Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo.
Department of Gastroenterology, Kitasato University East Hospital, Sagamihara.
Ann Oncol. 2015 Jan;26(1):141-148. doi: 10.1093/annonc/mdu472. Epub 2014 Oct 14.
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 ≥grade 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.
JapicCTI-101021.
我们评估了 S-1 加奥沙利铂（SOX）作为一线化疗治疗晚期胃癌（AGC）中顺铂加 S-1（CS）替代方案的疗效和安全性。
在这项随机、开放标签、多中心 III 期研究中，患者被随机分配接受 SOX（S-1 80-120mg/天，连用 2 周，第 1 天给予 100mg/m2奥沙利铂，每 3 周 1 次）或 CS（S-1 连用 3 周，第 8 天给予 60mg/m2顺铂，每 5 周 1 次）。主要终点是使用分层因素调整后的风险比（HR）评估 SOX 的无进展生存期（PFS）和总生存期（OS）的非劣效性；表现状态和不可切除或复发（+辅助化疗）疾病。
2010 年 1 月至 2011 年 10 月，共有 685 例患者入组。在方案人群中，SOX（n=318）与 CS（n=324）的 PFS 非劣效[中位，5.5 个月比 5.4 个月；HR 1.004，95%置信区间（CI）0.840-1.199；预设非劣效性边界 1.30]。SOX 和 CS 的中位 OS 分别为 14.1 个月和 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≥3 级不良事件（SOX 与 CS）是中性粒细胞减少症（19.5%与 41.8%）、贫血（15.1%与 32.5%）、低钠血症（4.4%与 13.4%）、发热性中性粒细胞减少症（0.9%与 6.9%）和感觉神经病变（4.7%与 0%）。
SOX 对 AGC 的疗效与 CS 相当，安全性良好，因此 SOX 可替代 CS。
JapicCTI-101021。
