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
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) |
---|---|---|---|
Asthenia | 65.2 (90) | 2 | 0 |
Nausea | 39.9 (55) | 2 | 0 |
Epistaxis | 35.5 (49) | 0 | 0 |
Proteinuria | 31.2 (43) | 0 | 0 |
Neutropenia | 29.0 (40) | 18 | 9 |
Constipation | 26.1 (36) | 0 | 0 |
Diarrhoea | 25.4 (35) | 0 | 0 |
Anemia | 24.6 (34) | 10 | 0 |
Hematuria | 22.5 (31) | NA | NA |
Abdominal pain | 21.0 (29) | NA | NA |
Cephalgia | 20.3 (28) | 0 | 0 |
Vomiting | 19.6 (27) | 3 | 0 |
Dyspnea | 18.8 (26) | 1 | 0 |
Thrombopenia | 16.7 (23) | 2 | 3 |
Edema (lower limbs) | 13.8 (19) | NA | NA |
Anorexia | 13.0 (18) | 0 | 0 |
Arthralgia | 10.9 (15) | 0 | 0 |
Thromboembolic event | 9.4 (13) | NA | NA |
Back pain | 8.7 (12) | NA | NA |
*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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