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The fix for the problem Z1071 exposed. If the surgeon puts a marker in the lymph node that was biopsied at diagnosis and then goes back for that exact node after chemotherapy, the chance of missing leftover cancer falls from about one in ten to about one in fifty.
This prospective study enrolled 208 patients with biopsy-confirmed nodal metastases in whom a clip had been placed in the sampled node before treatment. After chemotherapy they had axillary surgery, and the pathology of the clipped node was compared with the rest. 191 went on to completion axillary clearance, and 120 of those (63 percent) had residual disease, so the false-negative rate could be measured.
The clipped node alone showed metastases in 115 patients, a false-negative rate of 4.2 percent (95 percent confidence interval 1.4 to 9.5). Sentinel node dissection alone, in the 118 patients who had both, gave 10.1 percent (4.2 to 19.8). Adding evaluation of the clipped node to sentinel node dissection brought it to 1.4 percent (0.03 to 7.3, p=0.03). In 85 patients who had formal targeted axillary dissection followed by clearance, the false-negative rate was 2.0 percent (one of fifty, 0.05 to 10.7).
The finding that explains why the technique is necessary is buried in the middle of the paper: the clipped node was not retrieved as a sentinel node in 23 percent of patients, 31 of 134, and six of those had negative sentinel nodes but metastasis in the clipped node. The node that was known to contain cancer is often not the node the tracer finds.
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.
208 enrolled.
95 percent confidence interval 4.2 to 19.8 · 95 percent confidence interval 0.03 to 7.3 · one of fifty, 95 percent confidence interval 0.05 to 10.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| False-negative rate after chemotherapyprimary | Sentinel node dissection alone | 118 | 10.1% | - | 0.03 | link |
| Sentinel node dissection plus the clipped node | 118 | 1.4% | ||||
| Targeted axillary dissection | 85 | 2% |
Shares Drugs before or after the operation, Targeted axillary dissection, ACOSOG Z1071 (Alliance), ATNEC.
Shares ATNEC, Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer.
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).
Shares Targeted axillary dissection, ATNEC, Sentinel node biopsy, Sentinel lymph node biopsy.
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).