Soni Aryaki, Morgan Jenna, Jacques Richard, Wyld Lynda
University of Sheffield Medical School, Beech Hill Rd, Broomhall, Sheffield, S10 2RX, UK; School of Medicine and Population Health, University of Sheffield, Barber House, 387 Glossop Road, Sheffield, S10 2HQ, UK.
University of Sheffield Medical School, Beech Hill Rd, Broomhall, Sheffield, S10 2RX, UK; School of Medicine and Population Health, University of Sheffield, Barber House, 387 Glossop Road, Sheffield, S10 2HQ, UK.
Eur J Surg Oncol. 2025 Aug;51(8):110023. doi: 10.1016/j.ejso.2025.110023. Epub 2025 Apr 12.
Axillary surgery for breast cancer has seen significant de-escalation in the past three decades. The ACOSOG Z0011 trial suggested that completion axillary clearance was not necessary in women with low disease burden after sentinel node biopsy (SLNB). Flaws in the design of the trial undermined confidence in its findings which delayed widespread adoption and caused practice heterogeneity globally. This systematic review evaluated the impact of Z0011 (and similar trials) on the rate and extent of axillary conservation in women with node-positive, low-risk early breast cancer. A search was conducted on the Ovid MEDLINE, Scopus, Web of Science and COCHRANE databases. Screening of titles and abstracts was undertaken according to eligibility criteria. Data were quality assessed using the ROBINS-1 and Robvis tools. The review retrieved 1362 papers, of which 30 papers were included, representing data from 290,754 women across nine countries. All articles were retrospective cohort studies. Included studies showed a statistically significant downward temporal trend in rates of ALND following the publication of the Z0011 trial but the extent of change ranged from a 5.6 %-73.4 % reduction in axillary clearance rates. This review demonstrated the Z0011 trial has been practice-changing. However, it also identified that few patients are eligible for de-escalation due to tight inclusion criteria. Finally, most articles were from Western countries, from research-focused hospitals, which limits generalizability. Further research across a wider range of settings is needed to understand the extent to which Z0011 has been implemented globally.
在过去三十年中,乳腺癌腋窝手术已出现显著的简化。美国外科医师学会肿瘤学组(ACOSOG)Z0011试验表明,前哨淋巴结活检(SLNB)后疾病负担低的女性无需进行腋窝淋巴结清扫术。该试验设计上的缺陷削弱了人们对其研究结果的信心,这延迟了该结果的广泛应用,并导致全球范围内的实践异质性。本系统评价评估了Z0011(及类似试验)对淋巴结阳性、低风险早期乳腺癌女性腋窝保留率和范围的影响。在Ovid MEDLINE、Scopus、科学网和考克兰数据库中进行了检索。根据纳入标准对标题和摘要进行筛选。使用ROBINS-1和Robvis工具对数据进行质量评估。该评价检索到1362篇论文,其中纳入30篇论文,代表来自9个国家的290754名女性的数据。所有文章均为回顾性队列研究。纳入研究显示,Z0011试验发表后,腋窝淋巴结清扫术(ALND)的发生率在时间上有统计学意义的下降趋势,但变化程度范围为腋窝清扫率降低5.6%至73.4%。本评价表明Z0011试验改变了临床实践。然而,它也指出,由于纳入标准严格,很少有患者符合简化治疗的条件。最后,大多数文章来自西方国家、以研究为重点的医院,这限制了研究结果的普遍性。需要在更广泛的环境中进行进一步研究,以了解Z0011在全球范围内的实施程度。