Lenalidomide is safe and active in waldenstrom ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
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Title :
Lenalidomide is safe and active in waldenstrom macroglobulinemia
Author(s) :
Fouquet, Guillemette [Auteur]
Guidez, Stephanie [Auteur]
Petillon, Marie-Odile [Auteur]
Louni, Chanaz [Auteur]
Ohyba, Bella [Auteur]
Dib, Malek [Auteur]
Poulain, Stephanie [Auteur]
Herbaux, Charles [Auteur]
Martin, Audrey [Auteur]
Thielemans, Beatrice [Auteur]
Brice, Pauline [Auteur]
Choquet, Sylvain [Auteur]
Bakala, Jana [Auteur]
Bories, Claire [Auteur]
Demarquette, Helene [Auteur]
Nudel, Morgane [Auteur]
Tournilhac, Olivier [Auteur]
Arnulf, Bertrand [Auteur]
Legouill, Steven [Auteur]
Morel, Pierre [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Banos, Anne [Auteur]
Karlin, Lionel [Auteur]
Salles, Gilles [Auteur]
Leblond, Véronique [Auteur]
Leleu, Xavier [Auteur]
Guidez, Stephanie [Auteur]
Petillon, Marie-Odile [Auteur]
Louni, Chanaz [Auteur]
Ohyba, Bella [Auteur]
Dib, Malek [Auteur]
Poulain, Stephanie [Auteur]
Herbaux, Charles [Auteur]
Martin, Audrey [Auteur]
Thielemans, Beatrice [Auteur]
Brice, Pauline [Auteur]
Choquet, Sylvain [Auteur]
Bakala, Jana [Auteur]
Bories, Claire [Auteur]
Demarquette, Helene [Auteur]
Nudel, Morgane [Auteur]
Tournilhac, Olivier [Auteur]
Arnulf, Bertrand [Auteur]
Legouill, Steven [Auteur]
Morel, Pierre [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Banos, Anne [Auteur]
Karlin, Lionel [Auteur]
Salles, Gilles [Auteur]
Leblond, Véronique [Auteur]
Leleu, Xavier [Auteur]
Journal title :
American journal of hematology
Abbreviated title :
Am. J. Hematol.
Volume number :
90
Pages :
1055-1059
Publication date :
2015-11-01
ISSN :
0361-8609
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Lenalidomide is manageable and effective in multiple myeloma, particularly in elderly patients. Surprisingly, the combination of lenalidomide with rituximab produced clinically significant anemia at 25 mg/day for 21/28 ...
Show more >Lenalidomide is manageable and effective in multiple myeloma, particularly in elderly patients. Surprisingly, the combination of lenalidomide with rituximab produced clinically significant anemia at 25 mg/day for 21/28 days, the highest possible dose, in Waldenström's Macroglobulinemia (WM). We aimed to determine the maximum tolerated dose (MTD) of single agent lenalidomide and determine its impact on WM. RV-WM-0426 is a multicenter dose escalation open label phase 1/2 study of lenalidomide in relapsed/refractory WM (RRWM). Lenalidomide was given orally 21/28 days per cycle for 1 year, at escalated dose of 15 to 20 mg during phase 1 to determine the MTD; the phase 2 part was conducted at the MTD. Seventeen RRWM patients were included. The MTD was established at 15 mg/day 21/28. By ITT analysis, the overall response rate was 29%. With a median follow-up of 36 months, median TTP was 16 months (95% CI 5.5-26), the 5-year OS was 91%. The most frequent adverse events ≥ grade 3 at 15 mg were 14% anemia and 43% neutropenia. The MTD of lenalidomide is 15 mg/day 21/28 days in RRWM. Lenalidomide is active in the treatment of RRWM and the safety profile appears manageable. Future studies may look into combinations of lenalidomide and continuous dosing.Show less >
Show more >Lenalidomide is manageable and effective in multiple myeloma, particularly in elderly patients. Surprisingly, the combination of lenalidomide with rituximab produced clinically significant anemia at 25 mg/day for 21/28 days, the highest possible dose, in Waldenström's Macroglobulinemia (WM). We aimed to determine the maximum tolerated dose (MTD) of single agent lenalidomide and determine its impact on WM. RV-WM-0426 is a multicenter dose escalation open label phase 1/2 study of lenalidomide in relapsed/refractory WM (RRWM). Lenalidomide was given orally 21/28 days per cycle for 1 year, at escalated dose of 15 to 20 mg during phase 1 to determine the MTD; the phase 2 part was conducted at the MTD. Seventeen RRWM patients were included. The MTD was established at 15 mg/day 21/28. By ITT analysis, the overall response rate was 29%. With a median follow-up of 36 months, median TTP was 16 months (95% CI 5.5-26), the 5-year OS was 91%. The most frequent adverse events ≥ grade 3 at 15 mg were 14% anemia and 43% neutropenia. The MTD of lenalidomide is 15 mg/day 21/28 days in RRWM. Lenalidomide is active in the treatment of RRWM and the safety profile appears manageable. Future studies may look into combinations of lenalidomide and continuous dosing.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Université de Lille
Université de Lille
Submission date :
2019-12-09T16:52:33Z