A randomized trial comparing intravesical instillations of mitoxantrone and doxorubicin in patients with superficial bladder cancer.
BACKGROUND
This randomized trial was conducted to compare the efficacy and side effects of intravesical mitoxantrone instillation with those of doxorubicin in superficial bladder cancer following transurethral resection.


METHODS
Sixty-three patients were randomized into mitoxantrone and doxorubicin groups. Most of the patients enrolled were elderly people (mean age, 71 years). The instilled doses of doxorubicin and mitoxantrone were 30 and 14 mg, respectively. Disease recurrence and side effects were compared using Fisher's exact test. The interval to recurrence was shown by Kaplan-Meier survivorship curves, and the log-rank test was used to compare the time to recurrence.


RESULTS
The median follow-up period was 36 months. Thirty-three patients received mitoxantrone, whereas 30 patients used doxorubicin. The recurrence rate in the doxorubicin group was 30% (95% CI: 19.8%-38.8%), while it was 27.3% (95% CI: 17.5%-36.8%) in the mitoxantrone group. The median recurrence-free survival in the mitoxantrone group and in the doxorubicin group was 22 and 20 months, respectively (p=0.580). Higher recurrence rates were found for Grade III and multiple primary tumors. There was no significant difference in response rates (p=0.784). The incidence of side effects was 20% in the doxorubicin group and 21.2% in the mitoxantrone group. However, the difference was not significant (p>0.99).


CONCLUSIONS
The results revealed that the efficacy and side effects of mitoxantrone were similar to those of doxorubicin. Especially for patients with pulmonary tuberculosis or aged patients with primary bladder tumors, mitoxantrone and doxorubicin may be the tolerable and effective intravesical agents.
Huang
Jen-Seng
JS
Division of Hemato-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Keelung, Taiwan, ROC. ruby800@cgmh.org.tw
Chen
Wen Hsiang
WH
Lin
Cheng-Chia
CC
Liaw
Chung-Chi
CC
Wang
Chen-Hsu
CH
Lan
Yii-Jenq
YJ
Lai
Chien-Hong
CH
Liu
Jen-Pei
JP
D000283:Administration, Intravesical; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage* / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D004317:Doxorubicin; D008942:Mitoxantrone