浸润性乳腺癌ⅠⅡAⅡB或T3N1M0腋淋巴结手术分期

浸润性乳腺癌Ⅰ、ⅡA、ⅡB或T3N1M0

Surgical Axillary Staging

腋淋巴结手术分期

The NCCN Guidelines for Breast Cancer include a section for surgical staging of the axilla for stages I, IIA, IIB, and IIIA (T3, N1, M0) breast cancer. Pathologic confirmation of malignancy using ultrasound-guided fine-needle aspiration (FNA) or core biopsy must be considered in patients with clinically positive nodes to determine whether ALN dissection is needed.

乳腺癌NCCN指南包括一章关于Ⅰ、ⅡA、ⅡB和ⅢA(T3N1M0)期乳腺癌腋窝区的手术分期。在临床阳性的淋巴结患者中必须考虑使用超声引导的细针穿刺抽吸(FNA)或空芯针活检病理学证实恶性肿瘤以确定是否需要腋淋巴结解剖。

Performance of SLN mapping and resection in the surgical staging of the clinically negative axilla is recommended by the panel for assessment of the pathologic status of the ALNs in patients with clinical stage I, stage II, and stage IIIA (T3, N1, M0) breast cancer. This recommendation is supported by results of randomized clinical trials showing decreased arm and shoulder morbidity (eg, pain, lymphedema, sensory loss) in patients with breast cancer undergoing SLN biopsy compared with patients undergoing standard ALN dissection. No significant differences in the effectiveness of the SLN procedure or level I and II dissection in determining the presence or absence of metastases in axillary nodes were seen in these studies. However, not all women are candidates for SLN resection. An experienced SLN team is mandatory for the use of SLN mapping and excision. Women who have clinical stage I or II disease and do not have immediate access to an experienced SLN team should be referred to an experienced SLN team for the definitive surgical treatment of the breast and surgical ALN staging. In addition, potential candidates for SLN mapping and excision should have clinically negative ALNs at the time of diagnosis, or a negative core or FNA biopsy of any clinically suspicious ALN(s). In many institutions, SLNs are assessed for the presence of metastases by both hematoxylin and eosin (H&E) staining and cytokeratin IHC. The clinical significance of a lymph node that is negative by H&E staining but positive by cytokeratin IHC is not clear. Because the historical and clinical trial data on which treatment decisions are based have relied on H&E staining, the panel does not recommend routine cytokeratin IHC to define node involvement and believes that current treatment decisions should be made based solely on H&E staining. This recommendation is further supported by a randomized clinical trial (ACOSOG Z0010) for patients with H&E negative nodes where further examination by cytokeratin IHC was not associated with improved OS over a median of 6.3 years. In the uncommon situation in which H&E staining is equivocal, reliance on the results of cytokeratin IHC is appropriate. Multiple attempts have been made to identify cohorts of women with involved SLNs who have a low enough risk for non-SLN involvement that complete axillary dissection might be avoided if the SLN is positive. None of the early studies identified a low-risk group of patients with positive SLN biopsies but consistently negative non-sentinel nodes. Nonetheless, a randomized trial (ACOSOG Z0011) compared SLN resection alone with ALN dissection in women greater than or equal to 18 years of age with T1/T2 tumors, fewer than 3 positive SLNs, and undergoing breast-conserving surgery and whole breast irradiation. In this study, there was no difference in local recurrence, DFS, or OS between the two treatment groups. Only ER-negative status, age less than 50, and lack of adjuvant systemic therapy were associated with decreased OS. At a median follow-up of 6.3 years, locoregional recurrences were noted in 4.1% of the ALN dissection group (n = 420) and 2.8% of the SLN dissection patients (n = 436) (P = .11). Median OS was approximately 92% in each group. Therefore, based on these results after SLN mapping and excision, if a patient has a T1 or T2 tumor with 1 to 2 positive SLNs, did not receive neoadjuvant therapy, and is treated with lumpectomy and whole breast radiation, the panel recommends no further axillary surgery.

临床Ⅰ、Ⅱ和ⅢA(T3N1M0)期乳腺癌患者腋窝临床阴性的手术分期小组推荐进行SLN定位图与切除术用于腋淋巴结病理情况的评估。支持该推荐的随机临床试验的结果显示与接受标准腋淋巴结清扫的患者相比接受哨淋巴结活检降低乳腺癌患者臂和肩并发症(例如疼痛、淋巴水肿、感觉缺失)。在这些研究中SLN活检或Ⅰ和Ⅱ级清扫在确定有或没有腋窝淋巴结转移的有效性方面没有见到显著差异。但是，不是所有的女性都适于SLN切除。SLN定位和切除术要求必须有一个有经验的SLN小组。临床Ⅰ或Ⅱ期疾病女性以及不能立即享受到一个有经验前哨淋巴结小组者应该介绍到一个有经验前哨淋巴结小组进行乳腺根治术和腋淋巴结手术分期。另外，潜在的前哨淋巴结定位与切除候选者应该在诊断时腋淋巴结临床阴性或在任何临床可疑的腋淋巴结当中芯针或细针穿刺活检阴性。在许多机构中，通过苏木精和伊红(H&E)染色以及细胞角蛋白免疫组化两者评估前哨淋巴结是否存在转移。一个淋巴结H&E染色阴性但是细胞角蛋白免疫组化阳性的临床意义尚不清楚。因为历史与临床试验数据其治疗决策依赖于H&E染色，小组不推荐为了确定淋巴结受累常规细胞角蛋白免疫组化并且认为应该仅基于H&E染色做出当前的治疗决策。此推荐进一步获得一项随机临床试验(ACOSOG Z0010)的支持，对于淋巴结H&E阴性患者通过细胞角蛋白免疫组化进一步检测与改善中位OS超过6.3年无关。在H&E染色可疑的罕见情况下，信赖细胞角蛋白免疫组化的结果是合理的。已经做了许多尝试以从非前哨淋巴结受累者中识别出风险足够低的前哨淋巴结受累女性组如果前哨淋巴结阳性可能避免彻底的腋窝淋巴结清扫术。早期研究之中没有一个识别出哨淋巴结活检阳性患者之中的低危组但是均识别出非前哨淋巴结阴性组中的低危患者。尽管如此，一项随机试验(ACOSOG Z0011)比较了在T1/T2、阳性SLNs<3个、年龄≥18岁女性中单独切除SLN结与SLN清扫联合保乳术与全乳照射。在该研究中，局部复发率、DFS或OS两治疗组间没有差异。只有ER阴性、年龄小于50岁及无辅助系统治疗与OS降低有关。在中位随访6.3年时，局部复发率腋淋巴结清扫组(n＝420)是4.1%而前哨淋巴结清扫组(n＝436)是2.8%(P =.11)。每组中位OS大约是92%。因此，基于这些前哨淋巴结定位与切除后的结果，如果患者是T1或T2肿瘤有1-2个阳性前哨淋巴结、未接受新辅助治疗并且接受乳房局部病灶切除术治疗与全乳照射，专家组推荐不要进一步腋窝手术。

The panel recommends level I or II axillary dissection 1) when patients have clinically positive nodes at the time of diagnosis that is confirmed by FNA or core biopsy; or 2) when sentinel nodes are not identified. For patients with clinically negative axillae who are undergoing mastectomy and for whom radiation therapy is planned, the panel notes that axillary radiation may replace axillary dissection level I/II for regional control of disease.

专家组推荐Ⅰ或Ⅱ级腋窝淋巴结清扫1)当患者在诊断时有临床阳性的淋巴结经细针穿刺活检或空芯针活检证实时；或2)当未发现前哨淋巴结时。

Traditional level I and level II evaluation of ALN requires that at least 10 lymph nodes should be provided for pathologic evaluation to accurately stage the axilla. ALN should be extended to include level III nodes only if gross disease is apparent in the level II nodes. In the absence of gross disease in level II nodes, lymph node dissection should include tissue inferior to the axillary vein from the latissimus dorsi muscle laterally to the medial border:1px solid #000;"MsoNormal">对于接受乳房切除术腋窝临床阴性以及准备放疗的患者，小组强调腋窝照射可以代替腋窝Ⅰ/Ⅱ级解剖用于疾病的区域控制。为了准确的腋窝分期传统的Ⅰ级和Ⅱ级腋淋巴结评估应该需要提供至少10枚淋巴结用于病理检测。只有在Ⅱ级淋巴结肉眼病变明显的时候腋淋巴结才应该扩展至包括Ⅲ级淋巴结。在Ⅱ级淋巴结没有显著病变的情况下，淋巴结清扫术应该包括从背阔肌侧缘到胸小肌内侧缘腋静脉下方的组织(Ⅰ/Ⅱ级)。

Furthermore, according to the panel, without definitive data demonstrating superior survival with ALN dissection or SLN resection, these procedures may be considered optional in patients who have particularly favorable tumors, patients for whom the selection of adjuvant systemic therapy will not be affected by the results of the procedure, elderly patients, and patients with serious comorbid conditions. Women who do not undergo ALN dissection or ALN irradiation are at increased risk for ipsilateral lymph node recurrence.

此外，根据小组的意见，没有确切数据证明腋淋巴结清扫或前哨淋巴结切除的生存优势，这些措施在预后特别良好的肿瘤患者中可以考虑选择，对于选择辅助系统治疗的患者、老年患者以及具有严重合并症的患者将不受措施结果的影响。不接受腋淋巴结清扫或腋淋巴结照射的女性同侧淋巴结复发风险增加。

Breast cancer NCCN 2015v3