HAS A 3-FOLD DECREASED DOSE OF BACILLUS CALMETTE-GUERIN THE SAME EFFICACY AGAINST RECURRENCES AND PROGRESSION OF T1G3 AND TIS BLADDER TUMORS THAN THE STANDARD DOSE? RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL

ABSTRACTPurpose: We determined if a third of the dose of intravesical bacillus Calmette-Guerin (BCG) has the same efficacy than a standard dose for decreasing the risk of recurrence and progression after transurethral resection in patients with superficial high risk (stages T1G3 and carcinoma in situ) bladder cancer. Also, we evaluated toxic side effects.Material and Methods: A total of 155 patients with a mean age ± SD of 67 ± 10.1 years with superficial bladder cancer, including stages T1G3 in 90, a Tis primary tumor in 23 and associated Tis disease in 42, were enrolled and randomly assigned to be treated after transurethral resection of all visible lesions with intravesical BCG, Connaught strain (weekly × 6 and fortnightly × 6 thereafter) with the standard dose of 81 mg or with the decreased dose of 27 mg.Results: Median followup was 61 months (range 3 to 102). Disease recurred in 32 patients (39%) treated with the standard dose and in 33 (45%) treated with the decreased dose. Median time to recurrence...