Clinical safety and tolerance of mitoxantrone.

Mitoxantrone has been administered to more than 4000 patients worldwide. From this data base, a summary of the latest information is presented on the effect of mitoxantrone on bone marrow, on its nonmyelosuppressive acute toxicities, on its local tolerability, and on measurements of organ function. Most of these patients had solid tumors and were treated with an initial dose of mitoxantrone (12 to 14 mg/m2). Predictable leucopenia was dose limiting, but clinically significant suppression of RBC or platelet count was rare. Other hematologic or blood chemistry abnormalities were infrequent. The most common adverse clinical effects were nausea and vomiting, stomatitis, and alopecia, though the majority of these cases were mild. Many patients experienced no adverse reactions to mitoxantrone; there have been no reports of cellulitis, vesication, or tissue necrosis following extravasation. From the global experience with mitoxantrone, it seems that for patients who have not previously received anthracycline therapy, the risk of congestive heart failure is minimal up to a cumulative mitoxantrone dose of 160 mg/m2. In randomized, comparative clinical trials in advanced breast cancer, using mitoxantrone or doxorubicin either as single agents or in combination with other standard drugs, the incidence of moderate or severe acute toxic side effects was much lower for patients treated with mitoxantrone or mitoxantrone-containing combinations. From these data, it is clear that mitoxantrone has an exceptional safety profile, particularly with regard to acute nonmyelosuppressive toxicity and local tolerability. This offers the patient a better quality of life during antineoplastic chemotherapy.