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The largest trial of skipping the armpit operation, and the one with six years of follow-up. Women who had no lymph node surgery did as well as those who did, and had less arm swelling, better shoulder movement and less pain.
INSEMA randomised 5,502 eligible patients in a 1:4 ratio to no axillary surgery or to sentinel lymph node biopsy. All had clinically node-negative T1 or T2 invasive breast cancer and were scheduled for breast-conserving surgery; 90 percent had clinical T1 disease and 79 percent pathological T1 disease. The per-protocol population was 4,858, of whom 962 had no axillary surgery.
At a median follow-up of 73.6 months, the estimated five-year invasive disease-free survival was 91.9 percent (95 percent confidence interval 89.9 to 93.5) without axillary surgery and 91.7 percent (90.8 to 92.6) with sentinel node biopsy, a hazard ratio of 0.91 (0.73 to 1.14), below the non-inferiority margin of 1.271. Of the 525 first primary-outcome events, the apparent differences were in axillary recurrence, 1.0 percent without surgery against 0.3 percent with it, and in death, 1.4 against 2.4 percent. Patients who had no axillary surgery had less lymphoedema, greater arm mobility and less pain on moving the arm or shoulder.
The axillary recurrence figures are the number to hold on to: omitting the operation roughly triples a very small risk, from three in a thousand to ten in a thousand at five years, and does not change how long women live. Whether the same holds for invasive lobular carcinoma is disputed: a single-institution series found high rates of occult nodal positivity in lobular tumours meeting INSEMA and SOUND criteria.
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.
5,502 randomised.
95 percent confidence interval 89.9 to 93.5 · 95 percent confidence interval 90.8 to 92.6
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survival at 5 yearsprimary | No axillary surgery | 962 | 91.9% | 0.91 (0.73 to 1.14) | - | link |
| Sentinel lymph node biopsy | 3,896 | 91.7% | ||||
| Axillary recurrence as a first primary-outcome event | No axillary surgery | 962 | 1% | - | - | link |
| Sentinel lymph node biopsy | 3,896 | 0.3% |
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.