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Metronomic oral combination chemotherapy with capecitabine and cyclophosphamide: a phase II study in patients with HER2-negative metastatic breast cancer

Yoshimoto M et al. – Oral XC is an effective first– or second–line therapy for metastatic breast cancer (MBC), demonstrating high activity in both luminal A and triple–negative disease with few severe side effects. This metronomic oral combination chemotherapy could be beneficial for the treatment of HER2–negative MBC.

Methods
  • Patients received capecitabine 828mg/m2 twice daily with cyclophosphamide 33mg/m2 twice daily, days 1–14 every 3weeks.
  • The primary endpoint was overall response rate (ORR).
  • Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Results
  • Between May 2007 and April 2009, 51 patients were enrolled and 45 were included in the efficacy analysis.
  • The median follow-up was 18.1months.
  • ORR was 44.4% and stable disease (≥24weeks) was achieved in 13.4%, resulting in a 57.8% clinical benefit response rate.
  • Median PFS was 12.3months (95% confidence interval: 8.9-18.9months).
  • Median PFS was 10.7months in triple-negative disease and 13.2months in estrogen-receptor positive, HER2-negative disease.
  • The 1- and 2-year OS rates were 86 and 71%, respectively.
  • Median OS has not been reached.
  • Grade 3 adverse events comprised leukopenia (26%), neutropenia (16%), and decreased hemoglobin (2%).
  • There was no grade 3 hand-foot syndrome.
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