Results of the VENUS study: Bevacizumab efficacy and safety in platinum-sensitive recurrent ovarian cancer (OC)—A real-life ambispective study.

Authors

Isabelle Laure Ray-Coquard

Isabelle Laure Ray-Coquard

Centre Léon-Bérard, Lyon, France

Isabelle Laure Ray-Coquard , Jerome Alexandre , Francois Goldwasser , Jean-Philippe Spano , Dominique Berton-Rigaud , Aude-Marie Savoye , Michel Fabbro , Fernando Bazan , Elsa Kalbacher , Nadia Raban , Claire Giraud , Virginie Pottier , Frédéric Selle , Anne Patsouris , Claire Garnier-Tixidre , Anne Mercier Blas , Jocelyne Provencal , Fabien Brocard , Jessica Berdougo-Tritz , Vincent Launay-Vacher

Organizations

Centre Léon-Bérard, Lyon, France, Department of Medical Oncology, Hopital Cochin, Université Paris Descartes, CARPEM, APHP, Paris, France, Department of Medical Oncology, ARIANE, Cochin Hospital, Paris Descartes University, AP-HP, CARPEM, Paris, France, Pitié-Salpêtrière Hospital, Sorbonne University, Cancer University Institute, Paris, France, ICO Centre Rene Gauducheau, Saint-Herblain, France, Department of Medical Oncology, Institut Jean Godinot, Reims, France, ICM Val d'Aurelle, Montpellier, France, Institut Regional du Cancer en Franche-Comté-University Hospital, Besançon, France, CHU Besançon, Besançon, France, GINECO and CHU La Milétrie, Poitiers, France, Centre Leonard de Vinci, Dechy, France, Universite Pierre et Marie Curie, Oncology, GHU-Est Tenon, Paris, France, Institute of West Cancerology Paul Papin, Angers, France, GHM Grenoble, Grenoble, France, Centre Hospitalier Privé de Saint-Grégoire, Saint-Gregoire, France, Centre Hospitalier Métropole Savoie, Chambery, France, GINECO-Oracle-Centre d'Oncologie de Gentilly, Nancy, France, Pitié-Salpêtrière Hospital, Paris, France

Research Funding

Pharmaceutical/Biotech Company

Background: The VENUS study reports on the efficacy/safety of bevacizumab (Bev) in patients (pts) treated in the real-life setting. Methods: In this multicentric observational ambispective VENUS study, all Pts were naive of any antiVEGF and received Bev +/- chemotherapy. Pts were followed until progression or death, for a maximum of 3 years since Bev initiation. De novo side effects were defined as symptoms for which patients were naïve at baseline. Results: 148 OC pts were included (27 centres), 10 excluded and 8 were lost of follow-up. 52 were retrospective. Median age 64 years (55-70). 84.1% were advanced. Median duration of Bev was 8.6 months, min 1 max 36 months. Initial Bev dose was 15 mg/kg Q3W for 65.3%, 10.0 for 22.5%, 7.5 for 10.2% and 5.0 for 2%. 2 pts presented with thrombotic micro-angiopathy (1.4%). Before Bev, hypertension (HTN) was present in 28.9%; proteinuria in 11.3%. Incidence of de novo HTN was 25%. 43 pts (31.2%) experienced de novo Grade 1-2 Pu, for a total of 56 events, no grade 3-4 was observed. A total of 12 Grade 4 events occurred: 9 neutropenia and 3 thrombopenia. Mean overall survival (OS) and progression free survival (PFS) were 30.0 and 13.3 months, respectively. Conclusions: 1) 1/3 of pts were treated at low doses in this real-life study; 2) safety of Bev in real-life was manageable and as expected, 3) OS and PFS were consistent with those reported in the OCEANS study: PFS 12.4 and OS 33.6 months but lower than in the GOG-0213 study: PFS 13.8 and OS 42.6 months. De novo events recorded during follow-up.

Event% of pts (n)Grade 3 (n events)Grade 4 (n events)
Asthenia65.2 (90)20
Nausea39.9 (55)20
Epistaxis35.5 (49)00
Proteinuria31.2 (43)00
Neutropenia29.0 (40)189
Constipation26.1 (36)00
Diarrhoea25.4 (35)00
Anemia24.6 (34)100
Hematuria22.5 (31)NANA
Abdominal pain21.0 (29)NANA
Cephalgia20.3 (28)00
Vomiting19.6 (27)30
Dyspnea18.8 (26)10
Thrombopenia16.7 (23)23
Edema (lower limbs)13.8 (19)NANA
Anorexia13.0 (18)00
Arthralgia10.9 (15)00
Thromboembolic event9.4 (13)NANA
Back pain8.7 (12)NANA

*NCI-CTCAE 4.03; G=Grade; de novo = pt with no event at inclusion and who presented an event during f/u; NA: Not available, not graded. Other adverse events with all grade incidence <5% are not reported in this abstract. VENUS was supported by an unrestricted educational grant from Roche France.

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Citation

J Clin Oncol 37, 2019 (suppl; abstr 5540)

DOI

10.1200/JCO.2019.37.15_suppl.5540

Abstract #

5540

Poster Bd #

363

Abstract Disclosures