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Umberto Veronesi ran the European half of the argument, against the most mutilating operation in surgery. After twenty years, women who had a quarter of the breast removed and radiotherapy were as likely to be alive as women who had the breast, the chest muscles and the nodes taken away.
Between 1973 and 1980, 701 women with breast cancers of 2 cm or less were randomised at the Istituto Nazionale Tumori in Milan to Halsted radical mastectomy (349) or to quadrantectomy with axillary dissection followed by radiotherapy to the remaining breast tissue (352). From 1976 node-positive women in both arms received cyclophosphamide, methotrexate and fluorouracil.
At twenty years, thirty women in the conservation arm had a recurrence in the same breast against eight in the mastectomy arm, a crude cumulative incidence of 8.8 against 2.3 percent (p<0.001). Nothing else differed: contralateral breast cancers, distant metastases and second primary cancers were the same in both arms. Death from any cause was 41.7 percent after conservation and 41.2 percent after radical mastectomy (p=1.0); death from breast cancer 26.1 against 24.3 percent (p=0.8).
Read alongside NSABP B-06, Milan I is the reason the sentence "breast conservation is the treatment of choice for relatively small breast cancers" can be written at all. It also shows the shape of the trade: a higher chance of the cancer returning in the breast, paid for by keeping the breast, with no cost in life. Quadrantectomy itself, which takes a whole quadrant, is more than most surgeons remove now, and the 8.8 percent figure was achieved without the modern systemic therapy that lowers local recurrence further.
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.
701 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Crude cumulative incidence of ipsilateral breast recurrence at 20 yearsprimary | Quadrantectomy with radiotherapy | 352 | 8.8% | - | <0.001 | link |
| Halsted radical mastectomy | 349 | 2.3% | ||||
| Death from any cause at 20 years | Quadrantectomy with radiotherapy | 352 | 41.7% | - | 1.0 | link |
| Halsted radical mastectomy | 349 | 41.2% | ||||
| Death from breast cancer at 20 years | Quadrantectomy with radiotherapy | 352 | 26.1% | - | 0.8 | link |
| Halsted radical mastectomy | 349 | 24.3% |
Shares Oncoplastic breast surgery, Breast conservation or mastectomy, Lumpectomy (breast-conserving surgery), Mastectomy.
Shares Breast conservation or mastectomy, NSABP B-06, Mastectomy, HER2-positive breast cancer.
Shares EORTC 10801, Lumpectomy (breast-conserving surgery), HER2-positive breast cancer, Breast cancer (all types).
Shares Oncoplastic breast surgery, Lumpectomy (breast-conserving surgery), Mastectomy, Breast cancer (all types).
Shares Oncoplastic breast surgery, Mastectomy, HER2-positive breast cancer, Breast cancer (all types).
Shares EORTC 10801, Lumpectomy (breast-conserving surgery), HER2-positive breast cancer, Breast cancer (all types).
Shares Lumpectomy (breast-conserving surgery), Mastectomy, Breast cancer (all types).
Shares Lumpectomy (breast-conserving surgery), Mastectomy, Breast cancer (all types).