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 less than 0.0001). However, at a median followup 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 cyclophosphamide-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.
mesh_terms: D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D008207:Lymphatic Metastasis; D008598:Menstruation; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D010053:Ovary / Q000187:drug effects; D011241:Prednisone / Q000627:therapeutic use; D011897:Random Allocation
chemical_list: D003520:Cyclophosphamide; D005472:Fluorouracil; D011241:Prednisone; D008727:Methotrexate