High incidence of cetuximab-related infusion reactions in head and neck patients

Coloma, Virginia Palomar; Bravo, Patricia Medina; Lezghed, Naima; Mayache-Badis, L.; Gómez, Ruth Gabriela Herrera; Iacob, Mariana; Nicouleau, Laurence; Desmaris, Romain; Tao, Yungan; Leibu, Cristian; Matias, Margarida; Lemare, François; Even, Caroline; Annereau, Maxime; Ferté, Charles

doi:10.1136/esmoopen-2018-000346

Cited by 9 publications

(10 citation statements)

References 15 publications

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“…It is known that alpha-gal sensitization is caused by a lone star tick, 21 but since there is no such tick in Korea, it is presumed that sensitization was preceded by other mechanisms. Second, cetuximab-related HSR is reported to occur at higher incidence in patients with head and neck cancer compared to those with colorectal cancer, 22 , 23 who made up our study population. Third, only a limited number of patients agreed to SPT.…”

Section: Discussionmentioning

confidence: 92%

Nationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection

Park

Lee

Beom

et al. 2021

World Allergy Organization Journal

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Background Cetuximab (chimeric monoclonal antibody to human epidermal growth factor receptor) is used to treat colorectal and head and neck cancers. Due to cross-reactivity with galactose-α-1,3-galactose (alpha-gal), it can induce hypersensitivity even at first administration. We aimed to determine the incidence and clinical manifestation of cetuximab-induced anaphylaxis, and to establish a means of predicting its incidence in patients ahead of treatment. Methods Nationwide and single-center pharmacovigilance data from 2010 to 2017 were collected from the Korea Institute of Drug Safety-Korea Adverse Event Reporting System and Severance Regional Pharmacovigilance Center. Patients scheduled for cetuximab administration were enrolled prospectively. A skin prick test was carried out and serum IgE specific to cetuximab and cross-reactive allergens were measured. Reactions were monitored after cetuximab infusion. Results Over 8 years, there were 23 reports of anaphylaxis nationwide. In a single-center study, incidence of cetuximab-induced anaphylaxis was 1.1%. Most anaphylaxis occurred at first injection (93.3%), even under pretreatment with anti-allergic drugs. Four of 64 patients (6.3%) experienced severe anaphylaxis. The median cetuximab-specific IgE titer was 6.9 kU A /L in patients experiencing anaphylaxis and 0 kU A /L in those who did not (P < 0.001). The results of alpha-gal, beef sIgE, and cetuximab skin prick testing were similar to those of cetuximab sIgE. Patients who did not experience hypersensitivity were negative in all 4 allergy tests. Its positive and negative predictive values were 100%. Conclusions Specific IgE detection of cetuximab or alpha-gal can accurately predict cetuximab-induced anaphylaxis prior to first administration.

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Section: Discussionmentioning

confidence: 92%

Nationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection

Park

Lee

Beom

et al. 2021

World Allergy Organization Journal

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“…However, no statistical test was performed for severe CI-IRs due to small samples per group despite the large number of patients in the study. A previous French monocentric study found a 5.4% rate of CI-IRs in 428 patients treated for advanced HNSCC at Gustave Roussy cancer centre in Paris, Île de France (urban low-risk area) [ 29 ]. In another French small cohort of 229 patients living in the Normandy very-low-risk area, the CI-IRs rates were 10.5% (any grades) and 4.8% (grades 3–4) respectively [ 52 ].…”

Section: Discussionmentioning

confidence: 99%

“…Geography, allergy history, cancer type (HNSCC), ethnic group, premedication, tobacco and alcohol consumption have been reported as potential risk factors for CI-IRs, but these factors remain controversial [ 21 – 29 ].…”

Section: Introductionmentioning

confidence: 99%

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Incidence and associated factors of cetuximab-induced hypersensitivity infusion reactions in 1392 cancer patients treated in four French areas: a possible association with Lyme disease?

et al. 2022

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Background: Previous studies have observed an increased incidence of Cetuximab-induced hypersensitivity infusion reactions (CI-IRs) in the southeastern states of the USA. Tick’s bites were suspected of generating cross-reactions between cetuximab and alpha-gal. This study aims was to describe the incidence and associated risk factors of CI-IRs, in the French areas chosen according to their Lyme disease incidence. Patients and methods: A retrospective chart review was conducted on patients that received cetuximab infusion from January 2010 to June 2019 in 4 French areas with different Lyme disease incidence rates. Results: Of 1392 patients, 117 (8.4%) experienced a CI-IR, including 68 severe (grade 3 or 4) reactions (4.9%). This CI-IR incidence was significantly higher in the Lyme disease high-risk area than in the other areas (13.2% versus 7.1%, 8.1% and 6.4%; P = 0.016). Sex (P = 0.53), premedication (P = 0.91), primary cancer location (P = 0.46) and chemotherapy regimen type (P = 0.78) had no impact on CI-IR incidence in the overall population. In the head and neck squamous cell carcinoma (HNSCC) patient subgroup, CI-IRs were significantly more frequent in the high-risk area (16.4% versus 6.7%, 7.1% and 7.0%; P = 0.0015). Conclusion: This study suggests that patients treated in the French area with the highest incidence of Lyme disease are at a higher risk of CI-IRs.

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“…Patients unsuitable for cisplatin will not be treated with induction chemotherapy since cisplatin is a fundamental component of the induction chemotherapy in HNC. Cetuximab should be administered with caution in patients with a history of heavy smoking, alcohol abuse and allergy because of the elevated risk of infusion reactions in patients with all these risk factors 6…”

Section: Introductionmentioning

confidence: 99%

How I treat squamous ENT cancer

et al. 2019

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The definition of ‘head and neck cancer’ (HNC) identifies squamous cell carcinoma arising from the pharynx, the larynx and the oral cavity. Most of them are induced by smoking and alcohol abuse, but tumours arising in the nasopharynx and in the oropharynx may be virus induced, Epstein-Barr virus and human papillomavirus, respectively. Medical oncologists are involved in HNC in locally advanced disease and in relapsed/metastatic disease not suitable for salvage radiotherapy or surgery. A close cooperation with surgeons and in particular with radiation oncologists is required in the first situation. The second situation is almost completely responsibility of medical oncologists while surgeons and radiation oncologists are involved in specific situations requiring palliative treatments. Interventions in locally advanced diseases change according to the goal of treatment. Indeed, the target may be the cure of patients unresectable disease or that have refused surgery, the adjuvant treatment of resected diseases at high risk of relapse, or organ preservation, which means sparing demolitive surgery requiring severe functional impairment, such as definitive laryngectomy. In all these situations, a close cooperation between the medical oncologist and the radiation oncologist is mandatory. Treatment of relapsed/metastatic disease is rapidly changing due to the development of immunotherapy. Although the results of immune checkpoint inhibitors in HNC are less impressive than in other tumours such as melanoma or lung cancer, these drugs are effective and allow for long-term survivors that were not expected with chemotherapy and target therapy. In particular, first-line treatment will change soon. Indeed, due to the result of a large randomised trial, immunotherapy will replace the combination of cisplatin, fluorouracil and cetuximab at least in a large proportion of patients.

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High incidence of cetuximab-related infusion reactions in head and neck patients

Cited by 9 publications

References 15 publications

Nationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection

Nationwide pharmacovigilance data for cetuximab-induced anaphylaxis and predictive model validation using prospective specific IgE detection

Incidence and associated factors of cetuximab-induced hypersensitivity infusion reactions in 1392 cancer patients treated in four French areas: a possible association with Lyme disease?

How I treat squamous ENT cancer

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