Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials: The MD Anderson Cancer Center experience

Abstract

Background Infusion reactions (IRs) to anti-neoplastic agents require prompt recognition and immediate treatment to avert significant complications. Methods We conducted a retrospective review of the medical records of consecutive patients who received anti-neoplastic therapy in the outpatient treatment center of the Department of Investigational Cancer Therapeutics from January 1, 2013 to November 30, 2013. Results Of the 597 patients who received treatment, 9 (1.5%) had IRs (all ≤ grade 2). The most common IRs observed on first occurrence were chills (n=5), itching, rash, and facial flushing (n=3 each). There were no IR-related deaths. All the IRs were reversible with appropriate symptomatic treatment and the therapy was completed after temporary cessation of infusion in 7 of the 9 patients. The infusion was stopped in 2 patients due to symptoms suggestive of IgE-mediated allergic reaction and cytokine storm. Five of the 8 patients who were re-challenged with the same therapy developed a similar reaction. However, the infusion was completed in 4 of the 5 patients after administration of intravenous diphenhydramine and/or hydrocortisone, or slowing the rate of infusion and subsequently cycles with the same agents were uneventful. Conclusion IRs to anti-neoplastic agents are rare. Though the clinical presentations are overlapping, most IRs are not IgE-mediated allergic reactions. Appropriate premedication and slow rate of infusion facilitates uneventful administration of the anti-neoplastic agents in subsequent cycles. Further study in a larger cohort of patients to identify biomarkers of hypersensitivity is warranted.

Beyond the Classroom: An Observational Study to Assess Student Pharmacists’ Confidence and Perception of a High-Fidelity Manikin Chemotherapy Infusion Reaction Simulation

“…Up to 10% of documented hypersensitivity infusion reactions are severe, resulting in prolonged hospitalization and anaphylaxis treatment. [6][7][8][9] Training and experience responding to hypersensitivity reactions can significantly affect patient outcomes.…”

Management of infusion-related reactions in cancer therapy: strategies and challenges

“…Among 597 patients receiving anticancer therapies in early-phase clinical trials at the Department of Investigational Cancer Therapeutics of MD Anderson Cancer Center from January to November 2013, 1.5% ( n = 9) experienced an IRR of grade ≤ 2. 10 All IRRs were reversible with appropriate symptomatic treatment, and seven of the nine patients who experienced an IRR were able to complete treatment after temporary cessation of infusion. A retrospective chart review of 197 breast cancer patients who received trastuzumab showed an incidence of IRRs corresponding to 16.2% of patients and 1.8% of administered doses.…”

Evaluation of the Efficiency of the Magicramp® Device for Reducing Cramps Resulting from Oncological Treatments: "Double-blind, Randomized Clinical Trial"

“…Since the observation of reduced efficiency of chemotherapy in 22 types of neoplasms in 2004, where the "overall contribution of curative and adjuvant cytotoxic chemotherapy to 5-year survival in adults was estimated at 2.3% in Australia and 2.1% in the USA" [90], several works have warned about its high toxicity, with possible anticipation of death in patients treated in this way Chemotherapy brings about various side effects; cancer attack depends on there being no deviations of attack signals, which could lead to an increase in cytokine storms [97][98] [99]. Among these effects is Chemotherapy-Induced Peripheral Neuropathy (CIPN), which includes the symptom of cramp frequency.…”