TY - JOUR
T1 - Mitomycin C and capecitabine combination (MiXe) in heavily pretreated metastatic breast cancer patients. A dose-finding study
AU - Maisano, Roberto
AU - Caristi, Nicola
AU - Mare, Marzia
AU - Mafodda, Antonino
AU - Carboni, Rita
AU - Montalto, Erika
AU - Iorfida, Monica
AU - Nardi, Mario
PY - 2005/11
Y1 - 2005/11
N2 - 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 upregulation 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 earned 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/m
2 and capecitabine 1000 mg/m
2 days 2-15) dose-limiting toxicities were recorded in 2 patients (G4 thrombocytopenia, neutropenic fever, G4 neutropenia); dose level II (MMC 10 mg/m
2 and capecitabine 1000 mg/m
2 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.
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 upregulation 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 earned 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/m
2 and capecitabine 1000 mg/m
2 days 2-15) dose-limiting toxicities were recorded in 2 patients (G4 thrombocytopenia, neutropenic fever, G4 neutropenia); dose level II (MMC 10 mg/m
2 and capecitabine 1000 mg/m
2 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.
KW - Capecitabine
KW - Metastatic breast cancer
KW - Mitomycin
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M3 - Article
C2 - 16334135
AN - SCOPUS:28444479406
VL - 25
SP - 4513
EP - 4517
JO - Anticancer Research
JF - Anticancer Research
SN - 0250-7005
IS - 6 C
ER -