Hutchinson Alexander, Weaver Kelly, Gunaratnam Bakeerathan, Volz Lesley, Ingles Lauren, Figg Lindsay
Department of Pharmacy, UofL Health - Brown Cancer Center, Louisville, KY, USA.
J Oncol Pharm Pract. 2024 Jul 23:10781552241263832. doi: 10.1177/10781552241263832.
Hypersensitivity reactions (HSR) are a known adverse effect of paclitaxel, occurring in approximately 10% of patients, typically during the first or second infusion of the medication. Corticosteroids, histamine-1 and histamine-2 receptor antagonists are given prior to paclitaxel infusions to reduce the incidence of HSR. There are limited data that suggest administration of cetirizine given prior to a platinum infusion as secondary prophylaxis may reduce HSR rates.
The objective of this study was to assess the impact of a novel paclitaxel hypersensitivity prevention protocol including high-dose cetirizine administered 12 and 6 h prior to paclitaxel infusion on the rate of HSR compared to a historical control. The primary objective was the rate of HSR of any grade after the first cycle of paclitaxel. Secondary outcomes included grade of infusion reaction and incidence of severe HSR.
A total of 104 patients were included for analysis in the cetirizine group and 124 in the control group. Hypersensitivity reactions occurred in 37 (16.2%) patients in the overall population, and no statistical difference was observed between groups. (13.46% vs 18.55%; = 0.23). Numerically more grade 3-4 HSRs occurred in the control group than the treatment group (30.77% vs 69.23; = 0.51).
The addition of cetirizine to paclitaxel infusions resulted in numerically lower rates of HSR and a reduction in severity of grade 3-4 HSRs. Future studies with more robust compliance data and a larger patient population would be needed to appropriately assess the efficacy of our novel treatment regimen.
超敏反应(HSR)是紫杉醇已知的不良反应,约10%的患者会出现,通常在首次或第二次输注该药物期间。在输注紫杉醇前给予皮质类固醇、组胺-1和组胺-2受体拮抗剂以降低HSR的发生率。仅有有限的数据表明,在铂类输注前给予西替利嗪作为二级预防措施可能会降低HSR发生率。
本研究的目的是评估一种新型紫杉醇超敏反应预防方案(包括在紫杉醇输注前12小时和6小时给予高剂量西替利嗪)与历史对照组相比对HSR发生率的影响。主要目标是紫杉醇第一个周期后任何级别的HSR发生率。次要结局包括输注反应的分级和严重HSR的发生率。
西替利嗪组共有104例患者纳入分析,对照组有124例。总体人群中37例(16.2%)患者发生超敏反应,两组间未观察到统计学差异(13.46%对18.55%;P = 0.23)。对照组3-4级HSR在数值上多于治疗组(30.77%对69.23%;P = 0.51)。
在紫杉醇输注中添加西替利嗪在数值上使HSR发生率降低,且3-4级HSR的严重程度降低。需要开展有更强依从性数据和更大患者群体的未来研究,以恰当评估我们新型治疗方案的疗效。