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When chemotherapy is given first and clears the lymph nodes, can a surgeon trust the sentinel node to prove it? Z1071 found the sentinel node missed residual cancer about one time in eight, which is too often, and that finding forced the technique to be redesigned.
Z1071 enrolled 756 women at 136 institutions between 2009 and 2011 with clinical T0 to T4, N1 to N2, M0 breast cancer and biopsy-proven nodal disease. After chemotherapy every patient had both sentinel node surgery and completion axillary clearance, so the sentinel node result could be checked against the truth.
Of 649 evaluable patients with cN1 disease, a sentinel node could not be found in 46 (7.1 percent) and only one was excised in 78 (12.0 percent). Among the 525 with two or more sentinel nodes removed, 215 had no cancer anywhere in the axilla, a pathological complete nodal response of 41.0 percent (95 percent confidence interval 36.7 to 45.3). In 39 patients the sentinel nodes were clear but the clearance specimen was not, a false-negative rate of 12.6 percent (90 percent Bayesian credible interval 9.85 to 16.05). The pre-specified acceptable threshold was 10 percent, and the trial did not meet it.
Z1071 is filed here as a negative trial because it failed its own bar, and it is one of the most useful negative trials in surgical oncology: the response to it was not to abandon sentinel node surgery after chemotherapy but to fix it, with dual tracer mapping, a minimum of three nodes, and marking the biopsied node before chemotherapy so it can be found again. That last idea became targeted axillary dissection.
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.
756 enrolled.
90 percent Bayesian credible interval 9.85 to 16.05
Source95 percent confidence interval 36.7 to 45.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| False-negative rate of sentinel node surgery after chemotherapy (two or more sentinel nodes removed)primary | Sentinel node surgery after chemotherapy | 525 | 12.6% | - | - | link |
| Pathological complete nodal response | Node-positive at diagnosis, after chemotherapy | 525 | 41% | - | - | link |
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 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).
Shares Sentinel node biopsy, Alliance for Clinical Trials in Oncology, Sentinel lymph node biopsy, HER2-positive breast cancer.
Shares Sentinel node biopsy, Sentinel lymph node biopsy, HER2-positive breast cancer, Breast cancer (all types).