Key clinical point: A dose-escalation schema of everolimus plus exemestane was more effective than conventionally administered everolimus (10 mg) plus exemestane in reducing grade ≥2 stomatitis in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (mBC).
Major finding: Within 12 weeks, the incidence of grade ≥2 stomatitis episodes was significantly lower in the everolimus dose escalation vs the 10 mg everolimus arm (odds ratio 0.47; P = .026). Except for stomatitis, toxicity was not significantly different between both treatment arms.
Study details : Findings are from the phase 2, DESIREE trial including 160 postmenopausal women with HR+/HER2− mBC who were randomly assigned to receive exemestane with an escalating dose of everolimus (2.5, 5, 7.5, and 10 mg/day at weeks 1, 2, 3, and 4-24, respectively) or 10 mg/day everolimus.
Disclosures: This study was funded by Novartis, Germany. The authors declared receiving personal fees, grants, consulting fees, honoraria, or support for attending meetings or travel from several sources, including Novartis.
Source: Schmidt M et al. A multicentre, randomised, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer (DESIREE). ESMO Open. 2022;7(6):100601 (Nov 7). Doi: 10.1016/j.esmoop.2022.100601