Sentinel Lymph Node Dissection With and Without Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis: A Randomized Clinical Trial
By A. Giuliano, K. Hunt, K. Ballman, P. Beitsch, P. Whitworth, P. Blumencranz, A. Leitch, S. Saha, L. Mccall, M. Morrow. Journal of the American Medical Association (JAMA), 2011
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Context Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer. Objective To determine the impact of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer. Design and Setting The 115 sites participating in the American College of Surgeons Oncology Group Z0011 trial enrolled patients from May 1999 to December 2004. In this phase III noninferiority trial, patients with SLN metastasis were randomized to ALND or no further axillary treatment. Targeted enrollment was 1900 women, with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected. Patients Women with clinical T1–T2 invasive breast cancer, no palpable adenopathy, and 1–2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin and eosin staining on permanent section. Interventions All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of ≥10 nodes. Systemic therapy was at the discretion of the treating physician. Main Outcome Measures Overall survival (OS) was the primary endpoint, with a noninferiority margin of a one-sided hazard ratio of 1.3 or less favoring ALND. Disease-free survival (DFS) was a secondary endpoint. 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 date 03/04/2010), 5-year OS was 91.8% (95% CI: 89.1 to 94.5) with ALND and 92.5% (95% CI: 90.0 to 95.1) with SLND alone; 5-year DFS was 82.2% (95% CI: 78.3 to 86.3) with ALND and 83.9% (95% CI: 80.2 to 87.9) with SLND alone. Hazard ratio for treatment-related OS was 0.79 (90% CI: 0.56 to 1.11) without adjustment and 0.87 (90% CI: 0.62 to 1.23) after adjusting for age and adjuvant therapy. Conclusions Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND compared with ALND did not result in inferior survival.
Subfields: Cancer Research, Pathology and Forensic Medicine, Surgery
View Paper: https://www.semanticscholar.org/paper/fe132ff1a013c626f21122165af2065428491825
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Citations in the corpus
- Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. (2014, background): “In the four studies reporting these,5,6,11,13,20,21 the percentages of patients experiencing these deficits were statistically significantly lower in the SNB-alone arms.5,6,11,18,20 For example, residual arm tingling and numbness at 36 months were significantly lower in favor of SNB. Rates of sensor”
- Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2015, background): “3 years of median follow-up) for patients with clinical T1–T2 cN0 invasive breast cancer, 1–2 sentinel lymph nodes containing metastases, treated with BCS and tangential adjuvant radiation therapy reported noninferior rates of overall, disease-free, and locoregional recurrence-free survival [38].”
- Circulating Tumor Cells Predict Survival in Early Average-to-High Risk Breast Cancer Patients (2014, background): “Furthermore, because axillary operation will increasingly be confined to sentinel node biopsy, CTCs could be a helpful tool for selection of highrisk patients who might benefit from a more aggressive dose-dense chemotherapy regimen (27,28).”
- Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. (2015, background): “In the absence of NAC, the size of sentinel node (SN) metastases is correlated with the probability of non-SN involvement, and lowvolume disease in SNs does not always mandate CND when adjuvant radiotherapy and systemic therapy are planned.(11) Therefore, most guidelines do not support, in the absen”