Effects of Capecitabine (X) on Quality of Life (qol) in Patients (pts) with Metastatic Colorectal Cancer (MCRC)

8119 Background: : Through its superior activity, improved safety and convenience, × (Xeloda®) is replacing 5-FU/LV as the backbone of MCRC therapy and is now moving into the adjuvant setting. In addition to well-established measures of treatment response, the QoL benefits of oral agents like X over traditional i.v. drugs are becoming increasingly important in MCRC. Methods: : We evaluated QoL in pts receiving X for MCRC. Pts completed the EORTC QLQ C-30 (v3.0) and CR-38 questionnaires at baseline, before cycle 1, at weeks 7 and 13, and at treatment end. We analyzed the proportion of pts with improvement, stabilization or worsening of QoL scores from week 7 using linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2). Results: Baseline characteristics were: 357 evaluable pts, 51% male; median age 59 years (20–100); median ECOG PS 1 (0–3); majority Caucasian (86%). Female pts experienced significant improvements in: global health status (p=0.035), physical functioning (p=0.012), future perspective (p=0.003) defecation problems (0.008) and weight loss (p=0.004). In men, constipation (p=0.019), future perspective (p=0.006), sexual functioning (p=0.013), and weight loss (p=0.013) all improved significantly. The proportion of pts with stable or improved QoL was ≥60% for most scales (none <55%). At least 40% of women had improvements in the following from week 7 onwards: 49% global health status, 49% fatigue, 44% pain, 42% micturition problems, 42% sexual problems, 41% chemotherapy side-effects, and 40% future perspective. Improvements in micturition problems (45%), global health status (42%), future perspective (42%), and sexual functioning (40%) were seen in ≥40% of men. In both men and women, ECOG PS ≥3 at baseline correlated with a greater improvement in QoL compared with that seen in pts with a good PS. Conclusions: X measurably improves QoL in a typical MCRC pt population. These data support its increasing use in first-line and adjuvant settings. QoL should be considered alongside established measures (objective response, TTP and overall survival) when selecting the most appropriate therapy in MCRC. No significant financial relationships to disclose.