Abstract
Introduction: Oral combination chemotherapy using capecitabine and cyclophosphamide (XC) has demonstrated synergistic antitumor activity in preclinical studies. We investigated the efficacy and safety of early-linen XC therapy use in patients with metastatic breast cancer (MBC).
Methods: In this prospective cohort study conducted at 10 site in Kyushu, Japan, patients with human epidermal growth factor receptor 2 (HER2)-negative MBC, regardless of the history of previous treatment, were enrolled. XC therapy was administered at the recommended dose on a three-week schedule for at least six courses unless disease progression and unacceptable toxicities occurred. The primary endpoint was response rate (RR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and adverse events.
Results: Of the 83 patients enrolled, 71 (median age, 60 years [range, 34–86 years]) fulfilled the inclusion criteria and were analyzed. A total of 45 (63%) patients did not previously receive chemotherapy for metastatic disease, 10 (14%) received one chemotherapy regimen. The median number of cycles of XC was eight (range, 1–45), and the RR was 28%. Median PFS was 7.6 months (95% confidence interval [CI]: 5.7–9.5 months), and median OS was 26.4 months (95% CI: 13.9–38.9 months). The most frequent grade 3–4 adverse events were leukopenia (n = 20) and neutropenia (n = 15).
Conclusions: In clinical practice, XC therapy exhibited efficacy and manageable tolerability in Japanese women with MBC in early-line use. (ID: UMIN000044444)
