Efficacy and toxicity of capecitabine-based chemotherapy in patients with metastatic or advanced breast cancer: results from ten randomized trials

Abstract

Objective:

The efficacy and adverse effects of capecitabine-based chemotherapy versus other regimens reported in previous trials were discordant. The aim of the present study was to determine the efficacy and toxicity profiles of capecitabine-based chemotherapy versus capecitabine-free regimens in patients with metastatic and/or advanced breast cancer.

Methods:

Randomized trials in which capecitabine-based chemotherapy was compared with capecitabine-free chemotherapy were included by searching the PubMed database. Differences in efficacy and grade 3–4 toxicities between capecitabine-based chemotherapy and other chemotherapy were compared.

Results:

Ten randomized controlled trials were included in our meta-analysis. Compared to patients treated with capecitabine-free chemotherapy, patients treated with capecitabine-based chemotherapy did not have a significantly different complete response (odds ratio (OR): 1.25, 95% confidence interval (CI): 0.87–1.79, p = 0.231), partial response (OR: 1.16, 95% CI: 0.95–1.41, p = 0.147), and overall response (OR: 1.21, 95% CI: 1.00–1.47, p = 0.053). Compared to the capecitabine-free group, less hematological toxicity and more gastrointestinal toxicity occurred in patients treated with capecitabine-based chemotherapy, including neutropenia (OR: 0.34, 95% CI: 0.19–0.59, p < 0.001), anemia (OR: 0.41, 95% CI: 0.20–0.85, p = 0.016), leukocytopenia (OR: 0.50, 95% CI: 0.32–0.78, p = 0.002), and diarrhea (OR: 2.35, 95% CI: 1.62–3.42, p < 0.001). Furthermore, patients in the capecitabine group exhibited a significantly higher rate of grade 3 hand-foot syndrome than the capecitabine-free group (OR: 25.16, 95% CI: 12.27–51.58, p < 0.001).

Conclusions:

The present study suggests that capecitabine-based chemotherapy is as effective as capecitabine-free chemotherapy in patients with metastatic and/or advanced breast cancer with different toxicity profiles. Capecitabine-based chemotherapy may be better tolerated than capecitabine-free chemotherapy. Due to several limitations in our study, future large randomized trials are needed.

Keywords::

• Capecitabine
• Efficacy
• Meta-analysis
• Metastatic breast cancer
• Toxicity

Transparency

Declaration of funding

This work was supported by Chinese National Natural Science Foundation (30972822, 81001329, 81273274, 81 273 593), Jiangsu Province’s Key Provincial Talents Program (RC201170, H201108), Foundation of Pharmacology of Nanjing (H2011YX001), National Major Scientific and Technological Special Project for “Significant New Drugs Development” (2011ZX09302-003-02), Jiangsu Province Major Scientific and Technological Special Project (BM2011017), and A Project Funded by the Priority Academic Program Development of Jiangsu Higher Education Institutions.

Declaration of financial/other relationships

The authors have no relevant financial relationships to be declared. J.F.W. has contributed to the conception and design of the study, the analysis and interpretation of data, the revision of the article as well as final approval of the version to be submitted. Y.W., H.Y. and L.M. participated in the design of the study, performed the statistical analysis, searched and selected the trials, drafted and revised the article. All authors read and approved the final version of the manuscript.

CMRO peer reviewers on this manuscript have no relevant financial relationships to disclose.