Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial

Armando E. Giuliano, Karla V. Ballman, Linda McCall, Peter D. Beitsch, Meghan B. Brennan, Pond R. Kelemen, David W. Ollila, Nora M. Hansen, Pat W. Whitworth, Peter W. Blumencranz, A. Marilyn Leitch, Sukamal Saha, Kelly K. Hunt, Monica Morrow

Research output: Contribution to journalArticle

197 Citations (Scopus)

Abstract

IMPORTANCE: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). OBJECTIVE: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. DESIGN, SETTING, AND PARTICIPANTS: The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases. INTERVENTIONS: All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited. MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival. RESULTS: Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95% CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95% CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. CONCLUSIONS AND RELEVANCE: Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003855.

Original languageEnglish (US)
Pages (from-to)918-926
Number of pages9
JournalJAMA - Journal of the American Medical Association
Volume318
Issue number10
DOIs
StatePublished - Sep 12 2017

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Lymph Node Excision
Dissection
Randomized Controlled Trials
Breast Neoplasms
Neoplasm Metastasis
Survival
cyhalothrin
Disease-Free Survival
Breast
Sentinel Lymph Node
Recurrence
Phase III Clinical Trials
Segmental Mastectomy
Estrogen Receptors
Clinical Trials
Radiation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis : The ACOSOG Z0011 (Alliance) randomized clinical trial. / Giuliano, Armando E.; Ballman, Karla V.; McCall, Linda; Beitsch, Peter D.; Brennan, Meghan B.; Kelemen, Pond R.; Ollila, David W.; Hansen, Nora M.; Whitworth, Pat W.; Blumencranz, Peter W.; Leitch, A. Marilyn; Saha, Sukamal; Hunt, Kelly K.; Morrow, Monica.

In: JAMA - Journal of the American Medical Association, Vol. 318, No. 10, 12.09.2017, p. 918-926.

Research output: Contribution to journalArticle

Giuliano, AE, Ballman, KV, McCall, L, Beitsch, PD, Brennan, MB, Kelemen, PR, Ollila, DW, Hansen, NM, Whitworth, PW, Blumencranz, PW, Leitch, AM, Saha, S, Hunt, KK & Morrow, M 2017, 'Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial', JAMA - Journal of the American Medical Association, vol. 318, no. 10, pp. 918-926. https://doi.org/10.1001/jama.2017.11470
Giuliano, Armando E. ; Ballman, Karla V. ; McCall, Linda ; Beitsch, Peter D. ; Brennan, Meghan B. ; Kelemen, Pond R. ; Ollila, David W. ; Hansen, Nora M. ; Whitworth, Pat W. ; Blumencranz, Peter W. ; Leitch, A. Marilyn ; Saha, Sukamal ; Hunt, Kelly K. ; Morrow, Monica. / Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis : The ACOSOG Z0011 (Alliance) randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2017 ; Vol. 318, No. 10. pp. 918-926.
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abstract = "IMPORTANCE: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). OBJECTIVE: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. DESIGN, SETTING, AND PARTICIPANTS: The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases. INTERVENTIONS: All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited. MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival. RESULTS: Among 891 women who were randomized (median age, 55 years), 856 (96{\%}) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3{\%} in the SLND alone group and 83.6{\%} in the ALND group (HR, 0.85 [1-sided 95{\%} CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2{\%} in the SLND alone group and 78.2{\%} in the ALND group (HR, 0.85 [95{\%} CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. CONCLUSIONS AND RELEVANCE: Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003855.",
author = "Giuliano, {Armando E.} and Ballman, {Karla V.} and Linda McCall and Beitsch, {Peter D.} and Brennan, {Meghan B.} and Kelemen, {Pond R.} and Ollila, {David W.} and Hansen, {Nora M.} and Whitworth, {Pat W.} and Blumencranz, {Peter W.} and Leitch, {A. Marilyn} and Sukamal Saha and Hunt, {Kelly K.} and Monica Morrow",
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TY - JOUR

T1 - Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis

T2 - The ACOSOG Z0011 (Alliance) randomized clinical trial

AU - Giuliano, Armando E.

AU - Ballman, Karla V.

AU - McCall, Linda

AU - Beitsch, Peter D.

AU - Brennan, Meghan B.

AU - Kelemen, Pond R.

AU - Ollila, David W.

AU - Hansen, Nora M.

AU - Whitworth, Pat W.

AU - Blumencranz, Peter W.

AU - Leitch, A. Marilyn

AU - Saha, Sukamal

AU - Hunt, Kelly K.

AU - Morrow, Monica

PY - 2017/9/12

Y1 - 2017/9/12

N2 - IMPORTANCE: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). OBJECTIVE: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. DESIGN, SETTING, AND PARTICIPANTS: The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases. INTERVENTIONS: All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited. MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival. RESULTS: Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95% CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95% CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. CONCLUSIONS AND RELEVANCE: Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003855.

AB - IMPORTANCE: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). OBJECTIVE: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. DESIGN, SETTING, AND PARTICIPANTS: The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases. INTERVENTIONS: All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited. MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival. RESULTS: Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95% CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95% CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. CONCLUSIONS AND RELEVANCE: Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003855.

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