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document
Long-term follow-up of cytostatic intravesical instillation in patients with superficial bladder carcinoma . Is short-term , intensive instillation better than maintenance therapy ? OBJECTIVES Comparisons of two 3-year protocols , one 20-week protocol of mitomycin C instillation and one 3-year protocol of doxorubicin instillation for the prevention of recurrent tumors and progression in patients whose superficial bladder tumors had been removed by transurethral resection . METHODS A prospective , randomized parallel group multicenter trial was conducted . 419 patients were evaluated after a median follow-up of 57 months . Cox proportional hazards analysis was performed . RESULTS An overall recurrence rate of 22.7 % and an overall progression rate of 9.8 % was found . For time to progression a significant overall treatment effect was detected dependent on the recurrence status before entry into the study ( p = 0.0059 ) . Pairwise comparisons showed the mitomycin protocol with short-term intensive ( weekly ) combined with long-term maintenance instillation to have a highly beneficial effect compared to long-term maintenance instillation only especially for patients entering the study with recurrent tumors ( RR = 0.06 , 95 % CI : [ 0.008 , 0.506 ] . CONCLUSION These results show that intensive therapeutic instillation may have an advantage over less intensive , prophylactic regimens .
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Intervention_Pharmacological
cytostatic intravesical instillation
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Intervention_Pharmacological
mitomycin C instillation
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Intervention_Pharmacological
doxorubicin instillation
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Outcome_Physical
recurrent tumors
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Outcome_Physical
progression
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Outcome_Physical
overall
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Outcome_Other
recurrence rate
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Outcome_Other
overall progression rate
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Outcome_Adverse-effects
overall treatment effect
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Outcome_Other
beneficial effect
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Outcome_Physical
intensive therapeutic instillation
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Participant_Condition
patients with superficial bladder carcinoma .
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Participant_Condition
patients whose superficial bladder tumors had been removed by transurethral resection
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Participant_Sample-size
419 patients