title: 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.
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.
authors: Department of Hematology and Medical Oncology, Peter MacCallum Cancer Institute, Melbourne, Vic, Australia.
authors: J F
authors: JF
authors: Bishop
authors: J G
authors: JG
authors: Smith
authors: P N
authors: PN
authors: Jeal
authors: R
authors: R
authors: Murray
authors: R M
authors: RM
authors: Drummond
authors: P
authors: P
authors: Pitt
authors: I N
authors: IN
authors: Olver
authors: A K
authors: AK
authors: Bhowal
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D003613:Danazol / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D011379:Prognosis; D011960:Receptors, Estrogen / Q000032:analysis; D013629:Tamoxifen / Q000008:administration & dosage; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D010919:Placebos; D011960:Receptors, Estrogen; D013629:Tamoxifen; D003613:Danazol