Abstract
4150 Background: The results of a randomized phase II trial in pts with MGA showed that LV5FU2-irinotecan (CPT arm) combination as first-line therapy had a better efficacy and toxicity profile than LV5FU2 (5FU arm) alone or LV5FU2-cisplatin (CIS arm) (Bouche et al. Proc ASCO 2003; 22: 258). QoL was assessed using the EORTC QLQ-C30 to investigate the risk-benefit ratio and to test the infrastructure for future data collection before a phase III study. Methods: QLQ-C30 was self-administered at baseline and every 8 weeks in the 134 eligible pts: 5FU arm (45 pts), CIS (44 pts) and CPT (45 pts). Scores were compared to baseline with an analysis of variance (ANOVA). During a 6-month follow-up: - QLQ C30 scores and compliance were analyzed with mean (SD) and percent of missing scores; - a mixed ANOVA model for repeated measurements was applied to summarize the better longitudinal QoL profile. The same analyses were performed with the extreme poorest QLQ-C30 allocation for non-ignorable missing scores. Results: C...
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