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A deposit of cancer smaller than two millimetres in a lymph node is not a reason to clear the armpit. Ten years later the women who had nothing further done were doing slightly better, and had a quarter of the arm swelling.
IBCSG 23-01 recruited from 27 hospitals in nine countries between 2001 and 2010. Eligible women had a breast cancer of 5 cm or less and one or more sentinel nodes containing a micrometastasis of 2 mm or smaller without extracapsular extension, and were randomised before surgery to axillary clearance or none. 934 were randomised and three were later found ineligible.
At a median follow-up of 9.7 years, ten-year disease-free survival was 76.8 percent without clearance and 74.9 percent with it (hazard ratio 0.85, 95 percent confidence interval 0.65 to 1.11, log-rank p=0.24, non-inferiority p=0.0024). The morbidity difference is the reason to act on it: lymphoedema of any grade occurred in 16 of 453 patients (4 percent) without clearance and 60 of 447 (13 percent) with it, sensory neuropathy in 13 against 19 percent, and motor neuropathy in 3 against 9 percent.
The ten-year analysis was not pre-specified in the protocol and was not adjusted for repeated testing, which the authors say plainly. Read with Z0011, it is the reason NICE NG101 recommendation 1.4.14 says not to offer further axillary treatment for micrometastases at all.
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.
931 enrolled.
95 percent confidence interval 72.5 to 81.0 · 95 percent confidence interval 70.5 to 79.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 10 yearsprimary | No axillary dissection | 469 | 76.8% | 0.85 (0.65 to 1.11) | 0.24 log-rank, 0.0024 for non-inferiority | link |
| Axillary dissection | 465 | 74.9% | ||||
| Lymphoedema of any grade | No axillary dissection | 453 | 4% | - | - | link |
| Axillary dissection | 447 | 13% |
Shares SENOMAC, ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit.
Shares SENOMAC, ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit.
Shares Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy, Lymphadenectomy (lymph node dissection).
Shares Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy, Sentinel lymph node biopsy.
Shares ACOSOG Z0011 (Alliance), Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy.
Shares Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy, Sentinel lymph 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.