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)

• Published in: Anticancer research Vol. 42; no. 2; pp. 1031 - 1041
• Main Authors: Alexopoulos, Athanasios, Karanikiotis, Charisios, Ardavanis, Alexandros, Boukovinas, Ioannis, Makrantonakis, Parisios, Papadimitriou, Christos, Athanasiadis, Athanasios, Boutis, Anastasios, Giassas, Stylianos, Kakolyris, Stylianos, Koumakis, Georgios, Papazisis, Konstantinos, Psyrri, Adamantia, Ziras, Nikolaos, Baka, Sofia, Kentepozidis, Nikolaos, Michalaki, Vasiliki
• Format: Journal Article
• Language: English
• Published: Greece International Institute of Anticancer Research 01.02.2022
• Subjects: Adjuvant therapy; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - epidemiology; Breast Neoplasms - metabolism; Breast Neoplasms - pathology; Chemotherapy, Adjuvant; Cough; Disease Progression; Dosage; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions - epidemiology; Epidermal growth factor; ErbB-2 protein; Estrogen receptors; Estrogens; Everolimus - administration & dosage; Everolimus - adverse effects; Female; Greece - epidemiology; Growth factors; Humans; Menopause; Metastases; Metastasis; Middle Aged; Neoplasm Metastasis; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - epidemiology; Neoplasm Recurrence, Local - metabolism; Patients; Pneumonitis; Post-menopause; Postmenopause; Receptor, ErbB-2 - metabolism; Receptors; Receptors, Estrogen - metabolism; Receptors, Progesterone - metabolism; Safety; Stomatitis; Survival Analysis; Treatment Outcome; Greece; effectiveness; everolimus; first line; Advanced breast cancer; safety
• ISSN: 0250-7005; 1791-7530
• DOI: 10.21873/anticanres.15564

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.