Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial
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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DOI：
10.1093/annonc/mdn717
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发表时间：
2009-04-01
影响因子：
50.5
通讯作者：
McCloud, P. I.
中科院分区：
文献类型：
--
作者：
Kang, Y. -K.;Kang, W. -K.;McCloud, P. I.
背景资料：比较卡培他滨/顺铂与5-氟尿嘧啶/顺铂作为晚期胃癌（AGC）的一线治疗。患者和方法：在这项随机、开放标签、III期研究中，患者接受顺铂（80 mg/m2静脉注射，第1天）加口服卡培他滨（1000 mg/m2 b.i.d.，第1-14天）（XP）或5-FU（800 mg/m2/天，连续输注，第1-5天）（FP），每3周一次。主要终点是确认XP与FP相比无进展生存期（PFS）的非劣效性。结果：共有316例患者被随机分配至XP组（n = 160）或FP组（n = 156）。在符合方案人群中，XP（n = 139）与FP（n = 137）的中位PFS分别为5.6个月与5.0个月。达到主要终点的未校正风险比（HR）为0.81 [95%置信区间（CI）0.63-1.04，P < 0.001，非劣效性界值为1.25]。XP与FP的中位总生存期分别为10.5个月和9.3个月（未校正HR = 0.85，95% CI 0.64-1.13，P = 0.008，非劣效性界值为1.25）。XP与FP患者中最常见的治疗相关3/4级不良事件如下：中性粒细胞减少（16%与19%）、呕吐（7%与8%）和口腔炎（2%与6%）。结论：在AGC的一线治疗中，XP显示PFS与FP相比具有显著的非劣效性。XP可以被认为是FP的有效替代品。
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.