title: [Assessment of complications in a randomized controlled study on multimodality therapy for patients following breast-conserving surgery: Kansai Breast Cancer Radiotherapy Research Group (5'-KBR)].
abstract: OBJECTIVE
  We conducted a randomized controlled study to evaluate the safety and usefulness of a combined treatment of radiotherapy and chemotherapy with doxifluridine (5'-DFUR) plus tamoxifen (TAM) as an adjuvant therapy for breast cancer patients after conservative surgery. The complications observed in this trial are reported herein.
  
  
  METHODS
  A total of 550 patients were registered and randomized (based on factors such as T, N, with/without radiotherapy) to groups A and B. Drug regimens were: group A, 5'-DFUR 600 mg/body/day for 6 months and TAM 20 mg/body/day for 2 years; group B, 5'-DFUR 600 mg/body/day for 2 years and TAM 20 mg/body/day for 2 years. Radiotherapy (2 Gy x 5 times/week, for 5 weeks) was administered to 88.6% of evaluable patients (481/543). Radiation-related acute adverse reactions occurred in 28.5% of the 481 patients and moderate to severe reactions occurred in 1.5% of the patients. Delayed radiation-related adverse reactions occurred in 23.8% of the patients but none were severe. Chemo-endocrine therapy-related adverse reactions occurred in 17.9% of group A patients and 25.6% of group B patients. Grade 3 reactions occurred in 6 of the group A patients (2.4%) and in 5 of the group B patients (1.9%); all adverse reactions subsided after dose reduction or discontinuation. These findings suggest that the combination therapy of irradiation and 5'-DFUR with TAM is safe for patients after breast conserving surgery.
authors.affiliation: Dept. of Therapeutic Radiology and Oncology, Kyoto University Graduate School of Medicine.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hiraoka
authors.forename: Hiroki
authors.initials: H
authors.lastname: Koyama
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Inoue
authors.forename: Norio
authors.initials: N
authors.lastname: Kono
authors.forename: Michio
authors.initials: M
authors.lastname: Kono
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kodama
authors.forename: Hideo
authors.initials: H
authors.lastname: Inaji
authors.forename: Masao
authors.initials: M
authors.lastname: Sako
authors.forename: Ryuichiroh
authors.initials: R
authors.lastname: Suzuki
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D006801:Humans; D015412:Mastectomy, Segmental; D011878:Radiotherapy / Q000009:adverse effects; D013629:Tamoxifen / Q000008:administration & dosage
chemical_list: D005467:Floxuridine; D013629:Tamoxifen; C025034:doxifluridine