Intravenous versus oral regimens of dexamethasone for prophylaxis of paclitaxel-associated hypersensitivity reaction in primary ovarian, fallopian tube and peritoneal cancer patients: a double-blind randomized controlled trial

Abstract

Background: Paclitaxel-associated hypersensitivity reaction (P-HSR) is the important adverse event (AE) of patients received paclitaxel infusion. Prophylaxis of this AE is thus necessary. Objective: To compare the efficacy and side effects between intravenous and oral dexamethasone regimens (IV-D and PO-D) for P-HSR prophylaxis in primary ovarian, fallopian tube and peritoneal carcinoma (POC/PTC/PPC) patients receiving first cycle of combined paclitaxel plus carboplatin (TC). Methods: This was a double-blind randomized controlled trial conducted in POC/PTC/PPC patients aged 18-70 years received first cycle of TC. Those were randomly allocated in a 1:1 ratio to receive OV-D or PO-D regimens and were followed at 28 days thereafter. Randomization list was done by computer-generated random sequence, stratified by age and body mass index (BMI). Participants and outcome assessors were blinded to group assignment. Primary outcomes were incidence of overall and severe P-HSRs, while secondary outcomes were incidence of dexamethasone side effects, other AEs to chemotherapy, and quality-of-life (QoL), and analysis was done by intention-to-treat fashion. This study was registered with ClinicalTrials.gov Identifier NCT02349763. Results: Of 288 patients enrolled during February and July 2015, 7 were excluded and 281 were eligible for analysis, 140 allocated to IV-D and 141 allocated to PO-D regimen. Overall P-HSR rate in IV-D was not different from PO-D (17.9% versus 19.1%, p = 0.780). Severe P-HSR occurred in one woman of IV-D (0.7% versus 0%, p = 0.498). Other AEs to chemotherapy and QoL scores were not different. However, women in PO-D had more side effects of short-term corticosteroid use than those in IV-D, especially acne (10.6% versus 2.1%, p = 0.004). Conclusions: Efficacies of the IV-D and PO-D for P-HSR prophylaxis were not different. However, side effect of short-term dexamethasone use in IV-D was less prominent than in PO-D. The IV-D regimen is proper for P-HSR prophylaxis in POC/PTC/PPC patients received TC.