Capecitabine monotherapy is considered standard treatment in anthracycline- and taxane-pretreated metastatic breast cancer and has proven efficacy in this setting. Randomized studies and retrospective analyses have shown that, in patients who received capecitabine monotherapy, or in combination with docetaxel, dose modification of capecitabine is effective in the management of adverse events without compromising efficacy. Dose adjustment of capecitabine is easy to implement due to its twice-daily oral administration. This article reports the findings of a retrospective review of a large data set to consolidate the information about the impact of capecitabine dose modification on efficacy and safety outcomes in patients with metastatic breast cancer. Data on dose modification and outcomes were available from 4 phase II capecitabine monotherapy trials, 1 phase III capecitabine/docetaxel combination trial, and an analysis of consecutive patients who received capecitabine outside of a clinical trial (n = 971). Dose reductions were required in 41% of patients who received monotherapy (n = 131) and 65% of patients who received capecitabine/docetaxel (80% of these required dose reductions of both agents) (n = 163). Time to disease progression and overall survival were similar, or even slightly longer, among patients who received lower vs. full-dose capecitabine in all of the studies reviewed. Reduced capecitabine doses were associated with a lower incidence of treatment-related adverse events, specifically hand-foot syndrome, diarrhea, and stomatitis. Together, these data support the practice of dose-reducing capecitabine, including the possibility of starting at a lower dose (<1250 mg/m(2) twice daily), to reduce the incidence of adverse events without compromising efficacy.
Copyright © 2011. Published by Elsevier Inc.