Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: A randomized clinical trial

Armando E. Giuliano, Kelly K. Hunt, Karla V. Ballman, Peter D. Beitsch, Pat W. Whitworth, Peter W. Blumencranz, A. Marilyn Leitch, Sukamal Saha, Linda M. McCall, Monica Morrow

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Abstract

Context: Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival. Objective: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. Design, Setting, and Patients: The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollmentwas 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Interventions: All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures: Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point. Results: Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%)with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy. Conclusion: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival. Trial Registration clinicaltrials.gov Identifier: NCT00003855.

Original languageEnglish (US)
Pages (from-to)569-575
Number of pages7
JournalJAMA - Journal of the American Medical Association
Volume305
Issue number6
DOIs
StatePublished - Feb 9 2011

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Lymph Node Excision
Dissection
Randomized Controlled Trials
Breast Neoplasms
Neoplasm Metastasis
Confidence Intervals
Survival
cyhalothrin
Segmental Mastectomy
Disease-Free Survival
Sentinel Lymph Node
Touch
Frozen Sections
Therapeutics
Hematoxylin
Eosine Yellowish-(YS)

ASJC Scopus subject areas

  • Medicine(all)

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Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis : A randomized clinical trial. / Giuliano, Armando E.; Hunt, Kelly K.; Ballman, Karla V.; Beitsch, Peter D.; Whitworth, Pat W.; Blumencranz, Peter W.; Leitch, A. Marilyn; Saha, Sukamal; McCall, Linda M.; Morrow, Monica.

In: JAMA - Journal of the American Medical Association, Vol. 305, No. 6, 09.02.2011, p. 569-575.

Research output: Contribution to journalArticle

Giuliano, Armando E. ; Hunt, Kelly K. ; Ballman, Karla V. ; Beitsch, Peter D. ; Whitworth, Pat W. ; Blumencranz, Peter W. ; Leitch, A. Marilyn ; Saha, Sukamal ; McCall, Linda M. ; Morrow, Monica. / Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis : A randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2011 ; Vol. 305, No. 6. pp. 569-575.
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abstract = "Context: Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival. Objective: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. Design, Setting, and Patients: The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollmentwas 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Interventions: All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures: Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point. Results: Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8{\%} (95{\%} confidence interval [CI], 89.1{\%}-94.5{\%})with ALND and 92.5{\%} (95{\%} CI, 90.0{\%}-95.1{\%}) with SLND alone; 5-year disease-free survival was 82.2{\%} (95{\%} CI, 78.3{\%}-86.3{\%}) with ALND and 83.9{\%} (95{\%} CI, 80.2{\%}-87.9{\%}) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90{\%} CI, 0.56-1.11) without adjustment and 0.87 (90{\%} CI, 0.62-1.23) after adjusting for age and adjuvant therapy. Conclusion: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival. Trial Registration clinicaltrials.gov Identifier: NCT00003855.",
author = "Giuliano, {Armando E.} and Hunt, {Kelly K.} and Ballman, {Karla V.} and Beitsch, {Peter D.} and Whitworth, {Pat W.} and Blumencranz, {Peter W.} and Leitch, {A. Marilyn} and Sukamal Saha and McCall, {Linda M.} and Monica Morrow",
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T1 - Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis

T2 - A randomized clinical trial

AU - Giuliano, Armando E.

AU - Hunt, Kelly K.

AU - Ballman, Karla V.

AU - Beitsch, Peter D.

AU - Whitworth, Pat W.

AU - Blumencranz, Peter W.

AU - Leitch, A. Marilyn

AU - Saha, Sukamal

AU - McCall, Linda M.

AU - Morrow, Monica

PY - 2011/2/9

Y1 - 2011/2/9

N2 - Context: Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival. Objective: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. Design, Setting, and Patients: The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollmentwas 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Interventions: All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures: Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point. Results: Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%)with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy. Conclusion: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival. Trial Registration clinicaltrials.gov Identifier: NCT00003855.

AB - Context: Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival. Objective: To determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. Design, Setting, and Patients: The American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollmentwas 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Interventions: All patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures: Overall survival was the primary end point, with a non-inferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point. Results: Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%)with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy. Conclusion: Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival. Trial Registration clinicaltrials.gov Identifier: NCT00003855.

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