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Clinical Trial
. 2009 Apr;20(4):666-73.
doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.

Capecitabine/cisplatin Versus 5-fluorouracil/cisplatin as First-Line Therapy in Patients With Advanced Gastric Cancer: A Randomised Phase III Noninferiority Trial

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Clinical Trial

Capecitabine/cisplatin Versus 5-fluorouracil/cisplatin as First-Line Therapy in Patients With Advanced Gastric Cancer: A Randomised Phase III Noninferiority Trial

Y-K Kang et al. Ann Oncol. .

Abstract

Background: To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer (AGC).

Patients and methods: In this randomised, open-label, phase III study, patients received cisplatin (80 mg/m(2) i.v. day 1) plus oral capecitabine (1000 mg/m(2) b.i.d., days 1-14) (XP) or 5-FU (800 mg/m(2)/day by continuous infusion, days 1-5) (FP) every 3 weeks. The primary end point was to confirm noninferiority of XP versus FP for progression-free survival (PFS).

Results: A total of 316 patients were randomised to XP (n = 160) or FP (n = 156). In the per-protocol population, median PFS for XP (n = 139) versus FP (n = 137) was 5.6 versus 5.0 months. The primary end point was met with an unadjusted hazard ratio (HR) of 0.81 [95% confidence interval (CI) 0.63-1.04, P < 0.001 versus noninferiority margin of 1.25]. Median overall survival was 10.5 versus 9.3 months for XP versus FP (unadjusted HR = 0.85, 95% CI 0.64-1.13, P = 0.008 versus noninferiority margin of 1.25). The most common treatment-related grade 3/4 adverse events in XP versus FP patients were as follows: neutropenia (16% versus 19%), vomiting (7% versus 8%), and stomatitis (2% versus 6%).

Conclusions: XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC. XP can be considered an effective alternative to FP.

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