title: Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: the TABLE study.
abstract: OBJECTIVE
  Ovarian suppression with luteinizing hormone-releasing hormone (LHRH) agonists is an effective adjuvant treatment for premenopausal women with estrogen receptor (ER) -positive breast cancer. Whereas monthly LHRH agonist therapy has been well established, the value of every-3-months (3-monthly) formulations is unclear.
  
  
  METHODS
  This randomized phase III trial was performed to compare the 3-monthly depot LHRH agonist leuprorelin acetate (LAD-3M; n = 299) and chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (CMF; n = 300) in pre- or perimenopausal patients with ER-positive, node-positive breast cancer.
  
  
  RESULTS
  With a median follow-up of 5.8 years, recurrence-free survival was similar for patients treated with LAD-3M or CMF (hazard ratio [HR], 1.19; 95% CI, 0.94 to 1.51; P = .15). There was no substantial heterogeneity in the relative treatment effect among subgroups defined by age, progesterone receptor (PR) status, nodal status, hormone levels, or menstrual recovery after treatment. Exploratory overall survival analysis favored LAD-3M (HR, 1.50; 95% CI, 1.13 to 1.99; P = .005). Chemotherapy-related adverse effects such as nausea, vomiting, and alopecia were more common with CMF, whereas symptoms of estrogen suppression such as hot flushes and sweating were initially more pronounced with LAD-3M.
  
  
  CONCLUSIONS
  The 3-monthly depot LHRH-agonist leuprorelin acetate is an effective adjuvant treatment in premenopausal patients with hormone receptor-positive, node-positive breast cancer that is not inferior to CMF.
authors.affiliation: Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Mitte, Humboldt Universität zu Berlin, Germany. p.schmid@imperial.ac.uk
authors.forename: Peter
authors.initials: P
authors.lastname: Schmid
authors.forename: Michael
authors.initials: M
authors.lastname: Untch
authors.forename: Valentin
authors.initials: V
authors.lastname: Kossé
authors.forename: Grigorij
authors.initials: G
authors.lastname: Bondar
authors.forename: Leonid
authors.initials: L
authors.lastname: Vassiljev
authors.forename: Valerie
authors.initials: V
authors.lastname: Tarutinov
authors.forename: Ute
authors.initials: U
authors.lastname: Lehmann
authors.forename: Lutz
authors.initials: L
authors.lastname: Maubach
authors.forename: Juergen
authors.initials: J
authors.lastname: Meurer
authors.forename: Diethelm
authors.initials: D
authors.lastname: Wallwiener
authors.forename: Kurt
authors.initials: K
authors.lastname: Possinger
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005858:Germany; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage; D008207:Lymphatic Metastasis; D008727:Methotrexate / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local; D047648:Perimenopause; D017697:Premenopause; D015996:Survival Rate; D016896:Treatment Outcome; D014455:Ukraine
chemical_list: D003520:Cyclophosphamide; D016729:Leuprolide; D005472:Fluorouracil; D008727:Methotrexate