Long-term follow-up of G3T1 transitional cell carcinoma of the bladder treated with intravesical bacille Calmette-Guérin: 18-year experience.

OBJECTIVES: Immunotherapy with bacille Calmette-Guérin (BCG) has been proposed in the past decade as first-line treatment for high-grade superficial bladder cancer (G3T1). We report our 18-year experience in the treatment of patients with G3T1 bladder cancer.
METHODS: From January 1989 to July 1997, 670 patients underwent transurethral resection for superficial bladder cancer. Eighty-one patients (12%) had G3T1 tumors. All of these patients were treated with an innovative schedule of Pasteur strain BCG followed by maintenance BCG therapy. Treatment consisted of four cycles of 6 instillations per cycle of BCG. The first cycle was administered weekly x 6, the second was given every 2 weeks x 6, the third cycle was given monthly x 6, and the fourth was given every 3 months x 6 instillations.
RESULTS: Sixty-nine patients (84%) completed at least the first two cycles. At a median follow-up of 76 months (range 30 to 197), the overall recurrence rate was 33% (27 of 81). The median time to recurrence was 20 months (range 5 to 128). Of these patients, 12 (15%) had progression at a median follow-up of 16 months (range 8 to 58). Cystectomy was required in 7 patients (8%). Death from disease occurred in 5 (6%) of 81 patients. One patient died of adenocarcinoma at the ureterosigmoidostomy site. Sixty patients (74%) were alive at a median follow-up of 79+ months (range 15 to 182). Of these, 56 (69%) were alive with a functioning bladder.
CONCLUSIONS: Conservative treatment with BCG is a reasonable approach for patients with primary G3T1 transitional cell carcinoma of the bladder. The long-term results of BCG therapy are good. Cystectomy may not be justified as the therapy of choice in first-line treatment of high-grade superficial carcinoma of the bladder.