First-line monochemotherapy with mitoxantrone versus combination with fluorouracil, epirubicin and cyclophosphamide in high-risk metastatic breast cancer: A prospective randomized multicenter clinical trial

Background: The dogma that patients with high-risk, advanced breast cancer urgently need combination chemotherapy has never been proven in a prospecti vely randomized study. Patients and Methods: 412 patients with metastatic b reast cancer requiring chemotherapy were stratified into a low-risk and a h igh-risk group. They then were randomized to be treated with monotherapy mi toxantrone (N) or combination chemotherapy. The high-risk group (n=260), wh ich is reported here separately, got N 12 mg/m(2) or fluorouracil 500 mg/m( 2) plus epirubicin 50 mg/m(2) plus cyclophosphamide 500 mg/m(2) (FEC) every 3 weeks. Results: There was no significant difference between the two grou ps in terms of response rates or overall survival. There was, however, a si gnificantly better score for gain from treatment and quality of life (modif ied Brunner's score) in the single-agent N group. Conclusion: There is no e vidence that high-risk, advanced cancer patients need combination chemother apy. In order to maintain their quality of life, it may be wise to treat th em with a single agent such as N.