前哨淋巴结活检作为乳腺癌分期检查方法：一项随机对照研究的更新

Sentinel-lymph-node biopsy as a staging procedure in breast cancer: update of a randomised controlled study.

作者信息

Veronesi Umberto, Paganelli Giovanni, Viale Giuseppe, Luini Alberto, Zurrida Stefano, Galimberti Viviana, Intra Mattia, Veronesi Paolo, Maisonneuve Patrick, Gatti Giovanna, Mazzarol Giovanni, De Cicco Concetta, Manfredi Gianfranco, Fernández Julia Rodríguez

机构信息

Scientific Direction, European Institute of Oncology, Milan, Italy.

出版信息

Lancet Oncol. 2006 Dec;7(12):983-90. doi: 10.1016/S1470-2045(06)70947-0.

DOI:10.1016/S1470-2045(06)70947-0

PMID:17138219

Abstract

BACKGROUND

In women with breast cancer, sentinel-lymph-node biopsy (SLNB) provides information that allows surgeons to avoid axillary-lymph-node dissection (ALND) if the SLN does not have metastasis, and has a favourable effect on quality of life. Results of our previous trial showed that SLNB accurately screens the ALN for metastasis in breast cancers of diameter 2 mm or less. We aimed to update this trial with results from longer follow-up.

METHODS

Women with breast tumours of diameter 2 cm or less were randomly assigned after breast-conserving surgery either to SLNB and total ALND (ALND group), or to SLNB followed by ALND only if the SLN was involved (SLN group). Analysis was restricted to patients whose tumour characteristics met eligibility criteria after treatment. The main endpoints were the number of axillary metastases in women in the SLN group with negative SLNs, staging power of SLNB, and disease-free and overall survival.

FINDINGS

Of the 257 patients in the ALND group, 83 (32%) had a positive SLN and 174 (68%) had a negative SLN; eight of those with negative SLNs were found to have false-negative SLNs. Of the 259 patients in the SLN group, 92 (36%) had a positive SLN, and 167 (65%) had a negative SLN. One case of overt clinical axillary metastasis was seen in the follow-up of the 167 women in the SLN group who did not receive ALND (ie, one false-negative). After a median follow-up of 79 months (range 15-97), 34 events associated with breast cancer occurred: 18 in the ALND group, and 16 in the SLN group (log-rank p=0.6). The overall 5-year survival of all patients was 96.4% (95% CI 94.1-98.7) in the ALND group and 98.4% (96.9-100) in the SLN group (log-rank p=0.1).

INTERPRETATION

SLNB can allow total ALND to be avoided in patients with negative SLNs, while reducing postoperative morbidity and the costs of hospital stay. The finding that only one overt axillary metastasis occurred during follow-up of patients who did not receive ALND (whereas eight cases were expected) could be explained by various hypotheses, including those from cancer-stem-cell research.

摘要

背景

在乳腺癌女性患者中，前哨淋巴结活检（SLNB）可提供相关信息，若前哨淋巴结无转移，外科医生可避免进行腋窝淋巴结清扫（ALND），且对生活质量有积极影响。我们之前试验的结果表明，SLNB能准确筛查直径2毫米或更小的乳腺癌腋窝淋巴结是否转移。我们旨在通过更长时间随访的结果更新此试验。

方法

直径2厘米或更小的乳腺肿瘤女性患者在保乳手术后被随机分配至SLNB加全腋窝淋巴结清扫组（ALND组），或仅在前哨淋巴结受累时进行SLNB加腋窝淋巴结清扫组（SLN组）。分析仅限于治疗后肿瘤特征符合入选标准的患者。主要终点为SLN组前哨淋巴结阴性女性患者的腋窝转移数量、SLNB的分期能力、无病生存率和总生存率。

结果

ALND组的257例患者中，83例（32%）前哨淋巴结阳性，174例（68%）前哨淋巴结阴性；其中8例前哨淋巴结阴性患者被发现存在假阴性前哨淋巴结。SLN组的259例患者中，92例（36%）前哨淋巴结阳性，167例（65%）前哨淋巴结阴性。在SLN组未接受ALND的167例女性患者的随访中，发现1例明显的临床腋窝转移（即1例假阴性）。中位随访79个月（范围15 - 97个月）后，发生34例与乳腺癌相关的事件：ALND组18例，SLN组16例（对数秩检验p = 0.6）。ALND组所有患者的5年总生存率为96.4%（95%CI 94.1 - 98.7），SLN组为98.4%（96.9 - 100）（对数秩检验p = 0.1）。