1866P - Metabolic and quality of life changes with the use of dexamethasone pre-paclitaxel in patients with breast cancer

Background

Treatment for advanced breast cancer (ABC) patients is based on chemotherapy such as anthracyclines and taxanes. The administration of Dexamethasone (Dex) IV is recommended before these drugs to avoid nausea, vomiting and immediate allergic reactions. However, side effects resulting from high dosages of administration of Dex may occur. This study aims to evaluate whether omitting a dose of corticosteroid therapy as a premedication in ABC treatment after the second week of treatment with taxane in a curative intent scenario can prevent or reduce the incidence of metabolic changes, safety, and patients’ quality of life (QoL).

Methods

Prospective, randomized, single center, non-blind study. ABC patients’ candidates for neo or adjuvant treatment with AC-T (Doxorubicin, Cyclophosphamide, and weekly Paclitaxel) + Trastuzumab, were randomized to standard arm, with Dex 10 mg IV before every cycle of AC and wPaclitaxel or to experimental arm, in which Dex was omitted from the third to the last application of Paclitaxel. Blood samples and EORTC QLQ-C30 were obtained before AC chemotherapy, wPaclitaxel and after the last cycle of wPaclitaxel. The Ethics Committee approved the study.

Results

We enrolled 86 patients in the study, 43 in each arm. We observed in the experimental arm an increase in ACTH, a decrease in insulin level, a decrease in GH, a decrease in IGF-1 and a stability of aldosterone levels. In the control arm, we observed a stability in insulin, GH, IGF-1, and an increase in Aldosterone levels. No hypersensitivity reactions or other adverse events related to Dex omission were reported in the experimental arm and no deaths from any causes occurred. EORTC-QLQ-C30 symptoms scores such as diarrhea, constipation, lack of appetite, and insomnia were lower in the experimental group. The global health score was higher, in the experimental arm.

Conclusions

The omission of Dex improved QoL and is safe. The insulin levels were also lower in the experimental arm, with a potential reduction in the incidence of metabolic syndrome. The short-term safety and tolerability of this regimen justify its use in larger populations however larger studies are necessary to confirm our findings.

Clinical trial identification

NCT04350229.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.