Yazarlar : Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pégourié B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix

Yayın : Blood.

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/21849487

Konu : Myelom

Literatür İçeriği :  

Abstract

The IFM conducted a randomized trial to compare bortezomib-dexamethasone (VD) as induction prior to high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) to a combination consisting of reduced doses of bortezomib and thalidomide plus dexamethasone (vtD) in patients with multiple myeloma. Overall, a total of 199 patients were centrally randomly assigned to receive VD (99 patients) or vtD (100 patients). After four cycles, the complete response (CR) rate was the same in both groups (13% in the vtD arm, 12% in the VD arm, p = 0.74). However, the CR + very good partial response (VGPR) rate was significantly higher in the vtD arm (49% versus 36%, p = 0.05). After ASCT, the CR + VGPR rate was significantly higher in the vtD arm (74% versus 58%, p = 0.02). The reduced doses of bortezomib and thalidomide in the vtD arm translated into a reduced incidence of peripheral neuropathy (PN): grade ≥ 2 PN were reported in 34% in the VD arm versus 14% in the vtD arm (p=0.001). vtD including reduced doses of bortezomib and thalidomide yields higher VGPR rates as compared with VD and can be considered as a new effective triplet combination prior to HDT/ASCT. This study is registered with www.ClinicalTrials.gov (NCT00910897) and EudraCT (no. 2007-005204-40).

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