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 Vergote, Ignace
A1 Van Nieuwenhuysen, Els
A1 De Waele, Stefanie
A1 Vulsteke, Christof
A1 Lamot, Caroline
A1 Van den Bulck, Heidi
A1 Claes, Nele
A1 Graas, Marie-Pascale
A1 Debrock, Guy
A1 Spoormans, Isabelle
A1 Vuylsteke, Peter
A1 Honhon, Brigitte
A1 Verhoeven, Didier
A1 De Maeseneer, Daan
A1 Dirix, Luc
A1 Mebis, Jeroen
A1 Vroman, Philippe
A1 Denys, Hannelore
A1 Martinez Mena, Corina
A1 Pelgrims, Gino
A1 Van Steenberghe, Mona
A1 van Gorp, Toon
A1 Gennigens, Christine
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.