Randomized clinical trial of diethylstilbestrol versus tamoxifen in postmenopausal women with advanced breast cancer

J. N. Ingle, D. L. Ahmann, S. J. Green, J. H. Edmonson, H. F. Bisel, L. K. Kvols, W. C. Nichols, E. T. Creagan, R. G. Hahn, J. Rubin, S. Frytak

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Abstract

Before the introduction of tamoxifen, diethylstilbestrol (DES) was widely considered to be the hormonal treatment of choice in postmenopausal women with advanced breast cancer. The authors performed a randomized clinical trial of these two agents to determine their relative efficacy and toxicity. The trial involved 143 evaluable patients, of whom 99 had received no prior systemic therapy and 44 had received previous chemotherapy. The regression rates (complete plus partial) were higher in patients receiving DES (41%) than in those receiving tamoxifen (33%), but not significantly so (P = 0.37). In patients who had had no prior systematic therapy, the rates were 44% and 38%, respectively (P = 0.55), and in those who had had previous chemotherapy, 32% vs. 23% (P = 0.50). Analysis of the time until treatment failure for the two treatment groups showed no significant difference (medians: DES, 142 days; tamoxifen, 171 days). Toxicity was greater in patients receiving DES; nine of 74 patients (12%) discontinued therapy solely because of adverse reactions. Since there was no statistically significant difference in efficacy and since tamoxifen was less toxic, tamoxifen appears to be the preferred agent.

Original languageEnglish (US)
Pages (from-to)16-21
Number of pages6
JournalNew England Journal of Medicine
Volume304
Issue number1
StatePublished - 1981

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Diethylstilbestrol
Tamoxifen
Randomized Controlled Trials
Breast Neoplasms
Therapeutics
Drug Therapy
Poisons
Treatment Failure

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Ingle, J. N., Ahmann, D. L., Green, S. J., Edmonson, J. H., Bisel, H. F., Kvols, L. K., ... Frytak, S. (1981). Randomized clinical trial of diethylstilbestrol versus tamoxifen in postmenopausal women with advanced breast cancer. New England Journal of Medicine, 304(1), 16-21.

Randomized clinical trial of diethylstilbestrol versus tamoxifen in postmenopausal women with advanced breast cancer. / Ingle, J. N.; Ahmann, D. L.; Green, S. J.; Edmonson, J. H.; Bisel, H. F.; Kvols, L. K.; Nichols, W. C.; Creagan, E. T.; Hahn, R. G.; Rubin, J.; Frytak, S.

In: New England Journal of Medicine, Vol. 304, No. 1, 1981, p. 16-21.

Research output: Contribution to journalArticle

Ingle, JN, Ahmann, DL, Green, SJ, Edmonson, JH, Bisel, HF, Kvols, LK, Nichols, WC, Creagan, ET, Hahn, RG, Rubin, J & Frytak, S 1981, 'Randomized clinical trial of diethylstilbestrol versus tamoxifen in postmenopausal women with advanced breast cancer', New England Journal of Medicine, vol. 304, no. 1, pp. 16-21.
Ingle, J. N. ; Ahmann, D. L. ; Green, S. J. ; Edmonson, J. H. ; Bisel, H. F. ; Kvols, L. K. ; Nichols, W. C. ; Creagan, E. T. ; Hahn, R. G. ; Rubin, J. ; Frytak, S. / Randomized clinical trial of diethylstilbestrol versus tamoxifen in postmenopausal women with advanced breast cancer. In: New England Journal of Medicine. 1981 ; Vol. 304, No. 1. pp. 16-21.
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