title: A phase II study to evaluate WF10 in patients with late hemorrhagic radiation cystitis and proctitis.
abstract: OBJECTIVE
  To evaluate efficacy and safety of WF10 (TCDO iv solution) therapy in patients with late hemorrhagic radiation cystitis and proctitis in a long-term follow up.
  
  
  METHODS
  From February 1999 to July 2001, 30 symptomatic patients with endoscopically confirmed grade 2 and 3 late hemorrhagic cystitis (n = 16) and proctitis (n = 14) were treated with WF10. The dose was 0.5 ml/kg BW, diluted in 250 ml 5%D/W, administered by intravenous infusion over 2 h, 5 consecutive days, every 3 weeks for 2-4 cycles, combined with standard therapy. The patients were clinically followed up every 3 weeks for 3 months, then every 3 months for 1 year and then every 3-6 months. The study endpoints were immediate response with improvement to Grade 0-1 within 3 months and the incidence of recurrence to Grade > or =2 during the follow up time.
  
  
  RESULTS
  After completion of the WF10 therapy, 14 cystitis patients (88%) had improved to grade 0-1 hematuria, and 14 proctitis patients (100%) had improved in bleeding per rectum to grade 0-1 within 3 months. The median follow up time was 51 months. During the follow up period, among the responders, 4 cystitis patients (28%) had recurrent hematuria of grade 2 and two proctitis patients (14%) had recurrent bleeding per rectum of grade 2 and 3. No treatment toxicity was observed.
  
  
  CONCLUSIONS
  The WF10 therapy combined with conventional treatment is simple and safe with long-term efficacy in the treatment of late hemorrhagic radiation cystitis and proctitis.
authors.affiliation: Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand. Vutisiri@hotmail.com
authors.forename: Vutisiri
authors.initials: V
authors.lastname: Veerasarn
authors.forename: Wiroon
authors.initials: W
authors.lastname: Boonnuch
authors.forename: Chumpot
authors.initials: C
authors.lastname: Kakanaporn
mesh_terms: D002713:Chlorine / Q000009:adverse effects / Q000627:therapeutic use*; D003556:Cystitis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D005833:Genital Neoplasms, Female / Q000532:radiotherapy; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D010087:Oxides / Q000009:adverse effects / Q000627:therapeutic use*; D011349:Proctitis / Q000188:drug therapy* / Q000209:etiology; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology; D011837:Radiation-Protective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011878:Radiotherapy / Q000009:adverse effects
chemical_list: D010087:Oxides; D011837:Radiation-Protective Agents; D002713:Chlorine; C041955:tetrachlorodecaoxide