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二期研究白细胞介素-4 在惰性 B 细胞非霍奇金淋巴瘤和 B 细胞慢性淋巴细胞白血病中的作用:东部肿瘤协作组(E5Y92)的研究。

Phase II study of interleukin-4 in indolent B-cell non-Hodgkin lymphoma and B-cell chronic lymphocytic leukemia: a study of the Eastern Cooperative Oncology Group (E5Y92).

机构信息

New York Medical College, Valhalla, NY, USA.

出版信息

J Immunother. 2010 Nov-Dec;33(9):1006-9. doi: 10.1097/CJI.0b013e3181f5dfc5.

DOI:10.1097/CJI.0b013e3181f5dfc5
PMID:20948435
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3608515/
Abstract

Recombinant interleukin (IL)-4, 5 μg/kg thrice weekly for 3 weeks followed by a 2-week rest period (1 cycle) was administered to 32 eligible previously treated B-cell chronic lymphocytic leukemia (7 patients) or low-grade B-cell lymphoma patients (25 patients). Two cycles were given before response was evaluated. IL-6 serum levels were evaluated before therapy in all patients and at 12 weeks on study in 7 patients. None of the chronic lymphocytic leukemia patients responded. A partial response was observed in 3 lymphoma patients of 1.2, 3.0, and 3.5 months' duration and stable disease (median 1.5 mo) was observed in another 7 lymphoma patients. The median survival from registration on study was 29.7 months with 7 patients alive at the time of analysis for a median follow-up of 72.8 months. Toxicity was generally mild with no grade 4 nonhematologic toxicity observed. Recombinant IL-4 treatment was well tolerated in this study but had minimal antitumor activity.

摘要

重组白细胞介素 (IL)-4,每周 3 次给予 32 名符合条件的既往治疗过的 B 细胞慢性淋巴细胞白血病(7 名患者)或低级别 B 细胞淋巴瘤患者(25 名患者),每次 5μg/kg,持续 3 周,然后休息 2 周(1 个周期)。在评估反应之前,给予 2 个周期。所有患者在治疗前和 7 名患者在研究的第 12 周评估了 IL-6 血清水平。没有慢性淋巴细胞白血病患者有反应。3 名淋巴瘤患者出现部分缓解,缓解持续时间分别为 1.2、3.0 和 3.5 个月,另外 7 名淋巴瘤患者疾病稳定(中位 1.5 个月)。从登记研究开始的中位生存时间为 29.7 个月,在分析时 7 名患者存活,中位随访时间为 72.8 个月。毒性通常较轻,未观察到 4 级非血液学毒性。在这项研究中,重组 IL-4 治疗耐受性良好,但抗肿瘤活性很小。

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