Most patients received the designated number of treatment cycles (83% in the capecitabine arm and 87% in the 5-FU/FA arm). Dose modifications were required in 57% of patients receiving capecitabine versus 52% receiving 5-FU/FA. More interruptions (15% vs 5%) and delays (46% vs 29%) were also required with capecitabine.r
There was a statistically higher incidence of hand and foot syndrome (60% vs 9%) and hyperbilirubinaemia (50% vs 20%) in patients treated with capecitabine and higher diarrhoea (64% vs 46%), nausea or vomiting (51% vs 36%), stomatitis (60% vs 22%), alopecia (22% vs 6%) and neutropenia (63% vs 32%) with 5-FU/FA. It should be noted that the toxicity profile of 5-FU/FA is reflective of the Mayo regimen which is the most toxic of the 5-FU/FA administration schedules.
In both treatment groups, scores for global health status (EORTC-QLQ-C30) were constant over time (from baseline to 25 weeks of the trial treatment) and there were no statistically significant differences between groups.r
© New England Journal of Medicine 2005