Everolimus plus exemestane in hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer:: incidence and time course of adverse events in the phase IIIb BALLET population

• G. Jerusalem ^[1] ; E. Ciruelos ^[2] ; M. Martin ^[3] ; V. C. G. Tjan-Heijnen ^[4] ; P. Neven ^[7] ; J. Gavila ^[5] ; F. Montemurro ^[8] ; D. Generali ^[6] ; I. Lang ^[9] ; M. J. Martínez-Serrano ^[10] ; M. F. Perelló ^[10] ; P. Conte ^[11]
  1. [1] University of Liège

     University of Liège

     Arrondissement de Liège, Bélgica

     
  2. [2] Hospital Clinico Universitario de Valencia

     Hospital Clinico Universitario de Valencia

     Valencia, España

     
  3. [3] Instituto de Investigación Sanitaria Gregorio Marañón

     Instituto de Investigación Sanitaria Gregorio Marañón

     Madrid, España

     
  4. [4] Maastricht University Medical Centre

     Maastricht University Medical Centre

     Países Bajos

     
  5. [5] Instituto Valenciano de Oncologia

     Instituto Valenciano de Oncologia

     Valencia, España

     
  6. [6] University of Trieste

     University of Trieste

     Trieste, Italia

     
  7. [7] Department of Oncology, Multidisciplinary Breast Center, KULeuven-University of Leuven, Leuven, Belgium
  8. [8] Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy
  9. [9] Medical Oncology and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary
  10. [10] Medical Department, Novartis Oncology, Barcelona, Spain
  11. [11] Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 22, Nº. 10, 2020, págs. 1857-1866
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Background The addition of everolimus to exemestane therapy significantly improves progression-free survival in postmenopausal patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant breast cancer. However, the safety profile of this schedule still might be optimized.

    Methods Patients included in the BALLET trial were assessed. The objectives of this analysis were to provide additional information on the safety profile of this schedule depending on prior anticancer therapies and to characterize the time course of adverse events (AEs) and serious AEs (SAEs) of clinical interest throughout the study period. Non-infectious pneumonitis (NIP), stomatitis, asthenia and weight loss were selected as AEs of clinical interest.

    Results The safety population of this analysis comprised 2131 patients. There were similar incidences of AEs and SAEs of clinical interest regardless of previous anticancer therapies. Most stomatitis and asthenia events occurred within the first three months. Incidence of weight loss appeared to plateau except in the case of grade 3–4 events, which occurred rarely. The incidence of any grade NIP (between 2 to 6%) and grade 3–4 NIP (between 0 to 1%) was low across the study, but steady.

    Conclusions Everolimus plus exemestane is a well-known therapeutic option for aromatase inhibitor pretreated advanced breast cancer patients, and its toxicity profile is similar to that described in previous studies. Close monitoring, especially within the first three months, early intervention with preventive measures and patient education to help recognize the first signs and symptoms of AEs, will help to reduce their incidence and severity.