title: Phase II trial of a combination of vinorelbine, cyclophosphamide and 5-fluorouracil in the treatment of advanced breast cancer.
abstract: OBJECTIVE
  The aim of this study was to assess the efficacy and tolerance of a combination (CT) chemotherapy of Vinorelbine (VNB), Cyclophosphamide (CPA) and 5-Fluorouracil (FU) for the treatment of advanced breast cancer.
  
  
  METHODS
  Forty five women with measurable or evaluable metastatic, locoregionally advanced or relapsing breast cancer have entered the study. Thirty eight patients were not exposed to treatment other than adjuvant CT while 5 were heavily pretreated. Treatment consisted of VNB 25 mg/m2 by rapid i.v. infusion d1 and d3, CPA 600 mg/m2 i.v. as VNB, d2 and 5FU 750 mg/m2/d 1-3 in continuous i.v. infusion. The treatment was repeated every 21 days up to 6 courses if response or stability were obtained.
  
  
  RESULTS
  Forty three patients (38 in first line for advanced disease) were evaluable for response and tolerance. The overall response rate (UICC criteria) was 51% (95%; CI: 36-65%) with 12 and 39% CR and PR respectively, while an additional 33% had stable disease. The response and stability rate were similar in first and second line treated patients. Responses were observed in all sites while a well documented 50% partial response rate of bone metastases was noted. Median time to progression in first line treated patients was 10.5+ months Median overall survival has not yet been reached; however 61% of patients are alive after a 26 months median follow-up. A total of 236 courses has been administered. The main toxicity was neutropenia (88%) with only 3 cases with dose reduction and one withdrawal. Serious non-hematologic toxicity was limited to 3 cases of GIII mucositis. Digestive toxicity (88% G I-II), diarrhea (7% GI), constipation (19% G I-III), peripheral neuropathy (14% GI-II) and alopecia (42% GI-IV) were also noted but remained controllable. No toxic deaths were registered.
  
  
  CONCLUSIONS
  The combination of VNB, CPA and SFU in advanced or metastatic breast cancer yields a response rate, response duration and survival rate comparable to anthracycline--as well as VNB-containing combinations while maintaining a low toxicity profile. Although CPA seems to be a minor contributor to the efficacy of this regimen, further evaluation should identify the value of this combination, particularly in candidates for heavy chemotherapy breast cancer patients.
authors.affiliation: Department of Medical Oncology and Diseases of the Breast, St. Louis Hospital, Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Ardavanis
authors.forename: J M
authors.initials: JM
authors.lastname: Extra
authors.forename: M
authors.initials: M
authors.lastname: Espié
authors.forename: C
authors.initials: C
authors.lastname: Cuvier
authors.forename: M
authors.initials: M
authors.lastname: Marty
mesh_terms: D000328:Adult; D000368:Aged; 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; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D003520:Cyclophosphamide; D000077235:Vinorelbine; D005472:Fluorouracil