A phase I trial of gemcitabine, S-1 and LV combination (GSL) therapy in advanced pancreatic cancer
A phase I trial of gemcitabine, S-1 and LV combination (GSL) therapy in advanced pancreatic cancer
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吉西他滨、S-1 和 LV 联合 (GSL) 治疗晚期胰腺癌的 I 期试验
DOI：
10.1007/s00280-014-2563-0
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发表时间：
2014
影响因子：
3
通讯作者：
K. Koike
中科院分区：
文献类型：
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作者：
Y. Nakai;H. Isayama;Kei Saito;Takashi Sasaki;N. Takahara;T. Hamada;S. Mizuno;K. Miyabayashi;Keisuke Yamamoto;D. Mohri;H. Kogure;N. Yamamoto;K. Hirano;H. Ijichi;K. Tateishi;M. Tada;K. Koike
目的在我们先前的随机对照试验中，吉西他滨加用替吉奥（S-1）治疗晚期胰腺癌，尽管有较高的缓解率和较长的无进展生存期（PFS），但并没有显著延长总生存期（OS）。甲酰四氢叶酸是已知的，以提高疗效的S-1，我们进行了这一阶段的吉西他滨，S-1和甲酰四氢叶酸（GSL）的联合治疗的I期试验。MethodsPatients with advanced pancreatic cancer who had received no prior chemotherapy were eligible for this study。吉西他滨在第1天以600、800和1，000 mg/m2的递增剂量给药30分钟，第1-7天以40 mg/m2的剂量口服S-1，每日两次，并以25 mg的剂量口服亚叶酸，每日两次，每2周一次。一个标准的“3 + 3”I期剂量递增design.ResultsFifteen患者在三个剂量水平被招募。3例患者发生DLT：1级2例患者（1例3级厌食，1例3级厌食、口腔炎和腹泻），2级1例患者（3级深静脉血栓形成）。在3级中未观察到DLT。有效率和疾病控制率分别为33%和93%。中位PFS和OS分别为5.4和16.6个月。基线时CA 19 -9升高的12例患者中有10例（83%）下降≥ 50%。GSL耐受性良好，在晚期胰腺癌中显示出有希望的结果。
PurposeIn our previous randomized controlled trial, the addition of S-1 to gemcitabine for advanced pancreatic cancer did not prolong overall survival (OS) significantly, despite its higher response rate and longer progression-free survival (PFS). Leucovorin is known to enhance efficacy of S-1, and we conducted this phase I trial of combination therapy of gemcitabine, S-1 and leucovorin (GSL).MethodsPatients with advanced pancreatic cancer who had received no prior chemotherapy were eligible for this study. Gemcitabine was administered at an escalating dose of 600, 800 and 1,000 mg/m2 over 30 min on day 1, and oral S-1 at a dose of 40 mg/m2 twice daily and oral leucovorin at a dose of 25 mg twice daily on days 1–7, every 2 weeks. A standard “3 + 3” phase I dose escalation design was utilized.ResultsFifteen patients were enrolled across three dose levels. Three patients developed DLTs: two patients in level 1 (grade 3 anorexia in 1 and grade 3 anorexia, stomatitis and diarrhea in 1) and one patient in level 2 (grade 3 deep vein thrombosis). No DLT was observed in level 3. Response rate and the disease control rate were 33 and 93 %, respectively. The median PFS and OS were 5.4 and 16.6 months. Ten of 12 patients (83 %) with elevated CA19-9 at baseline had a ≥50 % decline.ConclusionsRD of gemcitabine in GSL was determined as 1,000 mg/m2. GSL was well tolerable and showed promising results in advanced pancreatic cancer.
伊立替康联合口服氟嘧啶S-1治疗转移性结直肠癌的I/II期研究
DOI：
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发表时间：
2007
期刊：
影响因子：
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作者：
ARITA S;Baba Ei;Shibata Y;Niiro H;Isobe T;Shimoda S;Hirano G;Makiyama A;Uchino K;Kusaba H;Nakano S;Harada M.;Baba E;Baba E
通讯作者：
Baba E
M. Okada：“口腔链球菌对齐墩果酸-β-环糊精包合物的体外敏感性。”
DOI：
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发表时间：
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期刊：
影响因子：
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作者：
通讯作者：
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影响因子：
45.3
作者：
Ueno, Hideki;Ioka, Tatsuya;Tanaka, Masao
通讯作者：
Tanaka, Masao