A phase II study of epirubicin in malignant lymphoma]

A new anthracycline analog, epirubicin (4'-epi-Adriamycin) was evaluated at eleven institutes in a phase II clinical study in patients with malignant lymphoma. Epirubicin was administered intravenously mainly with using the following two regimens; 50 to 60 mg/m2 every three weeks and 40 mg/m2 weekly. A total of 46 cases were entered into the study and 41 cases were evaluable. Clinical responses, complete plus partial remissions, were observed in 27 cases (65.9%) with 8 of these showing complete remission. There was no significant difference of response between the two regimens. Response rates taking into account previous chemotherapy were 90.9% (10/11) in previously nontreated cases, 61.9% (8/13) in cases previously treated with non-anthracyclines and 52.9% (9/17) in cases treated with anthracyclines. The major adverse effect was bone marrow suppression; leukopenia was observed in 83.8%, anemia in 60.5% and thrombocytopenia in 15.4%. Other adverse effects frequently observed were anorexia (59.0%), nausea-vomiting (48.8%) and alopecia (55.6%). These adverse effects seemed milder than those produced by doxorubicin. The results indicated that epirubicin seemed to be a markedly useful drug against malignant lymphoma.