Gilbert H S
Albert Einstein College of Medicine, Bronx, New York 10021, USA.
Cancer. 1998 Sep 15;83(6):1205-13. doi: 10.1002/(sici)1097-0142(19980915)83:6<1205::aid-cncr21>3.0.co;2-8.
Recombinant interferon-alpha-2b (rIFN-alpha-2b) has shown therapeutic potential in patients with chronic myelogenous leukemia and other myeloproliferative disorders (MPDs), including the ability to suppress the abnormal hematopoietic clone and to reverse myelofibrosis. This study was conducted to evaluate further the efficacy and safety of rIFN-alpha-2b in a large group of patients with polycythemia vera, essential thrombocythemia, or agnogenic myeloid metaplasia and to determine maintenance of response after treatment discontinuation.
Induction therapy began with subcutaneous rIFN-alpha-2b at 5.0 x 10(6) IU/day until a complete or partial response was achieved. Treatment continued at 2.5 x 10(6) IU/day until spleen size and hematologic parameters stabilized.
Fifty-four patients were studied (median follow-up, 7.3 years); at last follow-up 27 patients still were participating (median follow-up, 3.8 years). Twenty-four of 24 patients with thrombocythemia (100%) and 14 of 14 patients with hyperleukocytosis (100%) responded to induction therapy, whereas 26 of 39 patients (67%) experienced > 10% decrease in splenomegaly. Thirty-nine of 54 patients (72%) maintained response for a median of 39 weeks after withdrawal of rIFN-alpha-2b; repeat courses in previously responding patients produced similar results. The survival rate at 8 years was 60%. rIFN-alpha-2b generally was well tolerated, but toxicity caused treatment withdrawal in 7 patients (13%).
rIFN-alpha-2b can produce regression of splenomegaly and control of leukocyte and platelet counts in patients with MPD. These responses are sustained for prolonged periods in some patients after therapy discontinuation. In patients with recurrent disease, disease control can be attained again with reinitiation of rIFN-alpha-2b. Therefore this therapy should be an important treatment consideration for patients with MPD.
重组干扰素α-2b（rIFN-α-2b）已在慢性粒细胞白血病和其他骨髓增殖性疾病（MPD）患者中显示出治疗潜力，包括抑制异常造血克隆和逆转骨髓纤维化的能力。本研究旨在进一步评估rIFN-α-2b在一大组真性红细胞增多症、原发性血小板增多症或原因不明的髓样化生患者中的疗效和安全性，并确定停药后反应的维持情况。
诱导治疗开始时皮下注射rIFN-α-2b，剂量为5.0×10⁶IU/天，直至达到完全或部分缓解。治疗继续以2.5×10⁶IU/天进行，直到脾脏大小和血液学参数稳定。
共研究了54例患者（中位随访时间7.3年）；在最后一次随访时，27例患者仍在参与研究（中位随访时间3.8年）。24例血小板增多症患者中的24例（100%）和14例白细胞增多症患者中的14例（100%）对诱导治疗有反应，而39例患者中的26例（67%）脾脏肿大缩小>10%。54例患者中的39例（72%）在停用rIFN-α-2b后中位维持反应39周；先前有反应的患者重复疗程产生了类似结果。8年生存率为60%。rIFN-α-2b一般耐受性良好，但毒性导致7例患者（13%）停药。
rIFN-α-2b可使MPD患者的脾脏肿大消退，并控制白细胞和血小板计数。在一些患者中，这些反应在停药后可长期维持。在复发疾病的患者中，重新开始使用rIFN-α-2b可再次实现疾病控制。因此，这种治疗应成为MPD患者重要的治疗选择。
