Güth U, Myrick M E, Viehl C T, Schmid S M, Obermann E C, Weber W P
University Hospital Basel (UHB), Department of Gynecology and Obstetrics, Spitalstrasse 21, CH-4031 Basel, Switzerland.
Eur J Surg Oncol. 2012 Aug;38(8):645-50. doi: 10.1016/j.ejso.2012.04.018. Epub 2012 May 19.
BACKGROUND: The ACOSOG Z0011 trial (Z0011) expanded our thinking about breast cancer (BC) and showed that limited metastatic disease left behind in the axilla did not compromise oncological safety in a selected group of patients. The aim of the current study was to assess the potential impact of Z0011 on clinical practice by testing the applicability of its criteria to a European patient population. METHODS: We reviewed a consecutive series of 389 sentinel lymph node biopsies (SLNB) performed for invasive BC at the University Hospital Basel between 2003 and 2009 (65.6% of all surgically treated patients, n = 593). RESULTS: When compared to the axillary lymph node dissection (ALND) arm of Z0011, our patients had significantly less advanced LN involvement (≥ 3 LN: 8.5% vs. 21.0%, p = 0.048). Thirty-five patients (9.0%) met the Z0011 inclusion criteria and had 1-2 SLNs with macrometastases (5.9% of all surgically treated BC patients). If the inclusion criteria of Z0011 had been applied, a considerable number of LNs would have been missed in two cases (0.5% of all SLNBs). CONCLUSIONS: The application of the Z0011 led to the omission of completion ALND in less than 10% of all SLNB procedures (<6% of all surgically treated BC patients); therefore, we do not think that the perception of Z0011 as "practice changing" is justified. On the other side, skeptics of the routine implementation of the Z0011 protocol may overestimate its potential hazards. When performing a thorough preoperative clinical axillary staging, the number of patients who would have been undertreated is minimal.
背景:美国外科医师学会肿瘤学组Z0011试验(Z0011)拓展了我们对乳腺癌(BC)的认识,并表明在一组特定患者中,腋窝残留的有限转移性疾病并不影响肿瘤学安全性。本研究的目的是通过测试其标准在欧洲患者群体中的适用性,评估Z0011对临床实践的潜在影响。 方法:我们回顾了2003年至2009年间在巴塞尔大学医院为浸润性BC进行的连续389例前哨淋巴结活检(SLNB)(占所有手术治疗患者的65.6%,n = 593)。 结果:与Z0011的腋窝淋巴结清扫(ALND)组相比,我们的患者淋巴结受累程度明显较轻(≥3个淋巴结:8.5%对21.0%,p = 0.048)。35例患者(9.0%)符合Z0011纳入标准,有1 - 2个前哨淋巴结存在大转移灶(占所有手术治疗BC患者的5.9%)。如果应用Z0011的纳入标准,在两例病例中会遗漏相当数量的淋巴结(占所有SLNB的0.5%)。 结论:Z0011的应用导致在所有SLNB手术中不到10%的病例(占所有手术治疗BC患者的<6%)未进行补充ALND;因此,我们认为将Z0011视为“改变实践”的观点是不合理的。另一方面,对Z0011方案常规实施持怀疑态度的人可能高估了其潜在危害。在进行全面的术前临床腋窝分期时,治疗不足的患者数量极少。
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