Ann Surg Oncol. 2013 Dec;20(13):4145-52. doi: 10.1245/s10434-013-3193-1.
American College of Surgeons Oncology Group (ACOSOG) Z0011 demonstrated that eligible breast cancer patients with positive sentinel lymph nodes (SLN) could be spared an axillary lymph node dissection (ALND) without sacrificing survival or local control. Although heralded as a ‘‘practice-changing trial,’’ some argue that the stringent inclusion criteria limit the trial’s clinical significance. The objective was to assess the potential impact of ACOSOG Z0011 on axillary surgical management of Medicare patients and examine current practice patterns.
Medicare beneficiaries aged C66 years with nonmetastatic invasive breast cancer diagnosed from 2001 to 2007 were identified from the Surveillance, Epidemiology and End Results-Medicare database (n = 59,431). Eligibility for ACOSOG Z0011 was determined: SLN mapping, tumor\5 cm, no neoadjuvant treatment, breast conservation; number of positive nodes was determined. Actual surgical axillary management for eligible patients was assessed.
Twelve percent (6,942/59,431) underwent SLN mapping and were node positive. Overall, 2,637 patients (4.4 % (2,637/59,431) of the total cohort, but 38 % (2,637/6,942) of patients with SLN mapping and positive nodes) met inclusion criteria for ACOSOG Z0011, had 1 or 2 positive lymph nodes, and could have been spared an ALND. Of these 2,637 patients, 46 % received a completion ALND and 54 % received only SLN biopsy.
Widespread implementation of ACOSOG Z0011 trial results could potentially spare 38 % of older breast cancer patients who undergo SLN mapping with positive lymph nodes an ALND. However, 54 % of these patients are already managed with SLN biopsy alone, lessening the impact of this trial on clinical practice in older breast cancer patients.
美国外科医师学院肿瘤学组（ACOSOG）Z0011 研究表明，对于前哨淋巴结（SLN）阳性的可切除乳腺癌患者，如果不进行腋窝淋巴结清扫术（ALND），可以在不影响生存或局部控制的情况下进行治疗。尽管该研究被认为是一项“改变实践的试验”，但也有人认为其严格的纳入标准限制了该试验的临床意义。本研究旨在评估 ACOSOG Z0011 对 Medicare 患者腋窝手术管理的潜在影响，并研究当前的实践模式。
从监测、流行病学和最终结果-Medicare 数据库（n = 59,431）中确定了 2001 年至 2007 年诊断为非转移性浸润性乳腺癌、年龄≥66 岁的 Medicare 受益人的数据。确定符合 ACOSOG Z0011 标准的情况：SLN 作图、肿瘤≤5cm、无新辅助治疗、乳房保留；确定阳性淋巴结的数量。评估符合条件的患者的实际腋窝手术管理情况。
12%（6,942/59,431）患者进行了 SLN 作图且淋巴结阳性。总体而言，2,637 例患者（总队列的 4.4%（2,637/59,431），但 SLN 作图且阳性淋巴结患者的 38%（2,637/6,942））符合 ACOSOG Z0011 的纳入标准，有 1 或 2 个阳性淋巴结，且可以免于 ALND。在这 2,637 例患者中，46%接受了完成性 ALND，54%仅接受了 SLN 活检。
如果广泛实施 ACOSOG Z0011 试验结果，可能会使 38%的 SLN 作图且阳性淋巴结的老年乳腺癌患者免于 ALND。然而，54%的患者已经单独接受了 SLN 活检，这降低了该试验对老年乳腺癌患者临床实践的影响。
