title: Randomized trial of cyclophosphamide, methotrexate, and fluorouracil chemotherapy added to tamoxifen as adjuvant therapy in postmenopausal women with node-positive estrogen and/or progesterone receptor-positive breast cancer: a report of the National Cancer Institute of Canada Clinical Trials Group. Breast Cancer Site Group.
abstract: OBJECTIVE
  By the mid 1980s, tamoxifen alone was considered standard adjuvant therapy for postmenopausal women with node-positive, estrogen receptor (ER)- or progesterone receptor (PgR)-positive breast cancer. From 1984 through 1990, 705 eligible postmenopausal women with node-positive, ER- or PgR-positive breast cancer were randomized to a National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study that compared tamoxifen 30 mg by mouth daily for 2 years (TAM) versus TAM plus chemotherapy with all-intravenous cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 given every 21 days for eight cycles (CMF).
  
  
  RESULTS
  There were no significant differences in overall survival, recurrence-free survival, locoregional recurrence-free survival, or distant recurrence-free survival between the two treatment arms. However, there was significantly greater severe toxicity, which included leukopenia (P < .0001), nausea and vomiting (P < .0001), and thromboembolic events (P < .0001), as well as significantly more mild or greater toxicity, which included thrombocytopenia (P = .04), anemia (P = .02), infection (P = .0004), mucositis (P = .0001), diarrhea (P = .0001), and neurologic toxicity (P = .006), in women who received TAM plus CMF.
  
  
  CONCLUSIONS
  The addition of CMF to TAM adds no benefit and considerable toxicity in this group of women.
authors.affiliation: Toronto-Sunnybrook Regional Cancer Centre, University of Toronto, Ontario, Canada. kathy_pritchard@octrf.on.ca
authors.forename: K I
authors.initials: KI
authors.lastname: Pritchard
authors.forename: A H
authors.initials: AH
authors.lastname: Paterson
authors.forename: S
authors.initials: S
authors.lastname: Fine
authors.forename: N A
authors.initials: NA
authors.lastname: Paul
authors.forename: B
authors.initials: B
authors.lastname: Zee
authors.forename: L E
authors.initials: LE
authors.lastname: Shepherd
authors.forename: H
authors.initials: H
authors.lastname: Abu-Zahra
authors.forename: J
authors.initials: J
authors.lastname: Ragaz
authors.forename: M
authors.initials: M
authors.lastname: Knowling
authors.forename: M N
authors.initials: MN
authors.lastname: Levine
authors.forename: S
authors.initials: S
authors.lastname: Verma
authors.forename: D
authors.initials: D
authors.lastname: Perrault
authors.forename: P L
authors.initials: PL
authors.lastname: Walde
authors.forename: V H
authors.initials: VH
authors.lastname: Bramwell
authors.forename: M
authors.initials: M
authors.lastname: Poljicak
authors.forename: N
authors.initials: N
authors.lastname: Boyd
authors.forename: D
authors.initials: D
authors.lastname: Warr
authors.forename: B D
authors.initials: BD
authors.lastname: Norris
authors.forename: D
authors.initials: D
authors.lastname: Bowman
authors.forename: G R
authors.initials: GR
authors.lastname: Armitage
authors.forename: H
authors.initials: H
authors.lastname: Weizel
authors.forename: R A
authors.initials: RA
authors.lastname: Buckman
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D017698:Postmenopause; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate