Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer

The ACOSOG Z1071 (alliance) clinical trial

Judy C. Boughey, Vera J. Suman, Elizabeth A. Mittendorf, Gretchen M. Ahrendt, Lee G. Wilke, Bret Taback, A. Marilyn Leitch, Henry M. Kuerer, Monet Bowling, Teresa S. Flippo-Morton, David R. Byrd, David W. Ollila, Thomas B. Julian, Sarah A. McLaughlin, Linda McCall, W. Fraser Symmans, Huong T. Le-Petross, Bruce G. Haffty, Thomas A. Buchholz, Heidi Nelson & 1 others Kelly K. Hunt

Research output: Contribution to journalArticle

494 Citations (Scopus)

Abstract

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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00881361.

Original languageEnglish (US)
Pages (from-to)1455-1461
Number of pages7
JournalJAMA - Journal of the American Medical Association
Volume310
Issue number14
DOIs
StatePublished - 2013

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Clinical Trials
Breast Neoplasms
Drug Therapy
Lymph Node Excision
Sentinel Lymph Node
Surgeons
Lymph Nodes
Axilla
Methylene Blue
Colloids
Patient Selection
Neoplasms
Coloring Agents
Morbidity
Biopsy

ASJC Scopus subject areas

  • Medicine(all)

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Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer : The ACOSOG Z1071 (alliance) clinical trial. / 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.

In: JAMA - Journal of the American Medical Association, Vol. 310, No. 14, 2013, p. 1455-1461.

Research output: Contribution to journalArticle

Boughey, JC, Suman, VJ, Mittendorf, EA, Ahrendt, GM, Wilke, LG, Taback, B, Leitch, AM, Kuerer, HM, Bowling, M, Flippo-Morton, TS, Byrd, DR, Ollila, DW, Julian, TB, McLaughlin, SA, McCall, L, Symmans, WF, Le-Petross, HT, Haffty, BG, Buchholz, TA, Nelson, H & Hunt, KK 2013, 'Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: The ACOSOG Z1071 (alliance) clinical trial', JAMA - Journal of the American Medical Association, vol. 310, no. 14, pp. 1455-1461. https://doi.org/10.1001/jama.2013.278932
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. / Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer : The ACOSOG Z1071 (alliance) clinical trial. In: JAMA - Journal of the American Medical Association. 2013 ; Vol. 310, No. 14. pp. 1455-1461.
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abstract = "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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00881361.",
author = "Boughey, {Judy C.} and Suman, {Vera J.} and Mittendorf, {Elizabeth A.} and Ahrendt, {Gretchen M.} and Wilke, {Lee G.} and Bret Taback and Leitch, {A. Marilyn} and Kuerer, {Henry M.} and Monet Bowling and Flippo-Morton, {Teresa S.} and Byrd, {David R.} and Ollila, {David W.} and Julian, {Thomas B.} and McLaughlin, {Sarah A.} and Linda McCall and Symmans, {W. Fraser} and Le-Petross, {Huong T.} and Haffty, {Bruce G.} and Buchholz, {Thomas A.} and Heidi Nelson and Hunt, {Kelly K.}",
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T1 - Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer

T2 - The ACOSOG Z1071 (alliance) clinical trial

AU - Boughey, Judy C.

AU - Suman, Vera J.

AU - Mittendorf, Elizabeth A.

AU - Ahrendt, Gretchen M.

AU - Wilke, Lee G.

AU - Taback, Bret

AU - Leitch, A. Marilyn

AU - Kuerer, Henry M.

AU - Bowling, Monet

AU - Flippo-Morton, Teresa S.

AU - Byrd, David R.

AU - Ollila, David W.

AU - Julian, Thomas B.

AU - McLaughlin, Sarah A.

AU - McCall, Linda

AU - Symmans, W. Fraser

AU - Le-Petross, Huong T.

AU - Haffty, Bruce G.

AU - Buchholz, Thomas A.

AU - Nelson, Heidi

AU - Hunt, Kelly K.

PY - 2013

Y1 - 2013

N2 - 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00881361.

AB - 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00881361.

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