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Use of bevacizumab (Bev) in real life for first-line (fl) treatment of ovarian cancer (OC)/ The GINECO ENCOURAGE cohort of 500 French patients

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Dominique Berton-Rigaud

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

D. Berton-Rigaud1, A. Floquet2, D. Mollon-Grange3, A. Dechartres4, W. Lescaut5, M. Kaminsky-Forrett6, O. Tredan7, R. Largillier8, A.M. Savoye9, J. Alexandre10, C. Delbaldo11, E. Malaurie12, H. Barletta13, C. Bosacki14, C. GARNIER TIXIDRE15, P. Follana16, H. Laharie-Mineur17, C. Levaché18, E. Pujade-Lauraine19, F. Selle20

Author affiliations

  • 1 Oncologie Médicale, ICO Centre René Gauducheau, 44805 - Saint-Herblain Cédex/FR
  • 2 Oncologie Médicale, Institute Bergonié, 33076 - Bordeaux/FR
  • 3 Service Radiothérapie Et Oncologie Médicale, Centre Hospitalier Intercommunal de Cornouaille, 29107 - Quimper Cédex/FR
  • 4 Biostatistique, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, 75013 - Paris/FR
  • 5 Service De Médecine Interne Hématologie Oncologie, Centre Hospitalier Princesse Grâce, 98012 - Monaco Cédex/MC
  • 6 Oncologie Médicale, ICL Institut de Cancérologie de Lorraine, 54511 - Vandoeuvre les Nancy/FR
  • 7 Medical Oncology, Centre Léon Bérard, 69373 - Lyon Cédex /FR
  • 8 Oncologie Médicale, Centre Azuréen de Cancérologie, 06250 - Mougins Cédex /FR
  • 9 Service Rubis - Oncologie Médicale, Institut Jean Godinot, 51056 - Reims Cédex/FR
  • 10 Unité D'oncologie Médicale, Hôpital Cochin, 75014 - PARIS Cédex/FR
  • 11 Service Oncologie, Groupe Hospitalier Diaconesses-Croix Saint Simon, 75020 - PARIS/FR
  • 12 Oncologie - Radiothérapie, CH Intercommunal de Créteil, 94010 - Créteil Cédex/FR
  • 13 Chirurgie Et Cancérologie Gynécologiques, Centre Mistral, 07500 - Guilherand-Granges/FR
  • 14 Oncologie, Institut de Cancérologie Lucien Neuwirth, 42271 - Saint-Priest-en-Jarez/FR
  • 15 Institut Daniel Hollard, Groupe Hospitalier Mutualiste de Grenoble, 38028 - Grenoble Cédex /FR
  • 16 Onco-hématologie, Centre Anticancer Antoine Lacassagne, 06189 - Nice Cédex /FR
  • 17 Oncologie - Radiothérapie, Clinique Tivoli, 33000 - Bordeaux/FR
  • 18 Radiothérapie Et Oncologie Médicale, Clinique Francheville, 24004 - Périgueux Cédex/FR
  • 19 Recherche Clinique, Arcagy-Gineco, 75008 - Paris/FR
  • 20 Service D'oncologie Médicale, Groupe Hospitalier Diaconesses-Croix Saint Simon, 75020 - Paris/FR
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Resources

Abstract 3795

Background

Bevacizumab (bev) is approved in Europe (EU) for first line therapy of OC patients (pts). This study aimed to evaluate the use of Bev in real life, with a focus on toxicity.

Methods

Representative centers in France of French regions and of mode of practice were asked to participate. From 04/13 to 02/15, among the consecutive OC pts treated in each center, were selected those who were newly diagnosed and planned to receive Bev. An independent CRA captured the clinical data at baseline, 6, 12, 18 and 36 months.

Results

A total of 104 centers participated: Private practice (44%), non-academic hospital (31%), academic (11%), anticancer center (14%). 1290 pts were screened, 500 registered and 468 were evaluable. Pts characteristics at baseline were: median age 65 yrs, antihypertensive therapy (26%), anticoagulant (10%), cardiac history (5%), serous histology (83%), interval surgery (47%), complete surgical debulking (74%) and carboplatin-paclitaxel chemotherapy (98%). Only 3.4% were not FIGO stage IIIB-IV. Pts received Bev at 15 mg/kg (80%) during a median of 18 cycles (10-21) and 7.8% stopped treatment for toxicity. Main toxicity was HTA requiring new therapy (38%), PRES (1.3%), venous thrombosis (5%), proteinuria (9.8%) and nephrotic syndrome (2.6%). Other toxicities mostly reported include low grade epistaxis, gingivorrhagia, arthralgia, headache and dysphonia. Gastrointestinal perforation, fistula, arterial events and grade 3-4 bleeding were very low: 0.2%, 0.8%, 0,1% and 0.2% respectively. No pts developed congestive heart failure nor died from toxicity. Median PFS was 17.4 months (IC95% [16.4-19.1]) and % of pts alive at 3 years was 62.4% (IC95 % [58.1-67.1]).

Conclusions

In routine practice among French centers, first-line Bev administration is consistent with the EU label in most of the cases. Efficacy and safety in the real life were in line with that reported in trials excepted for a higher incidence of observed HTA and complications, suggesting the importance of increased education on HTA monitoring.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

ARCAGY-GINECO.

Funding

Roche.

Disclosure

A. Floquet: Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche. O. Tredan: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Lilly; Honoraria (self): BMS; Honoraria (self): MSD. J. Alexandre: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): PharmaMar; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Janssen; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Novartis. C. Garnier Tixidre: Honoraria (self): Lilly; Honoraria (self): AstraZeneca; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Pfizer. P. Follana: Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: AstraZeneca; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Tesaro. C. Levaché: Travel / Accommodation / Expenses: Sanofi. E. Pujade-Lauraine: Honoraria (self): AstraZeneca; Honoraria (self): Tesaro; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Genmab; Advisory / Consultancy: Incyte; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): Tesaro. F. Selle: Honoraria (self): Roche; Honoraria (self): MSD France; Honoraria (self): PharmaMar; Honoraria (self): Tesaro; Honoraria (self): Clovis; Honoraria (self): AstraZeneca; Advisory / Consultancy: Roche; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: MSD France; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca. All other authors have declared no conflicts of interest.

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