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
Guenther G. Steger,
Daniel Egle,
Rupert Bartsch,
Georg Pfeiler,
Edgar Petru,
Richard Greil,
Ruth Helfgott,
Christian Marth,
Leopold Öhler,
Michael Hubalek,
Alois Lang,
Christoph Tinchon,
Ferdinand Haslbauer,
Andreas Redl,
Karin Hock,
Mathias Hennebelle,
Bernhard Mraz,
Michael Gnant
Affiliations
Guenther G. Steger
Department of Internal Medicine I, Divison of Oncology, Comprehensive Cancer Center and Gaston H. Glock Research Center, Medical University of Vienna, Vienna, Austria; Corresponding author. Department of Internal Medicine I, Comprehensive Cancer Center and Gaston H. Glock Research Center, Medical University of Vienna, Vienna, Austria.
Daniel Egle
Department of Gynecology and Gynecological Oncology, Medical University of Innsbruck, Innsbruck, Austria
Rupert Bartsch
Department of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
Georg Pfeiler
Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria
Edgar Petru
Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria
Richard Greil
Department of Oncology, Medical University of Salzburg, Salzburg, Austria
Ruth Helfgott
Department of Surgery, Hospital Sisters of Charity, Linz, Linz, Austria
Christian Marth
Department of Gynecology and Gynecological Oncology, Medical University of Innsbruck, Innsbruck, Austria
Leopold Öhler
Department of Oncology, St. Josef Spital, Vienna, Vienna, Austria
Michael Hubalek
Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria
Alois Lang
Department of Oncology, Hospital of Feldkirch, Feldkirch, Austria
Christoph Tinchon
Department of Oncology, LKH Hochsteiermark, Leoben, Austria
Ferdinand Haslbauer
Department of Oncology, Hospital of Vöcklabruck, Vöcklabruck, Austria
Andreas Redl
Datamedrix GmbH, Vienna, Austria
Karin Hock
Novartis Pharma GmbH, Vienna, Austria
Mathias Hennebelle
Novartis Pharma GmbH, Vienna, Austria
Bernhard Mraz
Novartis Pharma GmbH, Vienna, Austria
Michael Gnant
Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
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.
