title: Accelerated BEP: a phase I trial of dose-dense BEP for intermediate and poor prognosis metastatic germ cell tumour.
abstract: BACKGROUND
  We used bleomycin, etoposide, cisplatin (BEP), the most effective regimen in the treatment of germ cell tumours (GCTs) and increased dose-density by using pegfilgrastim to shorten cycle length. Our aim was to assess safety and tolerability.
  
  
  METHODS
  Sixteen male patients with intermediate or poor prognosis metastatic GCT were treated with four cycles of 3-day BEP with G-CSF on a 14-day cycle for a planned relative dose-density of 1.5 compared with standard BEP.
  
  
  RESULTS
  Eleven intermediate and five poor prognosis patients were treated. In all, 14 of 16 patients completed the study treatment. Toxicities were comparable to previous studies using standard BEP, except for mucositis and haematological toxicity that were more severe. The overall relative dose-density for all 16 patients was mean 1.38 (range 0.72-1.5; median 1.46). Complete response was achieved after chemotherapy alone in two patients (13%) and following chemotherapy plus surgery in nine additional patients (56%). Four patients (25%) had a partial response and normalised their marker levels. At a median follow-up of 4.4 years (range 2.1-6.8) the estimated 5-year progression-free survival probability is 81% (95% CI 64-100%).
  
  
  CONCLUSIONS
  Accelerated BEP is tolerable without major additional toxicity. A randomised controlled trial will be required to obtain comparative efficacy data.
authors.affiliation: Oncology Centre, Box 193, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Hills Road, Cambridge CB2 0QQ, UK.
authors.forename: Y
authors.initials: Y
authors.lastname: Rimmer
authors.forename: J
authors.initials: J
authors.lastname: Chester
authors.forename: J
authors.initials: J
authors.lastname: Joffe
authors.forename: D
authors.initials: D
authors.lastname: Stark
authors.forename: J
authors.initials: J
authors.lastname: Shamash
authors.forename: T
authors.initials: T
authors.lastname: Powles
authors.forename: J
authors.initials: J
authors.lastname: White
authors.forename: J
authors.initials: J
authors.lastname: Wason
authors.forename: D
authors.initials: D
authors.lastname: Parashar
authors.forename: G
authors.initials: G
authors.lastname: Armstrong
authors.forename: D
authors.initials: D
authors.lastname: Mazhar
authors.forename: M V
authors.initials: MV
authors.lastname: Williams
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage*; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D034381:Hearing Loss / Q000139:chemically induced; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced; D008297:Male; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000473:pathology; D011092:Polyethylene Glycols; D011379:Prognosis; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; D001761:Bleomycin; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D005047:Etoposide; D000069585:Filgrastim; D002945:Cisplatin