title: Randomized trial of low-dose chemotherapy added to tamoxifen in patients with receptor-positive and lymph node-positive breast cancer.
abstract: OBJECTIVE
  To evaluate the outcome in patients with stage II hormone receptor-positive breast cancer treated or not treated with low-dose, short-term chemotherapy in addition to tamoxifen in terms of disease-free and overall survival.
  
  
  METHODS
  A total of 613 patients were randomized to receive either low-dose chemotherapy (doxorubicin 20 mg/m(2) and vincristine 1 mg/m(2) on day 1; cyclophosphamide 300 mg/m(2); methotrexate 25 mg/m(2); and fluorouracil 600 mg/m(2) on days 29 and 36 intravenously) or no chemotherapy in addition to 20 mg of tamoxifen orally for 2 years. A third group without any treatment (postmenopausal patients only) was terminated after the accrual of 79 patients due to ethical reasons.
  
  
  RESULTS
  After a median follow-up period of 7.5 years, the addition of chemotherapy did not improve the outcome in patients as compared with those treated with tamoxifen alone, neither with respect to disease-free nor overall survival. Multivariate analysis of prognostic factors for disease-free survival revealed menopausal status, in addition to nodal status, progesterone receptor, and histologic grade as significant. Both untreated postmenopausal and tamoxifen-treated premenopausal patients showed identical prognoses significantly inferior to the tamoxifen-treated postmenopausal cohort. Prognostic factors for overall survival in the multivariate analysis showed nodal and tumor stage, tumor grade, and hormone receptor level as significant.
  
  
  CONCLUSIONS
  Low-dose chemotherapy in addition to tamoxifen does not improve the prognosis of stage II breast cancer patients with hormone-responsive tumors. Tamoxifen-treated postmenopausal patients show a significantly better prognosis than premenopausal patients, favoring the hypothesis of a more pronounced effect of tamoxifen in the older age groups.
authors.affiliation: Department of Surgery, Internal Medicine, and Gynecology and Obstetrics, University of Vienna, Austria. raimund.jakesz@akh-wien.ac.at
authors.forename: R
authors.initials: R
authors.lastname: Jakesz
authors.forename: H
authors.initials: H
authors.lastname: Hausmaninger
authors.forename: K
authors.initials: K
authors.lastname: Haider
authors.forename: E
authors.initials: E
authors.lastname: Kubista
authors.forename: H
authors.initials: H
authors.lastname: Samonigg
authors.forename: M
authors.initials: M
authors.lastname: Gnant
authors.forename: D
authors.initials: D
authors.lastname: Manfreda
authors.forename: G
authors.initials: G
authors.lastname: Tschurtschenthaler
authors.forename: R
authors.initials: R
authors.lastname: Kolb
authors.forename: M
authors.initials: M
authors.lastname: Stierer
authors.forename: M
authors.initials: M
authors.lastname: Fridrik
authors.forename: B
authors.initials: B
authors.lastname: Mlineritsch
authors.forename: P
authors.initials: P
authors.lastname: Steindorfer
authors.forename: M
authors.initials: M
authors.lastname: Mittlböck
authors.forename: G
authors.initials: G
authors.lastname: Steger
mesh_terms: D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D002277:Carcinoma / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008207:Lymphatic Metastasis; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D012008:Recurrence; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage / Q000627:therapeutic use*; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate