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SOUND went one step further than every trial before it and asked whether the armpit needs to be operated on at all when the tumour is small and the scan is clear. For those women it does not: almost everyone was free of distant spread at five years either way.
SOUND randomised 1,463 women of any age in Italy, Switzerland, Spain and Chile between 2012 and 2017 who had a breast cancer of up to 2 cm and a negative preoperative axillary ultrasound, to sentinel node biopsy or to no axillary surgery. 1,405 were analysed by intention to treat. The median tumour was 1.1 cm and 87.8 percent were oestrogen receptor-positive and HER2-negative. In the sentinel node arm, 97 patients (13.7 percent) turned out to have positive nodes, which is the size of the staging information the other arm gave up.
At a median 5.7 years, five-year distant disease-free survival was 97.7 percent with sentinel node biopsy and 98.0 percent without axillary surgery (log-rank p=0.67, hazard ratio 0.84, 90 percent confidence interval 0.45 to 1.54, non-inferiority p=0.02). Locoregional relapses were 12 (1.7 percent) against 11 (1.6 percent), distant metastases 13 against 14, and deaths 21 (3.0 percent) against 18 (2.6 percent).
The trial attaches a condition that is often dropped when it is quoted: patients can be spared axillary surgery whenever the lack of pathological nodal information does not change the postoperative treatment plan. Where nodal status would decide chemotherapy, radiotherapy fields or the choice of endocrine agent, the information still has to come from somewhere.
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.
1,463 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Distant disease-free survival at 5 yearsprimary | No axillary surgery | 697 | 98% | 0.84 (0.45 to 1.54) | 0.02 for non-inferiority | link |
| Sentinel lymph node biopsy | 708 | 97.7% |
Shares NSABP B-32, 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 Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy, Sentinel lymph node biopsy.
Shares NSABP B-32, 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 Lymphoedema after breast cancer treatment, Doing less to the armpit, Sentinel node biopsy, Sentinel lymph 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, Sentinel lymph node biopsy, HER2-positive breast cancer.