Efficacy
In the intention-to-treat-population, median PFS for XP (n=160) versus FP (n=156) was 5.6 versus 5.0 months. The unadjusted hazard ratio (HR) was 0.80 (95% CI 0.63-1.03) and XP was significantly non-inferior compared with FP (p<0.001 versus the non-inferiority margin of 1.25). Median overall survival was 10.4 versus 8.9 months for XP versus FP (unadjusted HR = 0.85, 95% CI 0.65-1.11, p=0.005 versus noninferiority margin of 1.25).r
Progression-free and Overall Survivalr
Survival curves are shown for the per-protocol population, which excluded forty patients due to inadequate tumour burden information at baseline; insufficient/inadequate follow-up assessment of lesions found at baseline, violation of inclusion/exclusion criteria, and received less than two cycles of treatment.
© Annals of Oncology 2009
A recent meta-analysis suggested that overall survival was superior in patients treated with capecitabine-based combinations compared with 5-fluorouracil-based combinations (HR=0.87; 95% CI 0.77-0.98, p=0.02) although no significant difference in PFS between treatment groups was seen.r