Long-term complete remission in bladder carcinoma in situ with intravesical tice bacillus calmette guerin : overview analysis of six phase II clinical trials

Abstract Carcinoma in situ is a form of superficial transitional cell carcinoma, which is characterized by a lateral spread along the bladder epithelium, with high-grade malignancy and poor prognosis. Early radical cystectomy is considered the definitive treatment even in the absence of associated invasive cancer. In six prospective phase II studies, 123 carcinoma in situ patients were administered intravesical TICE bacillus Calmette-Guerin (BCG). Treatment consisted of at least six weekly instillations (induction) followed by twelve monthly instillations (maintenance) of BCG (50 mg: 1 to 8 × 10 8 colony-forming units). Of 119 evaluable patients, 90 (76%) achieved complete remission including 45 of 63 (71 %) patients who received prior intravesical chemotherapy. Forty-five responders (50 %) remain in complete remission with negative urine cytology with a median duration of response projected to be ≥ forty-eight months. There is no difference in survival between BCG responders and nonresponders, but there is a significant difference in cystectomy rates: 10 of 90 (11 %) responders vs. 16 of 29 (55 %) nonresponders ( P P