Author(s): Zhang RX, Wu XJ, Wan DS, Lu ZH, Kong LH, , Zhang RX, Wu XJ, Wan DS, Lu ZH, Kong LH,
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Abstract BACKGROUND: Hand-foot syndrome (HFS) is the most common adverse event induced by capecitabine. Some clinicians think that HFS is a type of inflammation limited to the hands and feet and can be prevented with a COX-2 inhibitor (celecoxib). METHODS: We designed a single-center, prospective randomized clinical trial to test the hypothesis. From August 2008 to December 2010, stage II and III colorectal cancer patients receiving capecitabine-based chemotherapy enrolled in the trial voluntarily. All patients were divided randomly into two groups treated with or without celecoxib. All adverse events were recorded. RESULTS: Grade 1 and grade 2 HFS were more common in the capecitabine group than in the capecitabine/celecoxib group (74.6\% versus 57.4\%, P = 0.034, 29.6\% versus 14.7\% P = 0.035). The use of celecoxib (P < 0.001, P = 0.003) and the level of dihydropyrimidine dehydrogenase (P = 0.048, P = 0.014) affected the incidence of grade 1 and 2 HFS, as determined by log-rank analysis. Multivariate Cox proportional hazards regression analysis indicated that the use of celecoxib was the only factor that affected the incidence of ≥ grade 1 HFS [Hazard Ratio (HR): 0.556, P = 0.001] and ≥ grade 2 HFS (HR: 0.414, P = 0.005). CONCLUSIONS: Celecoxib can be used effectively and safely to prevent capecitabine-related HFS.
This article was published in Ann Oncol
and referenced in Journal of Clinical & Experimental Dermatology Research