Tvedskov Tove Filtenborg, Szulkin Robert, Alkner Sara, Andersson Yvette, Bergkvist Leif, Frisell Jan, Gentilini Oreste Davide, Kontos Michalis, Kühn Thorsten, Lundstedt Dan, Offersen Birgitte Vrou, Bagge Roger Olofsson, Reimer Toralf, Sund Malin, Rydén Lisa, Christiansen Peer, de Boniface Jana
Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Breast Surgery, Gentofte Hospital, Gentofte, Denmark.
Lancet Reg Health Eur. 2024 Sep 26;47:101083. doi: 10.1016/j.lanepe.2024.101083. eCollection 2024 Dec.
Randomized trials have shown that axillary clearance (AC) can safely be omitted in patients with sentinel lymph node-positive breast cancer. At the same time, de-escalation of chemotherapy in postmenopausal patients with ER+HER2- breast cancer may depend on detailed axillary nodal stage. The aim of this pre-specified secondary analysis of the SENOMAC trial was to investigate whether the choice of axillary staging affected the proportion of patients receiving adjuvant chemotherapy, and recurrence-free survival (RFS).
Proportion receiving adjuvant chemotherapy was calculated according to AC or sentinel lymph node biopsy (SLNB) only, menopausal status, and region of inclusion, for 2168 patients with clinically node-negative ER+HER2- breast cancer and 1-2 sentinel lymph node macrometastases included in the SENOMAC trial.
In premenopausal patients, 514 out of 615 patients (83.6%) received adjuvant chemotherapy with no significant difference between randomization arms. In postmenopausal patients, the proportion receiving chemotherapy varied considerably by region and country (36.0-82.4%). In Denmark, where 194 out of 539 postmenopausal patients (36.0%) received adjuvant chemotherapy, rates differed significantly between the AC and the SLNB only arm (41.3% vs 31.4%, p = 0.019). After a median follow-up of 44.88 months for Danish postmenopausal patients, no significant difference was seen in 5-year RFS, which was 91% (85.6%-96.6%) for the SLNB only and 90.9% (86.3%-95.6%) for the AC arm (p = 0.42).
When omitting axillary clearance, and thus reducing the risk of long-term arm morbidity, potential under-treatment of postmenopausal patients with ER+HER2- breast cancer may require the development of new predictive and imaging tools.
Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, Swedish Breast Cancer Association.
随机试验表明,前哨淋巴结阳性的乳腺癌患者可安全地省略腋窝清扫术(AC)。与此同时,绝经后雌激素受体阳性(ER+)、人表皮生长因子受体2阴性(HER2-)乳腺癌患者化疗方案的降级可能取决于腋窝淋巴结的详细分期。这项针对SENOMAC试验预先设定的二次分析的目的是研究腋窝分期的选择是否会影响接受辅助化疗的患者比例以及无复发生存期(RFS)。
根据仅行AC或前哨淋巴结活检(SLNB)、绝经状态和纳入地区,计算SENOMAC试验中2168例临床淋巴结阴性、ER+HER2-乳腺癌且有1-2个前哨淋巴结大转移的患者接受辅助化疗的比例。
在绝经前患者中,615例患者中有514例(83.6%)接受了辅助化疗,随机分组的两组之间无显著差异。在绝经后患者中,接受化疗的比例因地区和国家而异(36.0%-82.4%)。在丹麦,539例绝经后患者中有194例(36.0%)接受了辅助化疗,AC组和仅行SLNB组的比例差异显著(41.3%对31.4%,p = 0.019)。丹麦绝经后患者中位随访44.88个月后,5年RFS无显著差异,仅行SLNB组为91%(85.6%-96.6%),AC组为90.9%(86.3%-95.6%)(p = 0.42)。
省略腋窝清扫术从而降低长期手臂并发症风险时,绝经后ER+HER2-乳腺癌患者可能存在潜在的治疗不足,这可能需要开发新的预测和成像工具。
瑞典研究理事会、瑞典癌症协会北欧癌症联盟、瑞典乳腺癌协会。