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

Abstract

BACKGROUNDAlthough 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.METHODSOne 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.RESULTSOf 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%).CONCLUSIONSThese 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

Efficacy of Postoperative Bladder Irrigation with Water for Injection in Reducing Recurrence Rates of Non Muscle Invasive Bladder Cancer

“…Water for injection irrigation achieved very similar RFR to those observed in the study of Okamura et al who included patients who received single intravesical chemotherapy (90% vs 92,4% in the first year, 83% vs 82,7% in the second year and 79% vs 78,8% in the third year) (Okamura et al, 2002). After a single postoperative intravesical instillation of mitomycin for low-risk tumors Solsona et al observed RFR of 98.2%, 84.2% and 80.7% in the first, second and third year respectively while our corresponding percentages were 90%, 83% and 79%, which indicates similar percentages in the second and third year of monitoring (Solsona et al, 1999).…”

Intravesical administration of pirarubicin against superficial bladder cancer: Relationship between tumor tissue concentration and exposure time in the bladder or therapeutic effect

“…The present results corroborate those of Yamamoto et al (27), who reported that pirarubicin was not detected in the plasma after single intravesical administration of pirarubicin, and by a report by Okamura et al (17), who reported that there were no severe local toxicities after a single dose of pirarubicin for 60 min.…”

“…The concentration of pirarubicin in the tumor tissue becomes markedly high in a relatively short time after administration into the bladder (15). It is reported that the intravesical instillation with pirarubicin produces an antitumor effect against bladder cancer, and that the prophylactic effect of recurrence in the bladder after intravesical instillation chemotherapy with pirarubicin is higher than that after TUR-BT only (17). Moreover, short-time intravesical instillation chemotherapy is performed to obtain a greater antitumor effect and to prevent an increase in side effects, as this method has the advantage of a higher penetration of pirarubicin into bladder tumor tissues (18).…”

“…The role involving the exposure time of the bladder to pirarubicin in the prophylactic effect against recurrence of bladder cancer has been extensively studied (17)(18)(19), whereas the contribution of the concentration of pirarubicin in bladder tumor tissue to the prophylactic effect against recurrence of bladder cancer remains unclear.…”

<b><i>NOS3</i></b> 895G&gt;T and <b><i>CBR3</i></b> 730G&gt;A Are Associated with Recurrence Risk in Non-Muscle-Invasive Bladder Cancer with Intravesical Instillations of THP

“…There were 91 patients in our cohort with NMIBC. The recurrence rate of these patients (17.6%, 16/91) was similar to the results reported by Okamura et al [15]. The results of our research showed that rs1056892 on CBR3 and rs1799983 on NOS3 were significantly associated with tumor recurrence risk after TUR and intravesical instillations of THP in patients with NMIBC.…”