Adverse Reactions to Taxanes in Premedicated Cancer Patients: A Prospective Observational Study

Abstract

Introduction: Taxanes, including paclitaxel, docetaxel, and cabazitaxel, are widely used anticancer agents that disrupt cell division by binding to microtubules, but are associated with significant adverse reactions, particularly infusion-related reactions (IRRs), such as flushing, urticaria, and respiratory symptoms. Despite premedication with steroids, antihistamines, and antiemetics per guidelines, taxane-induced side effects remain prevalent and can result in treatment delays or discontinuation, impacting patient outcomes. This study aimed to observe and document the incidence and spectrum of adverse reactions to taxanes among premedicated cancer patients to improve management and overall chemotherapy success.

Objectives: To estimate the frequency of adverse reactions to taxanes (paclitaxel, docetaxel, and cabazitaxel) in premedicated cancer patients and assess the causality, severity, and nature of these observed events. Methodology: Our study was a prospective observational study conducted over six months (July 2023-December 2023). Patients receiving docetaxel, paclitaxel, or cabazitaxel and visiting the Medical Oncology Department of the Amrita Institute of Medical Sciences and Research Center, Kochi, were selected for the study. Patients were monitored for IRRs and other adverse effects during and after the infusion of these drugs. Premedication was administered to all patients before the initiation of chemotherapy. Adverse reactions were recorded and graded according to CTCAE version 5.0 (Common Terminology Criteria for Adverse Events). Causality was assessed by the World Health Organization-Uppsala Monitoring Center (WHO-UMC) system.

Results: A total of 206 cycles were observed in 56 patients. A total of 236 adverse reactions were recorded, out of which nine were IRRs. The most common non-infusion-related adverse reactions were alopecia, numbness, myalgia, and mucositis. The most commonly observed IRRs were flushing, chest tightness, and dyspnea. Both types of adverse reactions showed a severity of less than or equal to grade 2 in the majority of subjects. These adverse effects, which commonly occur during the initial couple of chemotherapy cycles, were mostly deemed to be probable/possible reactions, as per the WHO/UMC causality assessment scale.

Conclusions: IRRs accounted for only a small number of adverse events (3.8%) due to taxanes in premedicated cancer patients, and neither these reactions nor non-IRRs led to the discontinuation of therapy. Integrating desensitization protocols and the Paclitaxel-Hypersensitivity Reaction (Pac-HSR) scoring system into standard practice could further improve the management of IRRs/HSRs in patients on taxane therapy, ensuring better treatment continuity while maintaining high safety standards.

Keywords: adverse reactions; cancer; infusion reaction; pre medication; taxane.

Figure 1. The graph illustrates the incidence of common infusion-related reactions, including chest tightness, dyspnea, and flushing, associated with taxane administration over four cycles, with a higher frequency observed during the initial cycles.

Figure 2. The graph depicts the incidence of common non-infusion-related reactions associated with taxane administration over four cycles, with a higher number of adverse reactions being observed during the second and third cycles.