Head & Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody
to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment
for colorectal cancer and head and neck cancer. It is known that allergic reactions can
occur in more than 5% of the patients, although the side effects are relatively low
compared with other chemotherapeutic agents. It is known that cetuximab can induce
hypersensitivity even at the first administration, unlike other anticancer drugs. In
this study, we aimed to establish a model to predict patients with hypersensitivity
reaction before administration of cetuximab and to provide safe chemotherapy.
2. Recruitment method and consent procedure The study is designed for analysis patients
scheduled for administration of cetuximab for the first time. Patients matching the
selection and exclusion criteria with voluntary agreement to the study will be enrolled.
Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab
administration.
- Acquisition of agreement Agreement, explanation, and consent form for study of human
derived sample those that approved by the IRB are obtained from patients who
prospectively voluntarily participate in the study and provide human derived sample.
- Observation and evaluation values
① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before
administration of cetuximab
② Cetuximab Skin test using before cetuximab administration
③ Clinical symptoms after cetuximab administration through chart review (vital signs,
occurrence of adverse drug reaction)
④ Check patient's underlying disease and allergy history
- Statistical analysis method Chi-square test, Fisher's exact test, Student t-test,
Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will
be used
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