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. 2014 Jun 20;383(9935):2127–2135. doi: 10.1016/S0140-6736(14)60488-8

Table.

Availability of data from randomised trials beginning before the year 2000 and comparing radiotherapy to the chest wall and regional nodes after mastectomy and axillary surgery versus no radiotherapy but the same surgery

Women Deaths Woman-years since diagnosis*
Women given systemic therapy(%)
Median per woman Total (×103) Distribution by years (×103)
Chemotherapy Tamoxifen and ER+ Any
<10 10–19 ≥20
(A) Axillary dissection
pN0 700 480 20·1 13·5 6·1 4·4 3·0 22% 27% 47%
pN+ 3131 2074 7·2 30·1 20·3 7·9 1·9 75% 22% 91%
pN1–3 1314 759 12·3 17·3 10·3 5·3 1·6 65% 24% 86%
pN4+ 1772 1286 4·8 12·4 9·7 2·5 0·3 81% 21% 95%
pN?+ 45 29 6·7 0·4 0·3 0·1 <0·1 100% 0% 100%
pN unknown 56 39 10·6 0·7 0·4 0·2 0·1 29% 71% 98%
Total 3887 2593 9·0 44·3 26·8 12·5 4·9 64% 24% 83%
(B) Axillary sampling
pN0 870 595 17·6 15·4 7·5 5·1 2·8 10% 11% 21%
pN+ 2541 1689 7·8 24·2 17·0 6·4 0·2 56% 28% 84%
pN unknown 654 460 9·3 7·1 4·6 2·1 0·4 44% 30% 74%
Total 4065 2744 9·8 46·8 29·1 13·7 4·0 44% 25% 69%
(C) Axillary surgery, but extent unknown
pN0 24 12 8·5 0·2 0·2 <0·1 .. 100% 0% 100%
pN+ 149 69 11·5 1·3 1·1 0·2 .. 100% 0% 100%
pN unknown 10 6 11·0 0·1 0·1 <0·1 .. 100% 0% 100%
Total 183 87 10·1 1·6 1·4 0·2 .. 100% 0% 100%
Total (A)+(B)+(C) 8135 5424 9·4 92·7 57·3 26·4 9·0 55% 24% 77%

Data were available for 22 trials, start dates 1964–86, and were unavailable for four trials including about 400 women. In all 22 trials for which data were available, radiotherapy was given to the chest wall and the supraclavicular or the axillary fossa (or both). In 20 of these 22 trials it was also given to the internal mammary chain. Details of the treatments given in these 22 trials are in appendix pp 10–12. Details of other trials of radiotherapy in combination with mastectomy are in appendix pp 52–53, 64–65, 70–71, 78–79. pN0=pathologically node-negative. pN+=pathologically node-positive. pN1–3=one to three pathologically positive nodes. pN4+=at least four pathologically positive nodes. pN?+=known to be pN+, but not whether pN1–3 or pN4+. pN unknown=pathological nodal status unknown.

*

Numbers of woman-years of follow-up for mortality; many trials followed up women for only 10 years for recurrence.

Chemotherapy was usually cyclophosphamide, methotrexate, and fluorouracil (CMF); only 3% of women were classified as oestrogen-receptor positive (ER+) and were in trials where both tamoxifen and chemotherapy were given.

Oestrogen-receptor positive.