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Among women with high-risk early breast cancer, the addition of Xeloda® (capecitabine) to a standard chemotherapy regimen reduces the risk of cancer recurrence. These results were recently presented at the 2008 San Antonio Breast Cancer Symposium (SABCS).

Xeloda is an oral chemotherapy drug that is used in the treatment patients with advanced breast or colorectal cancers.

To evaluate Xeloda in combination with other chemotherapy drugs for the treatment of high-risk early breast cancer, researchers conducted a Phase III clinical trial known as FinXX. Patients were considered to have high-risk cancer if their cancer was node positive or if their cancer was larger than 20 mm and progesterone receptor-negative.

The trial has enrolled 1,500 patients from 20 medical centers in Finland and Sweden. Approximately 43% of patients were premenopausal and three-quarters of patients had hormone-sensitive cancers.

Study participants were assigned to one of two treatment groups:

  1. T-CEF: Taxotere® (docetaxel) followed by cyclophosphamide, Ellence® (epirubicin), and 5-FU.
  2. TX-CEX: Taxotere and Xeloda followed by cyclophosphamide, Ellence, and Xeloda.
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The results presented at SABCS were interim results; final analysis of study results is expected to take place in 2010.

Thus far, patients have been followed for a median of three years.

  • Recurrence-free survival was 92.5% among patients treated with TX-CEX (the regimen that includes Xeloda) and 88.9% among patients treated with T-CEF (the regimen that does not include Xeloda).
  • Overall survival was 95.6% with TX-CEX and 94.9% with T-CEF.
  • More patients discontinued therapy in the Xeloda arm.
  • Grades III/IV hand-foot syndrome, stomatitis, and diarrhea were more common in patients treated with TX-CEX. Neutropenia, on the other hand, was more common in patients treated with T-CEF.

These results suggest that the addition of Xeloda to chemotherapy for high-risk early breast cancer reduces the risk of cancer recurrence. The final analysis of this study is expected to take place in 2010.

Reference: Joensuu H, et al. Significant improvement in recurrence-free survival (RFS) when capecitabine (X) is integrated into docetaxel (T) → 5-FU + epirubicin + cyclophosphamide (CEF) adjuvant therapy for high-risk early breast cancer (BC): interim analysis of the FinXX-trial. Proceedings from the 2008 San Antonio Breast Cancer Symposium. Abstract 82.

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