title: [Early phase II clinical trial of amrubicin hydrochloride in patients with malignant lymphoma].
abstract: An early phase II multi-center collaborative study of amrubicin hydrochloride, a novel synthetic anthracycline derivative anticancer agent, was conducted for malignant lymphoma at 12 institutions nationwide. A total of 41 patients were enrolled in this study between January 1988 and October 1990. Of these, 36 patients, six patients with Hodgkin's disease (HD) and 30 patients with non-Hodgkin's lymphoma (NHL), were eligible for the study. The starting dose of amrubicin hydrochloride was 100 mg/m2 (body surface area) and it was administered once every three weeks, in principle. The efficacy was assessed for 34 patients, excluding two patients: one who has not been followed up adequately and the other violated the dosing schedule (once per week). The overall response rates (CR + PR) were 50.0% (3/6) for HD and 42.9% (12/28) for NHL. Furthermore, a relatively high response rate was noted in 8 (36.4%) of 22 NHL patients who had been treated with other anthracycline derivatives prior to the trial. The safety of amrubicin hydrochloride was assessed for 36 eligible patients. Leukopenia (grade 3 or higher) and thrombocytopenia were noted in 21 patients (58.3%) and 10 patients (27.8%), respectively. Anorexia, nausea/vomiting, fever, alopecia, decrease in hemoglobin and elevations of GOT and GPT levels were observed with a relatively high frequency. Other than myelosuppression, the following adverse reactions (grade 3 or higher) occurred during the course of the trial: diarrhea (two patients), alopecia (two patients), stomatitis (one patient), anorexia (one patient), nausea/vomiting (one patient) and fever (one patient). In conclusion, these results indicate that amrubicin hydrochloride is effective in the treatment of patients with malignant lymphoma.
authors.affiliation: Fifth Dept. of Internal Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases.
authors.forename: T
authors.initials: T
authors.lastname: Masaoka
authors.forename: M
authors.initials: M
authors.lastname: Ogawa
authors.forename: K
authors.initials: K
authors.lastname: Inoue
authors.forename: K
authors.initials: K
authors.lastname: Sanpi
authors.forename: Y
authors.initials: Y
authors.lastname: Kuraishi
authors.forename: H
authors.initials: H
authors.lastname: Toki
authors.forename: K
authors.initials: K
authors.lastname: Tamura
authors.forename: T
authors.initials: T
authors.lastname: Takagi
authors.forename: A
authors.initials: A
authors.lastname: Shibata
authors.forename: M
authors.initials: M
authors.lastname: Hirano
authors.forename: K
authors.initials: K
authors.lastname: Ezaki
authors.forename: S
authors.initials: S
authors.lastname: Shirakawa
authors.forename: T
authors.initials: T
authors.lastname: Matsuda
authors.forename: I
authors.initials: I
authors.lastname: Kimura
mesh_terms: D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; C055866:amrubicin