| Popis: |
Between April 1974 and December 1979, 348 women, with Stage I or II breast cancer without node involvement on lymph node sampling, were randomized, after simple mastectomy, for routine postoperative radiotherapy or no further treatment in a trial conducted in the South-east of Scotland. After a median follow-up of 15 years from randomization for the alive patients, the two treatment groups had very similar results for both distant disease-free rates and total survival. A non-significant advantage in event-free survival was found for those irradiated (HR = 1.21, CI = 0.91–1.61) which was accounted for by a significant increase in loco-regional relapse in those not given radiotherapy (HR = 2.19, CI = 1.38–3.48). In one-third of those randomized, no information on node histology was available. Subgroup analysis within the resulting two categories of nodal status confirmed an advantage in distant disease-free rates for those classified histologically as node negative compared to those without node histology (HR = 0.54, CI = 0.38–0.77). It is concluded that, for women with stage I or II breast cancer, when histological examination of lower axillary nodes suggests absence of axillary spread, a watching policy is safe but that when no nodes have been examined, postoperative radiotherapy should be considered in order to achieve maximal local control of disease. |
