Febina M B, Palatty Princy L, Pavithran Keechilat, D Mahesh K
Department of Pharmacology, Amrita Institute of Medical Sciences and Research Center, Amrita Vishwa Vidhyapeetham, Kochi, IND.
Department of Pharmacology, Amrita Institute of Medical Sciences and Research Center, Amrita Vishwa Vidhyapeetham, Ernakulam, IND.
Cureus. 2025 Aug 7;17(8):e89590. doi: 10.7759/cureus.89590. eCollection 2025 Aug.
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.
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.
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.
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.
紫杉烷类药物，包括紫杉醇、多西他赛和卡巴他赛，是广泛使用的抗癌药物，它们通过与微管结合来干扰细胞分裂，但会引发显著的不良反应，尤其是输注相关反应（IRR），如潮红、荨麻疹和呼吸道症状。尽管按照指南使用类固醇、抗组胺药和止吐药进行预处理，紫杉烷类药物引起的副作用仍然普遍存在，可能导致治疗延迟或中断，影响患者的治疗结果。本研究旨在观察并记录接受预处理的癌症患者中紫杉烷类药物不良反应的发生率和范围，以改善管理并提高整体化疗成功率。
估计接受预处理的癌症患者中对紫杉烷类药物（紫杉醇、多西他赛和卡巴他赛）不良反应的发生频率，并评估这些观察到的事件的因果关系、严重程度和性质。
我们的研究是一项为期六个月（2023年7月至2023年12月）的前瞻性观察研究。选择在高知阿育吠陀医学科学与研究中心医学肿瘤学部门就诊、接受多西他赛、紫杉醇或卡巴他赛治疗的患者作为研究对象。在输注这些药物期间及之后，对患者进行IRR和其他不良反应的监测。在化疗开始前，对所有患者进行预处理。根据CTCAE第5.0版（不良事件通用术语标准）记录不良反应并进行分级。采用世界卫生组织-乌普萨拉监测中心（WHO-UMC）系统评估因果关系。
共观察了56例患者的206个疗程。共记录了236例不良反应，其中9例为IRR。最常见的非输注相关不良反应为脱发、麻木、肌痛和粘膜炎。最常观察到的IRR为潮红、胸闷和呼吸困难。在大多数受试者中，这两种不良反应的严重程度均小于或等于2级。根据WHO/UMC因果关系评估量表，这些通常在最初几个化疗周期出现的不良反应大多被认为是很可能/可能的反应。
在接受预处理的癌症患者中，IRR仅占紫杉烷类药物所致不良事件的一小部分（3.8%），这些反应和非IRR均未导致治疗中断。将脱敏方案和紫杉醇超敏反应（Pac-HSR）评分系统纳入标准实践中，可进一步改善紫杉烷类药物治疗患者的IRR/HSR管理，确保更好的治疗连续性，同时维持高安全标准。
