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.
Okamura
Kikuo
K
Department of Urology, Chubu National Hospital, Gengo, Morioka-cho, Obu, Japan.
Ono
Yoshinari
Y
Kinukawa
Tsunero
T
Matsuura
Osamu
O
Yamada
Shin
S
Ando
Tadashi
T
Fukatsu
Toshiaki
T
Ohno
Yoshiyuki
Y
Ohshima
Shinichi
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000633:toxicity; D004317:Doxorubicin / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000633:toxicity; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery
D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin; C027260:pirarubicin