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| |  SABCS: Xeloda (Capecitabine)/Taxotere (Docetaxel) Good Chemotherapy Combination MISSISSAUGA, ON -- December 11, 2001 -- Hoffmann-La Roche's cancer drug Xeloda (capecitabine), in combination with Aventis' Taxotere (docetaxel) demonstrated a unique survival benefit and was highly cost-effective in a study presented at the 24th Annual San Antonio Breast Cancer Symposium in Texas, United States. Xeloda/Taxotere (X+T) is the first chemotherapy regimen to demonstrate significantly superior survival compared to a standard treatment of Taxotere monotherapy in a study of patients with metastatic breast cancer. In addition to its survival benefit, the combination therapy was highly cost-effective. With a cost per life year gained of less than US$5,000, the additional survival with Xeloda/Taxotere is gained at minimal additional cost. Therapies offering additional survival at a cost of less than $50,000 per life year gained are generally accepted as cost-effective. "The X+T combination is a major step forward for the care of women with metastatic breast cancer. The three month survival benefit is so important because it is very rare to be able to clearly improve survival in these patients," said Dr. Joyce O'Shaughnessy, co-director of breast cancer research at Baylor-Sammons Cancer Center and US Oncology and the lead investigator of the study. "More women with metastatic breast cancer will live longer thanks to the Xeloda/Taxotere combination - and this improvement is achieved cost effectively. This is heartening news for these women and their families." The large global study compared Xeloda/Taxotere to Taxotere monotherapy and included more than 500 patients who had failed prior therapy with anthracyclines. Patients treated with Xeloda/Taxotere demonstrated a three- month survival advantage at the median (14.5 months versus 11.5 months) compared to those treated with Taxotere alone. In addition to the survival advantage, patients in the Xeloda/Taxotere group demonstrated statistically superior improvements in both time to disease progression (median of 6.1 months versus 4.2 months) and tumour response rates (42 percent versus 30 percent). An oral chemotherapy drug, Xeloda is unique in that it is activated by an enzyme that is found at higher levels in cancer than in healthy tissue. This leads to more of the cancer-killing agent 5-FU being produced in the tumor, where it is needed. Taxotere further increases the levels of this enzyme, potentially leading to even more Xeloda being converted into cancer-killing 5-FU. After a priority review by the U.S. Food and Drug Administration (FDA), the Xeloda/Taxotere combination therapy was approved in September for the treatment of patients with metastatic breast cancer for whom prior anthracycline chemotherapy had failed. The combination is currently under a priority review with Health Canada. In Canada this year, an estimated 19,500 women will be diagnosed with breast cancer and 5,500 women will die from the disease. Breast cancer is the second leading cause of cancer-related deaths among Canadian women after lung cancer. Although breast cancer mortality rates have declined slightly in Canada, the incidence of new cases continues to increase. This pattern is attributed to the improvements in cancer screening programs and treatments.
References - O'Shaughnessy JA et al, Pharmacoeconomic analysis of Xeloda (capecitabine) in combination with docetaxol for the treatment of advanced breast cancer pretreated with anthracyclines. San Antonio Breast Cancer Symposium, San Antonio, US; December 10-13 2001; 264a SOURCE: Hoffmann-La Roche Limited
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