A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer
A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer
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DOI：
10.1007/s10637-018-0691-9
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发表时间：
2019-04-01
影响因子：
3.4
通讯作者：
Koike, Kazuhiko
中科院分区：
文献类型：
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作者：
Saito, Kei;Isayama, Hiroyuki;Koike, Kazuhiko
目的本研究的I期临床试验提示在替吉奥和吉西他滨治疗晚期胰腺癌的基础上加用亚叶酸（LV）的可行性。这项II期试验的目的是评估吉西他滨、S-1和LV（GSL）联合治疗晚期胰腺癌的疗效和毒性。方法收集经组织学或细胞学证实的未经化疗的晚期胰腺癌患者。吉西他滨1000 mg/m2，第1天30 min静脉滴注，S-1 40 mg/m2，口服，2次/d，LV 25 mg，第1 ~ 7天，每2周1次。主要终点为无进展生存期（PFS）。结果49例晚期胰腺癌患者（局部晚期19例，转移性30例）均入选。总有效率为32.7%，疾病控制率为87.8%。中位PFS和总生存期（OS）分别为10.8（95%置信区间[CI]，7.4-13.5）和20.7（95% CI 13.0-NA）个月，1年生存率为73.4%。主要3-4级毒性为中性粒细胞减少（22.4%）和口腔炎（14.3%）。未观察到毒性相关死亡。结论：在这项单中心II期临床试验中，吉西他滨、替吉奥和LV联合治疗是可以耐受的，有可能成为晚期胰腺癌的一种治疗选择。
Purpose Our previous phase I trial suggested feasibility of addition of leucovorin (LV) to S-1 and gemcitabine therapy in advanced pancreatic cancer. The aim of this phase II trial was to assess the efficacy and toxicity of gemcitabine, S-1 and LV (GSL) combination therapy for advanced pancreatic cancer. Methods Chemotherapy-naive patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1000mg/m2 by 30min infusion on days 1, S-1 40mg/m2 orally twice daily and LV 25mg orally twice daily on days 1 to 7 every 2weeks. Primary end point was progression free survival (PFS). Results A total of 49 patients with advanced pancreatic cancer (19 locally advanced and 30 metastatic) were enrolled. Overall response rate and disease control rate were 32.7% and 87.8%. The median PFS and overall survival (OS) were 10.8 (95% confidence interval [CI], 7.4-13.5) and 20.7 (95% CI 13.0-NA) months with 1-year survival rate of 73.4%. Major Grade 3-4 toxicities were neutropenia (22.4%) and stomatitis (14.3%). No toxicity related death was observed. Conclusions In this single center, phase II trial, gemcitabine, S-1 and LV combination therapy was tolerable and can potentially be a treatment option for advanced pancreatic cancer.