title: High-dose oral medroxyprogesterone acetate or tamoxifen as adjuvant hormone therapy for node-negative early-stage breast cancer: randomized trial with 7-year update.
abstract: A randomized adjuvant trial compared tamoxifen 20 mg daily for 5 years with high-dose oral medroxyprogesterone acetate (MPA) 1 g orally for 9 months. One hundred ninety-four patients with histologically proven primary node-negative breast carcinoma were enrolled between December 1990 and October 1996, with 98 patients randomized into the tamoxifen arm and 96 into the MPA arm. At a median follow-up of 86 months, 25 relapses and 13 deaths were recorded. The relapse-free survival rate at 7 years in the tamoxifen arm was 93%, versus 81% in the MPA arm (P = 0.02). The difference was observed in patients with stage T2 disease (100% in the tamoxifen group vs. 64% in the MPA group; P = 0.01), in younger and/or premenopausal patients (in patients < 50 years of age, 100% in the tamoxifen arm vs. 81% in the MPA arm [P = 0.02], and in patients > or = 50 years of age, 90% in the tamoxifen arm vs. 82% in the MPA arm [P = 0.16]). Also, the overall survival rate at 7 years was lower in women < 50 years of age (P = 0.04).
authors.affiliation: Clinique Saint-Joseph, Centre Hospitalier Chretien a Liege, Belgium. christian.focan@chc.be
authors.forename: Christian
authors.initials: C
authors.lastname: Focan
authors.forename: Marc
authors.initials: M
authors.lastname: Beauduin
authors.forename: Francoise
authors.initials: F
authors.lastname: Majois
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Canon
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cusumano
authors.forename: Danielle
authors.initials: D
authors.lastname: Focan-Henrard
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lobelle
mesh_terms: D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D001530:Belgium; D001707:Biopsy, Needle; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D008198:Lymph Nodes / Q000473:pathology*; D008408:Mastectomy / Q000379:methods; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage*; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen; D017258:Medroxyprogesterone Acetate