Mitoxantrone (Novantrone) as single agent and in combination chemotherapy in the treatment of advanced breast cancer.

Nineteen out of 62 evaluable patients with advanced breast cancer achieved an objective tumour response to mitoxantrone (31%) given in a dose of 12-14 mg/m2 by i.v. infusion repeated at 3-weekly intervals. The response rate in patients who had received no prior chemotherapy for advanced disease was 35%, compared with 22% in previously treated patients. Median duration of response was 10 months. Responses were seen in three out of nine patients who failed to respond to adriamycin. Neutropenia was dose limiting and eight out of 65 patients evaluable for toxicity had a neutropenic infection. Two patients developed readily reversible cardiac failure and two more developed physiological features of cardiac impairment, all after prolonged treatment. Other toxicities were mild and the drug was well tolerated; severe alopecia occurred in only one patient. Nine patients treated with a combination of mitoxantrone, vincristine and methotrexate all developed leukopenia with a mean white blood count of 1400/mm2 (range 200-2400) although no episodes of neutropenic infection were seen and the combination was otherwise well tolerated. Mitoxantrone is an active, well tolerated drug in the treatment of advanced breast cancer and merits further evaluation.