PMID- 32170637 OWN - NLM STAT- MEDLINE DCOM- 20210603 LR - 20210603 IS - 1699-3055 (Electronic) IS - 1699-048X (Linking) VI - 22 IP - 10 DP - 2020 Oct TI - 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. PG - 1857-1866 LID - 10.1007/s12094-020-02327-5 [doi] AB - 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. FAU - Ciruelos, E AU - Ciruelos E AUID- ORCID: 0000-0002-2796-1042 AD - Department of Medical Oncology, Breast Cancer Unit, University Hospital 12 de Octubre, Avda. De Cordoba, s/n, 28041, Madrid, Spain. eva.ciruelos@gmail.com. FAU - Jerusalem, G AU - Jerusalem G AD - Centre Hospitalier Universitaire du Sart-Tilman, University of Liege, Liege, Belgium. FAU - Martin, M AU - Martin M AD - Department of Medical Oncology, Instituto de Investigacion Sanitaria Gregorio Maranon, Universidad Complutense, GEICAM, CIBERONC, Madrid, Spain. FAU - Tjan-Heijnen, V C G AU - Tjan-Heijnen VCG AD - Department of Medical Oncology, GROW, Maastricht University Medical Centre, Maastricht, The Netherlands. FAU - Neven, P AU - Neven P AD - Department of Oncology, Multidisciplinary Breast Center, KULeuven-University of Leuven, Leuven, Belgium. FAU - Gavila, J AU - Gavila J AD - Department of Medical Oncology, Instituto Valenciano de Oncologia, Valencia, Spain. FAU - Montemurro, F AU - Montemurro F AD - Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy. FAU - Generali, D AU - Generali D AD - Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy. FAU - Lang, I AU - Lang I AD - Medical Oncology and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary. FAU - Martinez-Serrano, M J AU - Martinez-Serrano MJ AD - Medical Department, Novartis Oncology, Barcelona, Spain. FAU - Perello, M F AU - Perello MF AD - Medical Department, Novartis Oncology, Barcelona, Spain. FAU - Conte, P AU - Conte P AD - Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy. AD - Medical Oncology, Istituto Oncologico Veneto, Padova, Italy. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study DEP - 20200313 PL - Italy TA - Clin Transl Oncol JT - Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico JID - 101247119 RN - 0 (Androstadienes) RN - 0 (Receptors, Estrogen) RN - 9HW64Q8G6G (Everolimus) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - NY22HMQ4BX (exemestane) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Androstadienes/*administration & dosage/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Breast Neoplasms/chemistry/*drug therapy/pathology MH - Disease Progression MH - Everolimus/*administration & dosage/adverse effects MH - Female MH - Humans MH - Incidence MH - Middle Aged MH - Receptor, ErbB-2/analysis MH - Receptors, Estrogen/analysis OTO - NOTNLM OT - Aromatase inhibitors OT - Breast neoplasm OT - Endocrine therapy OT - Everolimus OT - Post-menopausal women OT - Targeted therapy EDAT- 2020/03/15 06:00 MHDA- 2021/06/04 06:00 CRDT- 2020/03/15 06:00 PHST- 2019/11/12 00:00 [received] PHST- 2020/02/19 00:00 [accepted] PHST- 2020/03/15 06:00 [pubmed] PHST- 2021/06/04 06:00 [medline] PHST- 2020/03/15 06:00 [entrez] AID - 10.1007/s12094-020-02327-5 [pii] AID - 10.1007/s12094-020-02327-5 [doi] PST - ppublish SO - Clin Transl Oncol. 2020 Oct;22(10):1857-1866. doi: 10.1007/s12094-020-02327-5. Epub 2020 Mar 13.