RT Journal Article SR Electronic T1 Mitomycin C and Capecitabine Combination (MiXe) in Heavily Pretreated Metastatic Breast Cancer Patients. A Dose-finding Study JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 4513 OP 4517 VO 25 IS 6C A1 MAISANO, ROBERTO A1 CARISTI, NICOLA A1 MARE, MARZIA A1 MAFODDA, ANTONINO A1 CARBONI, RITA A1 MONTALTO, ERIKA A1 IORFIDA, MONICA A1 NARDI, MARIO YR 2005 UL http://ar.iiarjournals.org/content/25/6C/4513.abstract AB Background: No standard chemotherapy has been defined for metastatic breast cancer patients pretreated with anthracyclines and taxanes. In preclinical studies, mitomycin C (MMC) and capecitabine showed a synergistic effect by up-regulation of thymidine phosphorylase, and both drugs were active against breast cancer with a lack of overlapping toxicity, making their combination a well-tolerated regimen. Patients and Methods: A dose-finding study was carried out in order to determine the maximum tolerable dose of MMC combined with fixed-dose capecitabine and to describe the dose-limiting toxicities. Results: Twenty-one patients were enrolled, with metastatic breast cancer pretreated at least with anthracyclines and taxanes (3 at dose level I, 15 at dose level II, 3 at dose level III). At dose level III (MMC 12 mg/m2 and capecitabine 1000 mg/m2 days 2-15) dose-limiting toxicities were recorded in 2 patients (G4 thrombocytopenia, neutropenic fever, G4 neutropenia); dose level II (MMC 10 mg/m2 and capecitabine 1000 mg/m2 days 2-15) was extended for a better safety evaluation. No severe toxicity was noted at this dose level, and therefore this dose was recommend for the phase II study. With regard to activity, 4 partial responses and 2 stable diseases (28%) were recorded. Conclusion: Our data show that the combination is feasible, well tolerated and active in this set of patients. Copyright© 2005 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved