6/27/23, 11:46 PM ACOSOG Z0011 (10-year survival) Pathway Feedback Search Clinical Topics Home Studies ACOSOG Z0011 10-year survival) 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 % 86.3 83.6 64.7 % 43.1 % Difference not exceeding nonferiority margin 21.6 % 0.0 % Sentinel lymph node dissection Axillary lymph node dissection 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) https://web.pathway.md/studies/rec5gySjrcaFuZd2B 1/2 6/27/23, 11:46 PM ACOSOG Z0011 (10-year survival) Pathway 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. Open reference URL https://web.pathway.md/studies/rec5gySjrcaFuZd2B 2/2