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
- PMID: 28898379
- PMCID: PMC5672806
- DOI: 10.1001/jama.2017.11470
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
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.
Conflict of interest statement
Figures
Comment in
-
Breast Cancer Surgery: Less Is More.JAMA. 2017 Sep 12;318(10):909-911. doi: 10.1001/jama.2017.12890. JAMA. 2017. PMID: 28898365 No abstract available.
-
Axillary vs Sentinel Lymph Node Dissection in Women With Invasive Breast Cancer.JAMA. 2018 Jan 16;319(3):306. doi: 10.1001/jama.2017.18312. JAMA. 2018. PMID: 29340668 No abstract available.
Similar articles
-
Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial.JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90. JAMA. 2011. PMID: 21304082 Free PMC article. Clinical Trial.
-
Locoregional Recurrence After Sentinel Lymph Node Dissection With or Without Axillary Dissection in Patients With Sentinel Lymph Node Metastases: Long-term Follow-up From the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 Randomized Trial.Ann Surg. 2016 Sep;264(3):413-20. doi: 10.1097/SLA.0000000000001863. Ann Surg. 2016. PMID: 27513155 Free PMC article. Clinical Trial.
-
Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial.Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32. Ann Surg. 2010. PMID: 20739842 Free PMC article. Clinical Trial.
-
Evolution of axillary nodal staging in breast cancer: clinical implications of the ACOSOG Z0011 trial.Cancer Control. 2012 Oct;19(4):267-76. doi: 10.1177/107327481201900403. Cancer Control. 2012. PMID: 23037494 Review.
-
To do or not to do: axillary nodal evaluation after ACOSOG Z0011 Trial.Radiographics. 2014 Nov-Dec;34(7):1807-16. doi: 10.1148/rg.347130141. Radiographics. 2014. PMID: 25384280 Review.
Cited by
-
Radiomic features of axillary lymph nodes based on pharmacokinetic modeling DCE-MRI allow preoperative diagnosis of their metastatic status in breast cancer.PLoS One. 2021 Mar 1;16(3):e0247074. doi: 10.1371/journal.pone.0247074. eCollection 2021. PLoS One. 2021. PMID: 33647031 Free PMC article.
-
External Validation of the SERC Trial Population: Comparison with the Multicenter French Cohort, the Swedish and SENOMIC Trial Populations for Breast Cancer Patients with Sentinel Node Micro-Metastasis.Cancers (Basel). 2020 Oct 11;12(10):2924. doi: 10.3390/cancers12102924. Cancers (Basel). 2020. PMID: 33050650 Free PMC article.
-
Surgery paradigm for locally advanced breast cancer following neoadjuvant systemic therapy.Front Surg. 2024 Sep 6;11:1410127. doi: 10.3389/fsurg.2024.1410127. eCollection 2024. Front Surg. 2024. PMID: 39308852 Free PMC article. Review.
-
Positive predictive value of axillary lymph node cortical thickness and nodal, clinical, and tumor characteristics in newly diagnosed breast cancer patients.Breast Cancer Res Treat. 2024 Feb;203(3):511-521. doi: 10.1007/s10549-023-07155-z. Epub 2023 Nov 10. Breast Cancer Res Treat. 2024. PMID: 37950089
-
MRI radiomics and biological correlations for predicting axillary lymph node burden in early-stage breast cancer.J Transl Med. 2024 Sep 6;22(1):826. doi: 10.1186/s12967-024-05619-4. J Transl Med. 2024. PMID: 39243024 Free PMC article.
References
-
- Halsted WS. I: a clinical and histological study of certain adenocarcinomata of the breast: and a brief consideration of the supraclavicular operation and of the results of operations for cancer of the breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann Surg. 1898;28(5):557–576. - PMC - PubMed
-
- Lowery AJ, Kell MR, Glynn RW, Kerin MJ, Sweeney KJ. Locoregional recurrence after breast cancer surgery: a systematic review by receptor phenotype. Breast Cancer Res Treat. 2012;133(3):831–841. - PubMed
-
- Giuliano AE, Jones RC, Brennan M, Statman R. Sentinel lymphadenectomy in breast cancer. J Clin Oncol. 1997;15(6):2345–2350. - PubMed
Publication types
MeSH terms
Associated data
Grants and funding
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical