Achievement of VGPR to induction therapy is an important prognostic factor for longer PFS in the IFM 2005-01 trial

Author:

Moreau Philippe1,Attal Michel2,Pégourié Brigitte3,Planche Lucie1,Hulin Cyrille4,Facon Thierry5,Stoppa Anne-Marie6,Fuzibet Jean-Gabriel7,Grosbois Bernard8,Doyen Chantal9,Ketterer Nicolas10,Sebban Catherine11,Kolb Brigitte12,Chaleteix Carine13,Dib Mamoun14,Voillat Laurent15,Fontan Jean16,Garderet Laurent17,Jaubert Jérôme18,Mathiot Claire19,Esseltine Dixie20,Avet-Loiseau Hervé1,Harousseau Jean-Luc21,

Affiliation:

1. University Hospital, Nantes, France;

2. University Hospital, Toulouse, France;

3. University Hospital, Grenoble, France;

4. University Hospital, Nancy, France;

5. University Hospital, Lille, France;

6. Institut Paoli-Calmettes, Marseille, France;

7. University Hospital, Nice, France;

8. University Hospital, Rennes, France;

9. University Hospital, Yvoir, Belgium;

10. University Hospital, Lausanne, Switzerland;

11. Centre Lyon-Bérard, Lyon, France;

12. University Hospital, Reims, France;

13. University Hospital, Clermont-Ferrand, France;

14. University Hospital, Angers, France;

15. University Hospital, Chalon-sur-Saône, France;

16. University Hospital, Besançon, France;

17. University Hospital Saint-Antoine, Paris, France;

18. University Hospital, Saint-Etienne, France;

19. Institut Curie, Paris, France;

20. Millenium Pharmaceuticals, Cambridge, NJ; and

21. Centre René Gauducheau, Nantes/St Herblain, France

Abstract

Abstract In the 2005-01 trial, we have demonstrated that bortezomib-dexamethasone as induction therapy before autologous stem cell transplantation was superior to vincristine-adriamycin-dexamethasone. We conducted a post-hoc analysis to assess the prognostic impact of initial characteristics as well as response to therapy in patients enrolled in this study. Multivariate analysis showed that ISS stages 2 and 3 and achievement of response less than very good partial response (VGPR) both after induction therapy and after autologous stem cell transplantation were adverse prognostic factors for progression-free survival, the most important one being achievement of response less than VGPR after induction. Progression-free survival was significantly improved with bortezomib-dexamethasone induction therapy in patients with poor-risk cytogenetics and ISS stages 2 and 3 compared with vincristine-adriamycin-dexamethasone. In these 2 groups of patients, achievement of at least VGPR after induction was of major importance. This study is registered with EudraCT (https://eudract.ema.europa.eu; EUDRACT 2005-000537-38) and http://clinicaltrials.gov (NCT00200681).

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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