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Original research
Prospective non-interventional BELOVA/BGOG-ov16 study on safety of frontline bevacizumab in elderly patients with FIGO stage IV ovarian cancer: a study of the Belgian and Luxembourg Gynaecological Oncology Group
  1. Ignace Vergote1,
  2. Els Van Nieuwenhuysen1,
  3. Stefanie De Waele2,
  4. Christof Vulsteke3,4,
  5. Caroline Lamot5,
  6. Heidi Van den Bulck6,
  7. Nele Claes7,
  8. Marie-Pascale Graas8,
  9. Guy Debrock9,
  10. Isabelle Spoormans10,
  11. Peter Vuylsteke11,
  12. Brigitte Honhon12,
  13. Didier Verhoeven13,
  14. Daan De Maeseneer2,
  15. Luc Dirix14,
  16. Jeroen Mebis15,
  17. Philippe Vroman16,
  18. Hannelore Denys17,
  19. Corina Martinez Mena18,
  20. Gino Pelgrims19,
  21. Mona Van Steenberghe20,
  22. Toon van Gorp1 and
  23. Christine Gennigens21
  1. 1Division of Gynaecological Oncology, Department of Gynaecology and Obstetrics, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium
  2. 2AZ Sint-Lucas, Gent, Belgium
  3. 3Integrated Cancer Center Ghent, AZ Maria Middelares, Gent, Belgium
  4. 4Center for Oncological Research (CORE), Antwerp University, Edegem, Belgium
  5. 5AZ Nikolaas, Sint-Niklaas, Belgium
  6. 6Imeldaziekenhuis, Bonheiden, Belgium
  7. 7AZ Sint-Jan, Brugge, Belgium
  8. 8CHC Mont Légia, Liege, Belgium
  9. 9Ziekenhuis Oost-Limburg, Genk, Belgium
  10. 10AZ Damiaan Oostende, Oostende, Belgium
  11. 11CHU UCL Sainte Elisabeth, Namur, Belgium
  12. 12Grand Hôpital de Charleroi, Charleroi, Belgium
  13. 13AZ Klina, Brasschaat, Belgium
  14. 14Sint-Augustinus, Wilrijk, Belgium
  15. 15Limburgs Oncologisch Centrum, Campus Virga Jesse, Hasselt, Belgium
  16. 16Oncologisch Centrum West, Veurne, Belgium
  17. 17UZ Gent, Gent, Belgium
  18. 18CHU Saint-Pierre, Brussels, Belgium
  19. 19AZ Turnhout, Turnhout, Belgium
  20. 20Roche nv/sa, Brussels, Belgium
  21. 21CHU of Liège, Medical Oncology Department, University Hospital, Liege, Belgium
  1. Correspondence to Professor Ignace Vergote, Division of Gynaecological Oncology, Department of Gynaecology and Obstetrics, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium, European Union; ignace.vergote{at}uz.kuleuven.ac.be

Abstract

Objective Because elderly patients with ovarian cancer are underrepresented in randomized studies, this study aimed to expand our knowledge on the safety and effectiveness of frontline treatment with bevacizumab in combination with standard carboplatin and paclitaxel chemotherapy in patients aged 70 years and older with a diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage IV ovarian cancer in routine clinical practice in Belgium.

Methods Patients aged 70 years and older with FIGO stage IV ovarian cancer were included in a multicenter, non-interventional prospective study

to evaluate the safety and effectiveness of treatment with bevacizumab in combination with frontline carboplatin and paclitaxel chemotherapy. Comprehensive geriatric assessments were performed at baseline and during treatment.

Results The most frequently reported adverse events for bevacizumab were hypertension (55%), epistaxis (32%) and proteinuria (21%). The Kaplan-Meier estimate of progression-free survival was 14.5 months. The results of the comprehensive geriatric assessments during treatment indicated a slight improvement in the geriatric eight health status screening tool score for general health status and the mini-nutritional assessment score for nutritional status. The median change from baseline score was close to zero for the instruments measuring independency, activity of daily living and instrumental activities of daily living, and for the mobility-tiredness test measuring self-perceived fatigue.

Conclusions No new safety signals were registered in this study in patients aged 70 years and older treated with bevacizumab and frontline carboplatin and paclitaxel for FIGO stage IV ovarian cancer. Elderly patients should not be excluded from treatment for advanced ovarian cancer based on age alone.

EU PAS register ENCEPP/SDPP/13849.

ClinicalTrials.gov identifier NCT02393898.

  • ovarian cancer

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/ijgc-2021-003190

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @CVulsteke

    • Contributors IV, HD, CG, TvG, EVN, DV, and PV are members of the Scientific Committee of the study and were involved in the development of the protocol, design of the study, analysis and disclosing of the results and maintaining ethical and scientific standards. All authors critically revised the manuscript and approved the version to be published. All authors agree to be accountable for all the aspects of the publication of the study results. IV is responsible for the overall content as guarantor.

    • Funding This work was supported by F. Hoffmann-La Roche Ltd.

    • Competing interests IV reports consulting: for Agenus (2021), Aksebio (2021), Amgen (Europe) GmbH (2019), AstraZeneca (2019-2022), Bristol Myers Squibb (2021), Clovis Oncology Inc. (2019-2019), Carrick Therapeutics (2019), Deciphera Pharmaceuticals (2020-2021), Eisai (2021), Elevar Therapeutics (2020), F. Hoffmann-La Roche Ltd (2019-2021), Genmab (2019-2021), GSK (2019-2021), Immunogen Inc. (2019-2022), Jazzpharma (2021-2022), Karyopharm (2021), Mersana (2020), Millennium Pharmaceuticals (2019), MSD (2019-2022), Novocure (2020-2022), Novartis (2021), Octimet Oncology NV (2019), Oncoinvent AS (2019-2022), Seagen (2021), Sotio a.s. (2019-2022), Verastem Oncology (2020), Zentalis (2020); Contracted Research (via KU Leuven) from Oncoinvent AS (2019-2020) and Genmab (2019); Grant or corporate sponsored research from Amgen (2019-2020) and Roche (2019); Accomodations, travel expenses (2019-2020) from Amgen, MSD, Tesaro, AstraZeneca and Roche. CV reports for the present publication study funding from Roche and support from Lutgart Opstaele from ANZ Medical Writing; Institutional Grant from MSD/Merck, Consultancy for Janssen-Cilag, Roche, GSK, Atheneum Partners, Astellas Pharma, MSD, BMS and Leo-Pharma, Presentation and advisory Boards: Janssens Cilag, Leo Pharma, Presentation: Bayer; Advisory Board: Merck MSD, GSK, Astrazeneca; Travel support from Roche and Pfizer. PV reports for the present publication support from Roche (medical writing and article processing charges; consulting fees from Astrazeneca and Roche, Participation on a data safety monitoring board or advisory board: Astrazeneca and Roche; unpaid leadership or fiduciary role: BSMO president 2019. MVS is employee of Roche NV. All other authors declared no conflicts of interest.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.