PHASE II EFFICACY STUDY OF ROFERON A IN HAIRY CELL LEUKEMIA

“停止这项研究是作为一种疗效开始的。 PTS患者血清干扰素-2a水平的研究患有毛细胞白血病。它被观察到 那就是大多数分数。对干扰素有应答，但很少有人完全 目前正在获得答复。在其他地方进行的研究 已确认完全缓解率较低。一旦停止了干扰素， 几乎一致的疾病发展需要重新建立 观察治疗效果。即使有的话，似乎也很少。谁 不需要治疗。由于这些发现，我们选择了 对PTS持续给予干扰素治疗。他们最初对 这种药。在53个可评估的PTS中。(在参与这项研究的56人中) 完全缓解1例，部分缓解41例，轻微缓解1例 回答，9分。病情稳定，只有1分。带着疾病 进步。13分。继续接受干扰素治疗，不间断 持续干扰素治疗的中位时间为9.2年。 34分。停用干扰素的原因有很多，最常见的 获得性干扰素耐药性的发生与发展 携带干扰素抗体。对干扰素的耐药性很早就表现出来了， 治疗前18个月，除2例外。外围 需要停用干扰素的神经病出现为 只有这种疗法的长期毒性。这其中的一个重要发现 血液学研究持续缓慢，但意义重大 粒细胞和血小板绝对数超过18的改善 几个月的治疗，从而表明延长的治疗 结果是持续受益，而不是产生抗体 并随后发展为对干扰素的耐药性。尽管很明显 从这项研究来看，毛细胞性白血病可以在 长期使用干扰素，需要更长的随访时间 确定持续使用干扰素治疗是否优于间歇治疗 心理治疗。年内未发生继发性血液系统恶性肿瘤 这组患者与其他患有这种疾病的患者形成了对比 疾病。“

"DISCONTINUED This study began as an efficacy study of IFN-2A in pts. with hairy cell leukemia. It was observed that most pts. responded to IFN, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once IFN was stopped, nearly uniformly disease progression requiring reinstitution of therapy was observed. There appear to be very few if any pts. who will not require treatment. Because of these findings, we opted to administer IFN continuously to pts. who were initially responsive to this drug. Of the 53 evaluable pts. (of the 56 entered on this study), there was 1 complete remission, 41 partial remissions, 1 minor response, 9 pts. with stable disease and only 1 pt. with disease progression. 13 pts. continue to receive IFN without interruption with a median duration of continuous IFN treatment of 9.2 years. 34 pts. discontinued IFN for a variety of reasons, the most common being the development of acquired IFN resistance in association with IFN antibodies. The resistance to IFN was manifested early, in the first 18 months of treatment, except in 2 cases. Peripheral neuropathy requiring discontinuation of interferon emerges as the only long-term toxicity of this regimen. An important finding in this study is the continued slow, but significant, hematologic improvement in absolute granulocyte and platelet counts beyond 18 months of therapy, thereby indicating that prolonged treatment results in continued benefit rather than the production of antibodies with subsequent development of IFN resistance. Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with IFN, longer follow-up will be necessary to determine if continuous therapy with IFN is better than intermittent therapy. No secondary hematologic malignancies have developed in this cohort of patients in contrast with other patients with this disease."