Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy following autologous hematopoietic stem-cell transplantation in patients with newly diagnosed multiple myeloma
Menée sur 321 patients atteints d'un myélome multiple et inclus dans un essai de phase III, cette étude compare l'efficacité de deux traitements de consolidation après une greffe autologue de cellules souches hématopoïétiques
ABSTRACT In a randomized, phase 3 study, superior complete/near complete response (CR/nCR) rates and extended progression-free survival (PFS) were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autotransplantation (ASCT) for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n=236; TD, n=238). This per-protocol analysis (VTD, n=160; TD, n=161) was aimed to specifically assess the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs. 46.6%) and CR/nCR (73.1% vs. 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar's test). With a median follow-up of 30.4 months from start of consolidation, PFS at 3 years was significantly longer for the VTD group (60% vs. 48% for the TD group). Grade 2-3 peripheral neuropathy (8.1% vs. 2.4%) was more frequent with VTD (grade 3: 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite re-administration as consolidation therapy after double ASCT. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as NCT01134484.