Sentinel Lymph Node Surgery After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer The ACOSOG Z1071 (Alliance) Clinical Trial

被引:1229
作者
Boughey, Judy C. [1 ]
Suman, Vera J. [2 ]
Mittendorf, Elizabeth A. [3 ]
Ahrendt, Gretchen M. [7 ]
Wilke, Lee G. [8 ]
Taback, Bret [9 ]
Leitch, A. Marilyn [10 ]
Kuerer, Henry M. [3 ]
Bowling, Monet [11 ]
Flippo-Morton, Teresa S. [12 ]
Byrd, David R. [13 ]
Ollila, David W. [14 ]
Julian, Thomas B. [15 ]
McLaughlin, Sarah A. [16 ]
McCall, Linda [17 ]
Symmans, W. Fraser [4 ]
Le-Petross, Huong T. [5 ]
Haffty, Bruce G. [18 ]
Buchholz, Thomas A. [6 ]
Nelson, Heidi [1 ]
Hunt, Kelly K. [3 ]
机构
[1] Mayo Clin, Dept Surg, Rochester, MN USA
[2] Mayo Clin, Dept Hlth Sci Res, Rochester, MN USA
[3] Univ Texas MD Anderson Canc Ctr, Dept Surg Oncol, Houston, TX 77030 USA
[4] Univ Texas MD Anderson Canc Ctr, Dept Pathol, Houston, TX 77030 USA
[5] Univ Texas MD Anderson Canc Ctr, Dept Diagnost Radiol, Houston, TX 77030 USA
[6] Univ Texas MD Anderson Canc Ctr, Dept Radiat Oncol, Houston, TX 77030 USA
[7] Univ Pittsburgh, Magee Womens Hosp, Med Ctr, Dept Surg, Pittsburgh, PA 15213 USA
[8] Univ ofWisconsin Madison, Dept Surg, Madison, WI USA
[9] Columbia Univ, Med Ctr, Dept Surg, New York, NY USA
[10] Univ Texas SW Med Ctr Dallas, Dept Surg, Dallas, TX 75390 USA
[11] Indiana Univ, Dept Surg, Indianapolis, IN 46204 USA
[12] Carolinas Med Ctr, Dept Surg, Charlotte, NC 28203 USA
[13] Univ Washington, Dept Surg, Seattle, WA 98195 USA
[14] Univ N Carolina, Dept Surg, Chapel Hill, NC USA
[15] Allegheny Gen Hosp, Allegheny Canc Ctr, Dept Surg, Pittsburgh, PA 15212 USA
[16] Mayo Clin, Dept Surg, Jacksonville, FL 32224 USA
[17] Amer Coll Surg, Oncol Grp, Ctr Stat, Durham, NC USA
[18] Canc Inst New Jersey, Dept Radiat Oncol, New Brunswick, NJ USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2013年 / 310卷 / 14期
关键词
PREOPERATIVE CHEMOTHERAPY; AXILLARY DISSECTION; BIOPSY; LYMPHADENECTOMY;
D O I
10.1001/jama.2013.278932
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IMPORTANCE Sentinel lymph node (SLN) surgery provides reliable nodal staging information with less morbidity than axillary lymph node dissection (ALND) for patients with clinically node-negative (cN0) breast cancer. The application of SLN surgery for staging the axilla following chemotherapy for women who initially had node-positive cN1 breast cancer is unclear because of high false-negative results reported in previous studies. OBJECTIVE To determine the false-negative rate (FNR) for SLN surgery following chemotherapy in women initially presenting with biopsy-proven cN1 breast cancer. DESIGN, SETTING, AND PATIENTS The American College of Surgeons Oncology Group (ACOSOG) Z1071 trial enrolled women from 136 institutions from July 2009 to June 2011 who had clinical T0 through T4, N1 through N2, M0 breast cancer and received neoadjuvant chemotherapy. Following chemotherapy, patients underwent both SLN surgery and ALND. Sentinel lymph node surgery using both blue dye (isosulfan blue or methylene blue) and a radiolabeled colloid mapping agent was encouraged. MAIN OUTCOMES AND MEASURES The primary end point was the FNR of SLN surgery after chemotherapy in women who presented with cN1 disease. We evaluated the likelihood that the FNR in patients with 2 or more SLNs examined was greater than 10%, the rate expected for women undergoing SLN surgery who present with cN0 disease. RESULTS Seven hundred fifty-six women were enrolled in the study. Of 663 evaluable patients with cN1 disease, 649 underwent chemotherapy followed by both SLN surgery and ALND. An SLN could not be identified in 46 patients (7.1%). Only 1 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 an FNR of 12.6% (90% Bayesian credible interval, 9.85%-16.05%). CONCLUSIONS AND RELEVANCE 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.
引用
收藏
页码:1455 / 1461
页数:7
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