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) (Bouché 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: Compliance decreased with time: missing scores for global QoL increased from 18% (5FU arm), 25% (CIS arm), 16% (CPT arm) at baseline to 59%, 62% and 52% at 6 months respectively. At inclusion, 5FU arm pts reported more constipation than in CIS arm or CPT (p<0.01) and more sleep disorders than in CPT arm (p< 0.05). During the 6-month follow-up: 1 - Global QoL improved whatever the treatment, but 14/15 scores were better in CPT arm than in 5FU arm or CIS (including 5 scales with a mean difference (MD) > 5 points); 2 - the poorest allocation analysis showed a QoL deterioration whatever the treatment, however 14 QLQ-C30 scores were better in CPT arm than in 5FU arm (4 scales with MD > 5 points) and 15 scores were better in the CPT arm than CIS arm (14 scales with MD > 5 points). Conclusion: Although QoL variability at inclusion and missing data represent a limitation, this study shows a favourable impact of LV5FU2-irinotecan on QoL during the 6-month study period and confirms its better risk-benefit ratio in 1st line MGA. Supported by Aventis, Baxter and the ARC No significant financial relationships to disclose.
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