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.
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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.
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