[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.
I
I
Ormanov
Kh
Kh
Kumanov
P
P
Panchev
S
S
Kirilov
A
A
Filev
K
K
Ianev
D
D
Maki
D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000009:adverse effects / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000628:therapy*; D002295:Carcinoma, Transitional Cell / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy*; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
C087507:BCG Connaught; D001500:BCG Vaccine
Nachalni klinichni prouchvaniia na preparata Immucyst za imunoterapiia pri bolni s kartsinom in situ (CIS) na pikochniia mekhur.