title: Polyadenylic-polyuridylic acid plus locoregional and pelvic radiotherapy versus chemotherapy with CMF as adjuvants in operable breast cancer. A 6 1/2 year follow-up analysis of a randomized trial of the French Federation of Cancer Centers (F.F.C.C.).
abstract: In this study, patients with operable breast cancer T2 or T3, treated by mastectomy + axillary dissection and with invaded axillary nodes (N+), were randomized to receive either: 1) postoperative locoregional and pelvic radiotherapy (RX) and Poly(A).Poly(U) (AU), 60 mg IV once a week for 6 weeks, or 2) CMF (cyclophosphamide 100 mg/sqm P.O. on days 1-14, methotrexate 40 mg/sqm IV on day 1 and 8, fluorouracil 600 mg/sqm IV on day 1 and 8; monthly cycle, for 6 months. Between March 1982 and December 1985, 517 patients were enrolled, 257 of whom were treated by RX + AU and 260 with CMF. The main clinical, pathological and prognostic characteristics were equally distributed in the two groups. The present analysis was conducted after a mean follow-up of 69 months (S.D. = 13). There was no significant difference in overall survival (OS) between the two groups (test adjusted by center and menopausal status); the five-year OS rate was 74% in the RXAU group and 77% in the CMF group. Relapse-free survival (RFS) was significantly higher (p = 0.05) in the RXAU group compared to the MCF group; the five-year RFS rates were 57% and 46% in the two groups respectively. This short, well-tolerated combined RXAU treatment appears to be as efficient as CMF and might offer an alternative to chemo- or hormonotherapy, in case of contraindications to these treatments.
authors.affiliation: Institut Gustave-Roussy, Villejuif, France.
authors.forename: J
authors.initials: J
authors.lastname: Lacour
authors.forename: A
authors.initials: A
authors.lastname: Laplanche
authors.forename: T
authors.initials: T
authors.lastname: Delozier
authors.forename: J
authors.initials: J
authors.lastname: Berlie
authors.forename: N
authors.initials: N
authors.lastname: Mourali
authors.forename: J P
authors.initials: JP
authors.lastname: Julien
authors.forename: C
authors.initials: C
authors.lastname: De Gislain
authors.forename: M
authors.initials: M
authors.lastname: Namer
authors.forename: J C
authors.initials: JC
authors.lastname: Petit
authors.forename: V
authors.initials: V
authors.lastname: Denis
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000401:mortality / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008593:Menopause; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D010388:Pelvis; D011063:Poly A-U / Q000627:therapeutic use*; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D011063:Poly A-U; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate