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. Gudgeon; A. 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

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

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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 language	English (US)
Pages (from-to)	4454-4459
Number of pages	6
Journal	Cancer Research
Volume	45
Issue number	9
State	Published - Sep 1985
Externally published	Yes

ASJC Scopus subject areas

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.

Goldhirsch, A, Stjemsward, J, Hartmann, W, Davis, B, Zava, D, Jordan, VC, Zimmermann, A, Baggenstoss, AH, Wiedmer, C, Ramminger, C, Gelber, R, Price, K, Stanley, K, Zelen, M, Istey, M, Parsons, M, Szymoniak, L, Helman, P, Hacking, A, Gudgeon, A, Tiltman, A, Dowdle, E, Schmidt, CG, Zchaber, R, Schning, F, Hköffken, K, Leder, LD, Ludwig, H, Cailles, R, Rudenstam, CM, Save-Soderbergh, J, Cahlin, E, Johnsen, C, Mattsson, J, Salander, H, Svensson, JO, Nilsson, S, Pomander, J, Mattsson, L, Bäckstrom, CG, Bergegardh, S, Dahlin, S, Fahl, N, Hessman, Y, Holmberg, S, Ruusvik, O, Niklasson, L, Ljungqvist, U, Andersson, C, Ivarsson, L, Mark, J, Ostberg, G & 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, vol. 45, no. 9, pp. 4454-4459.

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title = "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",

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.",

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

year = "1985",

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language = "English (US)",

volume = "45",

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T1 - 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

AU - Goldhirsch, A.

AU - Stjemsward, J.

AU - Hartmann, W.

AU - Davis, B.

AU - Zava, D.

AU - Jordan, V. C.

AU - Zimmermann, A.

AU - Baggenstoss, A. H.

AU - Wiedmer, C.

AU - Ramminger, C.

AU - Gelber, R.

AU - Price, K.

AU - Stanley, K.

AU - Zelen, M.

AU - Istey, M.

AU - Parsons, M.

AU - Szymoniak, L.

AU - Helman, P.

AU - Hacking, A.

AU - Gudgeon, A.

AU - Tiltman, A.

AU - Dowdle, E.

AU - Schmidt, C. G.

AU - Zchaber, R.

AU - Schning, F.

AU - Hköffken, K.

AU - Leder, L. D.

AU - Ludwig, H.

AU - Cailles, R.

AU - Rudenstam, C. M.

AU - Save-Soderbergh, J.

AU - Cahlin, E.

AU - Johnsen, C.

AU - Mattsson, J.

AU - Salander, H.

AU - Svensson, J. O.

AU - Nilsson, S.

AU - Pomander, J.

AU - Mattsson, L.

AU - Bäckstrom, C. G.

AU - Bergegardh, S.

AU - Dahlin, S.

AU - Fahl, N.

AU - Hessman, Y.

AU - Holmberg, S.

AU - Ruusvik, O.

AU - Niklasson, L.

AU - Ljungqvist, U.

AU - Andersson, C.

AU - Ivarsson, L.

AU - Mark, J.

AU - Ostberg, G.

AU - Dahl, I.

PY - 1985/9

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N2 - 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.

AB - 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.

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AN - SCOPUS:0022410425

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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

Abstract

ASJC Scopus subject areas

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