ACOSOG Z0011 (10-year survival)
Trial question
Is sentinel lymph node dissection noninferior to axillary lymph node dissection in patients with invasive breast cancer and sentinel lymph node metastasis?
Study design
Multi-center
Open label
RCT
Population
891 female patients
Inclusion criteria: women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases
Key exclusion criteria: lactation; previous treatment with chemotherapy; estrogen receptor antagonists or selective estrogen receptor modulators; concurrent invasive bilateral breast malignancies; previous ipsilateral axillary surgery
Interventions
N=446 sentinel lymph node dissection (sentinel lymph node dissection alone without axillary lymph node dissection)
N=445 axillary lymph node dissection (axillary lymph node dissection followed by whole breast irradiation)
Primary outcome
Overall survival at 10 year follow-up
86.3
83.6
86.3 %
64.7 %
43.1 %
21.6 %
0.0 %
Sentinel lymph node dissection
Axillary lymph node dissection
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in overall survival at 10 year follow-up (86.3% vs. 83.6%; HR 0.85, 95% CI 0 to 1.16)
Secondary outcomes
No significant difference in disease-free survival at 10 years (80.2% vs. 78.2%; HR 1.17, 95% CI 0.85 to 1.61)
No significant difference in locoregional relapse-free survival at 10 years (83% vs. 81.2%; HR 1.14, 95% CI 0.82 to 1.61)
Conclusion
In women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, sentinel lymph node dissection was noninferior to axillary lymph node dissection with respect to overall survival at 10 year follow-up.
Reference
Armando E Giuliano, Karla V Ballman, Linda McCall et al. 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. 2017 Sep 12;318(10):918-926.
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