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| |  ECCO11: Combination Capecitabine/Docetaxel Improves Survival In Women With Advanced And Metastatic Breast Cancer By Ana Hidalgo-Simón LISBON, PORTUGAL -- October 24, 2001 -- A survival update report of the SO14999 phase III breast cancer trial shows that addition of capecitabine to docetaxel monotherapy improves chances of survival for women with advanced breast cancer. Previous trials have demonstrated that capecitabine, an oral fluoropyrimidine, is effective for treating colorectal cancer and metastatic breast cancer that progresses despite other therapies. The combination of capecitabine and docetaxel has been proven effective in pre-clinical studies. To test the effects of capecitabine/docetaxel combination versus docetaxel monotherapy in locally advanced and metastatic breast cancer, a large multicenter international phase III study was conducted. Dr. R. Leonard, from the South Wales Cancer Institute, Swansea, United Kingdom, presented the results yesterday (Oct. 23) at ECCO11, the European Cancer Conference, in Lisbon, Portugal. Researchers recruited 511 women with either locally advanced or metastatic breast cancer, who did not respond to anthracycline treatment. They were randomised to oral capecitabine 1250 mg/mē twice daily plus docetaxel 75 mg/mē at day 1 (n=255) or to docetaxel 100 mg/mē at day 1 (n=256). The two groups of patients were well balanced regarding baseline characteristics. Around a third of them had the study therapy as first line therapy and half of them as second line therapy. Results demonstrated that overall survival was superior in the combination arm (hazard ratio=0.775, p<0.012), with a follow-up median of 14.5 months, versus a shorter follow-up of 11.5 months for docetaxel monotherapy. The number of events recorded was 72 percent and 79 percent for combination and monotherapy, respectively. Differences in survival curves were also found: 56.8 percent of patients survived one year with the combination treatment and 46.9 percent with monotherapy (95 percent CI 51-63 and 41-53, respectively). Approximately two thirds of the patients received post-study chemotherapy in both treatment arms. The risk ratio for overall tumour response rate was also statistically and significantly superior for the combination: 41.6 percent versus 29.7 percent (p=0.006), as was the time to progression (6.1 months median for the combination and 4.2 percent months for docetaxel alone). "At any one time the risk of relapsing is 15 percent less with the combination therapy than with monotherapy," Dr Leonard said. Patients receiving monotherapy experienced a higher incidence of neutropenia and arthralgia. Gastrointestinal complications such as diarrhoea, stomatitis, nausea and vomiting, were more common with the combination therapy.
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