Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial
Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial
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DOI：
10.1016/s1470-2045(07)70278-4
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发表时间：
2007-10-01
期刊：
影响因子：
51.1
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
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作者：
Krag, David N.;Anderson, Stewart J.;Wolmark, Norman
背景：腋窝淋巴结清扫术（ALND）的目的是最大限度地提高生存率，提供局部控制，并对患者进行分期。然而，这种技术有很大的副作用。B-32试验的目的是确定前哨淋巴结（SLN）切除是否能达到与传统ALND相同的治疗目标，但副作用更少。本文的目的是报道SLN切除加ALND与单独SLN切除相比在技术上的成功和准确性。方法在B-32试验中，5611例浸润性乳腺癌患者随机分为两组，一组接受SLN切除术后立即行常规ALND (n=2807，组1)，另一组接受SLN切除术，如果SLN术中细胞学和组织学检查均为阴性，则不行ALND （n=2804，组2）。2组患者如果未发现sln，或术中细胞学检查或随后的组织学检查中发现一个或多个sln阳性，则行ALND。主要终点，包括生存、区域控制和发病率，将在稍后报告。次要终点是准确性和技术成功，在这里报告。该试验已在临床试验注册中心注册，编号为NCT00003830。5611例患者中有5536例获得技术成功数据；75例拒绝方案治疗，未切除SLN，或未切除SLN。两组合并后，97.2%的患者（5536例中的5379例）成功切除了sln。切口前热点的识别与更大的SLN去除相关（51281例中的98.9% 5072例）。13171例SLN标本中仅有1.4%（189例）位于腋窝I和II水平以外。65.1%（13 171例中8571例）的S LN标本呈放射性和蓝色；一小部分仅通过触诊确诊（3.9%[515 / 13171]）。第一组患者SLN切除术的总体准确率为97.1%(2619例中有2544例；95% CI为96.4-97.7)，假阴性率为9.8%（766例中有75例；95% CI为7.8-12.2）。肿瘤位置、活检类型和sln切除数量的差异显著影响假阴性率。在有毒性作用数据的患者中，有0.7%（5588人中有37人）发生了与蓝色染料相关的过敏反应。本文报道的研究结果表明，两组随机患者的临床特征很好地平衡，并且SLN切除术的成功率很高。这些发现很重要，因为试验的B-32是唯一一项足够规模的试验，可以提供与主要结局指标、生存和区域控制相关的明确信息。切除多于一个单细胞淋巴结和避免切除活检是降低假阴性率的重要因素。
Background The goals of axillary-lymph-node dissection (ALND) are to maximise survival, provide regional Control, and stage the patient. However, this technique has substantial side-effects. The purpose of the B-32 trial is to establish whether sentinel-lymph-node (SLN) resection can achieve the same therapeutic goals as conventional ALND but with decreased side-effects. The aim of this paper is to report the technical success and accuracy of SLN resection plus ALND versus SLN resection alone.Methods 5611 women with invasive breast cancer were randomly assigned to receive either SLN resection followed by immediate conventional ALND (n=2807; group 1) or SLN resection without ALND if SLNs were negative on intraoperative cytology and histological examination (n=2804; group 2) in the B-32 trial. Patients in group 2 underwent ALND if no SLNs were identified or if one or more SLNs were positive on intraoperative cytology or subsequent histological examination. Primary endpoints, including survival, regional control, and morbidity, will be reported later. Secondary endpoints are accuracy and technical success and are reported here. This trial is registered with the Clinical Trial registry, number NCT00003830.Findings Data for technical success were available for 5536 of 5611 patients; 75 declined protocol treatment, had no SLNs removed, or had no SLN resection done. SLNs were successfully removed in 97.2% of patients (5379 of 5536) in both groups combined. Identification of a preincision hot spot was associated with greater SLN removal (98.9% 5072 of 51281). Only 1.4% (189 of 13171) of SLN specimens were outside of axillary levels I and II. 65.1% (8571 of 13 171) of S LN specimens were both radioactive and blue; a small percentage was identified by palpation only (3.9% [515 of 13171]). The overall accuracy of SLN resection in patients in group 1 was 97.1% (2544 of 2619; 95% CI 96.4-97.7), with a false-negative rate of 9.8% (75 of 766; 95% CI 7.8-12.2). Differences in tumour location, type of biopsy, and number of SLNs removed significantly affected the false-negative rate. Allergic reactions related to blue dye occurred in 0.7% (37 of 5588) of patients with data on toxic effects.Interpretation The findings reported here indicate excellent balance in clinical patient characteristics between the two randomised groups and that the success of SLN resection was high. These findings are important because the B-32 of trial is the only trial of sufficient size to provide definitive information related to the primary outcome measures survival and regional control. Removal of more than one SLN and avoidance of excisional biopsy are important variables in reducing the false-negative rate.