A phase II study to evaluate WF10 in patients with late hemorrhagic radiation cystitis and proctitis.
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.
Veerasarn
Vutisiri
V
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand. Vutisiri@hotmail.com
Boonnuch
Wiroon
W
Kakanaporn
Chumpot
C
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
D010087:Oxides; D011837:Radiation-Protective Agents; D002713:Chlorine; C041955:tetrachlorodecaoxide