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Published on: December 1, 2016
Acute hypersensitivity reactions to paclitaxel polymeric micelles during malignant tumor treatment: a retrospective
Xing Xia1, Dongliang Han2, Lin Wang3
1Department of Pharmacy, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Background And Aims:
Paclitaxel polymeric micelles (pm-Pac) are widely used for solid tumors, but real-world data on acute hypersensitivity reactions (HSRs) are limited. This exploratory study aimed to characterize the clinical features, risk factors, and dynamic laboratory changes in pm-Pac-associated acute HSRs.
Methods:
This retrospective study included 220 patients treated with pm-Pac from March 2023 to April 2026. Clinical data were extracted from electronic medical records. Analyses included chi-square tests, linear-by-linear association, logistic regression, and linear mixed-effects models.
Results:
The overall HSR incidence was 6.8% (15/220). Most HSRs were mild-to-moderate (grade 1: 40.0%; grade 2: 33.3%) and 26.7% were grade 3. Reactions occurred predominantly within the first 60 minutes (60.0%); 88.9% of moderate-to-severe reactions (grade ≥2) occurred within this window. Fourteen events (93.3%) occurred during the second cycle, and one (6.7%) during the third cycle, with no recurrence in six patients who continued treatment. Rash and pruritus were most common manifestations, followed by cardiovascular symptoms. Conventional risk factors showed no significant associations, and routine laboratory parameters were similar between groups. Baseline autoantibody positivity was 66.7% in HSR compared with 41.2% in non-HSR patients (P=0.055). HSR severity grade was correlated with treatment outcome (P=0.001; improvement rates were 0% for grade 1, 100% for grade 2, and 66.7% for grade 3). Among evaluable patients receiving a glucocorticoid-antihistamine-calcium gluconate combination, 85.7% improved.
Conclusions:
Pm-Pac-induced acute HSRs were predominantly mild-to-moderate cutaneous reactions, occurring within the first 60 minutes and during the second cycle; grade ≥2 reactions were more frequent in the early time window. No recurrent reactions were observed in subsequent cycles. Routine laboratory monitoring did not differentiate between patients with and without HSRs; symptom surveillance is essential. Baseline autoantibody positivity showed a non-significant trend that requires validation. Given the small sample (n=15), all findings are exploratory and require confirmation in larger cohorts.
