ACOSOG Z0011
Axillary dissection versus no axillary dissection in women with invasive breast cancer and sentinel node metastasis
Phase 3N = 891NCT00003855
- Population
- Women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 or 2 sentinel lymph nodes containing metastases.
- Design
- Phase 3 noninferiority trial at 115 sites, May 1999 to December 2004; all patients had lumpectomy and tangential whole-breast irradiation; randomised to ALND (10 or more nodes) or no further axillary treatment; systemic therapy at the physician's discretion. Targeted enrolment was 1900 women with final analysis after 500 deaths; the trial closed early because mortality was lower than expected.
- Primary endpoint
- OS
- Arms
- Axillary lymph node dissection (control, n = 445): Completion axillary lymph node dissection (10 or more nodes) after lumpectomy and whole-breast irradiation
- Sentinel node dissection alone (experimental, n = 446): Sentinel lymph node dissection alone, no further axillary treatment, after lumpectomy and whole-breast irradiation
- People
- Giuliano AE, American College of Surgeons Oncology Group (ACOSOG), now Alliance
OSHR 0.79Δ 60-month OS+0.7 pointsΔ 60-month DFS+1.7 pointsOSHR 0.85Δ 120-month OS+2.7 pointsDFSHR 0.85 (95% CI 0.62–1.17)
Show the numbers
| Endpoint | Analysis | Sentinel node dissection alone | Axillary lymph node dissection | Effect |
|---|---|---|---|---|
| OSRandomised women (891) | primarymedian follow-up 6.3 yearsGiuliano 2011 | 92.5% at 5 y (90.0–95.1%) | 91.8% at 5 y (89.1–94.5%) | HR 0.79Published hazard ratio 0.79 with a 90% confidence interval of 0.56 to 1.11 (not a 95% CI, so not entered in the CI field); adjusted for age and adjuvant therapy 0.87 (90% CI 0.62 to 1.23). Noninferiority margin: 1-sided HR below 1.3. |
| DFSRandomised women (891) | primarymedian follow-up 6.3 yearsGiuliano 2011 | 83.9% at 5 y (80.2–87.9%) | 82.2% at 5 y (78.3–86.3%) | — |
| OSRandomised women (891) | long term-updatemedian follow-up 9.3 yearsGiuliano 2017 | 86.3% at 10 y | 83.6% at 10 y | HR 0.85P=noninferiority P=.02The published interval for the hazard ratio is a 1-sided 95% CI of 0 to 1.16, not a two-sided 95% CI (not entered in the CI field). Noninferiority margin HR 1.3. |
| DFSRandomised women (891) | long term-updatemedian follow-up 9.3 yearsGiuliano 2017 | 80.2% at 10 y | 78.2% at 10 y | HR 0.85 (95% CI 0.62–1.17)P=.32 |
| Endpoint | Analysis | Sentinel node dissection alone | Axillary lymph node dissection | Effect |
|---|---|---|---|---|
| OSRandomised women (891) | primarymedian follow-up 6.3 yearsGiuliano 2011 | 92.5% at 5 y (90.0–95.1%) | 91.8% at 5 y (89.1–94.5%) | HR 0.79Published hazard ratio 0.79 with a 90% confidence interval of 0.56 to 1.11 (not a 95% CI, so not entered in the CI field); adjusted for age and adjuvant therapy 0.87 (90% CI 0.62 to 1.23). Noninferiority margin: 1-sided HR below 1.3. |
| DFSRandomised women (891) | primarymedian follow-up 6.3 yearsGiuliano 2011 | 83.9% at 5 y (80.2–87.9%) | 82.2% at 5 y (78.3–86.3%) | — |
| OSRandomised women (891) | long term-updatemedian follow-up 9.3 yearsGiuliano 2017 | 86.3% at 10 y | 83.6% at 10 y | HR 0.85P=noninferiority P=.02The published interval for the hazard ratio is a 1-sided 95% CI of 0 to 1.16, not a two-sided 95% CI (not entered in the CI field). Noninferiority margin HR 1.3. |
| DFSRandomised women (891) | long term-updatemedian follow-up 9.3 yearsGiuliano 2017 | 80.2% at 10 y | 78.2% at 10 y | HR 0.85 (95% CI 0.62–1.17)P=.32 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.85 | 0.62–1.17 |
Appears in
Sources
Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305(6):569-75.
Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, 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;318(10):918-926.