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Annals of Oncology 13:1717-1729, 2002
© 2002 European Society for Medical Oncology

Original Paper

Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial

E. Heidemann1,+, H. Stoeger2, R. Souchon3, W.-D. Hirschmann4, H. Bodenstein5, C. Oberhoff6, J. T. Fischer7, M. Schulze8, M. Clemens9, R. Andreesen10, M. Mahlke11, M. König12, A. Scharl13, K. Fehnle14 and M. Kaufmann On behalf of the Interdisciplinary Breast Cancer Working Group of the German Cancer Society15

1 Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany; 2 Department of Medical Oncology, University of Graz, Austria; 3 Department of Radiation Oncology, General Hospital of Hagen; 4 Department of Medical Oncology, City Hospital of Kassel; 5 Department of Medical Oncology, City Hospital of Minden; 6 Gynecological Department, University of Essen; 7 Department of Medical Oncology, City Hospital of Karlsruhe; 8 Department of Medical Oncology, City Hospital of Zittau; 9 Department of Medical Oncology, Boromaeerinnen Hospital Trier; 10 Department of Hematology and Medical Oncology, University of Regensburg; 11 Gynecological Department, University of Mainz; 12 Gynecological Department, University of Tuebingen; 13 Gynecological Department, University of Cologne; 14 Algora Munich; 15 Gynecological Department, University of Frankfurt, Germany

Received 14 January 2002; revised 13 May 2002; accepted 5 June 2002

Background:

To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment.

Patients and methods:

A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m2 or the combination of fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status.

Results:

After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment.

Conclusions:

No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.

Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression


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