NSABP B-32
Trial question
What is the role of sentinel lymph node resection in female patients with invasive breast cancer and clinically negative lymph nodes?
Study design
Multi-center
Open label
RCT
Population
5611 female patients.
Inclusion criteria: female patients with invasive breast cancer and clinically negative lymph nodes.
Key exclusion criteria: age < 18 years, positive ipsilateral axillary lymph nodes or prior removal of ipsilateral axillary lymph nodes, ulceration, erythema, infiltration of the skin or underlying chest wall, prior or concurrent breast implants, or prior breast malignancy.
Interventions
N=1975 routine axillary node dissection (sentinel node resection with axillary dissection).
N=2011 selective axillary node dissection (sentinel node resection with axillary dissection only if SLNs were positive).
Primary outcome
Overall survival, as per log-rank comparison
96.4%
95%
96.4 %
72.3 %
48.2 %
24.1 %
0.0 %
Routine axillary node
dissection
Selective axillary node
dissection
No significant
difference ↔
No significant difference in overall survival, as per log-rank comparison (96.4% vs. 95%; HR 1.2, 95% CI 0.96 to 1.5).
Secondary outcomes
Borderline significant increase in disease-free survival (84.1% vs. 83.3%).
Conclusion
In female patients with invasive breast cancer and clinically negative lymph nodes, routine axillary node dissection was not superior to selective axillary node dissection with respect to overall survival, as per log-rank comparison.
Reference
Krag DN, Anderson SJ, Julian TB et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):927-33.
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