TY - JOUR
T1 - Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial.
AU - Bringhen, Sara
AU - D'Agostino, Mattia
AU - Paris, Laura
AU - Ballanti, Stelvio
AU - Pescosta, Norbert
AU - Spada, Stefano
AU - Pezzatti, Sara
AU - Grasso, Mariella
AU - Rota-Scalabrini, Delia
AU - De Rosa, Luca
AU - Pavone, Vincenzo
AU - Gazzera, Giulia
AU - Aquino, Sara
AU - Poggiu, Marco
AU - Santoro, Armando
AU - Gentile, Massimo
AU - Baldini, Luca
AU - Petrucci, Maria Teresa
AU - Tosi, Patrizia
AU - Marasca, Roberto
AU - Cellini, Claudia
AU - Palumbo, Antonio
AU - Falco, Patrizia
AU - Hájek, Roman
AU - Boccadoro, Mario
AU - Larocca, Alessandra
PY - 2020/7/1
Y1 - 2020/7/1
N2 - n the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction therapy was prospectively evaluated in transplant-ineligible patients with multiple myeloma. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. The analysis presented here (median follow-up of 71 months) is focused on maintenance treatment and on subgroup analyses defined according to the International Myeloma Working Group Frailty Score. Of the 654 evaluable patients, 217 were in the lenalidomide-dexamethasone arm, 217 in the melphalan-prednisone-lenalidomide arm and 220 in the cyclophosphamide-prednisone-lenalidomide arm. With regards to the Frailty Score, 284 (43%) patients were fit, 205 (31%) were intermediate-fit and 165 (25%) were frail. After induction, 402 patients were eligible for maintenance therapy (lenalidomide arm, n=204; lenalidomide-prednisone arm, n=198). After a median duration of maintenance of 22.0 months, progression-free survival from the start of maintenance was 22.2 months with lenalidomide-prednisone 18.6 months with lenalidomide (hazard ratio 0.85, =0.14), with no differences across frailty subgroups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients; =0.001). Grade ≥3 non-hematologic adverse events were rare (
AB - n the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction therapy was prospectively evaluated in transplant-ineligible patients with multiple myeloma. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. The analysis presented here (median follow-up of 71 months) is focused on maintenance treatment and on subgroup analyses defined according to the International Myeloma Working Group Frailty Score. Of the 654 evaluable patients, 217 were in the lenalidomide-dexamethasone arm, 217 in the melphalan-prednisone-lenalidomide arm and 220 in the cyclophosphamide-prednisone-lenalidomide arm. With regards to the Frailty Score, 284 (43%) patients were fit, 205 (31%) were intermediate-fit and 165 (25%) were frail. After induction, 402 patients were eligible for maintenance therapy (lenalidomide arm, n=204; lenalidomide-prednisone arm, n=198). After a median duration of maintenance of 22.0 months, progression-free survival from the start of maintenance was 22.2 months with lenalidomide-prednisone 18.6 months with lenalidomide (hazard ratio 0.85, =0.14), with no differences across frailty subgroups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients; =0.001). Grade ≥3 non-hematologic adverse events were rare (
U2 - 10.3324/haematol.2019.226407
DO - 10.3324/haematol.2019.226407
M3 - Articolo
VL - 105
SP - 1937
EP - 1947
JO - Haematologica
JF - Haematologica
SN - 1592-8721
ER -