An open-label randomized controlled trial to evaluate the efficacy of antihistamine premedication and infusion prolongation in prevention of hypersensitivity reaction to oxaliplatin.

Lagampan Chalitaa and Tanasanvimon Suebponga

The Thai Cancer, 2021, 31.64.001

Abstract

Backgrond: Hypersensitivity reaction (HSR) is a common toxicity in patients receiving repeated oxaliplatin. Oxaliplatin induced HSR could be severe and results in treatment discontinuation.

Objective: To evaluate the efficacy of anti-histamine premedication and infusion prolongation in prevention of oxaliplatin induced HSR.

Method: We conducted a prospective, single center, open-label, randomized controlled trial comparing the standard premedication and 2-hour infusion protocol to the additional antihistamine premedication, intravenous chlorpheniramine, and 3-hour infusion protocol. The randomization was done at 5 th and 7 th cycles of 3-week and 2-week oxaliplatin based regimens, respectively. The primary endpoint was the incidence of HSR.

Results: From July 2020 to March 2021, A total of 160 patients underwent randomization (80 patients in both intervention group and control group). Seventy-four (92.5%) and seventy-six (95%) patients in the intervention group and the control group, respectively, had completed all planned treatment cycles. HSRs occurred in 1 (1.4 %) and 10 (13.2%) patients in intervention and control groups, respectively, p=0.009). There were 6 (7.8%) patients with more than grade 1 HSRs in control groups, but none in intervention group. In the intervention arm, one patient experienced a cutaneous reaction (grade 1 erythema) and grade 1 palpitation. None of the patients in intervention arm developed respiratory symptoms, gastrointestinal symptoms, or anaphylaxis.

Conclusion: Additional antihistamine premedication and infusion prolongation started in 2 nd half of treatment course can reduced HSR incidence in patients receiving oxaliplatin.