Intravesical BCG in Patients with Carcinoma in situ of the Urinary Bladder: Long–Term Results of EORTC GU Group Phase II Protocol 30861

Abstract

Objectives: This phase II study was designed to assess the response rate, side effects and long–term efficacy of BCG in the treatment of carcinoma in situ (Cis) of the urinary bladder. Methods: 103 eligible patients with Cis were treated with 6 consecutive weekly intravesical instillations of 120 mg BCG–Connaught. In case of no response, a second 6–week course was given. Results: A complete response (CR) was observed in 77 of the 103 eligible patients (75%) and 93 evaluable patients (83%). In 6 of 10 patients the CR was induced by a second cycle of 6 weekly instillations. After a median follow–up of 7.6 years, 39 of the 77 CR patients (50%) are still alive and have retained their bladder, 31 (40%) without tumor recurrence. Another 7 patients underwent cystectomy and are still alive while 16 (20%) have died due to bladder cancer. Ten patients stopped treatment due to toxicity. In 2 patients, cystectomy was done because of severe cystitis and reduced bladder capacity. Drug cystitis, bacterial cystitis and fever occurred in 45, 15 and 15% of the patients, respectively. Severe drug cystitis was noted in 3 out of 10 patients receiving more than 6 instillations, necessitating cystectomy in 1 case. Conclusion: Intravesical short–term BCG is an effective treatment modality in Cis, yielding a high CR rate. This therapy may however be suboptimal in some patients as the 5–year disease–free rate in complete responders drops to 60%. Still, this is an acceptable result for patients in whom cystectomy would otherwise be performed in virtually all cases.