Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial
2009; Elsevier BV; Volume: 20; Issue: 4 Linguagem: Inglês
10.1093/annonc/mdn717
ISSN1569-8041
AutoresYoon‐Koo Kang, Won Ki Kang, D.B. Shin, Jingyu Chen, Jianping Xiong, Jie Wang, Mikhail Lichinitser, Z. Guan, Р. Ш. Хасанов, Leizhen Zheng, Manuel Jesus Philco-Salas, T. Suarez, Javier Gutiérrez Santamarı́a, Gerhard Förster, P. McCloud,
Tópico(s)Gastrointestinal Tumor Research and Treatment
ResumoAbstract 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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