INTRAVESICAL BACILLUS-CALMETTE-GUERIN THERAPY PREVENTS TUMOR PROGRESSION AND DEATH FROM SUPERFICIAL BLADDER-CANCER - 10-YEAR FOLLOW-UP OF APROSPECTIVE RANDOMIZED TRIAL

Purpose: Superficial bladder rumors (stage Ta, T1, and Tis) may progre ss to invade the bladder muscle and cause death from metastatic cancer . Transurethral tumor resection (TURB) is the standard therapy for suc h tumors, but surgery alone may not prevent tumor progression. Intrave sical therapy is widely used as an adjunct to TURB. Bacillus Calmette- Guerin (BCG) is the most active intravesical agent, but whether BCG pr events tumor progression and death from bladder cancer is unknown. Pat ients and Methods: Between 1978 and 1981, 86 high-risk patients with s uperficial bladder cancer were randomly assigned to receive either TUR B (n=43) or TURB plus BCG (n=43). Adverse tumor features for progressi on were equally distributed between the two groups. BCG was administer ed weekly for 6 weeks. Patients were evaluated every 3 to 6 months the reafter for progression to muscle invasion or metastasis. Control (TUR B) patients with recurrent superficial tumors were eligible for crosso ver to the BCG arm. All patients have been monitored until event or fo r a minimum of 10 years (range, 10 to 14). Results: The 10-year progre ssion-free rate was 61.9% (95% confidence interval [Cl], 47.2% to 76.7 %) for patients treated with BCG and 37% (95% CI, 22.9% to 53.1%) for control patients. The median progression-free interval was not reached for the BCG group and was 46 months for the control group (P=.0063). Of 18 control patients crossed over to BCG (median, 29 months), 15 did not show tumor progression, TURB plus BCG resulted in a 10-year disea se-specific survival rate of 75%, compared with 55% with TURB alone (P =.03). Conclusion: This study shows that intravesical therapy with del ays tumor progression and death from tumor in patients who present wit h superficial bladder cancer. (C) 1995 by American Society of Clinical Oncology.