Résumé
Abstract only 4083
Background: A recent phase III trial in first-line MCRC showed that XELOX is well tolerated and non inferior to FOLFOX-4 in terms of progression-free survival (PFS) [Cassidy ESMO 2006]. We conducted a phase III trial of XELOX vs. FOLFOX-6 as first-line treatment for MCRC. Methods: 306 patients were randomized to receive either XELOX (n=156: capecitabine 1,000mg/m
2
bid d1–14, oxaliplatin 130mg/m
2
d1, q3w) or FOLFOX-6 (n=150: oxaliplatin 100mg/m
2
d1 LV 400mg/m
2
2h infusion then 5-FU 400mg/m
2
i.v. bolus then 2,400- 3,000mg/m
2
46h infusion, q2w) for 6 months. Primary objective: demonstrate non-inferiority of XELOX (best response rate, RECIST). A cost minimization has been conducted from the French hospital perspective. The hospitalizations for chemotherapy (drug administration) were compiled and the direct hospital costs estimated using official tariffs of the national ‘PMSI’ database, directly derived from the Diagnosis Related Group (DRG). Results: The ITT population comprises 306 patients (156 on XELOX, 150 on FOLFOX-6). Baseline characteristics were well balanced. Patients received an average of 6.1±2.4 and 9.2±3.2 cycles of XELOX and FOLFOX-6, respectively. The number of hospitalizations was 6.5±2.6 and 9.5±4.1 for XELOX and FOLFOX-6, respectively. The costs of hospitalization for chemotherapy are available for 282 patients (142 in the XELOX arm and 140 in the FOLFOX-6 arm). The average cost of chemotherapy per cycle per patient was 608±446€ in the XELOX arm and 1,043±787€ in the FOLFOX-6 arm (p<0.001). Conclusions: As we have shown in the efficacy and safety abstracts also presented at this meeting, XELOX is non inferior to FOLFOX-6 in terms of best response rate with a comparable safety profile. In addition, XELOX appears to decrease hospital resource consumption compared with FOLFOX-6.
No significant financial relationships to disclose.