Trial reportCancer chemotherapy and pharmacology2026
Pharmacologic de-escalation of dexamethasone during weekly paclitaxel: a randomized phase III trial evaluating safety, endocrine effects, and quality of life.
Trial report in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04350229 (Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Endocrinological Changes Due to Pre-medications of Chemotherapy in Patients With Breast Cancer
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3 authors.
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Abstract
objectiveDexamethasone is routinely used as premedication during weekly paclitaxel to prevent hypersensitivity reactions; however, prolonged corticosteroid exposure may induce clinically relevant metabolic, endocrine, and patient-reported adverse effects. This study evaluated whether selective omission of dexamethasone after the second paclitaxel infusion is safe and explored its effects on quality of life, metabolic/endocrine parameters, and short-term oncologic outcomes, including recurrence and disease-related mortality.
methodsIn this prospective, randomized, open-label phase III trial, 86 women with stage I-III breast cancer receiving neoadjuvant or adjuvant AC-T or AC-TH chemotherapy were randomized 1:1 to standard dexamethasone premedication or omission after the second weekly paclitaxel infusion. The primary endpoint was safety, defined by hypersensitivity reactions and adverse events. Secondary and exploratory endpoints included patient-reported quality of life using the EORTC QLQ-C30, metabolic and endocrine parameters, and short-term oncologic outcomes. Longitudinal changes were analyzed using generalized estimating equations.
resultsEighty-four patients were included in the final analysis. No hypersensitivity reactions occurred after dexamethasone omission, and treatment completion rates were comparable between groups. After a median follow-up of 3.15 years, recurrence and disease-related mortality were similar between groups in descriptive analyses. The omission strategy was associated with improvements in role functioning and reduced worsening of pain (p = 0.02), constipation (p = 0.01), and nausea/vomiting (p = 0.03). No statistically significant differences were observed for emotional or physical functioning. Endocrine analyses demonstrated reduced IGF-1 levels and a trend toward lower insulin levels. These secondary analyses should be interpreted as exploratory.
conclusionSelective omission of dexamethasone after the second weekly paclitaxel infusion was safe and well tolerated in this randomized trial. The findings support the feasibility of a corticosteroid-sparing strategy during weekly paclitaxel and suggest potential benefits in selected patient-reported and endocrine outcomes, which warrant confirmation in larger studies.
trial registrationNCT04350229, registered on 16 April 2020.
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