A late phase II study of S-1 for metastatic pancreatic cancer
A late phase II study of S-1 for metastatic pancreatic cancer
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DOI：
10.1007/s00280-007-0514-8
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发表时间：
2008-04-01
影响因子：
3
通讯作者：
Saito, Hiroshi
中科院分区：
文献类型：
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作者：
Okusaka, Takuji;Funakoshi, Akihiro;Saito, Hiroshi
本研究评估了S-1（一种口服氟嘧啶衍生物）在转移性胰腺癌患者中的抗肿瘤效果和安全性。首次化疗的胰腺腺癌患者和可测量的转移性病变被纳入研究。S-1每天饭后口服两次，剂量为80、100或120 mg/天，体表面积（bsa）分别小于1.25 m(2)、1.25 m(2)至小于1.5 m(2)或大于1.5 m(2)，连续28天，然后休息14天。40例患者中有15例（37.5%）对治疗有反应，其中1例完全缓解，14例部分缓解。中位进展时间和总生存时间分别为3.7个月（95%可信区间，2.2-5.6个月）和9.2个月（95%可信区间，7.5-10.8个月）。主要不良事件为厌食、疲劳、血红蛋白减少、恶心和色素改变，尽管大多数是可耐受和可逆的。虽然2例患者发生弥漫性血管内凝血，但经抗凝治疗后病情得到缓解。S-1是一种有效且耐受性良好的药物。该药的有效性应在III期研究中得到证实。
This study evaluated the antitumor effect and safety of S-1, an oral fluoropyrimidine derivative, in patients with metastatic pancreatic cancer. Chemo-naive patients with pancreatic adenocarcinoma, and measurable metastatic lesions were enrolled. S-1 was administered orally twice daily after meals at a dose of 80, 100, or 120 mg/day for body surface areas (BSAs) of less than 1.25 m(2), between 1.25 m(2) and less than 1.5, or 1.5 m(2) or greater, respectively, for 28 consecutive days, followed by a 14-day rest. Fifteen (37.5%) of 40 patients responded to treatment, including 1 complete response and 14 partial responses. The median time to progression and the overall survival time were 3.7 months (95% confidence interval, 2.2-5.6 months) and 9.2 months ( 95% confidence interval, 7.5-10.8 months), respectively. The major adverse events were anorexia, fatigue, hemoglobin reduction, nausea and pigmentation change, although most were tolerable and reversible. Although disseminated intravascular coagulation occurred in two patients, the condition resolved with anticoagulant therapy. S-1 is an effective and well-tolerated drug. The effectiveness of this drug should be confirmed in a phase III study.