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.

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.

Informations de copyright

Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

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.