Safety and Efficacy of RAD001 (Everolimus) Administered Upon Relapse During or After Adjuvant Treatment in Post-menopausal Women With Hormone Receptor Positive, HER2/neu Negative Locally Advanced or Metastatic Breast Cancer (CRAD001JGR08 "MELPOMENI" study).

Anticancer research 2022 Feb

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This study aimed to provide real-world safety and effectiveness data of everolimus (EVE) plus exemestane (EXE) in estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced breast cancer (aBC). This prospective observational study was conducted by 19 hospital-based oncologists in Greece. Eligible patients were treated with EVE+EXE in the first-line setting; EVE was initiated according to the approved label. Overall, 75 eligible patients (mean age: 66.9 years; visceral metastases: 49.3%; bone-only metastases: 37.3%) were included in the effectiveness analyses. Over a median (interquartile range) of 12.1 months (range=4.2-20.5 months) of EVE treatment, the median progression-free survival was 18.0 months and the overall response rate was 22.7%. Among patients that received ≥1 EVE dose (n=80), the incidence of EVE-related adverse events was 72.5% (serious: 55.0%); stomatitis (22.5%), fatigue (22.5%), pneumonitis (18.8%); and cough (18.8%) were the most common. In the routine care in Greece, EVE demonstrates clinical benefit and a predictable safety profile. Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Citation

Athanasios Alexopoulos, Charisios Karanikiotis, Alexandros Ardavanis, Ioannis Boukovinas, Parisios Makrantonakis, Christos Papadimitriou, Athanasios Athanasiadis, Anastasios Boutis, Stylianos Giassas, Stylianos Kakolyris, Georgios Koumakis, Konstantinos Papazisis, Adamantia Psyrri, Nikolaos Ziras, Sofia Baka, Nikolaos Kentepozidis, Vasiliki Michalaki. Safety and Efficacy of RAD001 (Everolimus) Administered Upon Relapse During or After Adjuvant Treatment in Post-menopausal Women With Hormone Receptor Positive, HER2/neu Negative Locally Advanced or Metastatic Breast Cancer (CRAD001JGR08 "MELPOMENI" study). Anticancer research. 2022 Feb;42(2):1031-1041