Long-Term Follow-up of Patients with Stage T1 High-Grade Transitional Cell Carcinoma Managed by Bacille Calmette-Guérin Immunotherapy

Objectives: To report the long-term outcome of patients with Stage T1 high-grade transitional cell carcinoma of the bladder treated initially by transurethral resection and adjuvant intravesical bacille Calmette-Guérin. Methods: From June 1984 to November 1995, 78 consecutive patients with Stage T1 high-grade bladder cancer underwent transurethral resection and adjuvant intravesical bacille Calmette-Guérin therapy. The results at the interim follow-up (median 56 months) were reported in 1998. The median duration of follow-up for the present study was 107 months (range 16 to 238). The endpoints were tumor recurrence (Stage Ta, T1, or Tis), tumor progression (to T2 or greater), and disease-specific survival. Results: Of the 78 patients, 34 (44%) were alive for the present analysis and 44 (56%) had died, 12 (16%) of transitional cell carcinoma and 32 (72%) of other causes. Recurrence was documented in 27 patients (35%) at a median of 8.5 months (range 5 to 129) after treatment, and progression in 14 patients (18%) at a median of 31.4 months (range 5 to 88) after treatment. The 2, 5, and 10-year recurrence-free survival and progression-free survival rates were 76%, 72%, and 62% and 92%, 82%, and 80%, respectively. The corresponding disease-free survival rates were 99%, 90%, and 85%. Disease progression occurred in 10 (37%) of 27 patients with recurrence, of whom 9 died. Of the 14 patients with disease progression, 12 died of their disease. Conclusions: Bacille Calmette-Guérin is an effective conservative treatment for patients with Stage T1 high-grade bladder cancer. More than one half the recurrences appeared within the first year, but a small risk remains throughout the patient's life. Progression during follow-up appears to carry a high risk of cancer-specific death.