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.

MATERIAL AND 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.

CONCLUSION:

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: Vutisiri Veerasarn, Wiroon Boonnuch, Chumpot Kakanaporn
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 100 Issue 1 Pg. 179-84 (Jan 2006) ISSN: 0090-8258 [Print] United States
• PMID: 16169580 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Oxides
• Radiation-Protective Agents
• Chlorine
• tetrachlorodecaoxide

Topics

• Chlorine (adverse effects, therapeutic use)
• Cystitis (drug therapy, etiology)
• Female
• Follow-Up Studies
• Genital Neoplasms, Female (radiotherapy)
• Hemorrhage (etiology)
• Humans
• Middle Aged
• Oxides (adverse effects, therapeutic use)
• Proctitis (drug therapy, etiology)
• Radiation Injuries (drug therapy, etiology)
• Radiation-Protective Agents (adverse effects, therapeutic use)
• Radiotherapy (adverse effects)