[Initial clinical studies of the preparation Immucyst for immunotherapy in patients with carcinoma in situ (CIS) of the bladder].

Over a 12-month period, thirteen patients, 10 men and 3 women, with recurrent surface transitional cell carcinomas of the urinary bladder in conjunction with CIS, are picked out and subjected to treatment. Distribution of the patients: primary multiple carcinomas combined with CIS, Ta-T1/G1-G2-4 cases; recurrent multiple carcinomas, with CIS, Ta-T1/G2-two, recurrent multiple carcinomas, combined with CIS, Ta-T1/G2-five, and T1/G3-two cases. In all instances transurethral resection (TUR) of both visible carcinomas, and CIS areas, is performed. Induction Immucyst therapy is carried out according to protocol: 3 vials BCG vaccine, dissolved in 50 ml serum, inserted intravesically once weekly over 6 weeks. The fluid is retained by the patients for up to 2 hours. Therapy is commenced within 7-14 days after TUR. Cystoscopy, cytology and biopsy of suspected areas ar done at 3, 6 and 12 days. Six of the patients reported on undergo 12-month follow-up study. The remainder (6 cases) are followed up for periods ranging from 3 to 6 months. At the actual stage of study, twelve patients are free of recurrences, and present negative cytological findings. One patient alone with carcinoma stage T1/G3 develops recurrence, treated with TUR and laser coagulation followed by immunotherapy. Two thirds of the patients sustain transitory pollakiuria and dysuria, and one third-subfebrile temperature persisting for 48 hours.