ALTERNATING 2'-DCF AND RECOMBINANT LEUKOCYTE A IFN IN HAIRY CELL LEUKEMIA

交替 2-DCF 和重组白细胞 A 干扰素治疗毛细胞白血病

• 批准号: 3853299
• 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/3853299
• 关键词: antileukemic agent; antineoplastic antibiotics; antineoplastics; biopsy; blood cell count; bone marrow exam; clinical trials; combination chemotherapy; deoxycoformycin; drug adverse effect; hairy cell leukemia; human subject; human therapy evaluation; human tissue; interferons; longitudinal human study; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer remission /regression

We administered deoxycoformycin (dCF) and interferon-alpha (IFN-alpha) sequentially to patients with hairy cell leukemia in an attempt to improve the response rate and duration observed in earlier studies using each drug alone. Further rationale for this study included the observation that IFN-alpha resistant patients were nearly uniformally responsive to second line dCF. As there was some overlapping toxicity, we decided to administer the drugs sequentially rather than concurrently. In this study, we evaluated patients for response by performing bilateral iliac crest bone marrow biopsies and aspirates since the peripheral blood normalizes rapidly after either IFN-alpha or dCF treatment but disease becomes patchy in the bone marrow and might be missed if only unilateral bone marrow biopsies had been performed. Other studies using IFN-alpha or dCF alone used unilateral marrow examinations in evaluating response. Using these more relaxed criteria of response, authors had published high rates of complete remission to dCF. Of 15 patients entered in our study, 14 are evaluable for response with one patient having diffuse osteosclerosis not being evaluable for marrow response. All patients had rapid normalization of peripheral blood counts and all 14 marrow-evaluable patients were found to have very small numbers (less than 5% of the total marrow cellularity) of residual hairy cells at the completion of treatment. With a median follow-up now of 49 months, no patient has had an increase in the number of hairy cells in the bone marrow or any change in the peripheral blood. Although the initial response rate to the combination of dCF and interferon appears to be no better than that observed with dCF alone, the response duration may be longer. These patients continue to be followed for determination of response duration.

我们给予脱氧考福霉素 (dCF) 和干扰素-α (IFN-α) 依次对毛细胞白血病患者进行治疗，试图 提高早期研究中观察到的反应率和持续时间 每种药物单独。 这项研究的进一步理由包括 观察发现 IFN-α 耐药患者几乎一致 对二线 dCF 敏感。 由于存在一些重叠的毒性， 我们决定按顺序给药而不是 同时。 在这项研究中，我们通过以下方式评估患者的反应： 进行双侧髂嵴骨髓活检和抽吸 因为外周血在 IFN-α 或 IFN-α 治疗后迅速恢复正常。 dCF 治疗，但疾病在骨髓中变得不均匀，并且可能是 如果仅进行单侧骨髓活检，则可能会漏诊。 其他单独使用 IFN-α 或 dCF 的研究使用单侧骨髓 评估反应的考试。 使用这些更宽松的标准 的回应，作者发表了很高的完全缓解率 dCF。 在参与我们研究的 15 名患者中，有 14 名可评估疗效 一名患有弥漫性骨硬化症的患者无法进行评估 骨髓反应。 所有患者的外周血流均迅速恢复正常 血细胞计数和所有 14 名可进行骨髓评估的患者均被发现有 数量非常少（少于骨髓细胞总数的 5%） 治疗完成时残留的毛细胞。 有中位数 现已随访 49 个月，无患者数量增加 骨髓中的毛细胞或外周血中的任何变化。 尽管 dCF 和 dCF 组合的初始响应率 干扰素似乎并不比单独使用 dCF 观察到的效果更好， 响应时间可能会更长。 这些患者仍在继续 随后确定响应持续时间。