Randomized study of single early instillation of (2″R)‐4′‐ O ‐tetrahydropyranyl‐doxorubicin for a single superficial bladder carcinoma

BACKGROUND Although transurethral resection of a bladder tumor (TUR‐Bt) alone has been standard treatment for single superficial bladder carcinoma, some authors reported a certain prophylactic effect of a single immediate intravesical instillation of chemotherapeutic agent after TUR‐Bt. A prospective randomized study was conducted to determine whether a single (2″R)‐4′‐ O ‐tetrahydropyranyl‐doxorubicin (THP) instillation immediately after TUR‐Bt is beneficial to patients with a single superficial bladder carcinoma. METHODS One hundred seventy patients with a single resectable superficial bladder carcinoma (Ta‐1, primary or recurrent with no recurrence during the last 1 year) were enrolled in this study. THP (30 mg/30 mL of normal saline) was administered into the bladder within 6 hours after TUR‐Bt in arm A, while TUR‐Bt alone was done in arm B. RESULTS Of the 170 patients, 160 (94.1%) were eligible and were followed up for a median time of 40.8 months. There was a significant difference in the recurrence free curve between the 2 arms (log‐rank test; P = 0.0026), with 92.4% recurrence free rate at 1 year, 82.7% at 2 years, and 78.8% at 3 years in arm A (84 patients) and 67.0%, 55.7%, and 52.6%, respectively, in arm B. The recurrence rate per year was 0.11 ± 0.22 in arm A and 0.24 ± 0.36 in arm B, with a significant difference ( P = 0.007). Toxicity included pain with micturition in 9 patients (10.7%), urinary frequency/urgency in 5 patients (6.0%), and macroscopic hematuria in 7 patients (8.3%). CONCLUSIONS These data indicate that a single THP instillation immediately after TUR reduces the recurrence of superficial bladder carcinoma. Cancer 2002;94:2363–8. © 2002 American Cancer Society. DOI 10.1002/cncr.10496