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

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.

• Authors: Ignace Vergote, Els Van Nieuwenhuysen, Stefanie De Waele, Christof Vulsteke, Caroline Lamot, Heidi Van den Bulck, Nele Claes, Marie-Pascale Graas, Guy Debrock, Isabelle Spoormans, Peter Vuylsteke, Brigitte Honhon, Didier Verhoeven, Daan De Maeseneer, Luc Dirix, Jeroen Mebis, Philippe Vroman, Hannelore Denys, Corina Martinez Mena, Gino Pelgrims, Mona Van Steenberghe, Toon van Gorp, Christine Gennigens
• Journal: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society (Int J Gynecol Cancer) Vol. 32 Issue 6 Pg. 753-760 (06 06 2022) ISSN: 1525-1438 [Electronic] England
• PMID: 35063943 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Bevacizumab
• Carboplatin
• Paclitaxel

Topics

• Activities of Daily Living
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Belgium (epidemiology)
• Bevacizumab
• Carboplatin
• Carcinoma, Ovarian Epithelial (drug therapy)
• Female
• Humans
• Luxembourg
• Ovarian Neoplasms (drug therapy, etiology)
• Paclitaxel (adverse effects)
• Prospective Studies