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

ROFERON A (RO22-8181/002) 治疗毛细胞白血病的 II 期疗效研究

• 批准号: 3853307
• 负责人: J W SMITH
• 金额: --
• 依托单位: DIVISION OF CANCER TREATMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3853307
• 关键词: antiidiotype antibody; antileukemic agent; antineoplastics; biological response modifiers; blood cell count; drug administration rate /duration; drug adverse effect; drug resistance; hairy cell leukemia; human subject; human therapy evaluation; human tissue; interferons; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer remission /regression

This study began as an efficacy study of interferon Alpha-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 receiving 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, 40 partial remissions, 2 minor responses, 9 patients with stable disease and only 1 patient with disease progression. In the last year, one of the patients with a minor response has now obtained a partial remission. Thirty-two patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 6.5 years. Twenty-one patients discontinued interferon for a variety of reasons, the most common being the development of acquired interferon resistance in association with interferon antibodies. The resistance to interferon was manifested early, in the first 18 months of treatment. 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 interferon resistance. Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with interferon, longer follow-up will be necessary to determine if continuous therapy with interferon is better than intermittent therapy.

本研究最初是干扰素 Alpha-2a 对患者的疗效研究 患有毛细胞白血病。 据观察，大多数患者有反应 干扰素，但几乎没有获得完整的反应。 其他地方进行的研究证实了完全缓解率较低。 一旦停止干扰素，疾病几乎一致进展 观察到需要重新开始治疗。 似乎有 极少数患者在术后不需要进一步治疗 接受12或18个月的连续干扰素治疗。 因为 根据这些发现，我们选择持续施用干扰素 最初对该药物有反应的患者。 53 个可评估的 患者（参与本研究的 56 名患者中），有一名完整的 缓解，40 名部分缓解，2 名轻微缓解，9 名患者 疾病稳定，只有 1 名患者出现疾病进展。 在最后 今年，其中一名反应轻微的患者现已获得 部分缓解。 32名患者继续接受干扰素治疗 无间断，持续干扰素的中位持续时间 治疗6.5年。 21 名患者停止使用干扰素 原因有多种，最常见的是后天的发展 干扰素抵抗与干扰素抗体有关。 这 对干扰素的抵抗很早就表现出来，在出生后的前18个月 治疗。 这项研究的一个重要发现是， 但绝对粒细胞和血液学改善显着 血小板计数超过治疗 18 个月，从而表明 长期治疗会带来持续的益处，而不是 产生抗体并随后开发干扰素 反抗。 尽管这项研究清楚地表明毛细胞 干扰素可以长期控制白血病 需要进行随访以确定是否持续治疗 干扰素优于间歇疗法。