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.

[more...]