Foon K A, Bottino G C, Abrams P G, Fer M F, Longo D L, Schoenberger C S, Oldham R K
Am J Med. 1985 Feb;78(2):216-20. doi: 10.1016/0002-9343(85)90429-2.
Recombinant leukocyte A interferon is a highly purified single molecular species of alpha-interferon prepared by recombinant DNA methods. In 1982, a phase II trial to evaluate the efficacy of recombinant leukocyte A interferon for patients with previously treated chronic lymphocytic leukemia was begun, and 19 patients were entered in this study. Patients received one of two dose schedules depending on their pretreatment platelet counts. Those with platelet counts greater than 100,000/mm3 received 50 X 10(6) units/m2 intramuscularly three times weekly, with dose reductions to 25 X 10(6) units/m2 and 5 X 10(6) units/m2 for unacceptable toxicity. Those with platelet counts less than 100,000/mm3 received 5 X 10(6) units/m2 intramuscularly three times weekly. Toxicity was dose-dependent and included fever, chills, fatigue, anorexia, myalgias, headache, leukopenia, and thrombocytopenia. Response was evaluable in all but one of the patients entered in this study. Two of the 12 patients treated with 50 X 10(6) units/m2 had a partial response, three had no response, and seven had progressive disease. Of the six patients starting at 5 X 10(6) units/m2 in whom response was evaluable, two had no response and four had progressive disease. Five patients with progressive disease (three at 50 X 10(6) units/m2 and two at 5 X 10(6) units/m2) had an acceleration of disease while receiving recombinant leukocyte A interferon. It is concluded that the dose and schedule of recombinant leukocyte A interferon therapy tested in this study are not effective in previously treated patients with advanced chronic lymphocytic leukemia.
重组白细胞A干扰素是一种通过重组DNA方法制备的高度纯化的α干扰素单分子种类。1982年，一项评估重组白细胞A干扰素对既往接受过治疗的慢性淋巴细胞白血病患者疗效的II期试验开始，19名患者进入该研究。患者根据其预处理血小板计数接受两种剂量方案之一。血小板计数大于100,000/mm³的患者每周三次肌肉注射50×10⁶单位/m²，若出现不可接受的毒性则剂量减至25×10⁶单位/m²和5×10⁶单位/m²。血小板计数小于100,000/mm³的患者每周三次肌肉注射5×10⁶单位/m²。毒性呈剂量依赖性，包括发热、寒战、疲劳、厌食、肌痛、头痛、白细胞减少和血小板减少。除一名进入本研究的患者外，所有患者的反应均可评估。接受50×10⁶单位/m²治疗的12名患者中有2名部分缓解，3名无反应，7名疾病进展。在开始接受5×10⁶单位/m²治疗且反应可评估的6名患者中，2名无反应，4名疾病进展。5名疾病进展的患者（3名接受50×10⁶单位/m²治疗，2名接受5×10⁶单位/m²治疗）在接受重组白细胞A干扰素治疗时疾病加速进展。得出的结论是，本研究中测试的重组白细胞A干扰素治疗的剂量和方案对既往接受过治疗的晚期慢性淋巴细胞白血病患者无效。
