S Delaloge1, D Pérol2, C Courtinard3, E Brain4, B Asselain3, T Bachelot2, M Debled5, V Dieras4, M Campone6, C Levy7, W Jacot8, V Lorgis9, C Veyret10, F Dalenc11, J M Ferrero12, L Uwer13, P Kerbrat14, A Goncalves15, M A Mouret-Reynier16, T Petit17, C Jouannaud18, L Vanlemmens19, G Chenuc20, T Guesmia3, M Robain3, C Cailliot3. 1. Department of Cancer Medicine, Institut Gustave Roussy, Villejuif suzette.delaloge@gustaveroussy.fr. 2. Department of Biostatistics, Centre Léon Bérard, Lyon. 3. Department of Research and Development, R&D Unicancer, Paris. 4. Department of Medical Oncology, Institut Curie, Paris and Saint-Cloud. 5. Department of Medical Oncology, Institut Bergonié, Bordeaux. 6. Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes and Angers. 7. Department of Medical Oncology, Centre François Baclesse, Caen. 8. Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier. 9. Department of Medical Oncology, Centre Georges François Leclerc, Dijon. 10. Department of Medical Oncology, Centre Henri Becquerel, Rouen. 11. Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse. 12. Department of Medical Oncology, Centre Antoine Lacassagne, Nice. 13. Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy. 14. Department of Medical Oncology, Centre Eugène Marquis, Rennes. 15. Department of Medical Oncology, Institut Paoli-Calmettes, Marseille. 16. Department of Medical Oncology, Centre Jean Perrin, Clermont Ferrand. 17. Department of Medical Oncology, Centre Paul Strauss, Strasbourg. 18. Department of Medical Oncology, Institut de Cancérologie Jean-Godinot, Reims. 19. Department of Medical Oncology, Centre Oscar Lambret, Lille. 20. Capionis, Paris, France.
Abstract
BACKGROUND: Bevacizumab combined with paclitaxel as first-line chemotherapy for patients with HER2-negative metastatic breast cancer (MBC) has led to mixed results in randomized trials, with an improvement in progression-free survival (PFS) but no statistically significant overall survival (OS) benefit. Real-life data could help in assessing the value of this combination. PATIENTS AND METHODS: This study aimed to describe the outcome following first-line paclitaxel with or without bevacizumab in the French Epidemiological Strategy and Medical Economics (ESME) database of MBC patients, established in 2014 by Unicancer. The primary and secondary end points were OS and PFS, respectively. RESULTS: From 2008 to 2013, 14 014 MBC patient files were identified, including 10 605 patients with a HER2-negative status. Of these, 3426 received paclitaxel and bevacizumab (2127) or paclitaxel (1299) as first-line chemotherapy. OS adjusted for major prognostic factors was significantly longer in the paclitaxel and bevacizumab group compared with paclitaxel [hazard ratio (HR) 0.672, 95% confidence interval (CI) 0.601-0.752; median survival time 27.7 versus 19.8 months]. Results were consistent in all supportive analyses (using a propensity score for adjustment and as a matching factor for nested case-control analyses) and sensitivity analyses. Similar results were observed for the adjusted PFS, favoring the combination (HR 0.739, 95% CI 0.672-0.813; 8.1 versus 6.4 months). CONCLUSIONS: In this large-scale, real-life setting, patients with HER2-negative MBC who received paclitaxel plus bevacizumab as first-line chemotherapy had a significantly better OS and PFS than those receiving paclitaxel. Despite robust methodology, real-life data are exposed to important potential biases, and therefore, results need to be treated with caution. Our data cannot therefore support extension of current use of bevacizumab in MBC.
BACKGROUND:Bevacizumab combined with paclitaxel as first-line chemotherapy for patients with HER2-negative metastatic breast cancer (MBC) has led to mixed results in randomized trials, with an improvement in progression-free survival (PFS) but no statistically significant overall survival (OS) benefit. Real-life data could help in assessing the value of this combination. PATIENTS AND METHODS: This study aimed to describe the outcome following first-line paclitaxel with or without bevacizumab in the French Epidemiological Strategy and Medical Economics (ESME) database of MBCpatients, established in 2014 by Unicancer. The primary and secondary end points were OS and PFS, respectively. RESULTS: From 2008 to 2013, 14 014 MBCpatient files were identified, including 10 605 patients with a HER2-negative status. Of these, 3426 received paclitaxel and bevacizumab (2127) or paclitaxel (1299) as first-line chemotherapy. OS adjusted for major prognostic factors was significantly longer in the paclitaxel and bevacizumab group compared with paclitaxel [hazard ratio (HR) 0.672, 95% confidence interval (CI) 0.601-0.752; median survival time 27.7 versus 19.8 months]. Results were consistent in all supportive analyses (using a propensity score for adjustment and as a matching factor for nested case-control analyses) and sensitivity analyses. Similar results were observed for the adjusted PFS, favoring the combination (HR 0.739, 95% CI 0.672-0.813; 8.1 versus 6.4 months). CONCLUSIONS: In this large-scale, real-life setting, patients with HER2-negative MBC who received paclitaxel plus bevacizumab as first-line chemotherapy had a significantly better OS and PFS than those receiving paclitaxel. Despite robust methodology, real-life data are exposed to important potential biases, and therefore, results need to be treated with caution. Our data cannot therefore support extension of current use of bevacizumab in MBC.
Authors: Sherko Kümmel; Christian Jackisch; Volkmar Müller; Andreas Schneeweiss; Sandra Klawitter; Michael P Lux Journal: Cancer Manag Res Date: 2018-11-08 Impact factor: 3.989
Authors: Mads H Haugen; Ole Christian Lingjærde; Ingrid Hedenfalk; Øystein Garred; Elin Borgen; Niklas Loman; Thomas Hatschek; Anne-Lise Børresen-Dale; Bjørn Naume; Gordon B Mills; Gunhild M Mælandsmo; Olav Engebraaten Journal: JCO Precis Oncol Date: 2021-01-28
Authors: P Gougis; M Carton; C Tchokothe; M Campone; F Dalenc; A Mailliez; C Levy; W Jacot; M Debled; M Leheurteur; T Bachelot; A Hennequin; C Perrin; A Gonçalves; L Uwer; J C Eymard; T Petit; M A Mouret-Reynier; E Chamorey; G Simon; M Saghatchian; C Cailliot; C Le Tourneau Journal: Breast Date: 2019-10-19 Impact factor: 4.380