Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial.
Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial.
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DOI：
10.1001/jama.2013.278932
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发表时间：
2013-10-09
影响因子：
120.7
通讯作者：
Hunt, Kelly K.
中科院分区：
文献类型：
--
作者：
Boughey, Judy C.;Suman, Vera J.;Mittendorf, Elizabeth A.;Ahrendt, Gretchen M.;Wilke, Lee G.;Taback, Bret;Leitch, A. Marilyn;Kuerer, Henry M.;Bowling, Monet;Flippo-Morton, Teresa S.;Byrd, David R.;Ollila, David W.;Julian, Thomas B.;McLaughlin, Sarah A.;McCall, Linda;Symmans, W. Fraser;Le-Petross, Huong T.;Haffty, Bruce G.;Buchholz, Thomas A.;Nelson, Heidi;Hunt, Kelly K.
前哨淋巴结(SLN)手术为临床淋巴结阴性(CN0)乳腺癌患者提供了可靠的淋巴结分期信息，且发病率低于腋窝淋巴结清扫(ALND)。SLN手术对最初患有结节阳性乳腺癌(CN1)的女性化疗后腋窝分期的应用尚不清楚，因为先前的研究报告了高度假阴性结果。目的：确定经活检证实为结节阳性乳腺癌患者化疗后行SLN手术的假阴性率(FNR)。ACOSOG Z1071试验招募了临床T0-4 N1-2，M0乳腺癌患者，她们接受了新辅助化疗。化疗后，患者同时接受SLN手术和ALND。建议同时使用蓝色染料和放射性标记胶体标记剂进行SLN手术。主要终点是患有cN1疾病的妇女化疗后SLN手术的FNR。我们检查了那些检查了2个或更多SLN的患者的FNR大于10%的可能性，这是接受SLN手术的女性出现临床结节阴性疾病的预期比率。共有756名患者入选。在663名可评估的cN1疾病患者中，649人接受了化疗，随后接受了SLN手术和ALND。未发现SLN者46例(7.1%)。78例(12.0%)仅切除1枚SLN。在其余525例切除2个或2个以上SLN的患者中，215例患者的腋窝淋巴结未发现癌，病理完全淋巴结缓解率为41.0%(95%可信区间：36.7%~45.3%)。在39例SLN中未发现癌，但在ALND获得的淋巴结中发现了癌，FNR为12.6%(90%贝叶斯可信区间，9.85%-16.05%)。在接受新辅助化疗的cN1乳腺癌患者中，检查了2个或更多SLN，FNR未发现为10%或更低。考虑到这一FNR阈值，方法和患者选择的改变导致更高的敏感性是必要的，以支持SLN手术作为ALND的替代选择。ClinicalTrials.gov；试验标识NCT00881361。
Sentinel lymph node (SLN) surgery provides reliable nodal staging information with less morbidity than axillary lymph node dissection (ALND) for clinically node-negative (cN0) breast cancer patients. The application of SLN surgery for staging the axilla following chemotherapy for women who initially had node-positive breast cancer (cN1) is unclear because of high false negative results reported in previous studies. To determine the false negative rate (FNR) for SLN surgery following chemotherapy in patients initially presenting with biopsy-proven node-positive breast cancer. The ACOSOG Z1071 trial enrolled women with clinical T0–4 N1–2, M0 breast cancer who received neoadjuvant chemotherapy. Following chemotherapy, patients underwent both SLN surgery and ALND. SLN surgery using both blue dye and a radiolabeled colloid mapping agent was encouraged. The primary endpoint was the FNR of SLN surgery after chemotherapy in women who presented with cN1 disease. We examined the likelihood that the FNR in those with 2 or more SLNs examined was greater than 10%, the rate expected for women undergoing SLN surgery who present with clinically node-negative disease. Seven hundred fifty-six patients were enrolled from 136 institutions. Of 663 evaluable patients with cN1 disease, 649 underwent chemotherapy followed by both SLN surgery and ALND. A SLN could not be identified in 46 patients (7.1%). Only one SLN was excised in 78 patients (12.0%). Of the remaining 525 patients with 2 or more SLNs removed, no cancer was identified in the axillary lymph nodes of 215 patients yielding a pathological complete nodal response of 41.0% (95% CI: 36.7%–45.3%). In 39 patients, cancer was not identified in the SLNs but was found in lymph nodes obtained with ALND resulting in a FNR of 12.6% (90% Bayesian Credible Interval, 9.85%–16.05%). Among women with cN1 breast cancer receiving neoadjuvant chemotherapy who had 2 or more SLNs examined, the FNR was not found to be 10% or less. Given this FNR threshold, changes in approach and patient selection that result in greater sensitivity would be necessary to support the use of SLN surgery as an alternative to ALND. clinicaltrials.gov; trial identifier NCT00881361.
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影响因子：
2.5
作者：
Reitsamer, R;Peintinger, F;Prokop, E
通讯作者：
Prokop, E
DOI：
10.1046/j.1524-4741.2002.08205.x
发表时间：
2002-03-01
期刊：
The breast journal
影响因子：
--
作者：
Brady, Elizabeth W
通讯作者：
Brady, Elizabeth W
影响因子：
45.3
作者：
Hennessy, BT;Hortobagyi, GN;Valero, V
通讯作者：
Valero, V
影响因子：
9.6
作者：
Xing, Y.;Foy, M.;Cormier, J. N.
通讯作者：
Cormier, J. N.
影响因子：
3.7
作者：
Balch, GC;Mithani, SK;Kelley, MC
通讯作者：
Kelley, MC