Combined cytotoxic and endocrine therapy in postmenopausal patients with advanced breast cancer. A randomized eortc study of CMF vs CMF + tamoxifen

H. T. Mouridsen, C. Rose, E. Engelsmann, R. Sylvester, N. Rotmensz

Research output: Contribution to journalArticlepeer-review

Abstract

Two hundred and sixty-three patients with advanced measurable breast cancer were randomized to receive cyclophosphamide, methotrexate and 5-fluorouracil (CMF) or CMF + tamoxifen (T). Each cycle of CMF (C, 100 mg/m2 p.o. days 1-14, M, 40 mg/m2 i.v. days 1 and 8, F, 600 mg/m2 i.v. days 1 and 8) was repeated every 4 weeks. Tamoxifen, 20 mg twice daily, was given continuously. The treatment results as assessed by external reviewing were as follows in the CMF and CMF + T groups, respectively: PD 24 and 10%, NC 27 and 15%, PR 29 and 44%, CR 20 and 31%. The difference between response (CR + PR) rates is highly significant (P = 0.0001). Derived from life-table analysis, the median duration of remission was 12 months in the CMF-treated group and 18 months in patients treated with CMP + T (P = 0.04). Median duration of survival was 19 and 24 months, respectively (P = 0.12), but in the group of responders CMF+T was significantly superior to CMF (32 months vs 21 months, P = 0.03). The addition of T was of benefit to all subgroups but the difference only reached statistical significance in patients with the dominant site of disease in viscera, in patients with a Karnofsky index of 100 and in patients of more than 60 years of age. The amount of CMF given was identical in the two groups with a trend for a decrease in dose with increasing age. No relation between response rate and amount of dose given was observed. In conclusion, the addition of T to CMF improves the therapeutic results in patients with advanced breast cancer although the superiority of the combined treatment is statistically significant only in some subsets of patients.

Original languageEnglish
Pages (from-to)1141-1146
Number of pages6
JournalJournal of Steroid Biochemistry
Volume23
Issue number6 PART 2
DOIs
Publication statusPublished - 1985

ASJC Scopus subject areas

  • Biochemistry
  • Endocrinology

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