The effect of danazol on tumour control and weight loss in patients on tamoxifen therapy for advanced breast cancer: A randomised double-blind placebo controlled trial

James F. Bishop, Jennifer Smith, Peter Jeal, Robin Murray, Roslyn Drummond, Paula Pitt, Ian Olver, Ankur Bhowal
In: European Journal of Cancer · 1993 · vol. 29(6) , pp. 814–818 · doi:10.1016/s0959-8049(05)80415-0 · PMID:8484970 · W1972656449
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This randomized double-blind placebo-controlled trial investigated the effects of danazol on tumor control and weight loss in advanced breast cancer patients receiving tamoxifen therapy.

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Abstract

To assess the effect of danazol in advanced breast cancer 183 patients were randomised to receive either tamoxifen plus danazol or tamoxifen plus placebo. Patients underwent systemic work-up pretreatment then every 12 weeks or sooner if they clinically progressed. There were no differences in objective response rates with tamoxifen plus danazol vs. tamoxifen plus placebo (27% vs. 24%), time to progression (median 6.4 vs. 6.2 months) or survival (median 22.6 vs. 23.5 months) when the two arms were compared (all P > 0.5). The addition of danazol to tamoxifen had no effect on time to progression when adjusted for significant prognostic factors in a multivariate analysis. However, it was found incidentally that weight was stable on tamoxifen plus danazol (average gain 0.6 kg, S.E. 0.6 kg) compared with a significant loss on tamoxifen plus placebo (average loss 2.0 kg, S.E. 0.6 kg, P = 0.003). The average weight was maintained on tamoxifen plus danazol even in patients who did not respond to treatment.

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chemicals 12
danazol tamoxifen danazol tamoxifen danazol tamoxifen tamoxifen danazol tamoxifen danazol tamoxifen danazol

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