106 O - Sitam-01 adjuvant breast trial for patients > 50 years

This pragmatic, large scale randomised trial was designed after considering the evidences emerged from the 1985 systematic overiew of all trials about adjuvant tamoxifen in women with early breast cancer, also confirmed in the 1990 systematic overview, that have demonstratad a highly significant improvement in 10-years survival. For the patients over the age of 50, the main question addressed in this protocol is whether the duration of tamoxifen therapy affects disease-free on overall survival. However, it is not yet known how long women with breast cancer should continue 10 take adjuvant tamoxifen. The obvious question, for this trial started in 1989, is whether a longer period, say 5 years, is more beneficial. For the protocol of this study all women 50 years and < 70 years with “operable” breast cancer, irrespective of nodal or menopausal status, where eligible. After primary therapy all patients were registered into the study through the coordinating center and received 20 mg tamoxifen daily for 2 years and, if they remained disease-free, were eligible for randomisation to stop or continue therapy for further 3 years. This protocol also permitted optional randomisation of patients to systemic chemotherapy or control, since there was little evidence, at that time, as to wheter additional benefits would be gained by using both chemotherapy and hormone therapy. This trial is the biggest trial about adjuvant treatments ever conducted in Italy, having recruited 2511 patients until January 1996 from 53 participating centers, of which 1722 were randomised to stop (862) or to continue (860) treatment. After 2 years of therapy, 16% of patients were not eligible for randomisation because they had relapsed and 4% had refused randomisation. Overall 1083 (47%) patients are N+ (139 of them with 3 nodes involved), 295 (12%) patients underwent adjuvant chemotherapy, 1277 (56%) patients are ER+, 374 (16%) ER-, 105 (5%) ER borderline and 524 (23%) did not perform the determination of the ER status (data not yet available for 231 patients). 10.5% of the patients has experienced side-effects attributable to tha hormone-therapy. After a median follow-up of 36 months, 1967 (78.4%) patients are disease-free, 147 (5.8%) have relapsed, 48 (1.9%) have developed a second tumour (7 endometrial cancer), 178(7.1%) have died and 171 (6.8%) have been lost to follow-up.