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Heidemann, E; Stoeger, H; Souchon, R; Hirschmann, WD; Bodenstein, H; Oberhoff, C; Fischer, JT; Schulze, M; Clemens, M; Andreesen, R; Mahlke, M; König, M; Scharl, A; Fehnle, K; Kaufmann, M.
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.
Ann Oncol. 2002; 13(11):1717-1729 Doi: 10.1096/annonc/mdf306 [OPEN ACCESS]
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Co-authors Med Uni Graz: Stöger Herbert
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Abstract:: 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/m(2) or the combination of fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2) and cyclophosphamide 500 mg/m(2) (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.
Find related publications in this database (using NLM MeSH Indexing): Adult -; Aged -; Antineoplastic Combined Chemotherapy Protocols - administration and dosage; Biopsy, Needle - administration and dosage; Bone Neoplasms - drug therapy; Breast Neoplasms - drug therapy; Cyclophosphamide - administration and dosage; Disease-Free Survival - administration and dosage; Epirubicin - administration and dosage; Female - administration and dosage; Fluorouracil - administration and dosage; Germany - administration and dosage; Humans - administration and dosage; Liver Neoplasms - drug therapy; Logistic Models - drug therapy; Lung Neoplasms - drug therapy; Middle Aged - drug therapy; Mitoxantrone - administration and dosage; Neoplasm Staging - administration and dosage; Probability - administration and dosage; Proportional Hazards Models - administration and dosage; Quality of Life - administration and dosage; Risk Assessment - administration and dosage; Sensitivity and Specificity - administration and dosage; Statistics, Nonparametric - administration and dosage; Survival Analysis - administration and dosage; Treatment Outcome - administration and dosage
Find related publications in this database (Keywords): metastatic breast cancer; quality of life; single-agent treatment; survival; time to progression