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Randomized Controlled Trial
. 2022 Jun 6;32(6):753-760.
doi: 10.1136/ijgc-2021-003190.

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

Ignace Vergote  1 , Els Van Nieuwenhuysen  2 , Stefanie De Waele  3 , Christof Vulsteke  4   5 , Caroline Lamot  6 , Heidi Van den Bulck  7 , Nele Claes  8 , Marie-Pascale Graas  9 , Guy Debrock  10 , Isabelle Spoormans  11 , Peter Vuylsteke  12 , Brigitte Honhon  13 , Didier Verhoeven  14 , Daan De Maeseneer  3 , Luc Dirix  15 , Jeroen Mebis  16 , Philippe Vroman  17 , Hannelore Denys  18 , Corina Martinez Mena  19 , Gino Pelgrims  20 , Mona Van Steenberghe  21 , Toon van Gorp  2 , Christine Gennigens  22
Affiliations
Randomized Controlled Trial

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

Ignace Vergote et al. Int J Gynecol Cancer. .

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 studyto 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.

Clinicaltrialsgov identifier: NCT02393898.

Keywords: ovarian cancer.

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Conflict of interest statement

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.

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