PHASE II EFFICACY STUDY OF ROFERON A (RO22-8181/002) IN HAIRY CELL LEUKEMIA

本研究开始时是干扰素α-2a在患者中的疗效研究 患有毛细胞白血病 据观察，大多数患者对 干扰素，但很少有完全的反应正在获得。 在其他地方进行的研究证实了完全缓解率低。 一旦停止干扰素，几乎一致的疾病进展需要 观察到重新开始治疗。 似乎很少，如果有的话 在12或18个月后不需要进一步治疗的患者 持续干扰素治疗。 由于这些发现，我们选择 给那些最初 对这种药物有反应。 在53例可评价患者中（在56例入组患者中 在这项研究中），有一个完全缓解，34个部分缓解，3个完全缓解。 轻微缓解，9例患者病情稳定，仅1例患者 疾病进展。 32名患者继续接受干扰素治疗 无中断，持续干扰素的中位持续时间 治疗60个月。 21例患者停用干扰素， 各种原因，其中最常见的是发展 与干扰素抗体相关的获得性干扰素抗性。 虽然从这项研究中可以清楚地看到，这种疾病可以在 长期使用干扰素，需要更长时间的随访， 确定这种形式的治疗是否优于间歇性治疗， 干扰素

This study began as an efficacy study of interferon alfa-2a in patients with hairy cell leukemia. It was observed that most patients responded to interferon, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once interferon was stopped, nearly uniformly disease progression requiring reinstitution of therapy was observed. There appear to be very few if any patients who will not require further therapy after 12 or 18 months of continuous interferon treatment. Because of these findings, we opted to administer interferon continuously to patients who were initially responsive to this drug. Of the 53 evaluable patients (of the 56 entered on this study), there was one complete remission, 34 partial remissions, 3 minor responses, 9 patients with stable disease and only 1 patient with disease progression. Thirty-two patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 60 months. Twenty-one patients discontinued interferon for a variety of reasons the most common of which being the development of acquired interferon resistance in association with interferon antibodies. Although it is clear from this study that the disease can be controlled in the long-term with interferon, longer follow-up will be necessary to determine if this form of therapy is better than intermittent therapy with interferon.