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The trial that made it safe to take one or two lymph nodes instead of twenty. Where the first node the cancer drains to is clear, clearing the rest of the armpit adds nothing to survival and adds a lifetime of arm swelling risk.
NSABP B-32 randomised 5,611 women with clinically node-negative invasive breast cancer at 80 centres in the United States and Canada between 1999 and 2004. Group 1 had sentinel node resection followed by axillary clearance whatever the sentinel node showed; group 2 had sentinel node resection alone, with clearance only if the sentinel node contained cancer. Mapping used both blue dye and a radioactive tracer. The primary endpoint was overall survival among the 3,989 patients whose sentinel nodes were negative.
At a mean 95.6 months, 309 deaths had occurred among the 3,986 sentinel node-negative patients with follow-up: 140 of 1,975 in group 1 and 169 of 2,011 in group 2. The unadjusted hazard ratio for overall survival was 1.20 (95 percent confidence interval 0.96 to 1.50, p=0.12), with eight-year estimates of 91.8 against 90.3 percent. Disease-free survival gave a hazard ratio of 1.05 (0.90 to 1.22, p=0.54), with eight-year estimates of 82.4 against 81.5 percent. Regional node recurrence as a first event occurred in eight patients in group 1 and fourteen in group 2 (p=0.22).
B-32 is the largest trial of the sentinel node concept ever run, and its conclusion is unqualified: when the sentinel node is negative, sentinel node surgery alone is appropriate, safe and effective.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
5,611 enrolled.
95 percent confidence interval 88.8 to 91.8 · 95 percent confidence interval 90.4 to 93.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 8 years (sentinel node-negative patients)primary | Sentinel node resection alone | 2,011 | 90.3% | 1.2 (0.96 to 1.5) | 0.12 | link |
| Sentinel node resection plus axillary clearance | 1,975 | 91.8% | ||||
| Disease-free survival at 8 years | Sentinel node resection alone | 2,011 | 81.5% | 1.05 (0.9 to 1.22) | 0.54 | link |
| Sentinel node resection plus axillary clearance | 1,975 | 82.4% |
Shares ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy.
Shares ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy.
Shares ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy.
Shares ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy.
Shares Doing less to the armpit, Sentinel node biopsy, Lymphadenectomy (lymph node dissection), Sentinel lymph node biopsy.
Shares Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy, Sentinel lymph node biopsy.
Shares NSABP B-04, NSABP Foundation, NRG Oncology, HER2-positive breast cancer.
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).