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Research ArticleClinical Studies

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)

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 and VASILIKI MICHALAKI
Anticancer Research February 2022, 42 (2) 1031-1041; DOI: https://doi.org/10.21873/anticanres.15564
ATHANASIOS ALEXOPOULOS
1“HYGEIA” Hospital, Athens, Greece;
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  • For correspondence: a.alexo@yahoo.gr
CHARISIOS KARANIKIOTIS
2“EUROMEDICA” General Clinic, Thessaloniki, Greece;
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ALEXANDROS ARDAVANIS
3“Ag. Savvas” Regional Cancer Hospital, Athens, Greece;
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IOANNIS BOUKOVINAS
4“BIOKLINIKI” Hospital, Thessaloniki, Greece;
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PARISIOS MAKRANTONAKIS
5INTERBALKAN Medical Center, Thessaloniki, Greece;
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CHRISTOS PAPADIMITRIOU
6“IASO” General Hospital, Athens, Greece;
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ATHANASIOS ATHANASIADIS
7“Koutlimbaneio and Triantafylleio” General Hospital, Larissa, Greece;
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ANASTASIOS BOUTIS
8“THEAGENEIO” Anticancer Hospital, Thessaloniki, Greece;
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STYLIANOS GIASSAS
9“REA” Hospital, Athens, Greece;
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STYLIANOS KAKOLYRIS
10University General Hospital of Alexandroupolis, Alexandroupolis, Greece;
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GEORGIOS KOUMAKIS
3“Ag. Savvas” Regional Cancer Hospital, Athens, Greece;
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KONSTANTINOS PAPAZISIS
2“EUROMEDICA” General Clinic, Thessaloniki, Greece;
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ADAMANTIA PSYRRI
11“ATTIKO” University General Hospital, Athens, Greece;
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NIKOLAOS ZIRAS
12“Metaxa” Anticancer Hospital of Piraeus, Piraeus, Greece;
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SOFIA BAKA
5INTERBALKAN Medical Center, Thessaloniki, Greece;
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NIKOLAOS KENTEPOZIDIS
13251 Airforce General Hospital, Athens, Greece;
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VASILIKI MICHALAKI
14“ARETAIEIO” Hospital, Athens, Greece
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Abstract

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.

Key Words:
  • Advanced breast cancer
  • everolimus
  • first line
  • safety
  • effectiveness
  • Received November 29, 2021.
  • Revision received December 14, 2021.
  • Accepted December 15, 2021.
  • Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.
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Anticancer Research: 42 (2)
Anticancer Research
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February 2022
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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” stud…
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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)
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
Anticancer Research Feb 2022, 42 (2) 1031-1041; DOI: 10.21873/anticanres.15564

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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)
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
Anticancer Research Feb 2022, 42 (2) 1031-1041; DOI: 10.21873/anticanres.15564
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Keywords

  • Advanced breast cancer
  • everolimus
  • first line
  • safety
  • effectiveness
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