Clinical usefulness of anti-α3Gal immunoglobulin E assays for cetuximab-mediated anaphylaxis in head and neck cancer

Immuno-oncology technology Pub Date : 2025-03-01 DOI:10.1016/j.iotech.2025.101041

Y. Pointreau , C. Freneaux , T. Bejan-Angoulvant , D. Ternant , G. Calais , H. Watier

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引用次数: 0

Abstract

Background

Fatal anaphylactic reactions to cetuximab remain a clinical issue, although they are associated with preexisting immunoglobulin E (IgE) directed against the galactose-α1,3-galactose epitope (α3Gal). We aimed to compare the clinical usefulness of the two assays and determine the prevalence of preexisting anti-α3Gal IgE.

Patients and methods

An anti-α3Gal IgE assay was developed (70BP assay) and compared with a commercial assay [bovine thyroglobulin (bTG) assay]. Both assays were applied to two cohorts: 299 healthy blood donors and 41 patients with head and neck cancer treated with cetuximab, including four patients with a history of anaphylactic reaction (9.8%).

Results

The prevalence of anti-α3Gal IgE was 6% and 5% using 70BP and bTG assays, respectively, in healthy blood donors. Among the head and neck cancer patients, the four who had an anaphylactic reaction were included in the seven (17.1%) and six (14.6%) patients with a signal above the detection threshold using the 70BP and bTG assays, respectively. This resulted in a sensitivity and negative predictive value of 100% for both assays, with a specificity of 91.9% and 94.6%, respectively, and a positive predictive value of 57.1% and 66.6% for the 70BP and bTG assays, respectively. Using an optimized threshold in the bTG assay, the prevalence of anti-α3Gal IgE in blood donors decreased to 1.3%, and five patients (12.2%) were eventually considered positive, giving a specificity of 97.3% and a positive predictive value of 80%.

Conclusion

The predictive value of anti-α3Gal IgE using these two assays was excellent and useful in clinical practice.

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抗α 3gal免疫球蛋白E检测在西妥昔单抗介导的头颈癌过敏反应中的临床应用

西妥昔单抗致死性过敏性反应仍然是一个临床问题，尽管它们与预先存在的针对半乳糖-α1,3-半乳糖表位（α3Gal）的免疫球蛋白E （IgE）有关。我们的目的是比较这两种检测方法的临床有效性，并确定预先存在的抗α 3gal IgE的患病率。建立了抗α 3gal IgE测定法（70BP法），并与商业测定法（牛甲状腺球蛋白（bTG）测定法）进行了比较。两项检测均应用于两个队列：299名健康献血者和41名接受西妥昔单抗治疗的头颈癌患者，包括4名有过敏反应史的患者（9.8%）。结果健康献血者70BP和bTG检测抗α 3gal IgE阳性率分别为6%和5%。在头颈癌患者中，70BP和bTG检测信号高于检测阈值的患者分别为7例（17.1%）和6例（14.6%），其中4例发生了过敏反应。这导致两种检测方法的敏感性和阴性预测值均为100%，特异性分别为91.9%和94.6%，70BP和bTG检测方法的阳性预测值分别为57.1%和66.6%。使用优化的bTG检测阈值，献血者中抗α 3gal IgE的患病率降至1.3%，5例患者（12.2%）最终被认为是阳性，特异性为97.3%，阳性预测值为80%。结论两种方法对抗α 3gal IgE的预测价值较好，具有较好的临床应用价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Immuno-oncology technology Oncology

CiteScore

5.40

自引率

0.00%

发文量