title: Phase II trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic penis cancer (CRUK/09/001).
abstract: BACKGROUND
  Penis cancer is rare and clinical trial evidence on which to base treatment decisions is limited. Case reports suggest that the combination of docetaxel, cisplatin and 5-flurouracil (TPF) is highly active in this disease.
  
  
  METHODS
  Twenty-nine patients with locally advanced or metastatic squamous carcinoma of the penis were recruited into a single-arm phase II trial from nine UK centres. Up to three cycles of chemotherapy were received (docetaxel 75 mg m(-2) day 1, cisplatin 60 mg m(-2) day 1, 5-flurouracil 750 mg m(-2) per day days 1-5, repeated every 3 weeks). Primary outcome was objective response (assessed by RECIST). Fourteen or more responses in 26 evaluable patients were required to confirm a response rate of 60% or higher (Fleming-A'Hern design), warranting further evaluation. Secondary endpoints included toxicity and survival.
  
  
  RESULTS
  10/26 evaluable patients (38.5%, 95% CI: 20.2-59.4) achieved an objective response. Two patients with locally advanced disease achieved radiological complete remission. 65.5% of patients experienced at least one grade 3/4 adverse event.
  
  
  CONCLUSIONS
  Docetaxel, cisplatin and 5FU did not reach the pre-determined threshold for further research and caused significant toxicity. Our results do not support the routine use of TPF. The observed complete responses support further investigation of combination chemotherapy in the neoadjuvant setting.
authors.affiliation: Imperial College Healthcare NHS Trust, Department of Medical Oncology, Charing Cross Hospital, London W6 8RF, UK.
authors.forename: S
authors.initials: S
authors.lastname: Nicholson
authors.forename: E
authors.initials: E
authors.lastname: Hall
authors.forename: S J
authors.initials: SJ
authors.lastname: Harland
authors.forename: J D
authors.initials: JD
authors.lastname: Chester
authors.forename: L
authors.initials: L
authors.lastname: Pickering
authors.forename: J
authors.initials: J
authors.lastname: Barber
authors.forename: T
authors.initials: T
authors.lastname: Elliott
authors.forename: A
authors.initials: A
authors.lastname: Thomson
authors.forename: S
authors.initials: S
authors.lastname: Burnett
authors.forename: C
authors.initials: C
authors.lastname: Cruickshank
authors.forename: B
authors.initials: B
authors.lastname: Carrington
authors.forename: R
authors.initials: R
authors.lastname: Waters
authors.forename: A
authors.initials: A
authors.lastname: Bahl
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D000077143:Docetaxel; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010412:Penile Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil