title: Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: results from INT 0101 (E5188).
abstract: OBJECTIVE
  Chemotherapy, tamoxifen, and ovarian ablation/suppression (OA/OS) are effective adjuvant approaches for premenopausal, steroid hormone receptor-positive breast cancer. The value of combined therapy has not been clearly established.
  
  
  METHODS
  Premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer (1,503 eligible patients) were randomly assigned to six cycles of cyclophosphamide, doxorubicin, and fluorouracil (CAF), CAF followed by 5 years of monthly goserelin (CAF-Z), or CAF followed by 5 years of monthly goserelin and daily tamoxifen (CAF-ZT). The primary end points were time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS) for CAF-Z versus CAF, and CAF-ZT versus CAF-Z.
  
  
  RESULTS
  With a median follow-up of 9.6 years, the addition of tamoxifen to CAF-Z improved TTR and DFS but not OS. There was no overall advantage for addition of goserelin to CAF.
  
  
  CONCLUSIONS
  Addition of tamoxifen to CAF-Z improves outcome for premenopausal node-positive, receptor-positive breast cancer. The role of OA/OS alone or with other endocrine agents should be studied more intensely.
authors.affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Room 409, Baltimore, MD 21231, USA. davidna@jhmi.edu
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Davidson
authors.forename: Anne M
authors.initials: AM
authors.lastname: O'Neill
authors.forename: Allen M
authors.initials: AM
authors.lastname: Vukov
authors.forename: C Kent
authors.initials: CK
authors.lastname: Osborne
authors.forename: Silvana
authors.initials: S
authors.lastname: Martino
authors.forename: Douglas R
authors.initials: DR
authors.lastname: White
authors.forename: Martin D
authors.initials: MD
authors.lastname: Abeloff
mesh_terms: D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001365:Axilla; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D017273:Goserelin / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008207:Lymphatic Metastasis; D017697:Premenopause; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D013629:Tamoxifen / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D017273:Goserelin; D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil