Mitoxantrone in malignant lymphoma.

Two phase II trials of mitoxantrone in refractory malignant lymphoma have been conducted. In the first of these, mitoxantrone (5 mg/m2) was given weekly for 6 weeks, and in the second, 14 mg/m2 was administered every 3 weeks. The first trial was conducted by the Southeastern Cancer Study Group (SECSG), and the second was a multicenter trial sponsored by Lederle Laboratories. Of the 80 patients entered in the SECSG trial, 47 could be evaluated for response and 43 for toxicity. Granulocyte nadirs below 1.9 X 10(9)/L were recorded in 18 patients. Four partial responses and no complete responses were obtained. These results contrast with those of the high dose study in which 41 patients were entered, and 28 of these were evaluated for response. Responses were obtained in 15 patients (2 complete, 13 partial). Side effects on this 3 weekly dose regimen were minimal. WBC nadirs ranged from 1 to 4.3 X 10(9) cells/L (mean 2.5 X 10(9)/L). Three patients experienced mild nausea and vomiting, and two had mild alopecia. These preliminary data indicate that mitoxantrone has significant activity in malignant lymphoma. All of the responding patients had received extensive prior therapy, many of them with anthracyclines in combination or as single agents. The higher response rate to mitoxantrone given at 14 mg/m2 every 3 weeks suggests that careful consideration should be given to dose when this drug is examined further in phase III trials.