ACOSOG Z0011 (5-year survival)
Trial question
Is sentinel lymph node dissection noninferior to axillary lymph node dissection in female patients with clinical T1-T2 invasive breast cancer?
Study design
Multi-center
Open label
RCT
Population
891 female patients
Inclusion criteria: female patients with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 sentinel lymph nodes containing metastases
Key exclusion criteria: metastases identified initially or solely with immunohistochemical staining, ≥ 3 positive SLNs, matted nodes, gross extranodal disease, or receipt of neoadjuvant hormonal or chemotherapy
Interventions
N=446 sentinel lymph node dissection (no further axillary-specific intervention)
N=445 complete axillary lymph node dissection (dissection of ≥ 10 nodes)
Primary outcome
Overall survival at 5 years
92.5
91.8
92.5 %
69.4 %
46.3 %
23.1 %
0.0 %
Sentinel lymph node dissection
Complete axillary lymph node dissection
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in overall survival at 5 years (92.5% vs. 91.8%; HR 0.79, 90% CI 0.56 to 1.1)
Secondary outcomes
No significant difference in disease-free survival at 5 years (83.9% vs. 82.2%; HR 0.82, 95% CI 0.58 to 1.17)
No significant difference in local recurrence at 5 years (1.6% vs. 3.1%; RR 0.51, 95% CI -0.12 to 1.14)
No significant difference in locoregional recurrence-free survival at 5 years (96.7% vs. 95.7%; RR 1.01, 95% CI -0.81 to 2.83)
Conclusion
In female patients with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 sentinel lymph nodes containing metastases, sentinel lymph node dissection was noninferior to complete axillary lymph node dissection with respect to overall survival at 5 years.
Reference
Giuliano AE, Hunt KK, Ballman KV et al. 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.
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