title: Less efficacy with alternating regimen as adjuvant chemotherapy in stage II node-positive breast cancer: results at 8 years (Pronacam 85).
abstract: A randomized trial to compare adjuvant treatment with an alternating regimen with conventional chemotherapy was performed. A total of 589 node-positive patients were included and stratified according to number of positive nodes (N1-3 and N > 4) and menopausal status. Premenopausal N1-3 patients were randomized to cyclophosphamide, methotrexate and fluorouracil (CMF) or CMF/4'-epirubicin, cyclophosphamide (EC), post-menopausal N1-3 patients to fluorouracil, 4 epirubicin, cyclophosphamide (FEC) or CMF/EC and pre- and post-menopausal patients with N > or = 4 to fluorouracil, 4' epirubicin, cyclophosphamide, methotrexate, prednisone (FECMP) or CMF/EC. In premenopausal patients, CMF was superior to CMF/EC in terms of disease-free survival (DFS) (65% vs 45%, P = 0.0149) and survival (72.3% vs 50.2%, P = 0.0220) whereas, for N > or = 4 patients, differences between FECMP and CMF/EC did not achieve statistical significance (DFS 35% vs 26.2%; survival 50% vs 38.1%, P = NS). For post-menopausal patients, FEC was superior to CMF/EC in DFS (58.6% vs 36.8%, P = 0.0215) and survival (66.2% vs 46%, P = 0.0155). In post-menopausal patients with N > 4, differences favouring CMF/EC were significant in DFS (40.4% vs 22%, P = 0.0371) but not in survival (47.4% vs 32.2%, P = 0.1185). Alternating regimens did not offer better results in premenopausal and post-menopausal N1-3 patients. Results regarding post-menopausal N > 4 women require further confirmation.
authors.forename: R
authors.initials: R
authors.lastname: Chacon
authors.forename: L
authors.initials: L
authors.lastname: Romero Acuña
authors.forename: C
authors.initials: C
authors.lastname: Blajman
authors.forename: C
authors.initials: C
authors.lastname: Galvez
authors.forename: M
authors.initials: M
authors.lastname: Bruno
authors.forename: A
authors.initials: A
authors.lastname: Romero
authors.forename: G
authors.initials: G
authors.lastname: Chiessa
authors.forename: M
authors.initials: M
authors.lastname: Bader
authors.forename: R
authors.initials: R
authors.lastname: Schwan
authors.forename: C
authors.initials: C
authors.lastname: Albera
authors.forename: M T
authors.initials: MT
authors.lastname: Santarelli
authors.forename: F
authors.initials: F
authors.lastname: Sousa Martínez
authors.forename: J
authors.initials: J
authors.lastname: Nadal
authors.forename: M
authors.initials: M
authors.lastname: Viniegra
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D017698:Postmenopause; D015996:Survival Rate