Περίληψη:
PURPOSE To address the role of consolidation treatment for newly
diagnosed, transplant eligible patients with multiple myeloma in a
controlled clinical trial.
PATIENTS AND METHODS The EMN02/HOVON95 trial compared consolidation
treatment with two cycles of bortezomib, lenalidomide, and dexamethasone
(VRD) or no consolidation after induction and intensification therapy,
followed by continuous lenalidomide maintenance. Primary study end point
was progression-free survival (PFS).
RESULTS Eight hundred seventy-eight eligible patients were randomly
assigned to receive VRD consolidation (451 patients) or no consolidation
(427 patients). At a median follow-up of 74.8 months, median PFS with
adjustment for pretreatment was prolonged in patients randomly assigned
to VRD consolidation (59.3 v 42.9 months, hazard ratio [HR] = 0.81;
95% CI, 0.68 to 0.96; P = .016). The PFS benefit was observed across
most predefined subgroups, including revised International Staging
System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3
stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI,
1.37 to 2.04) were significant adverse prognostic factors. The median
duration of maintenance was 33 months (interquartile range 13-86
months). Response complete response (CR) after consolidation versus no
consolidation before start of maintenance was 34% versus 18%,
respectively (P < .001). Response >= CR on protocol including
maintenance was 59% with consolidation and 46% without (P < .001).
Minimal residual disease analysis by flow cytometry in a subgroup of 226
patients with CR or stringent complete response or very good partial
response before start of maintenance demonstrated a 74% minimal
residual disease-negativity rate in VRD-treated patients. Toxicity from
VRD was acceptable and manageable.
CONCLUSION Consolidation treatment with VRD followed by lenalidomide
maintenance improves PFS and depth of response in newly diagnosed
patients with multiple myeloma as compared to maintenance alone. (C)
2021 by American Society of Clinical Oncology
Συγγραφείς:
Sonneveld, Pieter
Dimopoulos, Meletios A.
Beksac, Meral
van
der Holt, Bronno
Aquino, Sara
Ludwig, Heinz
Zweegman, Sonja
and Zander, Thilo
Zamagni, Elena
Wester, Ruth
Hajek, Roman
and Pantani, Lucia
Dozza, Luca
Gay, Francesca
Cafro,
AnneMaria
De Rosa, Luca
Morelli, Annamaria
Gregersen, Henrik
and Gulbrandsen, Nina
Cornelisse, Petra
Troia, Rosella and
Oliva, Stefania
van de Velden, Vincent
Wu, KaLung
Ypma,
Paula F.
Bos, Gerard
Levin, Mark-David
Pour, Luca and
Driessen, Christoph
Broijl, Annemiek
Croockewit, Alexandra and
Minnema, Monique C.
Waage, Anders
Hveding, Cecilie
van de
Donk, Niels W. C. J.
Offidani, Massimo
Palumbo, Giuseppe A. and
Spencer, Andrew
Boccadoro, Mario
Cavo, Michele
