Dengel Lynn T, Van Zee Kimberly J, King Tari A, Stempel Michelle, Cody Hiram S, El-Tamer Mahmoud, Gemignani Mary L, Sclafani Lisa M, Sacchini Virgilio S, Heerdt Alexandra S, Plitas George, Junqueira Manuela, Capko Deborah, Patil Sujata, Morrow Monica
Breast Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, USA.
Ann Surg Oncol. 2014 Jan;21(1):22-7. doi: 10.1245/s10434-013-3200-6. Epub 2013 Aug 22.
The extent to which ACOSOG Z0011 findings are applicable to patients undergoing breast-conserving therapy (BCT) is uncertain. We prospectively assessed how often axillary dissection (ALND) was avoided in an unselected, consecutive patient cohort meeting Z0011 eligibility criteria and whether subgroups requiring ALND could be identified preoperatively.
Patients with cT1,2cN0 breast cancer undergoing BCT were managed without ALND for metastases in <3 sentinel nodes (SNs) and no gross extracapsular extension (ECE). Patients with and without indications for ALND were compared using Fisher's exact and Wilcoxon rank sum tests.
From August 2010 to November 2012, 2,157 invasive cancer patients had BCT. A total of 380 had histologic nodal metastasis; 93 did not meet Z0011 criteria. Of 287 with ≥1 H&E-positive SN (209 macrometastases), 242 (84 %) had indications for SN only. ALND was indicated in 45 for ≥3 positive SNs (n = 29) or ECE (n = 16). The median number of SNs removed in the SN group was 3 versus 5 in the ALND group (p < 0.0001). Age, hormone receptor and HER2 status, and grade did not differ between groups; tumors were larger in the ALND group (p < 0.0001). Of ALND patients, 72 % had additional positive nodes (median = 1; range 1-19). No axillary recurrences have occurred (median follow-up, 13 months).
ALND was avoided in 84 % of a consecutive series of patients having BCT, suggesting that most patients meeting ACOSOG Z0011 eligibility have a low axillary tumor burden. Age, ER, and HER2 status were not predictive of ALND, and the criteria used for ALND (≥3 SNs, ECE) reliably identified patients at high risk for residual axillary disease.
美国外科医师学会肿瘤学组（ACOSOG）Z0011研究结果适用于接受保乳治疗（BCT）患者的程度尚不确定。我们前瞻性评估了在符合Z0011入选标准的未经选择的连续患者队列中，避免腋窝淋巴结清扫（ALND）的频率，以及术前是否能够识别出需要进行ALND的亚组。
对接受BCT的cT1,2cN0乳腺癌患者，若前哨淋巴结（SN）转移灶＜3个且无大体包膜外扩展（ECE），则不进行ALND。对有和没有ALND指征的患者，采用Fisher精确检验和Wilcoxon秩和检验进行比较。
2010年8月至2012年11月，2157例浸润性癌患者接受了BCT。共有380例有组织学淋巴结转移；93例不符合Z0011标准。在287例有≥1个苏木精和伊红（H&E）染色阳性SN的患者中（209例为大转移灶），242例（84%）仅符合前哨淋巴结活检指征。45例因≥3个阳性SN（n = 29）或ECE（n = 16）而需进行ALND。前哨淋巴结活检组切除的SN中位数为3个，而腋窝淋巴结清扫组为5个（p < 0.0001）。两组患者的年龄、激素受体和HER2状态以及分级无差异；腋窝淋巴结清扫组的肿瘤更大（p < 0.0001）。在接受腋窝淋巴结清扫的患者中，72%有额外的阳性淋巴结（中位数 = 1；范围1 - 19）。未发生腋窝复发（中位随访时间13个月）。
在连续一系列接受保乳治疗的患者中，84%的患者避免了腋窝淋巴结清扫，这表明大多数符合ACOSOG Z0011入选标准的患者腋窝肿瘤负荷较低。年龄、雌激素受体（ER）和HER2状态不能预测是否需要进行腋窝淋巴结清扫，而用于腋窝淋巴结清扫的标准（≥3个前哨淋巴结、ECE）能够可靠地识别出腋窝残留疾病高危患者。
