Dougherty J B, Kelsen D, Kemeny N, Magill G, Botet J, Niedzwiecki D
Department of Medicine, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, NY.
J Natl Cancer Inst. 1989 Nov 15;81(22):1735-8. doi: 10.1093/jnci/81.22.1735.
In a phase I-II study, 28 patients with advanced pancreatic adenocarcinoma were treated with cisplatin, high-dose cytarabine (ARA-C), and caffeine. This clinical trial was based on a nude mouse-human tumor xenograft model, which demonstrated synergism of these agents by inhibiting the growth of human pancreatic tumors. Toxic effects noted in the clinical study included myelosuppression, moderate nausea and vomiting, and mild renal insufficiency. No toxic effects were directly attributable to caffeine. Eighteen of the 28 patients had measurable or assessable disease; seven (39%) had partial responses (95% confidence intervals, 18%-63%). The median response duration was 6.2 months. Median survival for responders was 9.5 months with two patients surviving for more than 18 months. Median survival for all patients was 6.1 months. The combination of cisplatin, ARA-C, and caffeine is an active and tolerable regimen in the treatment of advanced pancreatic cancer. A phase III trial in which this regimen is being compared with standard therapy is in progress.
在一项I-II期研究中，28例晚期胰腺腺癌患者接受了顺铂、大剂量阿糖胞苷（ARA-C）和咖啡因治疗。该临床试验基于裸鼠-人肿瘤异种移植模型，该模型显示这些药物通过抑制人胰腺肿瘤生长具有协同作用。临床研究中观察到的毒性作用包括骨髓抑制、中度恶心和呕吐以及轻度肾功能不全。没有毒性作用直接归因于咖啡因。28例患者中有18例具有可测量或可评估的疾病；7例（39%）有部分缓解（95%置信区间，18%-63%）。中位缓解持续时间为6.2个月。缓解者的中位生存期为9.5个月，有2例患者存活超过18个月。所有患者的中位生存期为6.1个月。顺铂、ARA-C和咖啡因联合用药是治疗晚期胰腺癌的一种有效且可耐受的方案。一项将该方案与标准治疗进行比较的III期试验正在进行中。
