Mitoxantrone in combination with prednimustine in treatment of unfavorable non-Hodgkin lymphoma.

Mitoxantrone (Novantrone) and prednimustine (Sterecyt) are both active as single agents in the treatment of unfavorable non-Hodgkin lymphoma (UNHL). The efficacy and toxicity of the combination of these agents (NOSTE) was evaluated in 28 patients with advanced histopathologically proven UNHL who were not eligible for aggressive conventional chemotherapy. The median age was 68, range 45-84. Sixteen patients were previously untreated. Eleven patients had received doxorubicin or epidoxorubicin containing regimens and 1 patient had received CVP as first line therapy. MUGA scan was used in monitoring cardiac function in patients with cardiac risk. Novantrone was administered at a dose of 8 mg/m2 IV on days 1 and 2 and Sterecyt as an absolute dose 100 mg/less than or equal to 1.6 m2-150 mg/greater than 1.6 m2 on days 1 through 5. The regimen was repeated every 4th week. The number of courses per patient ranged from 2 to 10. Objective response was obtained in 22 (78%) patients (20 CR and 2 PR). No response occurred in 6 patients (4 SD, 2 PD). Decreased left ventricular ejection fraction was recorded in 1 patient who suffered from asthma and ischemic heart disease. Hematological toxicity was tolerable. Gastrointestinal toxicity was rare. No hair loss was observed. After a median follow-up of 28 months the crude survival was 46%. Twelve of twenty complete responders are still in remission, the median duration of remission is 28.3 months, range 15-37. NOSTE in this pilot study showed a high response rate, good tolerance and mild toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)