Effect of dose-reduced paclitaxel pre-medication regimen on rates of hypersensitivity and corticosteroid-related adverse reactions

Introduction:  Paclitaxel-based chemotherapy continues to be a fundamental component in the treatment of many solid tumors.¹ Paclitaxel hypersensitivity reactions have been reported due to the solvent Cremophor-EL.² However, paclitaxel hypersensitivity reactions beyond the second dose have shown to be uncommon.¹

Objectives: This study evaluated a dose-reduced pre-medication regimen in patients receiving paclitaxel-based chemotherapy at a Veterans Affairs Healthcare System in order to evaluate if a reduction or elimination of dexamethasone pre-medication reduces adverse effects without increasing the rate of paclitaxel hypersensitivity reactions.

Study Design: Prospective study with a historical control group evaluating patients at VA Connecticut Healthcare System who were treated with paclitaxel-based chemotherapy.

Methods: The study will compare rates of hypersensitivity reactions and corticosteroid-induced adverse reactions for a pre-medication regimen higher than FDA recommendations (control group) versus a dose-reduced pre-medication regimen (cohort group).The control group included patients who received paclitaxel between 01/01/2014 and 04/30/2014 and the cohort group will include patients who received paclitaxel between 11/01/2015 and 02/29/2016. All pre-medications will be eliminated for subsequent weekly paclitaxel doses and only dexamethasone 8mg IV will be administered 30 minutes prior to dose for every three week paclitaxel infusions if no hypersensitivity reaction occurs in the cohort group. Patients’ demographics, cancer history, chemotherapy regimen, number of paclitaxel infusions, average dose of dexamethasone per cycle, occurrence of hypersensitivity reaction, and adverse reactions will be collected and analyzed.

Results: Paclitaxel hypersensitivity reactions did not occur in any of the 18 included patients in the control group. The average dose of dexamethasone per cycle per patient was 51.2mg in the control group. In regards to corticosteroid-related adverse effects in the control group: 61.1% experienced hyperglycemia, 11.1% suffered from insomnia, and 5.6% gained weight. Data collection for the cohort group will be complete on 02/29/2016. The data will be analyzed at that time resulting in the completion of the project.

Conclusions: N/A