12882
document
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 .
12883
Intervention_Pharmacological
mitoxantrone
12884
Intervention_Pharmacological
doxorubicin
12885
Intervention_Pharmacological
intravesical mitoxantrone instillation
12886
Intervention_Pharmacological
doxorubicin
12887
Intervention_Pharmacological
mitoxantrone
12888
Intervention_Pharmacological
doxorubicin
12889
Intervention_Pharmacological
doxorubicin
12890
Intervention_Pharmacological
mitoxantrone
12891
Intervention_Pharmacological
mitoxantrone
12892
Intervention_Pharmacological
doxorubicin
12893
Intervention_Pharmacological
doxorubicin
12894
Intervention_Pharmacological
mitoxantrone
12895
Intervention_Pharmacological
mitoxantrone
12896
Intervention_Pharmacological
doxorubicin
12897
Intervention_Pharmacological
doxorubicin
12898
Intervention_Pharmacological
mitoxantrone
12899
Intervention_Pharmacological
mitoxantrone
12900
Intervention_Pharmacological
doxorubicin
12901
Intervention_Pharmacological
mitoxantrone
12902
Intervention_Pharmacological
doxorubicin
12903
Outcome_Other
efficacy
12904
Outcome_Adverse-effects
side effects
12905
Outcome_Adverse-effects
Disease recurrence
12906
Outcome_Adverse-effects
side effects
12907
Outcome_Other
interval to recurrence
12908
Outcome_Other
time to recurrence
12909
Outcome_Other
recurrence rate
12910
Outcome_Mortality
median recurrence-free survival
12911
Outcome_Other
recurrence rates
12912
Outcome_Other
response rates
12913
Outcome_Adverse-effects
side effects
12914
Outcome_Other
efficacy