title: UFT and mitomycin plus tamoxifen for stage II, ER-positive breast cancer. Hokkaido ACETBC Study Group.
abstract: A trial was designed to examine the combination of UFT and mitomycin (Mutamycin) plus tamoxifen (Nolvadex) as postoperative adjuvant therapy in the treatment of patients with stage II, estrogen receptor (ER)-positive primary breast cancer. Mitomycin was administered intravenously at 13 mg/m2 on the day of surgery. Patients judged to be ER-positive were randomly allocated to either group A, which received oral tamoxifen 20 mg/day 14 days after surgery for 2 years, or group B, receiving oral UFT 400 mg/day plus tamoxifen 20 mg/day. A total of 219 patients were enrolled in group A, of which 213 (97.3%) were determined to be eligible; 225 patients enrolled in group B and 223 (99.1%) were eligible. The 5-year survival rates were 93.0% for group A and 95.4% for group B, with no significant difference between groups. The 5-year relapse-free survival rates were 83.1% for group A and 90.7% for group B, a significant advantage (P = .020) for the UFT plus tamoxifen group. Combination therapy with mitomycin, tamoxifen, and UFT proved to be an effective postoperative chemoendocrine therapy for stage II, ER-positive breast cancer.
authors.affiliation: Sapporo Social Insurance General Hospital, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Hata
authors.forename: J
authors.initials: J
authors.lastname: Uchino
authors.forename: K
authors.initials: K
authors.lastname: Asaishi
authors.forename: Y
authors.initials: Y
authors.lastname: Kubo
authors.forename: M
authors.initials: M
authors.lastname: Mito
authors.forename: T
authors.initials: T
authors.lastname: Tanabe
authors.forename: M
authors.initials: M
authors.lastname: Ogita
authors.forename: K
authors.initials: K
authors.lastname: Hirata
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D008937:Mitomycins / Q000627:therapeutic use*; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011960:Receptors, Estrogen / Q000097:blood*; D012189:Retrospective Studies; D015996:Survival Rate; D013629:Tamoxifen / Q000627:therapeutic use*; D005641:Tegafur / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000627:therapeutic use
chemical_list: D014408:Biomarkers, Tumor; D008937:Mitomycins; D011960:Receptors, Estrogen; D013629:Tamoxifen; D005641:Tegafur; D014498:Uracil