Background: Hand-foot syndrome (HFS) has been previously reported as a side effect in 45-56% of patients treated with capecitabine. However, the natural history of HFS has not been fully characterized. In this study, we investigate the incidence, severity, and time course of HFS.
Design: Toxicity data collected for 41 patients treated in two clinical trials were analyzedfor the occurrence of HFS. Proportions of patients developing HFS after capecitabine treatment were calculated, and the severity and time course of HFS were analyzed.
Results: Twenty-eight (68.3%) of the 41 patients had at least one episode of HFS. Most patients had their first (92.9%) or most severe (67.9%) episode of HFS within the first two cycles of treatment. Eighty-nine percent of the HFS episodes were grade 1 or 2; only 11% were grade 3.
Conclusions: HFS is common in patients treated with capecitabine, and usually starts within the first two cycles of therapy.