Background: Oxaliplatin hypersensitivity reactions (HSRs) are immunoglobulin E (IgE)-mediated and prevent maximum benefit from this drug. This study was designed to determine whether oxaliplatin HSRs could be prevented or reduced with omalizumab (Xolair), an anti-IgE antibody. Patients/Methods: This was a single-arm prospective pilot study. Patients receiving oxaliplatin-based chemotherapy for gastrointestinal cancers who were experiencing grade 1/2 HSRs were eligible. Patients received omalizumab 300 mg subcutaneously every 2 weeks, alternating with oxaliplatin-based chemotherapy. Nine patients enrolled. The primary end point was reduction of repeat HSR over the next 2 cycles. The sample size of 12 patients would achieve 79% power to detect a decrease from HSR rate of 70% (the null hypothesis) to 35% using a 1-sided binomial test. The study would be considered positive if fewer than 6 HSR events over 2 cycles occurred on omalizumab.
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