A Difference in the Incidences of Hypersensitivity Reactions to Original and Generic Taxanes

Abstract

Purpose: To compare incidences of hypersensitivity reaction (HSR) between original and generic taxanes including paclitaxel and docetaxel. Methods: We conducted a prospective study enrolling all patients receiving taxanes at King Chulalongkorn Memorial Hospital. Taxanes were infused accordingly to the step-wise rate escalation protocol at this hospital. Active surveillance for HSRs was performed. During the study period, there was only 1 generic brand used for each taxane. We primarily compared the incidences of HSR between original and generic drugs for each taxane. Results: During the period from January 1 to December 31, 2013, a total of 258 consecutive patients receiving taxanes were enrolled; 128 received paclitaxel, i.e. 65 and 63 in the original (Taxol) and generic arms, respectively, and 130 received docetaxel, i.e. 66 and 64 in the original (Taxotere) and generic arms, respectively. Premedication, including antihistamines and dexamethasone, was administered to all patients 30 min before taxane infusion. There were 26 (10.0%) HSR events including 24 grade 2 and 2 grade 3 HSRs. In the paclitaxel group, there were 9 (13.8%) and 7 (11.1%) HSRs in the original and generic arms, respectively (p = 0.791). In the docetaxel group, there were 9 (13.6%) and 1 (1.6%) HSRs in the original and generic arms, respectively (p = 0.017). No life-threatening symptoms or permanent discontinuation of taxanes occurred. Conclusions: In this prospective study, the incidences of HSR were similar with generic and original paclitaxel but significantly different with generic and original docetaxel.

Liposomal paclitaxel versus docetaxel in induction chemotherapy using Taxanes, cisplatin and 5-fluorouracil for locally advanced nasopharyngeal carcinoma

“…Furthermore, hypersensitivity reactions are important adverse events in paclitaxel-based treatment, and can lead to death. Studies have shown that 8–14% of patients develop hypersensitivity reactions during paclitaxel-based chemotherapy [37, 38]. In our study, a hypersensitivity reaction was not observed, a result that is consistent with that in other studies [39–41].…”

Effects of Diluent Volume and Administration Time on the Incidence of Anaphylaxis Following Docetaxel Therapy in Breast Cancer

“…On the other hand, activated basophils, one of the types of leukocytes, produce large amounts of T helper type 2 (Th2) cytokines, 33) and basophil CD203c is expected as a promising biomarker for the prediction of severe carboplatinrelated anaphylaxis. 34) Further investigation is necessary to elucidate the mechanism of docetaxel-related anaphylaxis.…”

Reacciones de hipersensibilidad a quimioterapéuticos y biológicos

“…La prevalencia de las reacciones varía entre estudios. Se ha reportado una prevalencia del 2% al 10% para taxanos [46,47]. Para platinos oscila entre el 46% en pacientes que han recibido más de 15 infusiones, hasta el 27% en aquellos que recibieron 7 o más, y 1% en individuos que han recibido 6 o menos infusiones [48].…”