title: Combination of capecitabine and mitomycin C as first-line treatment in patients with metastatic breast cancer.
abstract: Optimal first-line chemotherapy for metastatic breast cancer (MBC) is challenging, particularly in patients previously treated with (neo) adjuvant anthracyclines/taxanes. Based on preclinical synergy with mitomycin C (MMC) and capecitabine in human tumor xenografts, we conducted a phase II study of first-line capecitabine and MMC in MBC. Patients received 3-weekly chemotherapy comprising MMC 8 mg/m² day 1 and capecitabine 1000 mg/m² twice daily, days 1-14. Combination chemotherapy was administered for a maximum six cycles, single-agent capecitabine could be continued until progressive disease or unacceptable toxicity. Thirty patients were included, objective response rate was 65.5%. After a median follow-up of 18.5 months, median time to progression was 8.5 months and median overall survival was 29.8 months. The main adverse events were thrombocytopenia, pneumonitis and hemolytic uremic syndrome. Our data suggest that first-line capecitabine and MMC has good antitumor activity in MBC, but is associated with MMC-specific toxicity.
authors.affiliation: Department of Oncology, Clinical Hospital Split and University of Split School of Medicine, Spinciceva 1, 21000 Split, Croatia. vrdoljak@st.t-com.hr
authors.forename: E
authors.initials: E
authors.lastname: Vrdoljak
authors.forename: M
authors.initials: M
authors.lastname: Boban
authors.forename: T
authors.initials: T
authors.lastname: Omrcen
authors.forename: D
authors.initials: D
authors.lastname: Hrepic
authors.forename: V
authors.initials: V
authors.lastname: Fridl-Vidas
authors.forename: L
authors.initials: L
authors.lastname: Boskovic
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000627:therapeutic use*; D009362:Neoplasm Metastasis
chemical_list: D003841:Deoxycytidine; D016685:Mitomycin; D000069287:Capecitabine; D005472:Fluorouracil