Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naive patients with advanced gastric cancer
Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naive patients with advanced gastric cancer
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DOI：
10.1093/annonc/mdu472
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发表时间：
2015-01-01
影响因子：
50.5
通讯作者：
Hyodo, I.
中科院分区：
文献类型：
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作者：
Yamada, Y.;Higuchi, K.;Hyodo, I.
我们评估了S-1 +奥沙利铂（SOX）作为顺铂+ S-1 （CS）一线化疗治疗晚期胃癌（AGC）的疗效和安全性。在这项随机、开放标签、多中心的III期研究中，患者被随机分配接受SOX （80- 120mg /天S-1，持续2周，第1天100mg /m(2)奥沙利铂，每3周）或CS （S-1，持续3周，第8天60mg /m(2)顺铂，每5周）。主要终点是无进展生存期（PFS）的非劣效性和SOX的总生存期（OS）的相对有效性，使用校正风险比（hr）和分层因素；性能状况和不可切除或复发（+辅助化疗）疾病。从2010年1月到2011年10月，总共有685名患者被随机分组。在每个方案人群中，SOX （n = 318）在PFS中的表现不逊于CS (n = 324)[中位数，5.5个月对5.4个月；HR 1.004, 95%可信区间（CI） 0.840-1.199；预定义的非劣效裕度1.30]。SOX和CS的中位生存期分别为14.1和13.1个月（HR 0.958, 95% CI 0.803-1.142）。在意向治疗人群（SOX, n = 339； CS, n = 337）中，PFS和OS的hr分别为0.979 （95% CI 0.821-1.167）和0.934 （95% CI 0.786-1.108）。最常见的1千分之一的3级不良事件（SOX对CS）是中性粒细胞减少（19.5%对41.8%）、贫血（15.1%对32.5%）、低钠血症（4.4%对13.4%）、发热性中性粒细胞减少（0.9%对6.9%）和感觉神经病变（4.7%对0%）。对于AGC， SOX与CS一样有效，且具有良好的安全性，因此SOX可以替代CS。
We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) as an alternative to cisplatin plus S-1 (CS) in first-line chemotherapy for advanced gastric cancer (AGC).In this randomized, open-label, multicenter phase III study, patients were randomly assigned to receive SOX (80-120 mg/day S-1 for 2 weeks with 100 mg/m(2) oxaliplatin on day 1, every 3 weeks) or CS (S-1 for 3 weeks with 60 mg/m(2) cisplatin on day 8, every 5 weeks). The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease.Overall, 685 patients were randomized from January 2010 to October 2011. In per-protocol population, SOX (n = 318) was noninferior to CS (n = 324) in PFS [median, 5.5 versus 5.4 months; HR 1.004, 95% confidence interval (CI) 0.840-1.199; predefined noninferiority margin 1.30]. The median OS for SOX and CS were 14.1 and 13.1 months, respectively (HR 0.958 with 95% CI 0.803-1.142). In the intention-to-treat population (SOX, n = 339; CS, n = 337), the HRs in PFS and OS were 0.979 (95% CI 0.821-1.167) and 0.934 (95% CI 0.786-1.108), respectively. The most common a parts per thousand yengrade 3 adverse events (SOX versus CS) were neutropenia (19.5% versus 41.8%), anemia (15.1% versus 32.5%), hyponatremia (4.4% versus 13.4%), febrile neutropenia (0.9% versus 6.9%), and sensory neuropathy (4.7% versus 0%).SOX is as effective as CS for AGC with favorable safety profile, therefore SOX can replace CS.