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      Oral Capecitabine Improves Quality of Life in Patients With Anthracycline- And Taxane-Pretreated Metastatic Breast Cancer

      A DGReview of :"Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer"
      European Journal of Cancer

      03/01/2004
      By Emma Hitt, PhD


      Oral capecitabine appears to be effective and well tolerated in patients with anthracycline- and taxane-pretreated metastatic breast cancer, and it also improves quality of life (QOL), according to the findings of a new multicentre phase 2 study.

      Treating patients with anthracycline- and taxane-pretreated metastatic breast cancer represents a significant challenge. The oral fluoropyrimidine, capecitabine, is the only approved treatment for patients with anthracycline- and taxane-pretreated metastatic breast cancer. However, the impact of oral capecitabine monotherapy on QOL in these patients has not previously been determined.

      Pierre Fumoleau, MD, with the Centre Rene Gauducheau, Nantes-St Herblain, France, and colleagues conducted a phase 2 trial to evaluate the efficacy, safety and impact on QOL of capecitabine in 126 patients with anthracycline- and taxane-pretreated metastatic breast cancer.

      Patients received capecitabine 1250 mg/m2 twice daily, days 1 to 14, followed by a 7-day rest period. Median time to progression was 4.9 months; 28% of patients achieved an objective response, including 4% with complete responses. Median overall survival was 15.2 months.

      According to the researchers, capecitabine demonstrated a favourable safety profile, resulting in a low incidence of treatment-related grade 3/4 adverse events. The most common adverse events were hand-foot syndrome and gastrointestinal effects.

      QOL assessment indicated that capecitabine treatment was associated with an increased mean Global Health Score.

      "This study confirms that oral capecitabine is an effective and well-tolerated agent that also improves QOL in patients with anthracycline- and taxane- pretreated metastatic breast cancer," Dr. Fumoleau and colleagues conclude.

      The researchers point out that the inconvenience and toxicity associated with the administration of multiple intravenous agents present difficulties for heavily pretreated patients, for whom palliation and maintenance of QOL are the primary goals of treatment. "Therefore, capecitabine is the only treatment evaluated in anthracycline- and taxane-pretreated breast cancer that successfully combines meaningful clinical efficacy with a good safety profile," they note.

      "Given the clear preference among patients with advanced cancer for oral therapy, capecitabine merits consideration as 'standard therapy' for anthracycline and taxane-pretreated patients," they suggest.



      Eur J Cancer 2004;40:536-542. "Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer"

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