Lerner SP et al. (2007) Patterns of recurrence and outcomes following induction Bacillus Calmette–Guerin for high risk Ta, T1 bladder cancer. J Urol 177: 1727–1731

Radical cystectomy is the standard treatment for persistent or recurrent high-risk bladder cancer after Bacillus Calmette–Guerin (BCG) induction therapy. Delaying cystectomy in favor of alternative drug therapies or maintenance BCG could result in a raised risk of invasive disease. Lerner et al., therefore, analyzed the Southwest Oncology Group 8507 trial data for maintenance BCG therapy to investigate whether the timing of disease recurrence affected patient survival. They found that long-term survival was not affected by the timing of recurrence.

Of 550 patients with resected Ta or T1 tumors who were randomly assigned to BCG maintenance or observation, 501 were available for follow-up. Disease recurred in 251 patients, of whom 117 had early recurrence (<12 months after randomization) and 134 had late recurrence. In all, 59% of patients who had recurrence died. Recurrence more than doubled the risk of death compared with no recurrence, but the risks were similar for early and late recurrence. Cystectomy was performed in 56 of the 251 patients with recurrence; the median time to cystectomy was 11 months for patients on BCG therapy, compared with 24 months for those not receiving BCG. The risk of death among patients who underwent cystectomy was raised significantly compared with that among those who did not (hazard ratio 2.58, 95% CI 1.62–4.11), but maintenance BCG therapy plus cystectomy significantly reduced the risk of death (hazard ratio 0.37). These secondary findings should be considered hypothesis generating.