Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma

Autores de IIS La Fe

• 

  Javier De La Rubia Comos

  Autor

Participantes ajenos a IIS La Fe

• Benboubker L
• Dimopoulos MA
• Dispenzieri A
• Catalano J
• Belch AR
• Cavo M
• Pinto A
• Weisel K
• Ludwig H
• Bahlis N
• Banos A
• Tiab M
• Delforge M
• Cavenagh J
• Geraldes C
• Lee JJ
• Chen C
• Oriol A
• Qiu L
• White DJ
• Binder D
• Anderson K
• Fermand JP
• Moreau P
• Attal M
• Knight R
• Chen G
• Van Oostendorp J
• Jacques C
• Ervin-Haynes A
• Avet-Loiseau H
• Hulin C
• Facon T
• FIRST Trial Team

Grupos

• Hematología y Hemoterapia

Abstract

BACKGROUND The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches. METHODS We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT. RESULTS The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P<0.001 for both comparisons). Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points, including overall survival (at the interim analysis). Overall survival at 4 years was 59% with continuous lenalidomide-dexamethasone, 56% with 18 cycles of lenalidomide-dexamethasone, and 51% with MPT. Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT (70% vs. 78%). As compared with MPT, continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events, a moderate increase in infections, and fewer second primary hematologic cancers. CONCLUSIONS As compared with MPT, continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival, with an overall survival benefit at the interim analysis, among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation.