out in including clinically node-positive patients in both the neoadjuvant and upfront surgery setting, thereby investigating surgical de-escalation at the far-end of the risk spectrum of patients with breast cancer.
乳腺癌患者的腋窝手术史一直在逐步减少；然而，临床淋巴结阳性乳腺癌的手术仍停留在腋窝淋巴结清扫术（ALND）的教条水平。在这些患者中，目前避免 ALND 的唯一方法是新辅助全身治疗（NST），并通过选择性淋巴结切除诊断为淋巴结病理完全缓解（pCR）。然而，pCR 率高度依赖于肿瘤生物学，腔型肿瘤最为常见，但显示出最低的 pCR 率。因此，TAXIS 试验正在研究在临床淋巴结阳性患者中，无论是在 NST 后仍有残留疾病的患者，还是在初始手术情况下，是否可以安全地省略 ALND。所有患者均接受定制腋窝手术（TAS），包括切除活检和夹闭的淋巴结、前哨淋巴结以及所有可触及的可疑淋巴结，将临床阳性腋窝转化为临床阴性腋窝。TAS 的可行性最近在首次预设的 TAXIS 子研究中得到了证实。TAS 后进行腋窝放疗以治疗任何残留的淋巴结疾病。无病生存期是这项非劣效性试验的主要终点，发病率和生活质量是主要的次要终点，ALND 已知对两者都有相关的负面影响。目前，1500 名患者中有 663 名被随机分配；预计 2025 年完成入组。TAXIS 试验的突出特点是将临床淋巴结阳性患者纳入新辅助和初始手术治疗中，从而在乳腺癌患者风险谱的最远端研究手术降级。
