A Randomized Trial of Adjuvant Combination Chemotherapy With Or Without Prednisone in Premenopausal Breast Cancer Patients With Metastases in One to Three Axillary Lymph Nodes

A. Goldhirsch, J. Stjemsward, W. Hartmann, B. Davis, D. Zava, V. C. Jordan, A. Zimmermann, A. H. Baggenstoss, C. Wiedmer, C. Ramminger, R. Gelber, K. Price, K. Stanley, M. Zelen, M. Istey, M. Parsons, L. Szymoniak, P. Helman, A. Hacking, A. GudgeonA. Tiltman, E. Dowdle, C. G. Schmidt, R. Zchaber, F. Schning, K. Hköffken, L. D. Leder, H. Ludwig, R. Cailles, C. M. Rudenstam, J. Save-Soderbergh, E. Cahlin, C. Johnsen, J. Mattsson, H. Salander, J. O. Svensson, S. Nilsson, J. Pomander, L. Mattsson, C. G. Bäckstrom, S. Bergegardh, S. Dahlin, N. Fahl, Y. Hessman, S. Holmberg, O. Ruusvik, L. Niklasson, U. Ljungqvist, C. Andersson, L. Ivarsson, J. Mark, G. Ostberg, I. Dahl

Research output: Contribution to journalArticle

Abstract

The impact of adding “low-dose” continuous prednisone (7.5 mg daily) to an adjuvant cyclophosphamide-methotrexate-5-fluorouracil chemotherapy regimen was investigated in a randomized trial of 505 pre- and perimenopausal patients with operable breast cancer and one to three axillary lymph node metastases (Ludwig Breast Cancer Study I). As a consequence of lower hematological toxicity a significantly higher dose of cyclophosphamide-methotrexate-5-fluorouracil could be administered with added prednisone (P 0.0001). However, at a median follow-up of 48 months, no improvement in terms of disease-free survival (P = 0.35) or overall survival (P = 0.73) was observed. Induced amenorrhea was associated with a longer disease-free survival for younger patients, patients who received lower cydophosphamide-methotrexate-5-fluorouracil doses and patients with estrogen receptor-positive tumors. It is suggested that the chemotherapy regimen with or without prednisone may also influence tumor growth by suppression of ovarian endocrine function.

Original languageEnglish
Pages (from-to)4454-4459
Number of pages6
JournalCancer Research
Volume45
Issue number9
Publication statusPublished - 1985

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

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    Goldhirsch, A., Stjemsward, J., Hartmann, W., Davis, B., Zava, D., Jordan, V. C., Zimmermann, A., Baggenstoss, A. H., Wiedmer, C., Ramminger, C., Gelber, R., Price, K., Stanley, K., Zelen, M., Istey, M., Parsons, M., Szymoniak, L., Helman, P., Hacking, A., ... Dahl, I. (1985). A Randomized Trial of Adjuvant Combination Chemotherapy With Or Without Prednisone in Premenopausal Breast Cancer Patients With Metastases in One to Three Axillary Lymph Nodes. Cancer Research, 45(9), 4454-4459.