[A phase II study of mitoxantrone in malignant lymphoma]

A phase II study of mitoxantrone (MIT) was performed in 13 cases of refractory malignant lymphoma, 1 of Hodgkin's disease and 12 of non-Hodgkin lymphoma. The twelve non-Hodgkin lymphomas were previously treated with adriamycin. MIT was diluted in 50 approximately 100 ml saline solution and intravenously administered by drip infusion in 15 approximately 30 minutes. The dose of MIT was 3 mg/m2/day for 5 days (A) or 10 approximately 14 mg/m2/day, for 1 day (B). There were 2 CR, 1 MR, 1 NC and 2 PD among 8 cases treated by schedule A, and two cases were not evaluable. With schedule B, there was 1 MR among 5 cases, and four cases were not evaluable. In the 7 evaluable cases, remission rate was 2/7 (29%) with remission durations of 6+ weeks and 55 weeks. The dose limiting toxicity was granulocytopenia but no serious infection was observed. With schedule A, it was difficult to repeat the treatment every 3 weeks because of the delay in granulocyte recovery. Gastrointestinal toxicities were observed in about half of the treatment courses but they were mild in degree. A prolongation of QTc (greater than 0.44) was observed in 3 cases (4 treatment courses) among 9 cases (10 treatment courses) whose baseline QTc values were within normal limits. Baseline QTc values were above the normal limit in 4 cases and in two of them, QTc showed further prolongation after MIT treatment. No arrhythmia or congestive heart failure was observed.