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Published on: October 27, 2014
Adverse Reactions to Taxanes in Premedicated Cancer Patients: A Prospective Observational Study
M B Febina1, Princy L Palatty2, Keechilat Pavithran3
1Department of Pharmacology, Amrita Institute of Medical Sciences and Research Center, Amrita Vishwa Vidhyapeetham, Kochi, IND.
Infusion-related reactions (IRRs) are infrequent in premedicated cancer patients receiving taxane chemotherapy. These taxane side effects, including flushing and dyspnea, rarely lead to treatment discontinuation, suggesting effective management strategies.
Area of Science:
- Oncology
- Pharmacology
- Clinical Medicine
Background:
- Taxanes (paclitaxel, docetaxel, cabazitaxel) are vital chemotherapy agents targeting microtubules but cause significant adverse reactions, including infusion-related reactions (IRRs).
- Standard premedication protocols often fail to fully mitigate taxane-induced side effects, potentially leading to treatment delays or cessation.
- Understanding the incidence and spectrum of these reactions is crucial for optimizing patient care and treatment success.
Purpose of the Study:
- To determine the frequency of adverse reactions to taxanes in cancer patients receiving premedication.
- To assess the causality, severity, and nature of observed taxane-related adverse events.
- To inform improved management strategies for taxane chemotherapy.
Main Methods:
- A prospective observational study was conducted over six months, monitoring patients receiving taxane chemotherapy.
- Adverse reactions were recorded and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Causality of reactions was assessed using the World Health Organization-Uppsala Monitoring Center (WHO-UMC) system.
Main Results:
- A total of 236 adverse reactions were documented across 206 treatment cycles in 56 patients, with 9 instances of infusion-related reactions (IRRs).
- Common non-IRRs included alopecia, numbness, myalgia, and mucositis; common IRRs were flushing, chest tightness, and dyspnea, mostly of grade 2 or less.
- The majority of adverse events were classified as probable/possible reactions according to the WHO-UMC scale.
Conclusions:
- Infusion-related reactions (IRRs) represent a small fraction (3.8%) of taxane-related adverse events in premedicated cancer patients.
- Neither IRRs nor other adverse reactions necessitated treatment discontinuation in this cohort.
- Implementing desensitization protocols and the Paclitaxel-Hypersensitivity Reaction (Pac-HSR) scoring system may further enhance the management of IRRs/HSRs, ensuring treatment continuity and safety.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

