Randomized study of single early instillation of (2r)-4- o-tetrahydropyranyl-doxorubicin for a single superficial bladder carcinoma. : Cancer 2002;94:363–8.

Abstract

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 (2R)-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, whereas 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.