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

Aim: To compare the efficacies and side effects of intravenous and oral dexamethasone (IV-D and PO-D) for paclitaxel-associated hypersensitivity reaction (P-HSR) prophylaxis in patients with primary ovarian, fallopian tube and peritoneal carcinomas (POC/PFTC/PPC) receiving a first cycle of paclitaxel plus carboplatin (TC).

Methods: In this double-blind randomized controlled trial, patients with POC/PFTC/PPC receiving a first cycle of TC were randomly allocated in a 1:1 ratio to either the IV-D or PO-D groups. Those were followed at 28 days. Primary outcomes were incidence of overall and severe P-HSRs. Secondary outcomes included incidence of dexamethasone-related side effects, other chemotherapy-related adverse events (AEs), and quality-of-life (QoL).

Results: A total of 288 patients were enrolled from February to July 2015, of whom 281 were eligible for analysis, including 140 allocated to IV-D and 141 to PO-D. There was no significant difference in P-HSR rate between the IV-D and PO-D groups (17.9% vs. 19.1%, P = 0.780). Severe P-HSR occurred in one women in the IV-D group (0.7% vs. 0%, P = 0.498). There were no significant differences in other chemotherapy-related AEs and QoL scores. However, women in the PO-D had more side effects from short-term corticosteroid use than those in the IV-D group, especially acne (10.6% vs. 2.1%, P = 0.004).

Conclusions: IV-D and PO-D have similar efficacies for preventing P-HSR. However, short-term IV-D may be associated with fewer side effects than PO-D. IV-D is thus suggested for P-HSR prophylaxis in patients with POC/PFTC/PPC receiving a first cycle of TC.