Weber J, Gunn H, Yang J, Parkinson D, Topalian S, Schwartzentruber D, Ettinghausen S, Levitt D, Rosenberg S A
Surgery Branch, National Cancer Institute, Bethesda, Maryland 20892.
J Immunother Emphasis Tumor Immunol. 1994 May;15(4):292-302. doi: 10.1097/00002371-199405000-00008.
Eighteen patients were treated with escalating doses of recombinant, Escherichia coli-derived human interleukin-6 (IL-6) intravenously every 8 h. Therapy was given for two cycles of 7 days each separated by a week off therapy. Fevers and chills were observed in most patients. Mild renal and liver function abnormalities were noted at higher doses of IL-6. Dose-limiting toxicity was reached at 30 micrograms/kg i.v. every 8 h due to reversible neurotoxicity, but significant rapidly reversible anemia and hyperglycemia were seen at lower doses. Platelet counts, white blood cell counts, and acute phase reactant levels were substantially elevated. No antitumor responses were seen. A maximum tolerated dose of 10 micrograms/kg i.v. every 8 h for two 7-day cycles is recommended for future phase II trials.
18名患者接受了递增剂量的重组大肠杆菌衍生的人白细胞介素-6（IL-6）治疗，每8小时静脉注射一次。治疗进行两个周期，每个周期7天，中间停药一周。大多数患者出现发热和寒战。在较高剂量的IL-6时，观察到轻度肾功能和肝功能异常。由于可逆性神经毒性，每8小时静脉注射30微克/千克时达到剂量限制性毒性，但在较低剂量时出现显著的快速可逆性贫血和高血糖。血小板计数、白细胞计数和急性期反应物水平大幅升高。未观察到抗肿瘤反应。建议在未来的II期试验中，每8小时静脉注射10微克/千克，进行两个7天周期的最大耐受剂量。
