Kang Y-K, Kang W-K, Shin D-B, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud P I
Division of Oncology, Department of Internal Medicine, Asan Medical Center, Songpa-Gu, Seoul, Republic of Korea.
Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.
To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer (AGC).
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).
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%).
XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC. XP can be considered an effective alternative to FP.
比较卡培他滨/顺铂与5-氟尿嘧啶/顺铂作为晚期胃癌（AGC）一线治疗方案的疗效。
在这项随机、开放标签的III期研究中，患者每3周接受一次顺铂（静脉注射80mg/m²，第1天）加口服卡培他滨（1000mg/m²，每日2次，第1 - 14天）（XP方案）或5-氟尿嘧啶（持续静脉输注800mg/m²/天，第1 - 5天）（FP方案）。主要终点是确认XP方案在无进展生存期（PFS）方面不劣于FP方案。
共有316例患者被随机分为XP组（n = 160）或FP组（n = 156）。在意向性分析人群中，XP组（n = 139）与FP组（n = 137）的中位PFS分别为5.6个月和5.0个月。主要终点达到非劣效性标准，未调整的风险比（HR）为0.81[95%置信区间（CI）0.63 - 1.04，与非劣效性界值1.25相比，P < 0.001]。XP组与FP组的中位总生存期分别为10.5个月和9.3个月（未调整的HR = 0.85，95%CI 0.64 - 1.13，与非劣效性界值1.25相比，P = 0.008）。XP组与FP组患者中最常见的3/4级治疗相关不良事件如下：中性粒细胞减少（16%对19%）、呕吐（7%对8%）和口腔炎（2%对6%）。
在AGC一线治疗中，XP方案在PFS方面显示出显著的非劣效性。XP方案可被视为FP方案的有效替代方案。
