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Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer
BACKGROUND: Front-line maintenance therapy with bevacizumab demonstrates high efficacy and safety in epithelial ovarian cancer, as already shown in large phase III trials; however, the corresponding study populations are often not fully representative of patients in clinical routine. In this Austria...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Vienna
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9606045/ https://www.ncbi.nlm.nih.gov/pubmed/35146539 http://dx.doi.org/10.1007/s00508-022-02005-2 |
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author | Tsibulak, Irina Polterauer, Stephan Reinthaller, Alexander Schauer, Christian Berger, Jürg Marth, Christian |
author_facet | Tsibulak, Irina Polterauer, Stephan Reinthaller, Alexander Schauer, Christian Berger, Jürg Marth, Christian |
author_sort | Tsibulak, Irina |
collection | PubMed |
description | BACKGROUND: Front-line maintenance therapy with bevacizumab demonstrates high efficacy and safety in epithelial ovarian cancer, as already shown in large phase III trials; however, the corresponding study populations are often not fully representative of patients in clinical routine. In this Austria-based multicenter study, we aimed to explore the real-world outcomes of bevacizumab use in front-line treatment of ovarian cancer, including patients with comorbidities and poor performance status. PATIENTS: This study is an open label single arm multicenter noninterventional trial and included patients with newly diagnosed advanced epithelial ovarian cancer, who were treated with platinum-based chemotherapy and were candidates for receiving bevacizumab according to the product label. Data collection started in the third quarter of 2012 and ended in the third quarter of 2018. RESULTS: In this study 50 patients were included and 575 adverse events were reported for 90% of the patients. The majority of the adverse events were mild (47%) or moderate (37%). The most common adverse events were hypertension (60%), anemia (48%), leukopenia (42%), thrombocytopenia (36%), neutropenia (36%) and proteinuria (26%). A relation to bevacizumab was documented only for 10.3% of all adverse events. In almost 50% of all adverse events, no intervention was needed and bevacizumab treatment had to be interrupted only in 3.3% of all adverse events. The median progression-free survival was 1.3 years (95% CI 1.1–1.8). CONCLUSION: The routine use of front-line bevacizumab for advanced ovarian cancer is associated with high efficacy comparable with that obtained in randomized phase III clinical trials; however, hypertension and proteinuria were reported significantly more often in our Austria-based real-world population. SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s00508-022-02005-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-9606045 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Vienna |
record_format | MEDLINE/PubMed |
spelling | pubmed-96060452022-10-28 Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer Tsibulak, Irina Polterauer, Stephan Reinthaller, Alexander Schauer, Christian Berger, Jürg Marth, Christian Wien Klin Wochenschr Original Article BACKGROUND: Front-line maintenance therapy with bevacizumab demonstrates high efficacy and safety in epithelial ovarian cancer, as already shown in large phase III trials; however, the corresponding study populations are often not fully representative of patients in clinical routine. In this Austria-based multicenter study, we aimed to explore the real-world outcomes of bevacizumab use in front-line treatment of ovarian cancer, including patients with comorbidities and poor performance status. PATIENTS: This study is an open label single arm multicenter noninterventional trial and included patients with newly diagnosed advanced epithelial ovarian cancer, who were treated with platinum-based chemotherapy and were candidates for receiving bevacizumab according to the product label. Data collection started in the third quarter of 2012 and ended in the third quarter of 2018. RESULTS: In this study 50 patients were included and 575 adverse events were reported for 90% of the patients. The majority of the adverse events were mild (47%) or moderate (37%). The most common adverse events were hypertension (60%), anemia (48%), leukopenia (42%), thrombocytopenia (36%), neutropenia (36%) and proteinuria (26%). A relation to bevacizumab was documented only for 10.3% of all adverse events. In almost 50% of all adverse events, no intervention was needed and bevacizumab treatment had to be interrupted only in 3.3% of all adverse events. The median progression-free survival was 1.3 years (95% CI 1.1–1.8). CONCLUSION: The routine use of front-line bevacizumab for advanced ovarian cancer is associated with high efficacy comparable with that obtained in randomized phase III clinical trials; however, hypertension and proteinuria were reported significantly more often in our Austria-based real-world population. SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s00508-022-02005-2) contains supplementary material, which is available to authorized users. Springer Vienna 2022-02-10 2022 /pmc/articles/PMC9606045/ /pubmed/35146539 http://dx.doi.org/10.1007/s00508-022-02005-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Article Tsibulak, Irina Polterauer, Stephan Reinthaller, Alexander Schauer, Christian Berger, Jürg Marth, Christian Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
title | Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
title_full | Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
title_fullStr | Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
title_full_unstemmed | Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
title_short | Austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
title_sort | austria-based real-world data on bevacizumab in newly diagnosed epithelial ovarian cancer |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9606045/ https://www.ncbi.nlm.nih.gov/pubmed/35146539 http://dx.doi.org/10.1007/s00508-022-02005-2 |
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