Nagler A, Ackerstein A, Barak V, Slavin S
Department of Bone Marrow Transplantation, Hadassah University Hospital, Jerusalem, Israel.
J Hematother. 1994 Spring;3(1):75-82. doi: 10.1089/scd.1.1994.3.75.
The safety, tolerance, and clinical effects of combined therapy with recombinant interferon-alpha (IFN-alpha) and interleukin-2 (rIL-2) administered subcutaneously for 2 courses of 4 weeks each, with 4 weeks interval between courses, given as outpatient therapy have been assessed in 10 patients with Philadelphia chromosome (Ph1)-positive chronic myelogenous leukemia (CML). All patients were previously treated with conventional chemotherapy and 3 failed to respond to IFN-alpha administered prior to our study. Median duration of disease from diagnosis was 36 months. Seven patients were in first chronic phase and the other 3 were in blast crisis, second chronic phase, and relapse post-bone marrow transplantation (BMT), respectively. Hematological response (median follow-up 16 months) was observed in 9 patients, with a decline in number of white blood cells and platelets. Elimination of Ph1 was observed in the patient who relapsed post-BMT with complete elimination bcr/abl RNA by polymerase chain reaction. Rebound lymphocytosis and eosinophilia were observed in most of the patients. Toxicity was acceptable. The main adverse effects were fever, chills, fatigue, anorexia, nausea, and vomiting. The side effects were reversible and no interruption of treatment was required. There was no treatment-related hospitalization or deaths. These data suggest that simultaneous subcutaneous IFN-alpha and rIL-2 home therapy is feasible, reasonably well tolerated, and potentially beneficial in CML patients. These observations may have important implications for the treatment of minimal residual disease following allogeneic and autologous marrow transplantation.
对10例费城染色体（Ph1）阳性慢性粒细胞白血病（CML）患者进行了评估，他们接受了重组干扰素-α（IFN-α）和白细胞介素-2（rIL-2）皮下联合治疗，每个疗程4周，共2个疗程，疗程之间间隔4周，作为门诊治疗。所有患者此前均接受过传统化疗，其中3例在我们的研究之前对IFN-α治疗无反应。从诊断开始计算的疾病中位持续时间为36个月。7例患者处于慢性期，另外3例分别处于急变期、慢性期和骨髓移植（BMT）后复发。9例患者出现血液学反应（中位随访16个月），白细胞和血小板数量下降。在BMT后复发的患者中观察到Ph1消失，通过聚合酶链反应完全消除了bcr/abl RNA。大多数患者出现反弹性淋巴细胞增多和嗜酸性粒细胞增多。毒性是可接受的。主要不良反应为发热、寒战、疲劳、厌食、恶心和呕吐。副作用是可逆的，无需中断治疗。没有与治疗相关的住院或死亡。这些数据表明，皮下同时给予IFN-α和rIL-2进行家庭治疗在CML患者中是可行的，耐受性较好，且可能有益。这些观察结果可能对异基因和自体骨髓移植后微小残留病的治疗具有重要意义。
