amrubicin and Hematuria

A phase I study of intravesical chemotherapy with amrubicin hydrochloride for superficial bladder cancer was conducted. Amrubicin was dissolved in 30 ml of physiological saline and injected intravesically on 6 consecutive days. The drug solution was retained for 2 hours. The starting dose was 60 mg/day, and the dose was escalated to 150 mg/day in 30 mg/day increments. Fifteen patients were entered into this study, of whom 14 were eligible and assessable for toxicity, and 13 were assessable for efficacy. The incidence and severity of cystic irritabilities such as micturition pain, pollakisuria and hematuria were related to the doses of amrubicin. At 150 mg/day, one of three patients experienced grade 3 micturition pain and pollakisuria. The dose-limiting toxicities, therefore, were micturition pain and pollakisuria, and the maximal tolerated dose was estimated to be 150 mg/day, considering that none of the three patients could retain the drug solution for 2 hours. One complete response and four partial responses were obtained in 13 assessable patients, and the overall response rate was 38.5%. A breakdown according to the doses was as follows. One PR of 3 patients were achieved at 60 and 90 mg/day, respectively 2 PRs of 5 patients at 120 mg/day, and one CR of 2 patients at 150 mg/day.

Topics: Administration, Intravesical; Aged; Anthracyclines; Antineoplastic Agents; Drug Administration Schedule; Female; Hematuria; Humans; Male; Middle Aged; Pain; Urinary Bladder Neoplasms; Urination

An early phase II study (dose-finding study) of amrubicin hydrochloride for superficial bladder cancer was conducted. Amrubicin was dissolved in 30 ml of physiological saline and injected intravesically for 6 consecutive days. The drug solution was retained for 2 hours. Patients were randomly assigned to four groups, which were administered amrubicin at doses of 30, 60, 90, and 120 mg/day, respectively. Of 65 patients registered in this study, 63 were eligible and assessable for toxicities, and 55 assessable for efficacy. The response rate at each dose level was 50.0% (7PRs/14 patients) at 30 mg/day, 53.3% (8 PRs/15) at 60 mg/day, 61.5% (2 CRs + 6 PRs/13) at 90 mg/day, and 69.2% (2 CRs + 7 PRs/13) at 120 mg/day, respectively. These data suggests that the efficacy was related to the doses of amrubicin. The major toxicities were cystic irritabilities, such as micturition pain, pollakisuria and hematuria. These toxicities were related to the doses of amrubicin. Their incidence and the severity were not high compared with those reported about other anthracyclines such as doxorubicin and epirubicin. The optimal dose of amrubicin was estimated to be 90 to 120 mg/day in the intravesical treatment for superficial bladder cancer once a day for 6 consecutive days.

Topics: Administration, Intravesical; Aged; Anthracyclines; Antineoplastic Agents; Drug Administration Schedule; Female; Hematuria; Humans; Male; Middle Aged; Pain; Urinary Bladder Neoplasms; Urination