397P - Comparison between Y-site co-infusion versus standard dexamethasone for preventing hypersensitivity reactions from oxaliplatin administration: A randomized controlled trial

Background

Dexamethasone is the standard premedication for preventing nausea, vomiting and hypersensitivity reactions but the incidence of oxaliplatin hypersensitivity is varied. This study aimed to compare the incidence of any grade of oxaliplatin hypersensitivity between using the Y-site co-infusion of oxaliplatin and dexamethasone or standard premedication with intravenous dexamethasone to prevent hypersensitivity reactions (HSRs) and also to compare the degree of venous pain, objective response rate (ORR), progression free survival (PFS) and common adverse events.

Methods

Patients with stage III and IV of colorectal cancer who received capecitabine and oxaliplatin (CAPEOX) regimen at least 3 cycles from March 2022 to March 2023 were enrolled. At the 4th cycle, all enrolled patients were randomly assigned to receive either Y-site co-infusion of oxaliplatin and dexamethasone (arm A) or standard premedication with intravenous dexamethasone followed by Y-site co-infusion of oxaliplatin and placebo (arm B). The incidence of HSRs and the degree of venous pain between arm A and arm B were analyzed by using Chi-square and log-rank test was used for evaluate PFS.

Results

Nineteen of 37 patients were enrolled to arm A, and 18 of 37 patients were enrolled to arm B. There was no incidence of any grade of HSRs in both groups. The incidence of severe venous pain (grade 3) based on WHO classification between arm A and arm B were 16% and 39%, respectively (relative risk 0.41, 95% CI 0.12-1.33, P-value=0.114). The mean change of venous pain score between arm A and arm B based on numerical rating scale (NRS) were 5.01 and 5.64, respectively (P-value=0.402). There were no differences in ORR, PFS and common adverse events between two groups.

Conclusions

There was no incidence of any grade of HSRs between groups, so we could not conclude that using the Y-site co-infusion of oxaliplatin and dexamethasone was effective than standard premedication with intravenous dexamethasone for preventing HSRs from oxaliplatin administration. However, an incidence of severe venous pain may be reduced via through Y-site co-infusion of oxaliplatin and dexamethasone.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The Institutional Review Board of Royal Thai Army Medical Department (IRBRTA R194h/64).

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.