PMID- 32062536 OWN - NLM STAT- MEDLINE DCOM- 20201204 LR - 20201214 IS - 1532-3080 (Electronic) IS - 0960-9776 (Print) IS - 0960-9776 (Linking) VI - 50 DP - 2020 Apr TI - Efficacy and safety of everolimus plus exemestane in patients with HR+, HER2- advanced breast cancer progressing on/after prior endocrine therapy in routine clinical practice: Primary results from the non-interventional study, STEPAUT. PG - 64-70 LID - S0960-9776(20)30036-9 [pii] LID - 10.1016/j.breast.2020.01.035 [doi] AB - BACKGROUND: STEPAUT, an Austrian non-interventional study, evaluated the safety and efficacy of everolimus plus exemestane in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) recurring/progressing on/after nonsteroidal aromatase inhibitors (NSAIs) in routine clinical practice. METHODS: Postmenopausal women with HR+, HER2- ABC progressing on/after NSAIs receiving everolimus plus exemestane in accordance with routine practice and the current version of Summary of Product Characteristics were eligible. Planned individual observation period corresponded to the duration of treatment until formal study end. RESULTS: Overall, 236 patients (median age: 65 years) were enrolled at 17 sites across Austria. The median progression-free survival (mPFS) in the overall population was 9.5 months (95% confidence interval [CI]: 8.6-10.7 months). The mPFS (95% CI) in patients who received everolimus 10 and 5 mg was 9.9 months (7.3-11.5 months) and 8 months (4.7-10.7 months), respectively. The median time to progression was numerically longer in patients who had a therapy break (11.9 months, 95% CI: 10.0-14.6 months) versus those who did not have any therapy break (10.7 months, 95% CI: 8.9-12.6 months). Patients experienced grade 1 (53.7%), grade 2 (35.9%), grade 3 (9.9%), grade 4 (0.2%) adverse events (AEs). The most common AEs of any grade were stomatitis, mucositis (53.8%), rash, exanthema (29.7%), loss of appetite, nausea (28.4%). CONCLUSIONS: Real-world safety and efficacy data from STEPAUT were consistent with results from BOLERO-2, supporting everolimus plus exemestane as a suitable treatment option for HR+, HER2- ABC recurring/progressing on/after NSAIs. CI - Copyright (c) 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Steger, Guenther G AU - Steger GG AD - Department of Internal Medicine I, Divison of Oncology, Comprehensive Cancer Center and Gaston H. Glock Research Center, Medical University of Vienna, Vienna, Austria. Electronic address: guenther.steger@meduniwien.ac.at. FAU - Egle, Daniel AU - Egle D AD - Department of Gynecology and Gynecological Oncology, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: daniel.egle@tirol-kliniken.at. FAU - Bartsch, Rupert AU - Bartsch R AD - Department of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.bartsch@meduniwien.ac.at. FAU - Pfeiler, Georg AU - Pfeiler G AD - Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria. Electronic address: georg.pfeiler@meduniwien.ac.at. FAU - Petru, Edgar AU - Petru E AD - Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria. Electronic address: edgar.petru@medunigraz.at. FAU - Greil, Richard AU - Greil R AD - Department of Oncology, Medical University of Salzburg, Salzburg, Austria. Electronic address: r.greil@salk.at. FAU - Helfgott, Ruth AU - Helfgott R AD - Department of Surgery, Hospital Sisters of Charity, Linz, Linz, Austria. Electronic address: ruth.helfgott@bhs.at. FAU - Marth, Christian AU - Marth C AD - Department of Gynecology and Gynecological Oncology, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: christian.marth@i-med.ac.at. FAU - Ohler, Leopold AU - Ohler L AD - Department of Oncology, St. Josef Spital, Vienna, Vienna, Austria. Electronic address: leopold.oehler@sjk-wien.at. FAU - Hubalek, Michael AU - Hubalek M AD - Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: michael@hubalek.at. FAU - Lang, Alois AU - Lang A AD - Department of Oncology, Hospital of Feldkirch, Feldkirch, Austria. Electronic address: Alois.Lang@swmbrk.de. FAU - Tinchon, Christoph AU - Tinchon C AD - Department of Oncology, LKH Hochsteiermark, Leoben, Austria. Electronic address: Christoph.Tinchon@kages.at. FAU - Haslbauer, Ferdinand AU - Haslbauer F AD - Department of Oncology, Hospital of Vocklabruck, Vocklabruck, Austria. Electronic address: ferdinand.haslbauer@gespag.at. FAU - Redl, Andreas AU - Redl A AD - Datamedrix GmbH, Vienna, Austria. Electronic address: a.redl@datamedrix.com. FAU - Hock, Karin AU - Hock K AD - Novartis Pharma GmbH, Vienna, Austria. Electronic address: karin.hock@novartis.com. FAU - Hennebelle, Mathias AU - Hennebelle M AD - Novartis Pharma GmbH, Vienna, Austria. Electronic address: mathias.hennebelle@novartis.com. FAU - Mraz, Bernhard AU - Mraz B AD - Novartis Pharma GmbH, Vienna, Austria. Electronic address: bernhard.mraz@novartis.com. FAU - Gnant, Michael AU - Gnant M AD - Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. Electronic address: mgnant@icloud.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20200131 PL - Netherlands TA - Breast JT - Breast (Edinburgh, Scotland) JID - 9213011 RN - 0 (Androstadienes) RN - 0 (Aromatase Inhibitors) RN - 0 (Receptors, Estrogen) RN - 0 (Receptors, Progesterone) 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 - Aged MH - Androstadienes/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Aromatase Inhibitors/*therapeutic use MH - Austria/epidemiology MH - Breast Neoplasms/*drug therapy MH - Everolimus/*therapeutic use MH - Female MH - Humans MH - Postmenopause MH - *Practice Patterns, Physicians' MH - Progression-Free Survival MH - Receptor, ErbB-2/metabolism MH - Receptors, Estrogen/metabolism MH - Receptors, Progesterone/metabolism PMC - PMC7375626 OTO - NOTNLM OT - Everolimus OT - Hormone receptor-positive OT - Metastatic breast cancer OT - Non-interventional study OT - Real-world setting OT - STEPAUT COIS- Declaration of competing interest GS has received grants and personal fees from Novartis during the conduct of this study; DE has received personal fees and non-financial support from Pfizer and Novartis and personal fees from Roche, Celgene, and Pierre Fabre, outside the submitted work; RB has received grants and personal fees from Novartis during the conduct of the study; personal fees from AstraZeneca, Eli Lilly, Celgene, EISAI, Daiichi, Pfizer, and Roche, outside the submitted work; GP has received honoraria from Novartis, Amgen, Roche, Pfizer, and AstraZeneca, outside the conduct of this study; EP has received honoraria from Novartis during the conduct of the study; RG has received grant and personal fees from Roche, Celgene, Merck, Astra Zeneca, Novartis, Amgen, AbbVie, BMS, MSD, Takeda, Merck, Sandoz, outside the conduct of this study; AL has received grants from Novartis during the conduct of the study; KH, MH, and BM report employment with Novartis Pharma GmbH during the conduct of this study; MG has received grants from AstraZeneca, Novartis, Pfizer, and Roche; and personal fees from Accelsiors, Amgen, AstraZeneca, Celgene, Eli-Lilly, Ipsen, Nano String Technologies, Novartis, Pfizer, and Roche, outside the submitted work. All remaining authors have declared no conflicts of interest. EDAT- 2020/02/18 06:00 MHDA- 2020/12/15 06:00 PMCR- 2020/01/31 CRDT- 2020/02/17 06:00 PHST- 2019/07/12 00:00 [received] PHST- 2020/01/22 00:00 [revised] PHST- 2020/01/23 00:00 [accepted] PHST- 2020/02/18 06:00 [pubmed] PHST- 2020/12/15 06:00 [medline] PHST- 2020/02/17 06:00 [entrez] PHST- 2020/01/31 00:00 [pmc-release] AID - S0960-9776(20)30036-9 [pii] AID - 10.1016/j.breast.2020.01.035 [doi] PST - ppublish SO - Breast. 2020 Apr;50:64-70. doi: 10.1016/j.breast.2020.01.035. Epub 2020 Jan 31.