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.

我们给予脱氧共形霉素（dCF）和干扰素-α（IFN-α） 对患有毛细胞白血病的患者进行治疗， 改善早期研究中观察到的反应率和持续时间， 每种药物单独。 本研究的进一步依据包括： 观察到IFN-α抵抗患者几乎一致地 响应于第二线路dCF。 由于存在一些重叠毒性， 我们决定按顺序给药 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 由于在IFN-α或IFN-γ治疗后外周血迅速恢复正常， dCF治疗，但疾病在骨髓中变得不规则， 如果只进行了单侧骨髓活检，则漏诊。 其他单独使用IFN-α或DCF的研究使用单侧骨髓 检查评估反应。 使用这些更宽松的标准 作者发表了高完全缓解率， dCF。 在我们研究的15例患者中，14例可评价反应 其中1例患者患有弥漫性骨质疏松症， 骨髓反应 所有患者外周血淋巴细胞均迅速恢复正常， 血细胞计数和所有14名骨髓可评估的患者被发现有 极少量（少于总骨髓细胞的5%）的 处理完成时残留的毛细胞。 中位 现在随访49个月，没有患者数量增加 骨髓中的毛细胞或外周血中的任何变化。 尽管dCF和 干扰素似乎并不比单独使用DCF观察到的效果好， 响应持续时间可以更长。 这些患者仍然是 然后确定响应持续时间。