75 and a power of 90%. The analyses thing included several variables such as age, K?hne score, time interval between CRC diagnosis and metastatic disease, type of cancer, QoL and health-care satisfaction. Differences in QoL and morbidity were analysed using analysis of variance, accounting for differences in survival between groups. Mortality was compared using Kaplan�CMeier curves and log�Crank statistics. The primary analysis of QoL data was performed using a mixed-models analysis of variances for repeated measures. The reliability of the multi-item scales of QLQ-C30 and FACIT-CCSQ was assessed using Cronbach �� coefficient for internal consistency (Cronbach, 1951). A Cronbach �� coefficient >0.5 was considered as acceptable reliability, whereas a Cronbach �� coefficient >0.

7 was considered as good reliability (Nunally and Berstein, 1994). Results Study population A total of 306 patients were randomised: 245 patients (XELOX n=126, FOLFOX-6 n=119) answered the QLQ-C30 and 225 patients (XELOX n=111, FOLFOX-6 n=114) answered FACIT-CCSQ. The characteristics at baseline of these patients are presented in Table 1. No significant differences between XELOX and FOLFOX-6 groups regarding socio-demographic data, mCRC characteristics and other baseline characteristics were observed in the HRQoL sets. Table 1 Baseline demographic characteristics of patients QoL results Completion rate The completion rate of QoL assessments referred to the number of patients participating at the related visit. Overall, completion rates were satisfactory at the different visits, and were >80% for both questionnaires and for treatment groups.

Missing item rate The missing item rate referred to the number of missing items of data among received forms at the related visit. Overall, the missing item rates for both questionnaires were not significantly different between XELOX and FOLFOX-6 at baseline and at subsequent visits. The European Organisation for Research and Treatment of Cancer QLQ-C30 scores No relevant differences were observed between the FOLFOX-6 and XELOX arms at baseline and at subsequent visits. Compared with the FOLFOX-6 group, patients had significantly less dyspnoea in the XELOX group (18.0 (13.9; 22.1)90% vs 25.4 (20.9; 29.8)90%; P=0.017), but significantly more sleep disturbances (38.4 (33.3; 43.5)90% vs 29.1 (24.4; 33.7)90%; P=0.036) at baseline.

For all subsequent evaluations (C3/C4, C6/C8 and final visit), the QLQ-C30 functional and symptom scores were not significantly different between the XELOX and FOLFOX-6 arms. Results of the QLQ-C30 are summarised in Table 2. Moreover, when focusing on sleep disturbances and dyspnoea items, there were no clinically AV-951 relevant changes between baseline and final visit for either group, as the changes in scores were <10.