Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer.
Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer.
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多中心、随机、开放标签 II 期研究，比较 S-1 隔日口服疗法与标准每日治疗方案作为不可切除的晚期胰腺癌患者的一线治疗。
DOI：
10.1007/s00280-017-3250-8
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Shirasaka T.
中科院分区：
文献类型：
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作者：
Yamaue H;Shimizu A;Hagiwara Y;Sho M;Yanagimoto H;Nakamori S;Ueno H;Ishii H;Kitano M;Sugimori K;Maguchi H;Ohkawa S;Imaoka H;Hashimoto D;Ueda K;Nebiki H;Nagakawa T;Isayama H;Yokota I;Ohashi Y;Shirasaka T.
目的在一项多中心、随机、II期的研究中，对不能切除的日本晚期胰腺癌患者口服抗癌药物S-1隔日治疗与每日标准治疗的总生存期(OS)进行了非劣势评估。本试验在Umin临床试验登记(编号000008604)。方法化疗-局部晚期或转移性胰腺癌的初治患者被随机分为2：1治疗组(42天周期的第1天至42天交替天，每天两次)或每日(42天周期的第1天至第28天，每天两次)。主端点是OS。次要终点为无进展生存期(PFS)、治疗失败时间、有效率、生活质量评估和安全性。隔天治疗组和每日治疗组的中位OS分别为9.4和10.4个月[风险比(HR)，1.19；95%可信区间，0.86至1.64]，表明隔天治疗与每日治疗相比没有显示出非劣势。隔天组和每日组的中位PFS分别为3.0和4.2个月(HR，1.65；95%可信区间，1.20-2.29)。与每日治疗相比，隔日治疗中厌食、乏力、中性粒细胞、色素沉着和肺炎的发生率较低。结论根据隔日治疗中观察到的OS和PFS的降低以及安全性的边际改善，建议对晚期胰腺癌患者每天服用S-1。
PurposeNon-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604).MethodsChemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety.ResultsA total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20–2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment.ConclusionS-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group.