Is a low dose of dexamethasone sufficient to prevent paclitaxel-related hypersensitivity reactions? A retrospective study in patients with gynecologic malignancy

ABSTRACT

Background

Paclitaxel hypersensitivity reactions (HSRs) are prevalent, especially in females. The common paclitaxel pretreatment, dexamethasone, may inhibit chemotherapy efficacy and accelerate tumor progression. We aimed to balance paclitaxel HSRs and the lowest dexamethasone dose for gynecologic malignancies.

Methods

We retrospectively examined 1,074 cycles of 3-weekly paclitaxel-containing treatment for 231 gynecologic malignancies at Xiangya Hospital. HSR incidence with different dexamethasone regimens was the primary outcome. Risk factors were examined in all cycles using univariate and multivariate models with generalized estimating equations. A subgroup analysis of initial exposure to paclitaxel was also conducted.

Results

HSR occurred in 33 patients (14.29%) and 49 cycles (4.56%), including 69.39% in cycles 1–2. There were no severe HSRs (grade ≥3). Different premedication regimens, including dexamethasone dosage and route, ranitidine presence or absence, didn’t affect HSR incidence in univariate and multivariate analyzes (p > 0.05). Premenopausal women exerted fewer HSRs (OR_adj 0.22, 95%CI 0.08–0.58; p = 0.002). At the first exposure to paclitaxel, more than 10 mg of dexamethasone didn’t diminish HSRs (OR 0.83, 95%CI 0.27–2.59; p = 0.753).

Conclusions

In gynecologic malignancies, 10 mg dexamethasone along with 20 mg diphenhydramine may be adequate to prevent paclitaxel HSRs without ranitidine. It is necessary to reevaluate paclitaxel premedication regimens.

KEYWORDS:

• Paclitaxel
• dexamethasone
• premedication
• hypersensitivity reaction
• gynecologic malignancy

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study was conducted according to the guidelines of the Declaration of Helsinki, and was approved by the Institutional Review Board of Xiangya Hospital, Central South University (No. 2017068222). This is an observational clinical investigation in which the patient’s treatment is not altered. Consequently, informed consent is not required for this research.

Author contributions

D Xiao contributed to data collection, data analysis, and manuscript writing. Z Yang contributed to data collection and analysis. Y Shi contributed to data collection. W Yang contributed to data validation and manuscript revising. Y Zhang contributed to the design of the study and manuscript revising. All authors provided final approval for the submitted manuscript and agreed to be accountable for all aspects of the work.

Acknowledgments

We thank all patients reviewed in this study.

Data availability statement

All available data are provided in the manuscript.

Additional information

Funding

This manuscript was funded by the National Natural Science Foundation of China [No. 82073323]. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.