title: 1-hexylcarbamoyl-5-fluorouracil + cyclophosphamide + tamoxifen versus CMF + tamoxifen in women with lymph node-positive breast cancer after primary surgery: a randomized controlled trial.
abstract: We studied the usefulness of the oral 5-FU anti-cancer drug 1-hexylcarbamoyl-5-fluorouracil (HCFU) + cyclophosphamide (CPM) + tamoxifen (TAM) (HCT group) in comparison with CMF + TAM (CMFT group) in adjuvant therapy for breast cancer by a non-inferiority study based on a multi-institutional joint study. Clinical stage I, II primary breast cancers with histologically positive axillary lymph node metastasis were randomly assigned to the HCT group or the CMFT group after primary surgery. We registered 136 cases (HCT group 68 cases, CMFT group 68 cases). No significant difference in the 5-year overall survival rate (OS) and the 5-year disease-free survival rate (DFS) was found between the two groups. In the stratified analysis, DFS in cases in which the number of metastatic lymph nodes was 1-3 was significantly better in the HCT group (HCT group 84.3%, CMFT group 69.4%, log-rank test p=0.0496). No significant difference in the total incidence of adverse effects was found between the two groups, but there were significantly less adverse effects of grade 2 or over in the HCT group (p=0.034). The QOL survey at 3 months after surgery showed a significant decline of the QOL regarding lassitude, degree of difficulty in daily life, satisfaction with treatment and present mood in the CMFT group. Study results suggest that 2-year HCT therapy including the oral 5-FU anti-cancer drug HCFU is a useful adjuvant therapy which can replace CMFT therapy in early breast cancer cases with 3 or lower metastatic lymph nodes.
authors.affiliation: Breast Cancer Center, Toyosu Hospital, Showa University School of Medicine, Tokyo 135-8577, Japan. t-tominaga@hkg.odn.ne.jp
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Taro
authors.initials: T
authors.lastname: Asaga
authors.forename: Minoru
authors.initials: M
authors.lastname: Yoshida
authors.forename: Hiroharu
authors.initials: H
authors.lastname: Awane
authors.forename: Hiroki
authors.initials: H
authors.lastname: Koyama
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Syosyu
authors.initials: S
authors.lastname: Mitsuyama
authors.forename: Tadashi
authors.initials: T
authors.lastname: Ikeda
authors.forename: Masami
authors.initials: M
authors.lastname: Ogita
authors.forename: Hideaki
authors.initials: H
authors.lastname: Aoyama
authors.forename: Muneaki
authors.initials: M
authors.lastname: Sano
authors.forename: Rikiya
authors.initials: R
authors.lastname: Abe
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Nishi
authors.forename: Tomio
authors.initials: T
authors.lastname: Wada
authors.forename: Makoto
authors.initials: M
authors.lastname: Danno
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D044584:Carcinoma, Ductal / Q000188:drug therapy; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage
chemical_list: D013629:Tamoxifen; D003520:Cyclophosphamide; C017367:carmofur; D005472:Fluorouracil; D008727:Methotrexate