PT  - JOURNAL ARTICLE
AU  - MAISANO, ROBERTO
AU  - CARISTI, NICOLA
AU  - MARE, MARZIA
AU  - MAFODDA, ANTONINO
AU  - CARBONI, RITA
AU  - MONTALTO, ERIKA
AU  - IORFIDA, MONICA
AU  - NARDI, MARIO
TI  - Mitomycin C and Capecitabine Combination (MiXe) in Heavily Pretreated Metastatic Breast Cancer Patients. A Dose-finding Study
DP  - 2005 Nov 01
TA  - Anticancer Research
PG  - 4513--4517
VI  - 25
IP  - 6C
4099  - http://ar.iiarjournals.org/content/25/6C/4513.short
4100  - http://ar.iiarjournals.org/content/25/6C/4513.full
SO  - Anticancer Res2005 Nov 01; 25
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