Intravesical instillations of XXXX in the prophylaxis of high risk superficial @entity150 --results of a controlled prospective study.

@entity1 @entity5 @entity189 @entity150 @entity379
OBJECTIVE: To determine if intravesically administered recombinant @entity379 may serve as adjuvant first line treatment in prophylaxis of superficial @entity150 by reducing its risk for recurrence, in the short term. MATERIAL AND METHODS: A total of 54 @entity1 (43 males and 11 females) with superficial @entity150 (Ta/T1) initially treated with transurethral resection for their @entity5 were randomized into two groups: Twenty-eight @entity1 were left untreated after the transurethral resection (controls) whereas 26 @entity1 received intravesical @entity379 adjuvantly, at a dosage of 0.7 mg per week for 8 weeks. @entity1 with @entity5 and @entity189 in situ were excluded. The follow up had a mean time of 12.1 months. Recurrence or progression, as terminal events of the study, were recorded. The comparison of the recurrences between the two groups was performed by estimating: (a) the simple recurrence rate, and (b) the interval to @entity5 recurrence in each group. RESULTS: Tumor recurrence was detected in 24 controls (86%) and in 16 (62%) @entity1 of the @entity379 group (p = 0.043). The comparison of the Kaplan-Meier disease-free survival curves between the two groups of @entity1 indicated that intravesical instillations of @entity379 exerted a continuous protective effect to those who received the agent, in the follow up period (p = 0.0237). No serious side-effects were noted. CONCLUSIONS: Intravesically administered @entity379 has a demonstrable protective role as first line adjuvant treatment in superficial @entity150 . This role is mainly focused on prevention of recurrences in the short term. Further prospective studies with longer follow up are required, in order to define the exact place of the drug in the urologist's armamentarium.
