影像引导定位对临床淋巴结阳性乳腺癌患者定制腋窝手术效果的影响:TAXIS 内的前瞻性队列研究(OPBC-03、SAKK 23/16、IBCSG 57-18、ABCSG-53、GBG 101)。
Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer: Prospective Cohort Study Within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).
发表日期:2023 Oct 30
作者:
Walter P Weber, Martin Heidinger, Stefanie Hayoz, Zoltan Matrai, Christoph Tausch, Guido Henke, Daniel R Zwahlen, Günther Gruber, Frank Zimmermann, Giacomo Montagna, Mariacarla Andreozzi, Maite Goldschmidt, Alexandra Schulz, Andreas Mueller, Markus Ackerknecht, Ekaterini Christina Tampaki, Vesna Bjelic-Radisic, Christian Kurzeder, Ákos Sávolt, Viktor Smanykó, Daniela Hagen, Dieter J Müller, Michael Gnant, Sibylle Loibl, Florian Fitzal, Pagona Markellou, Inga Bekes, Daniel Egle, Jörg Heil, Michael Knauer
来源:
ANNALS OF SURGICAL ONCOLOGY
摘要:
定制腋窝手术(TAS)是针对临床淋巴结阳性乳腺癌的一种新颖的手术理念。它包括切除前哨淋巴结 (LN) 以及明显可疑的淋巴结。 TAS 技术可用于前期化疗和新辅助化疗 (NACT)。本研究评估了影像引导定位 (IGL) 是否/如何影响 TAS。这是在随机 III 期 OPBC-03/TAXIS 试验中预先计划的一项前瞻性观察队列研究。 IGL 是根据外科医生的判断进行的,目的是在 TAS 期间有针对性地切除淋巴结。根据 TAXIS 随机化,TAS 后立即进行备用腋窝淋巴结清扫术 (ALND)。纳入了来自 6 个国家 44 个乳腺中心的 500 名患者,其中 151 名 (30.2%) 接受了 NACT。 84.4% 的患者接受了 IGL,不同国家之间存在显着差异(77.6-100%,p < 0.001)。使用 IGL 去除的 LN 中位数(5 vs. 4,p = 0.3)和阳性 LN(2 vs. 2,p = 0.6)没有差异。在使用 IGL 的 TAS 期间移除的 LN 数量随着时间的推移保持稳定 (p = 0.8),但在不使用 IGL 的情况下显着减少,从 2019 年的 6 个 (IQR 4-6) 减少到 2022 年的 4 个 (IQR 3-4) (p = 0.015) 。对 249 名患者进行了 ALND,去除了另外 12 个(IQR 9-17)淋巴结,其中中位数为 1 个(IQR 0-4)呈阳性。 TAS 后有或没有 IGL 的残余淋巴结疾病没有显着差异(68.0% vs. 57.6%,p = 0.2)。IGL 没有显着改变 TAS 的表现或残余淋巴结肿瘤负荷的体积。ClinicalTrials.gov标识符:NCT03513614.© 2023。作者。
Tailored axillary surgery (TAS) is a novel surgical concept for clinical node-positive breast cancer. It consists of the removal of the sentinel lymph nodes (LNs), as well as palpably suspicious nodes. The TAS technique can be utilized in both the upfront and neoadjuvant chemotherapy (NACT) setting. This study assessed whether/how imaging-guided localization (IGL) influenced TAS.This was a prospective observational cohort study preplanned in the randomized phase-III OPBC-03/TAXIS trial. IGL was performed at the surgeon's discretion for targeted removal of LNs during TAS. Immediate back-up axillary lymph node dissection (ALND) followed TAS according to TAXIS randomization.Five-hundred patients were included from 44 breast centers in six countries, 151 (30.2%) of whom underwent NACT. IGL was performed in 84.4% of all patients, with significant variation by country (77.6-100%, p < 0.001). No difference in the median number of removed (5 vs. 4, p = 0.3) and positive (2 vs. 2, p = 0.6) LNs by use of IGL was noted. The number of LNs removed during TAS with IGL remained stable over time (p = 0.8), but decreased significantly without IGL, from six (IQR 4-6) in 2019 to four (IQR 3-4) in 2022 (p = 0.015). An ALND was performed in 249 patients, removing another 12 (IQR 9-17) LNs, in which a median number of 1 (IQR 0-4) was positive. There was no significant difference in residual nodal disease after TAS with or without IGL (68.0% vs. 57.6%, p = 0.2).IGL did not significantly change either the performance of TAS or the volume of residual nodal tumor burden.ClinicalTrials.gov Identifier: NCT03513614.© 2023. The Author(s).