title: Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study.
abstract: The poor outcome of patients with recurrent ovarian cancer constitutes a continuous challenge for decision-making in clinical practice. In this setting, molecular targets have recently been identified, and novel compounds are now available. Bevacizumab has been introduced for the treatment of patients with ovarian cancer and is, to date, the most extensively investigated targeted therapy in this setting. However, potential toxicities are associated with the use of this monoclonal antibody. These toxicities have been reported in clinical trials, and can also be observed outside of trials. As limited data is currently available regarding the safety of bevacizumab treatment in daily clinical practice, the current retrospective study was designed to evaluate this. Data from 156 patients with recurrent ovarian cancer who had received bevacizumab treatment between January 2006 and June 2009 were retrospectively identified from the institutional records of five French centers. In contrast to clinical trials, the patients in the present study were not selected and had a heterogeneous profile according to their prior medical history, lines of treatment prior to bevacizumab introduction and number of relapses. The results first confirm the effect of heavy pretreatment on the occurrence of serious and fatal adverse events in clinical practice, as previously reported for clinical trials and for other retrospective cohort studies. Importantly, the data also demonstrates, for the first time, that medical history of hypertension is an independent predictive risk factor for the development of high-grade hypertension during bevacizumab treatment. These results thus suggest that treating physicians must consider all risk factors for managing bevacizumab toxicity prior to its introduction. Such risk factors include the time of bevacizumab introduction, a patient's history of hypertension and a low incidence of pre-existing obstructive disease.
authors.affiliation: Department of Medical Oncology, Alliance For Cancer Research (APREC), Tenon Hospital, Public Assistance Hospitals of Paris (AP-HP), Paris 75020, France; Department of Clinical Oncology, Sorbonne University, Pierre-and-Marie-Curie University (University of Paris VI), Paris 75014, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Selle
authors.affiliation: Department of Medical Oncology, Cochin Hospital/Hotel Dieu, AP-HP, Paris Descartes University (University of Paris V), Paris 75014, France.
authors.forename: George
authors.initials: G
authors.lastname: Emile
authors.affiliation: Department of Medical Oncology, Gustave Roussy, Villejuif 94805, France.
authors.forename: Patricia
authors.initials: P
authors.lastname: Pautier
authors.affiliation: Oncology Department, Centre Léon Bérard, Lyon 69008, France.
authors.forename: Irène
authors.initials: I
authors.lastname: Asmane
authors.affiliation: Department of Medical Oncology, Alliance For Cancer Research (APREC), Tenon Hospital, Public Assistance Hospitals of Paris (AP-HP), Paris 75020, France.
authors.forename: Daniele G
authors.initials: DG
authors.lastname: Soares
authors.affiliation: Department of Medical Oncology, Alliance For Cancer Research (APREC), Tenon Hospital, Public Assistance Hospitals of Paris (AP-HP), Paris 75020, France.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Khalil
authors.affiliation: Department of Medical Oncology, Cochin Hospital/Hotel Dieu, AP-HP, Paris Descartes University (University of Paris V), Paris 75014, France.
authors.forename: Jerome
authors.initials: J
authors.lastname: Alexandre
authors.affiliation: Department of Medical Oncology, Gustave Roussy, Villejuif 94805, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Lhommé
authors.affiliation: Oncology Department, Centre Léon Bérard, Lyon 69008, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Ray-Coquard
authors.affiliation: Department of Medical Oncology, Alliance For Cancer Research (APREC), Tenon Hospital, Public Assistance Hospitals of Paris (AP-HP), Paris 75020, France; Department of Clinical Oncology, Sorbonne University, Pierre-and-Marie-Curie University (University of Paris VI), Paris 75014, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lotz
authors.affiliation: Department of Medical Oncology, Cochin Hospital/Hotel Dieu, AP-HP, Paris Descartes University (University of Paris V), Paris 75014, France.
authors.forename: François
authors.initials: F
authors.lastname: Goldwasser
authors.affiliation: Department of Medical Oncology, Gustave Roussy, Villejuif 94805, France.
authors.forename: Youssef
authors.initials: Y
authors.lastname: Tazi
authors.affiliation: Oncology Department, Centre Léon Bérard, Lyon 69008, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Heudel
authors.affiliation: Department of Medical Oncology, Cochin Hospital/Hotel Dieu, AP-HP, Paris Descartes University (University of Paris V), Paris 75014, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
authors.affiliation: Department of Medical Oncology, Gustave Roussy, Villejuif 94805, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Gouy
authors.affiliation: Oncology Department, Centre Léon Bérard, Lyon 69008, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Tredan
authors.affiliation: Department of Statistics, Auxesia, Decines-Charpieu 69150, France.
authors.forename: Marie O
authors.initials: MO
authors.lastname: Barbaza
authors.affiliation: Roche S.A.S., Boulogne-Billancourt 92650, France.
authors.forename: Nora
authors.initials: N
authors.lastname: Ady-Vago
authors.affiliation: Department of Medical Oncology, Alliance For Cancer Research (APREC), Tenon Hospital, Public Assistance Hospitals of Paris (AP-HP), Paris 75020, France.
authors.forename: Coraline
authors.initials: C
authors.lastname: Dubot
keywords: bevacizumab; clinical practice; hypertension; recurrent ovarian cancer; safety