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The third of the big conservation trials, and the one that deliberately included larger tumours. After twenty-two years there was still no difference in how long women lived, which is why keeping the breast became standard rather than optional.
EORTC 10801 recruited between 1980 and 1986 in eight centres in the United Kingdom, the Netherlands, Belgium and South Africa, and included tumours up to 5 cm, larger than Milan I allowed. 448 patients were randomised to breast-conserving therapy and 420 to modified radical mastectomy. The primary endpoint was time to distant metastasis.
After a median follow-up of 22.1 years, 175 patients (42 percent) in the mastectomy arm and 207 (46 percent) in the conservation arm had distant metastases, and 506 patients (58 percent) had died. Neither difference was significant: the hazard ratio for time to distant metastasis was 1.13 (95 percent confidence interval 0.92 to 1.38, p=0.23) and for time to death 1.11 (0.94 to 1.33, p=0.23). Twenty-year overall survival was 44.5 percent after mastectomy and 39.1 percent after conservation, and the trial reports these as not significantly different. There was no interaction with age.
The record is marked mixed rather than positive because the point estimates favour mastectomy on both endpoints while the confidence intervals include no difference, and because the earlier reports found better local control after mastectomy. What the trial establishes is that conservation costs nothing in survival, not that the two operations are identical.
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.
868 randomised.
95 percent confidence interval 34.4 to 43.9 · 95 percent confidence interval 39.3 to 49.5
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Time to distant metastasisprimary | Breast-conserving therapy | 448 | - | 1.13 (0.92 to 1.38) | 0.23 | link |
| Modified radical mastectomy | 420 | - | ||||
| Overall survival at 20 years | Breast-conserving therapy | 448 | 39.1% | 1.11 (0.94 to 1.33) | 0.23 | link |
| Modified radical mastectomy | 420 | 44.5% |
Shares Milan I (quadrantectomy against radical mastectomy), Breast conservation or mastectomy, Lumpectomy (breast-conserving surgery), Mastectomy.
Shares Breast conservation or mastectomy, NSABP B-06, Mastectomy, Lymphadenectomy (lymph node dissection).
Shares Tumour bed boost, NSABP B-06, Lumpectomy (breast-conserving surgery), HER2-positive breast cancer.
Shares Lumpectomy (breast-conserving surgery), Mastectomy, Lymphadenectomy (lymph node dissection), Breast cancer (all types).
Shares EORTC 22881-10882 (boost against no boost), Tumour bed boost, HER2-positive breast cancer, Breast cancer (all types).
Shares Lymphadenectomy (lymph node dissection), EORTC, HER2-positive breast cancer, Breast cancer (all types).
Shares Breast conservation or mastectomy, Lumpectomy (breast-conserving surgery), Mastectomy, HER2-positive breast cancer.
Shares Lumpectomy (breast-conserving surgery), Mastectomy, Breast cancer (all types).