A clinical trial of mitoxantrone (novantrone) versus doxorubicin (adriamycin) in combination chemotherapy for metastatic breast cancer.

Mitoxantrone (Novantrone, N) is a new anthracenedione derivative with structural similarities to doxorubicin (Adriamycin, A). It has shown significant activity during phase I and II clinical trials in the treatment of advanced breast cancer. The present trial compares the CNF regimen to CAF. All patients received cyclophosphamide (500 mg/m2) and 5-fluorouracil (500 mg/m2), with either N (10 mg/m2) or A (50-60 mg), repeated every three weeks. There were 30 patients in the mitoxantrone group and 30 patients in the doxorubicin group. The results presented are based on 60 patients: 70% were postmenopausal; 25% had received adjuvant chemotherapy; 29% had prior hormonal therapy in an adjuvant setting or for relapse. There were no significant differences between the pretreatment characteristics of each group. The response rate (complete + partial) for CNF was 57% and for CAF was 40%. The dose limiting toxicity was granulocytopenia seen after the 3rd cycle in the CNF group. Thrombocytopenia was not seen. There was less nausea and vomiting in the CNF group. No cardiotoxicity was seen in CNF; only 2 patients suffered from congestive heart failure in CAF. These preliminary data indicate that CNF seems to be an effective regimen for patients with advanced breast cancer and has fewer adverse effects than CAF.