A randomized cross-over trial comparing single-agents capecitabine (C) and UFT plus leucovorin (LV) in patients (Pts) with advanced colorectal cancer (CRC): Preliminary data of a patient preference study

558 Background: Oral fluoropyrimidines such as C and UFT plus LV (U) are widely used pro-drugs dedicated to the care of CRC. Although their toxicity profile may slightly differ, no direct comparison between these treatments has been done as both molecules are converted into fluorouracil. To help the physicians to choose between C and U, we initiated this randomized cross-over trial aimed to assess patient's preference. Methods: Pts with advanced CRC received either a first cycle of C (1,250mg/m2 x 2/d for 14 days, q3 wks) or a first cycle of U (UFT 300mg/m2/d plus LV 75 mg/d in 3 divided doses every 8 hrs for 28 days, repeated at 35-day intervals). Patients were randomized to receive C at cycle 1 followed by U (arm A) or U at cycle 1 followed by C (arm B). After 2 cycles, pts were asked which treatment they preferred. Treatment was then continued with the chosen regimen. Preferences rates are presented with 95% confidence intervals and the two groups are compared with the chi-squared test. Results: 89 pts were enrolled from 10/2005 to 6/2010. Treatment arms were well balanced for baseline characteristics: male 57%; median age 66 years; PS 0-1 81%. Most of the pts were heavily pretreated (0/1/2/ and >2 previous chemotherapy lines: 6/2/15/66). 64 (arm A: 35, arm B: 29)/89 pts received at least 2 cycles of chemotherapy and were evaluable for preference. At cycle 1, 21% and 43% of the pts presented at least 1 severe toxic event with C and U, respectively. Pts with U at cycle 1 presented more likely with severe fatigue and anorexia. There was 1 toxic death under C (gr. 3 diarrhea, gr.4 neutropenia) at cycle 1. Overall, 66% (95%CI: 52-77%) of evaluable pts expressed preference for C, and there was a statistically significant difference between arms A and B (p Conclusions: Pts with advanced CRC preferred C over U, especially when given during the first cycle. No significant financial relationships to disclose.