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

Abstract

ObjectiveBecause 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.MethodsPatients 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.ResultsThe 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.ConclusionsNo 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 registerENCEPP/SDPP/13849.ClinicalTrials.gov identifierNCT02393898.

Association of bevacizumab and stroke in ovarian cancer: a systematic review and meta-analysis

“…Twelve studies were included in this meta-analysis (Cannistra et al, 2007;Garcia et al, 2008;Konner et al, 2011;Perren et al, 2011;Aghajanian et al, 2012;Eisenhauer et al, 2014;Herzog et al, 2014;Tewari et al, 2019;Walker et al, 2019;Pfisterer et al, 2020;Pignata et al, 2021;Vergote et al, 2022). The specific screening flow chart is shown in Figure 1.…”

“…From 2007 to 2021, 5,003 patients with ovarian cancer were enrolled, including 3,733 on primary treatment and 1,270 with recurrent ovarian cancer. These clinical studies include six single-experimental-arm studies (Cannistra et al, 2007;Garcia et al, 2008;Konner et al, 2011;Eisenhauer et al, 2014;Herzog et al, 2014;Vergote et al, 2022). In the experimental arm, the treatment regimen is platinum-based chemotherapy combined with bevacizumab.…”

“…Clinical trial data have indicated that bevacizumab can significantly prolong overall survival (OS) and progression-free survival (PFS) in patients with advanced and relapsed ovarian cancer. However, adverse events in cerebrovascular, especially lifethreatening stroke, have been reported in randomized controlled trials (RCTs) (Cannistra et al, 2007;Garcia et al, 2008;Konner et al, 2011;Perren et al, 2011;Aghajanian et al, 2012;Eisenhauer et al, 2014;Herzog et al, 2014;Tewari et al, 2019;Walker et al, 2019;Pfisterer et al, 2020;Pignata et al, 2021;Vergote et al, 2022). Stroke is a collection of disorders that include ischemic and hemorrhagic stroke (which includes parenchymal hemorrhage, ventricular hemorrhage, and subarachnoid hemorrhage) in which a blood vessel in the brain suddenly bursts or limits blood flow to the brain, causing brain tissue damage.…”