A phase II oriented study with
mitoxantrone was undertaken in 31 patients with refractory non-Hodgkin's
lymphomas (NHL); 30 patients had evaluable disease. The
drug was administered through a 30-min
intravenous infusion at the dose of 14 mg/m2 every 3 weeks. A minimum of two cycles were required to define treatment response. Twenty patients were previously treated with
Adriamycin whose total dose was not exceeding 300 mg/m2. Complete response (CR) was documented in 9 patients, and partial response (PR), in 5 for a total response rate of 47% (14 of 30). Of 20 patients previously treated with
Adriamycin, CR occurred in five and PR in two. The median time to progression was 3 months.
Mitoxantrone was well tolerated, and no patient refused treatment. Mild
leukopenia was evident in 10 patients and
thrombocytopenia in 5 patients. In all cases, electrocardiograms (EKGs) was obtained before each treatment cycle. Systolic time intervals and left ventricular ejection fraction were repeated after 3 cycles and at the end of
therapy. Laboratory tests failed to document any major cardiac abnormality.
Mitoxantrone is an effective agent in refractory NHL and should be taken into consideration in the design of salvage regimens.