2025 Southeastern Residency Conference

Title: Paclitaxel infusion reaction evaluation and prevention strategies at a large community hospital outpatient chemotherapy infusion center
 
Authors: Emma Pride1; Allison Bass1; Amanda Ouzts1; Melissa Strobel2; F. Joseph Kelly2
Pharmacy Department, Huntsville Hospital – Huntsville, Alabama1
Tennessee Valley Gynecologic Oncology – Huntsville, Alabama2
 
Purpose/Background: Paclitaxel, a widely used drug in the treatment of gynecologic malignancies, is associated with hypersensitivity reactions in an estimated 2-4% of patients, and infusion related reactions in around 27% of patients, despite pre-medications.  There are known risk factors for paclitaxel reactions including respiratory dysfunction, obesity (defined as a body mass index ≥ 25), no history of alcohol consumption, and postmenopausal status. Recent updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide new insights into managing infusion-related reactions and hypersensitivity reactions in this setting, yet practical applications remain limited for management and prevention. Utilizing this information and other literature, this study aimed to evaluate the incidence of paclitaxel reactions at a large outpatient infusion center and implement a process improvement initiative focused on optimizing infusion protocols and premedication timing to enhance patient safety and support continued use of first-line therapy.
 
Methodology: This single-center, IRB-approved, pre-post implementation study evaluated female patients aged ≥18 years with gynecologic malignancies who received 3-hour paclitaxel infusions at Huntsville Hospital’s outpatient infusion center. The pre-intervention group included 224 patients who received paclitaxel from February 1, 2022, to December 31, 2024. Data collected from the electronical medical record included demographic factors, known reaction risk factors, and premedication timing. A new paclitaxel titration protocol and modified premedication timing strategy were implemented starting February 3, 2025 through April 1, 2025. Post-intervention data included patients receiving paclitaxel beginning on that date, regardless of treatment cycle. The primary endpoint was the occurrence of any documented reaction to paclitaxel. 
 
Results: A total of 224 patients were included in the pre-implementation analysis, of whom 44 (19.6%) experienced a reaction to paclitaxel. Of these, 11 (25%) were classified as hypersensitivity reactions, 28 (63.6%) as infusion-related reactions, and 5 (11.4%) could not be clearly classified. Common risk factors identified included BMI ≥ 25 (n=156), with 23% of these patients experiencing a reaction. Additionally, 84% of patients who reacted had premedications administered ≥45 minutes before paclitaxel. Following the implementation of updated premedication timing and infusion titration protocols, no reactions were documented in the initial 43 post-implementation administrations across cycle 1, cycle 2, and subsequent cycles. 
 
Conclusion: Implementation of an updated paclitaxel infusion protocol—including more prompt administration of premedications, priming lines with paclitaxel rather than normal saline, and a modified titration schedule—was associated with a reduction in infusion-related and hypersensitivity reactions. While initial post-intervention data is promising, continued monitoring is warranted to confirm the long-term impact in a larger cohort.