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在一项辅助性多中心试验中接受重组干扰素-α-2A治疗的肾细胞癌患者体内的干扰素-α抗体。Delta-P研究组。

Interferon-alpha antibodies in patients with renal cell carcinoma treated with recombinant interferon-alpha-2A in an adjuvant multicenter trial. The Delta-P Study Group.

作者信息

Prümmer O

机构信息

Department of Internal Medicine III, University of Ulm, Germany.

出版信息

Cancer. 1993 Mar 1;71(5):1828-34. doi: 10.1002/1097-0142(19930301)71:5<1828::aid-cncr2820710518>3.0.co;2-0.

DOI:10.1002/1097-0142(19930301)71:5<1828::aid-cncr2820710518>3.0.co;2-0
PMID:8448744
Abstract

BACKGROUND

Prolonged therapy with interferon (IFN) may lead to the formation of IFN antibodies.

METHODS

Patients with renal cell carcinoma (n = 270) with advanced localized disease were randomized after complete tumor resection to receive treatment with adjuvant recombinant IFN-alpha-2a (rIFN-alpha 2a) (9 x 10(6) IU subcutaneously, three times per week for a maximum of 12 months) versus no treatment. Patients (IFN-treated group, 106 patients; control group, 97 patients) were monitored for the presence of rIFN-alpha 2a antibodies.

RESULTS

Of 86 IFN-treated patients observed for more than 2 months, 40 (47%) had IFN-alpha 2a-binding and 25 (29%) had IFN-alpha 2a-neutralizing antibodies developed within a median of 3 and 6 months, respectively. A distinct peak in binding antibody titers occurred at 6-9 months. Therapy-induced neutralizing antibodies were equally reactive with two other recombinant IFN-alpha-2 subtypes but poorly recognized natural IFN-alpha (IFN-alpha), recombinant IFN-alpha-1/alpha-8, and recombinant IFN-omega-1. The duration of remission and rate of relapse were independent of the antibody status, although neutralizing and most non-neutralizing antibodies correlated with a reduction in the IFN-induced increase in beta-2-microglobulin levels.

CONCLUSIONS

Patients treated with IFN-alpha 2a should be monitored for the presence and clinical relevance of IFN-alpha antibodies to determine those who could respond to alternative treatment.

摘要

背景

干扰素(IFN)长期治疗可能导致IFN抗体形成。

方法

270例局限性晚期肾细胞癌患者在肿瘤完全切除后随机分组,接受辅助性重组IFN-α-2a(rIFN-α 2a)治疗(皮下注射9×10⁶IU,每周3次,最多12个月)或不治疗。对患者(IFN治疗组106例;对照组97例)监测rIFN-α 2a抗体的存在情况。

结果

在86例接受IFN治疗超过2个月的患者中,分别有40例(47%)在中位时间3个月时出现IFN-α 2a结合抗体,25例(29%)在中位时间6个月时出现IFN-α 2a中和抗体。结合抗体滴度在6 - 9个月出现明显峰值。治疗诱导的中和抗体与另外两种重组IFN-α-2亚型具有同等反应性,但对天然IFN-α(IFN-α)、重组IFN-α-1/α-8和重组IFN-ω-1的识别能力较差。缓解持续时间和复发率与抗体状态无关,尽管中和抗体和大多数非中和抗体与IFN诱导的β-2微球蛋白水平升高的降低相关。

结论

接受IFN-α 2a治疗的患者应监测IFN-α抗体的存在情况及其临床相关性,以确定那些可能对替代治疗有反应的患者。

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