Abstract

15022 Background: A recent randomized phase III trial of XP vs. continuous infusion of FP as first-line therapy in patients with AGC met its primary endpoint of non-inferior progression-free survival (PFS) [Kang et al. ASCO 2006]. There was a trend toward superior efficacy with XP in terms of both PFS (median 5.6 months for XP vs. 5.0 months for FP) and response rates. An economic evaluation was conducted to compare the costs of the two therapies from an Italian perspective. Methods: Direct medical costs during the study period were estimated from the perspective of the Italian health system. The costs of the 2 regimens were estimated based on the trial results on actual dose and the number of administrations, and unit costs in an Italian setting. The adverse event (AE) profiles were used to estimate the costs of treating AEs. An expert panel estimated typical treatment patterns and costs of treating major AEs. Indirect costs for time and travel for study drug administration were estimated. Results: Patients in the XP arm received 5.2 cycles of therapy vs. 4.6 cycles of FP. The substitution of oral capecitabine for infusional 5-FU reduced the number of hospital clinic visits by 17.6 (22.8 for FP vs. 5.2 for XP). Chemotherapy drug costs were estimated to be €1200 greater in the XP arm, but drug administration costs were €2900 lower, yielding a net cost saving of €1700 per patient. The AE profiles were similar: associated costs to treat major (grade 3/4) AEs were less than €170 per patient and were lower in the XP arm. Due to the additional 17.6 visits for infusion of 5-FU, FP patients incurred substantially greater indirect costs in terms of lost time and travel expenses. Conclusion: Oral capecitabine benefits AGC patients by reducing the number of infusion visits and time spent receiving treatment, and would produce significant direct medical cost savings in an Italian setting. AE costs are similar with the 2 regimens. Given the trend to superior efficacy, the projected direct and indirect cost savings, and the convenience of oral treatment, XP would be considered a dominant (less costly and more effective) regimen for AGC from both a health system and societal perspective. No significant financial relationships to disclose.

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