Dose EScalation Induction of EvERolimus

Summary

The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor; Routine use of everolimus shows an high rate of intolerability due to mucositis/stomatitis especially during the first 12 weeks of treatment leading cause for treatment discontinuation not related to tumor progression; GeparQuinto study (setting III: non-responders): everolimus was given as salvage treatment in combination with paclitaxel for patients without response to 4 cycles epirubicin/cyclophosphamide with/without bevacizumab. A dose-escalation schema was successfully used to improve tolerability of everolimus together with the cytotoxic Agent. Everolimus plus exemestane has improved the prognosis of metastatic breast cancer significantly. Desiree-study aims to improve the tolerability, which is necessary in order to achieve an adequate dose intensity for the patients in Routine care.

Timeline

Start

2015-05

Primary completion

2021-05

Completion

2021-07

Publications

• Schmidt M, Lubbe K, Decker T, Thill M, Bauer L, Muller V, Link T, Furlanetto J, Reinisch M, Mundhenke C, Hoffmann O, Zahn MO, Muller L, Denkert C, van Mackelenbergh M, Fasching PA, Burchardi N, Nekljudova V, Loibl S. 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 Dec;7(6):100601. doi: 10.1016/j.esmoop.2022.100601. Epub 2022 Nov 7.

Drugs

Indications