Paclitaxel Hypersensitivity Reactions

Henry, Agnès; Charpiat, B.; Pérol, Maurice; Vial, Thierry; Hilaire, Pierre Jousselin de Saint; Descotes, Jacques

doi:10.1097/00130404-200605000-00013

Cited by 12 publications

(7 citation statements)

References 34 publications

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“…Compared to previous reports of a 2-7% incidence of HSR to taxanes in patients receiving premedication [2,3,4,5,6,7,8], the 10% incidence of HSR to taxanes in our institute was quite high. This could be because it was a prospective study with a primary focus on HSR whereas previous reports were retrospective studies and/or did not primarily look for HSR incidence.…”

Section: Discussioncontrasting

confidence: 88%

“…We defined the significant differences as at least 4 times the difference in the incidence of HSR. Given the previous reports of a 4% incidence of grade 3 or 4 taxane HSR [3,8,9], to detect a 4-fold difference in relative risk using 80% power, we needed 64 patients per arm for each original and generic drug grouping of docetaxel and paclitaxel. The p value for statistical significance was <0.05.…”

Section: Methodsmentioning

confidence: 99%

“…After the introduction of premedications, consisting of antihistamines and corticosteroids, incidence rates were reduced to 2-7% [2,3,4,5,6,7,8]. The HSR was thought to be caused by an anaphylactoid reaction induced by the solvents Cremophor EL (polyoxyethylated castor oil) and polysorbate 80 [5,6] in paclitaxel and docetaxel, respectively.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2016

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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.

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Section: Discussioncontrasting

confidence: 88%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2016

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“…Loading paclitaxel in lipid nanoparticles and subsequently solubilized by Solutol ® HS15 increased oral bioavailability 3-fold over Taxol ® but huge inter-animal variability exists [9]. In addition to the low absorption, Cremophor EL ® in the Taxol ® formulation causes hypersensitivity reactions [8, 42, 43]. Although Cremophor may not be intestinally absorbed thus avoiding possible systemic allergic reactions, Cremophor can cause GI toxicity [40].…”

Section: Discussionmentioning

confidence: 99%

Cytotoxic and antiangiogenic paclitaxel solubilized and permeation-enhanced by natural product nanoparticles

et al. 2015

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Paclitaxel (PTX) is one of the most potent intravenous chemotherapeutic agents to date, yet an oral formulation has been problematic due to its low solubility and permeability. Using the recently discovered solubilizing properties of rubusoside (RUB), we investigated this unique PTX-RUB formulation. Paclitaxel was solubilized by RUB in water to levels of 1.6 to 6.3 mg/mL at 10 to 40% weight/volume. These, nanomicellar, PTX-RUB complexes were dried to a powder which was subsequently reconstituted in physiologic solutions. After 2.5 hrs in gastric fluid 85 to 99% of PTX-RUB remained soluble, while 79 to 96% remained soluble in intestinal fluid. The solubilization of PTX was mechanized by the formation of water-soluble spherical nanomicelles between PTX and RUB with an average diameter of 6.6 nm. Compared with Taxol®, PTX-RUB nanoparticles were nearly four times more permeable in Caco-2 cell monocultures. In a side-by-side comparison with DMSO-solubilized PTX, PTX-RUB maintained the same level of cytotoxicity against three human cancer cell lines with IC50 values ranging from 4 nM to 20 nM. Additionally, tubular formation and migration of HUVECs were inhibited at levels as low as 5 nM. These chemical and biological properties demonstrated by the PTX-RUB nanoparticles may improve oral bioavailability and enable further pharmacokinetic, toxicologic, and efficacy investigations.

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“…This result needs to be confirmed with a larger cohort but according to this data, patients treated with paclitaxel, on their first or second course, and especially those with a history of hypersensitivity, should be closely followed by a nurse during infusion. These patients could be candidates for a test dose of paclitaxel prior to being administered the full dose [41]. …”

Section: Discussionmentioning

confidence: 99%

A Search for Predictive Factors for Hypersensitivity Reactions to Paclitaxel and Platinum Salts in Chemotherapy for Gynecologic Pelvic Neoplasms

Piovano

Pivetta

Modaffari

et al. 2012

Gynecol Obstet Invest

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Aims: To investigate the frequency of and predictive factors for hypersensitivity reactions (HR) to taxanes and platinum salts in a cohort of patients treated for pelvic gynecologic malignancies. Methods: The medical records of all patients with gynecologic pelvic neoplasms treated with chemotherapy at the Department of Gynecologic Oncology, AO Mauriziano Umberto I of Turin, from September 2007 through August 2008, were retrospectively reviewed. Two multivariate models, regarding carboplatin and taxane chemotherapy, respectively, were performed to evaluate the potential predictive value of various clinical features. Results: The incidence of HR was 14% (22/157). Multivariate models showed that menopausal women had a significantly lower probability of HR (OR 0.12, CI 0.02–1.13, p = 0.06 for the carboplatin model and OR 0.05, CI 0.01–0.63, p = 0.02 for the taxane model) while a history of systemic hypersensitivity was associated with a higher but non-significant risk of HR (OR 2.64, CI 0.78–8.95, p = 0.11, for the carboplatin model and OR 3.42, CI 0.94–12.45, p = 0.06, for the taxane model). Conclusion: We confirmed a history of hypersensitivity as a risk factor for HR. Other larger cohorts should be analyzed: we need to find new predictive factors in order to select women who should be submitted to experimental prophylactic strategies.

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Paclitaxel Hypersensitivity Reactions

Abstract: To our knowledge, this is the largest study ever reported to test the potential cost-saving benefit of the implementation of a paclitaxel test-dose program to prevent hypersensitivity reactions. The results suggest that the routine use of a test dose is not a cost-effective measure.

Cited by 12 publications

References 34 publications

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

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

Cytotoxic and antiangiogenic paclitaxel solubilized and permeation-enhanced by natural product nanoparticles

A Search for Predictive Factors for Hypersensitivity Reactions to Paclitaxel and Platinum Salts in Chemotherapy for Gynecologic Pelvic Neoplasms

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