title: [Phase I study of amrubicin hydrochroride (SM-5887) for superficial bladder cancer in intravesical chemotherapy].
abstract: 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.
authors.affiliation: Dept. of Urology, Okayama University Medical School.
authors.forename: H
authors.initials: H
authors.lastname: Ohmori
authors.forename: T
authors.initials: T
authors.lastname: Yamato
authors.forename: T
authors.initials: T
authors.lastname: Asahi
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006417:Hematuria / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D014554:Urination
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; C055866:amrubicin