OBJECTIVE: To determine if intravesically administered recombinant interferon (IFN) gamma may serve as adjuvant first line treatment in prophylaxis of superficial bladder cancer by reducing its risk for recurrence, in the short term. MATERIAL AND METHODS: A total of 54 patients (43 males and 11 females) with superficial bladder tumours (Ta/T1) initially treated withtransurethral resection for their tumors were randomized into two groups: Twenty-eight patients were left untreated after the transurethral resection (controls) whereas 26 patients received intravesical IFN gamma adjuvantly, at a dosage of 0.7 mg per week for 8 weeks. Patients with G1 tumors and carcinoma 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 tumor recurrence in each group. RESULTS:Tumor recurrence was detected in 24 controls (86%) and in 16 (62%) patients of the IFN gamma group (p = 0.043). The comparison of the Kaplan-Meier disease-free survival curves between the two groups of patients indicated that intravesical instillations of IFN gamma 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 IFN gamma has a demonstrable protective role as first line adjuvant treatment in superficial bladder cancer. 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.
RCT Entities:
OBJECTIVE: To determine if intravesically administered recombinant interferon (IFN) gamma may serve as adjuvant first line treatment in prophylaxis of superficial bladder cancer by reducing its risk for recurrence, in the short term. MATERIAL AND METHODS: A total of 54 patients (43 males and 11 females) with superficial bladder tumours (Ta/T1) initially treated with transurethral resection for their tumors were randomized into two groups: Twenty-eight patients were left untreated after the transurethral resection (controls) whereas 26 patients received intravesical IFN gamma adjuvantly, at a dosage of 0.7 mg per week for 8 weeks. Patients with G1 tumors and carcinoma 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 tumor recurrence in each group. RESULTS:Tumor recurrence was detected in 24 controls (86%) and in 16 (62%) patients of the IFN gamma group (p = 0.043). The comparison of the Kaplan-Meier disease-free survival curves between the two groups of patients indicated that intravesical instillations of IFN gamma 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 IFN gamma has a demonstrable protective role as first line adjuvant treatment in superficial bladder cancer. 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.
Authors: E Ioachim; M C Michael; M Salmas; K Damala; E Tsanou; M M Michael; V Malamou-Mitsi; N E Stavropoulos Journal: BMC Cancer Date: 2006-05-29 Impact factor: 4.430