Capecitabine: new indication. In breast cancer: inadequately assessed

There is no consensus on treatment of locally advanced or metastatic breast cancer after failure of first-line cytotoxic chemotherapy. Common options are continuous infusion of a taxane (docetaxel or paclitaxel), vinorelbine or fluorouracil. Capecitabine is now licensed for use in breast cancer, both in combination with IV docetaxel after anthracycline failure, and as single-agent therapy after failure of anthracyclines and taxanes. The clinical evaluation dossier on capecitabine fails to answer the most important questions about comparative efficacy and safety. In second-line treatment, after anthracycline failure, the only available comparative trial showed that the capecitabine + docetaxel combination increased median survival time by about three months relative to placebo + docetaxel, but caused more adverse events. There are no trials comparing capecitabine with other options. There is no evidence that capecitabine increases the length or quality of survival, relative to intravenous vinorelbine, in women with breast cancer that is resistant to both anthracyclines and taxanes. The classical adverse effects of capecitabine are also observed in women with breast cancer, namely palmoplantar erythrodysesthesia, diarrhoea, nausea and vomiting, and major hyperbilirubinemia. Capecitabine can be taken by mouth and this may be an advantage. However, current evidence is too limited to justify using capecitabine outside of clinical trials.