Metronomic oral combination chemotherapy with capecitabine and cyclophosphamide: a phase II study in patients with HER2-negative metastatic breast cancer
Cancer Chemotherapy and Pharmacology, 05/15/2012
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.
- 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.