RT Journal Article
SR Electronic
T1 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
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP ijgc-2021-003190
DO 10.1136/ijgc-2021-003190
A1 Ignace Vergote
A1 Els Van Nieuwenhuysen
A1 Stefanie De Waele
A1 Christof Vulsteke
A1 Caroline Lamot
A1 Heidi Van den Bulck
A1 Nele Claes
A1 Marie-Pascale Graas
A1 Guy Debrock
A1 Isabelle Spoormans
A1 Peter Vuylsteke
A1 Brigitte Honhon
A1 Didier Verhoeven
A1 Daan De Maeseneer
A1 Luc Dirix
A1 Jeroen Mebis
A1 Philippe Vroman
A1 Hannelore Denys
A1 Corina Martinez Mena
A1 Gino Pelgrims
A1 Mona Van Steenberghe
A1 Toon van Gorp
A1 Christine Gennigens
YR 2022
UL http://ijgc.bmj.com/content/early/2022/01/20/ijgc-2021-003190.abstract
AB 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.ClinicalTrials.gov identifier NCT02393898.Data are available upon reasonable request.