title: A randomized phase II study comparing capecitabine alone with capecitabine and oral cyclophosphamide in patients with advanced breast cancer-cyclox II.
abstract: BACKGROUND
  Capecitabine and cyclophosphamide are active in patients with advanced breast cancer, have non-overlapping toxic effects and synergy pre-clinically. We explored the efficacy and toxic effect of an all-oral combination of capecitabine with cyclophosphamide versus capecitabine alone in a multicentre, randomized, phase II study.
  
  
  METHODS
  Patients with locally advanced or metastatic breast cancer were randomized to treatment with capecitabine given continuously (666 mg/m(2) b.i.d. days 1-28) alone (C) or with oral cyclophosphamide (100 mg/m(2) days 1-14 of a 28-day cycle) (CCy) for up to six cycles.
  
  
  RESULTS
  Eighty-two patients were randomized. There was no complete response. The proportions with partial response were 36% on C and 44% on CCy, a difference of 7.9% [95% confidence interval (CI) -13.4 to 29.1]. Significant toxic effect was uncommon: grade ≥3 diarrhoea in 4 (10%) versus 1 (3%) patients; grade ≥3 fatigue in 2 (5%) versus 5 patients (13%) and grade ≥2 hand-foot syndrome in 7 (17%) versus 11 (28%) patients receiving C versus CCy, respectively. Median progression-free survival was 3.1 months on C and 6.9 months on CCy, not significantly different statistically. There was no difference in overall survival.
  
  
  CONCLUSIONS
  The difference in tumour response suggests a reasonable chance that CCy is superior to C alone.
authors: Regional Cancer and Blood Centre, Auckland City Hospital, Auckland. Electronic address: vernonh@adhb.govt.nz.
authors: V J
authors: VJ
authors: Harvey
authors: Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland; Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin.
authors: K J
authors: KJ
authors: Sharples
authors: Midcentral Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North.
authors: R J
authors: RJ
authors: Isaacs
authors: Waikato Regional Cancer Centre, Waikato Hospital, Hamilton.
authors: M B
authors: MB
authors: Jameson
authors: Oncology Service, Christchurch Hospital, Christchurch.
authors: G M
authors: GM
authors: Jeffery
authors: Southern Blood and Cancer Service, Dunedin Hospital, Dunedin.
authors: B R
authors: BR
authors: McLaren
authors: Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.
authors: S
authors: S
authors: Pollard
authors: Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.
authors: G A
authors: GA
authors: Riley
authors: Wellington Blood and Cancer Centre, Wellington Hospital, Wellington, New Zealand.
authors: A B
authors: AB
authors: Simpson
authors: Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.
authors: V A
authors: VA
authors: Hinder
authors: Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.
authors: J N
authors: JN
authors: Scott
authors: Wellington Blood and Cancer Centre, Wellington Hospital, Wellington, New Zealand.
authors: M V
authors: MV
authors: Dzhelali
authors: Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.
authors: M P
authors: MP
authors: Findlay
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003520:Cyclophosphamide / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D003520:Cyclophosphamide; D005472:Fluorouracil
keywords: capecitabine; cyclophosphamide; metastatic breast cancer; randomized trial