Zhao Christine, Sriram Nina, Hitos Kerry, Hughes T Michael, Ngui Nicholas
Royal Prince Alfred Hospital, Sydney Local Health District, Sydney, Australia.
School of Medicine, The University of Sydney, Sydney, Australia.
ANZ J Surg. 2025 Mar;95(3):503-511. doi: 10.1111/ans.19404. Epub 2025 Jan 28.
The clinical management of the axilla in early breast cancer has changed since the Z0011 trial, which showed that axillary lymph node dissection (ALND) is not necessary in select patients with a positive sentinel lymph node biopsy (SLNB). Studies have shown a significant decrease in the rates of completion ALND (cALND) since Z0011. The aims of this study were to investigate the effect of the Z0011 trial on the management of positive axillary sentinel nodes and the trends in axillary surgical management since 2005 in Australia and New Zealand.
This study utilized prospectively maintained data from the BreastSurgANZ Quality Audit (BQA). Patients with early breast cancer between 2005 and 2023 satisfying the Z0011 trial inclusion criteria undergoing SLNB or SLNB followed by cALND were identified.
There were 91 196 patients who underwent breast-conserving surgery and SLNB of which 12 035 were node positive therefore satisfying the Z0011 trial inclusion criteria, of which 8194 (68.1%) received SLNB only with no cALND. There has been a 55.4% reduction in the rate of cALND after 2010 when the Z0011 trial was published (P < 0.001). There was a significant downward trend in the number of cALND performed per year (R = 0.890, P < 0.001).
The Z0011 trial was a practice changing trial and since its publication in 2010 has been correlated with de-escalation in surgical management of the axilla and decline in the rates of cALND in Australia and New Zealand.
自Z0011试验以来,早期乳腺癌腋窝的临床管理发生了变化,该试验表明,对于前哨淋巴结活检(SLNB)阳性的特定患者,腋窝淋巴结清扫(ALND)并非必要。研究表明,自Z0011试验以来,完成腋窝淋巴结清扫(cALND)的比率显著下降。本研究的目的是调查Z0011试验对腋窝前哨淋巴结阳性管理的影响以及自2005年以来澳大利亚和新西兰腋窝手术管理的趋势。
本研究利用了来自澳大利亚和新西兰乳腺外科质量审核(BQA)的前瞻性维护数据。确定了2005年至2023年间符合Z0011试验纳入标准并接受SLNB或SLNB后行cALND的早期乳腺癌患者。
有91196例患者接受了保乳手术和SLNB,其中12035例淋巴结阳性,因此符合Z0011试验纳入标准,其中8194例(68.1%)仅接受了SLNB,未进行cALND。在2010年Z0011试验发表后,cALND的比率下降了55.4%(P < 0.001)。每年进行cALND的数量有显著下降趋势(R = 0.890,P < 0.001)。
Z0011试验是一项改变实践的试验,自2010年发表以来,与澳大利亚和新西兰腋窝手术管理的降级以及cALND比率的下降相关。