Complete Axillary Lymph Node Dissection Versus Clinical Follow-up in Breast Cancer Patients with Sentinel Node Micrometastasis: Final Results from the Multicenter Clinical Trial AATRM 048/13/2000
Complete Axillary Lymph Node Dissection Versus Clinical Follow-up in Breast Cancer Patients with Sentinel Node Micrometastasis: Final Results from the Multicenter Clinical Trial AATRM 048/13/2000
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DOI：
10.1245/s10434-012-2569-y
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发表时间：
2013-01-01
影响因子：
3.7
通讯作者：
Vidal, Sergi
中科院分区：
文献类型：
--
作者：
Sola, Montserrat;Alberro, Jose A.;Vidal, Sergi
有人建议仅选择性前哨淋巴结（SN）活检可用于治疗早期乳腺癌，但缺乏支持这一观点的明确证据。本研究的目的是调查对于 SN 活检显示微转移的早期乳腺癌患者，不进行完全腋窝淋巴结清扫术 (ALND) 是否足以产生与进行完全腋窝淋巴结清扫术 (ALND) 相同的预后信息和疾病控制。这项前瞻性、随机临床试验纳入了新诊断的早期乳腺癌 (T < 3.5 cm，临床 N0、M0) 并接受手术切除作为主要治疗的患者。所有患者均具有微转移 SN。患者被随机分配到两个研究组之一：完整 ALND（对照组）或临床随访（实验组）。中位随访时间为 5 年，评估复发情况，主要终点是无病生存期。在 247 名患者的总样本中，14 人退出，留下 112 人在对照组，121 人在实验组。在 15 名对照受试者 (13%) 中，完成 ALND 呈阳性，肿瘤负荷较低。 4 名患者经历了疾病复发：108 名对照受试者中的 1 名（1%）和 119 名实验患者中的 3 名（2.5%）。两组之间的无病生存率（p = 0.325）没有差异，也没有癌症相关死亡。我们的结果强烈表明，在有 SN 微转移的早期乳腺癌患者中，选择性 SN 淋巴结切除术足以控制局部和远处疾病，对生存没有显着影响。
It has been suggested that selective sentinel node (SN) biopsy alone can be used to manage early breast cancer, but definite evidence to support this notion is lacking. The aim of this study was to investigate whether refraining from completion axillary lymph node dissection (ALND) suffices to produce the same prognostic information and disease control as proceeding with completion ALND in early breast cancer patients showing micrometastasis at SN biopsy.This prospective, randomized clinical trial included patients with newly diagnosed early-stage breast cancer (T < 3.5 cm, clinical N0, M0) who underwent surgical excision as primary treatment. All had micrometastatic SN. Patients were randomly assigned to one of the two study arms: complete ALND (control arm) or clinical follow-up (experimental arm). Median follow-up was 5 years, recurrence was assessed, and the primary end point was disease-free survival.From a total sample of 247 patients, 14 withdrew, leaving 112 in the control arm and 121 in the experimental arm. In 15 control subjects (13 %), completion ALND was positive, with a low tumor burden. Four patients experienced disease recurrence: 1 (1 %) of 108 control subjects and 3 (2.5 %) of 119 experimental patients. There were no differences in disease-free survival (p = 0.325) between arms and no cancer-related deaths.Our results strongly suggest that in early breast cancer patients with SN micrometastasis, selective SN lymphadenectomy suffices to control locoregional and distant disease, with no significant effects on survival.