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 Res. 2022 Feb;42(2):1031-1041. doi: 10.21873/anticanres.15564.


Background/aim: 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).

Patients and methods: 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.

Results: 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.

Conclusion: In the routine care in Greece, EVE demonstrates clinical benefit and a predictable safety profile.

Keywords: Advanced breast cancer; effectiveness; everolimus; first line; safety.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / epidemiology
  • Breast Neoplasms / metabolism
  • Breast Neoplasms / pathology
  • Chemotherapy, Adjuvant
  • Disease Progression
  • Drug Administration Schedule
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Everolimus* / administration & dosage
  • Everolimus* / adverse effects
  • Female
  • Greece / epidemiology
  • Humans
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / epidemiology
  • Neoplasm Recurrence, Local / metabolism
  • Postmenopause
  • Receptor, ErbB-2 / metabolism
  • Receptors, Estrogen / metabolism
  • Receptors, Progesterone / metabolism
  • Survival Analysis
  • Treatment Outcome


  • Receptors, Estrogen
  • Receptors, Progesterone
  • Everolimus
  • Receptor, ErbB-2