Reduced recurrence of late hemorrhagic radiation cystitis by WF10 therapy in cervical cancer patients: a multicenter, randomized, two-arm, open-label trial.
OBJECTIVE
To evaluate the efficacy and the safety of WF10 as adjunct to standard treatment in the management of late hemorrhagic radiation cystitis compared to standard treatment alone.


METHODS
Cervical cancer patients with Grade 2 or 3 late hemorrhagic radiation cystitis, were randomized and treated with WF10 0.5 ml/kg body weight, diluted in physiological saline or 5% dextrose water 250 ml, intravenous infusions over 2 h on 5 consecutive days, every 3 weeks for 2 cycles plus standard treatment (WF10 group) or standard treatment alone (control group). Fifty patients in each group were evaluated by questioning; urinalysis and cystoscopy during a 1 year follow up.


RESULTS
At week 7, 37 patients (74%) in the WF10 group and 32 patients (64%) in the control group showed complete resolution in objective hematuria (P = 0.28). Significantly lower use of antibiotics (P = 0.002) and antispasmodics (P < 0.001) was found in the WF10 group. Among the responders, 24 patients (77%) in the control group experienced recurrent objective hematuria, whereas in the WF10 group only 17 patients (47%) experienced a recurrence (P = 0.01). Recurrence of objective hematuria occurred significantly faster in the control group as evidenced by Kaplan-Meier and log-rank statistics (P = 0.004), suggesting a long-term effect of WF10. Cystoscopy, at the end of the treatment period and after the one year follow up showed overall improvement without significant difference between two groups. No severe toxicity was monitored.


CONCLUSIONS
WF10 therapy is a safe, non-invasive and convenient method in the management of late hemorrhagic radiation cystitis. WF10 therapy, as adjunct to standard treatment, has significantly reduced recurrence of objective hematuria, compared to standard treatment alone, during a one year follow up.
Veerasarn
Vutisiri
V
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Khorprasert
Chonlakiet
C
Lorvidhaya
Vicharn
V
Sangruchi
Supatra
S
Tantivatana
Thanatip
T
Narkwong
Ladawan
L
Kongthanarat
Yongyut
Y
Chitapanarux
Imjai
I
Tesavibul
Chanawat
C
Panichevaluk
Apichart
A
Puribhat
Sirisak
S
Sangkittipaiboon
Somphob
S
Sookpreedee
Lak
L
Lertsanguansinchai
Prasert
P
Phromratanapongse
Pramook
P
Rungpoka
Poonkiat
P
Trithratipvikul
Supamitr
S
Lojanapiwat
Bannakij
B
Ruangdilokrat
Sathit
S
Ngampanprasert
Pichai
P
D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D002713:Chlorine / Q000627:therapeutic use*; D003556:Cystitis / Q000188:drug therapy* / Q000209:etiology; D003558:Cystoscopy / Q000379:methods; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D010087:Oxides / Q000627:therapeutic use*; D011336:Probability; D011832:Radiation Injuries / Q000175:diagnosis / Q000188:drug therapy*; D012016:Reference Values; D018570:Risk Assessment; D055502:Secondary Prevention; D012720:Severity of Illness Index; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*
D010087:Oxides; D002713:Chlorine; C041955:tetrachlorodecaoxide