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Curr Med Res Opin. 2012 Dec;28(12):1911-9. doi: 10.1185/03007995.2012.748655. Epub 2012 Nov 27.

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

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  • 1Research Division of Clinical Pharmacology, the First Affiliated Hospital, Nanjing Medical University, Nanjing, China.



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.


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.


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).


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.

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