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Twenty-one operable breast cancer patients were treated with interferon-beta (IFN-beta) at the dosage of 3 x 10(6) IU every other day for a median time of 16 days. Estrogen receptors (ER), progesterone receptors (PgR), labelling index (LI) and DNA ploidy were evaluated on tumour tissue obtained during diagnostic biopsy and surgery, before and after treatment respectively. The study showed a statistically significant rise of ER (18 out of 21 evaluable cases) (p = 0.04) and no influence on ploidy status (8/21) in all evaluable samples. We also noticed a rise of PgR (18/21) and a decrease of LI (10/21 cases), but they were not statistically significant. Moreover, in the patients in whom both determination of ER and LI was possible (10 cases), a significant inverse correlation between the differences pre- and post-treatment was observed (p = 0.016). These preliminary results induce us to study a greater number of patients with the aim to confirm the biological effects of IFN-beta on ER, to clarify the trend of the rise of PgR and the decrease of LI and to analyse the relationship between these parameters.

The efficacy of the addition of prednisolone to tamoxifen as adjuvants to mastectomy in patients with primary breast cancer who were at a high risk of recurrence was investigated in a randomized trial. Primary carcinomas were collected from a series of 169 patients with loco-regional disease, undergoing mastectomy. The activities of alpha-glycerolphosphate dehydrogenase and 6-phosphogluconate dehydrogenase in the carcinomas were estimated biochemically and the ratio of the two enzymes was used to as the parameter to determine the risk of recurrence. 116 patients with a high risk of recurrence within five years of mastectomy were then randomized to either tamoxifen (2x20 mg/day) or tamoxifen+prednisolone (3x2.5 mg/per day) until recurrence. The patients are currently followed quarterly. The data were analysed at a median follow-up of 26 months (range 7-62 months). The probabilities of both disease-free and overall survival were not significantly different in either arm of the trial, indicating that there is no advantage in combining prednisolone with the antioestrogen. Recently, similar findings in terms of response have been reported for patients with metastatic disease treated with the same combination, raising doubts over the role of prednisolone in the management of patients with endocrine treatments.