1867P - Efficacy of lower dose of dexamethasone premedication in patient receiving docetaxel-based chemotherapy in preventing hypersensitivity reaction: A randomized controlled trial

Background

Infusion of docetaxel carries the risk of hypersensitivity reactions (HSR), prompting the use of dexamethasone (DEXA) premedication to mitigate this risk. However, the appropriate dosage has been a subject of debate. In our study, we investigated the efficacy of a lower dose of DEXA compared to a higher dose in preventing HSR.

Methods

A non-inferiority crossover randomized controlled trial was conducted. Patients received either a high dose of DEXA (16 mg/day) from the day before docetaxel infusion until one day after the injection, or a low dose of DEXA (10 mg on the day of docetaxel infusion and 4 mg/day on the two subsequent days). They were cross over to the opposite intervention for the next cycle. The primary endpoint was the proportion of the incidence of HSR between the two groups.

Results

In this trial, 46 patients were enrolled, of whom 43 successfully completed two cycles of chemotherapy. Within the low-dose group, only one event (2.2%) of acute HSR was documented. Logistic regression analysis indicated a slight 2.2% discrepancy in acute HSR rates between the low-dose and high-dose groups (95% CI: -2.0 to 6.4) based on per-protocol analysis. However, the low-dose group failed to meet the non-inferiority threshold of 3%. Regarding delayed HSR, there were 5 occurrences (10.9%) in the low-dose group compared to 1occurrence (2.2%) in the high-dose group. By per-protocol analysis, the low-dose dexamethasone group had a 9.1% higher likelihood of experiencing delayed HSR compared to the high-dose group (95% CI = -1.4 to 19.6).

Conclusions

Premedication with a lower dose of dexamethasone may be less effective in preventing HSR compared to high-dose dexamethasone. However, given the predominantly mild-grade reactions and the low overall incidence of HSR at only 2.2%, the low-dose regimen could still be considered a viable option for individuals needing to minimize high-dose steroid side effects.

Clinical trial identification

TCTR20230713001.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.