Langer Igor, Marti Walter Richard, Guller Ulrich, Moch Holger, Harder Felix, Oertli Daniel, Zuber Markus
Department of Surgery, University of Basel, Switzerland.
Ann Surg. 2005 Jan;241(1):152-8. doi: 10.1097/01.sla.0000149305.23322.3c.
To assess the axillary recurrence rate in breast cancer patients with negative sentinel lymph node (SLN) or SLN micrometastases (>0.2 mm to <or=2.0 mm) after breast surgery and SLN procedure without formal axillary lymph node dissection (ALND).
Under controlled study conditions, the SLN procedure proved to be a reliable method for the evaluation of the axillary nodal status in patients with early-stage invasive breast cancer. Axillary dissection of levels I and II can thus be omitted if the SLN is free of macrometastases. The prognostic value and potential therapeutic consequences of SLN micrometastases, however, remain a matter of great debate. We present the follow-up data of our prospective SLN study, particularly focusing on the axillary recurrence rate in patients with negative SLN and SLN micrometastases.
In this prospective study, 236 SLN procedures were performed in 234 patients with early-stage breast cancer between April 1998 and September 2002. The SLN were marked and identified with 99m technetium-labeled colloid and blue dye (Isosulfanblue 1%). The excised SLNs were examined by step sectioning and stained with hematoxylin and eosin and immunohistochemistry (cytokeratin antibodies Lu-5 or CK 22). Only patients with SLN macrometastases received formal ALND of levels I and II, while patients with negative SLN or SLN micrometastases did not undergo further axillary surgery.
The SLN identification rate was 95% (224/236). SLN macrometastases were found in 33% (74/224) and micrometastases (>0.2 mm to <or=2 mm) in 12% (27/224) of patients. Adjuvant therapy did not differ between the group of SLN-negative patients and those with SLN micrometastases. After a median follow-up of 42 months (range 12-64 months), 99% (222/224) of evaluable patients were reassessed. While 1 patient with a negative SLN developed axillary recurrence (0.7%, 1/122), all 27 patients with SLN micrometastases were disease-free at the last follow-up control.
Axillary recurrences in patients with negative SLN or SLN micrometastases did not occur more frequently after SLN biopsy alone compared with results from the recent literature regarding breast cancer patients undergoing formal ALND. Based on a median follow-up of 42 months-one of the longest so far in the literature-the present investigation does not provide evidence that the presence of SLN micrometastases leads to axillary recurrence or distant disease and supports the theory that formal ALND may be omitted in these patients.
评估在未进行正式腋窝淋巴结清扫术（ALND）的乳腺癌手术及前哨淋巴结（SLN）活检术后，前哨淋巴结阴性或存在微小转移（>0.2mm至≤2.0mm）的患者腋窝复发率。
在对照研究条件下，前哨淋巴结活检术被证明是评估早期浸润性乳腺癌患者腋窝淋巴结状态的可靠方法。如果前哨淋巴结无宏观转移，可省略Ⅰ级和Ⅱ级腋窝清扫。然而，前哨淋巴结微小转移的预后价值和潜在治疗后果仍存在很大争议。我们展示了前瞻性前哨淋巴结研究的随访数据，特别关注前哨淋巴结阴性和微小转移患者的腋窝复发率。
在这项前瞻性研究中，1998年4月至2002年9月期间，对234例早期乳腺癌患者进行了236次前哨淋巴结活检术。用99m锝标记的胶体和蓝色染料（1%异硫蓝）标记并识别前哨淋巴结。切除的前哨淋巴结进行连续切片检查，并用苏木精-伊红染色和免疫组织化学（细胞角蛋白抗体Lu-5或CK 22）染色。只有前哨淋巴结有宏观转移的患者接受了正式的Ⅰ级和Ⅱ级腋窝淋巴结清扫，而前哨淋巴结阴性或微小转移的患者未进行进一步的腋窝手术。
前哨淋巴结识别率为95%（224/236）。33%（74/2）患者发现前哨淋巴结有宏观转移，12%（27/224）患者有微小转移（>0.2mm至≤2mm）。前哨淋巴结阴性患者组和微小转移患者组的辅助治疗无差异。中位随访42个月（范围12 - 64个月）后，对99%（222/224）可评估患者进行了重新评估。1例前哨淋巴结阴性患者发生腋窝复发（0.7%，1/122），而所有27例前哨淋巴结微小转移患者在最后一次随访时均无疾病。
与近期有关接受正式腋窝淋巴结清扫术的乳腺癌患者的文献结果相比，仅进行前哨淋巴结活检术后，前哨淋巴结阴性或微小转移患者的腋窝复发并不更常见。基于中位随访42个月——这是目前文献中最长的随访时间之一——本研究没有提供证据表明前哨淋巴结微小转移会导致腋窝复发或远处疾病，并支持在这些患者中可省略正式腋窝淋巴结清扫术的理论。
