title: A phase II study of dose-dense docetaxel and mitoxantrone in the treatment of patients with high-risk metastatic breast cancer.
abstract: Doxetaxel (DCT) and mitoxantrone (MX) are highly active and potentially synergistic agents in the treatment of metastatic breast cancer (MBC). This pilot study evaluates the combination of dose-dense DCT and MX in patients with MBC to determine the efficacy and toxicity of this therapy. Thirty-six patients (56.1+/-1.7 years) were studied. The patients received DCT (35 mg/m(2) q1w) and MX (6 mg/m(2) q2w) for 6 weeks of an 8-week interval. Patients with tumor response or stable disease (SD) continued the treatment for a maximum of two additional periods. Hematologic and non-hematologic parameters were determined using the WHO common toxicity score. During this study 14 patients (40%) experienced partial response, 14 (40%) SD. In 20% of the cases the disease progressed on therapy. The treatment with DCT and MX was well tolerated. Seventeen patients (47%) experienced grade 3 leukopenia. Other hematologic and non-hematologic side effects did not exceed grade 2. One patient died during therapy because of a pulmonary embolism, which was unlikely related to active agents. Dose-dense DCT and MX combines both clinical activity and convenience for the patient. Therefore, we conclude that this regimen is a promising therapy in MBC, which warrants confirmation by large-scale clinical trials.
authors.affiliation: Department of Gynecology and Obstetrics, University of Cologne, 50924 Cologne, Germany.
authors.forename: Ellen
authors.initials: E
authors.lastname: König
authors.forename: Christian
authors.initials: C
authors.lastname: Kurbacher
authors.forename: Martin
authors.initials: M
authors.lastname: Schwonzen
authors.forename: Martina
authors.initials: M
authors.lastname: Breidenbach
authors.forename: Peter
authors.initials: P
authors.lastname: Mallmann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D008942:Mitoxantrone; D017239:Paclitaxel