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

Background: Treatment decisions in routine clinical practice are based on reports of clinical trials, which represent highly selected populations. Limited studies reported real-world evidences representing routine clinical practices in patients with renal-cell carcinoma (RCC) in Europe. The aim of this retrospective, noninterventional chart review was to collect data on the treatment landscape for patients with advanced/metastatic RCC in routine clinical practice in a broader patient population in Austria., Patients and Methods: Patients with advanced/metastatic RCC receiving systemic treatment between June 2010 and June 2016 across 12 centers in Austria were included. Parameters were entered into an electronic case report form from the participating sites via the application Hermesoft electronic data capture system. Progression-free survival (PFS) and overall survival (OS) were the 2 primary end points., Results: The median PFS and OS were 12 months and 44 months, respectively (first-line PFS was 14 months for pazopanib and 13 months for sunitinib; first-line OS was 44 months for pazopanib and 48 months for sunitinib). Factors influencing the OS were sex, with female patients at a significantly higher risk than male patients (hazard ratio = 1.719), Eastern Cooperative Oncology Group performance status > 0 increased the risk twice (hazard ratio = 2.048), and number of metastases > 3 before the first line doubled the risk compared to metastases (hazard ratio = 2.064)., Conclusion: OS in this retrospective chart review was considerably longer than the previous reports in real-world patients, underlining the benefit of current RCC treatment options in routine clinical practice., (Copyright © 2019. Published by Elsevier Inc.)