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Plasma Cell Disorders
Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 ran- domized trial
Ferrata Storti Foundation
Haematologica 2020 Volume 105(7):1937-1947
Sara Bringhen,1 Mattia D’Agostino,1 Laura Paris,2 Stelvio Ballanti,3 Norbert Pescosta,4 Stefano Spada,1 Sara Pezzatti,5 Mariella Grasso,6 Delia Rota- Scalabrini,7 Luca De Rosa,8 Vincenzo Pavone,9 Giulia Gazzera,1 Sara Aquino,10 Marco Poggiu,1 Armando Santoro,11 Massimo Gentile,12 Luca Baldini,13 Maria Teresa Petrucci,14 Patrizia Tosi,15 Roberto Marasca,16 Claudia Cellini,17 Antonio Palumbo,1° Patrizia Falco,18 Roman Hájek,19,20 Mario Boccadoro1 and Alessandra Larocca1
1Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero- Universitaria Città della Salute e della Scienza di Torino, Torino, Italy; 2Hematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy; 3Sezione di Ematologia e Immunologia Clinica, Ospedale Santa Maria della Misericordia, località Sant’Andrea delle Fratte, Perugia, Italy; 4Reparto Ematologia e Centro TMO, Ospedale Centrale, Bolzano, Italy; 5Divisione di Ematologia, Ospedale S. Gerardo, Monza, Italy; 6Azienda Ospedaliera S. Croce-Carle, Cuneo, Italy; 7Medical Oncology, Candiolo Cancer Institute FPO-IRCCS, Candiolo, Italy; 8Hematology and Stem Cell Transplantation Unit, Az. Osp. S. Camillo-Forlanini, Rome, Italy; 9UOC Ematologia e Trapianto, Az. Osp. C. Panico, Tricase (Lecce), Italy; 10Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 11Istituto Clinico Humanitas, Humanitas University, Rozzano-Milano, Italy; 12UOC Ematologia AO Cosenza, Cosenza, Italy; 13UOC Ematologia, Università degli Studi di Milano, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano, Italy; 14Hematology, Azienda Policlinico Umberto I, Roma, Italy; 15UO Ematologia, Ospedale di Rimini, AUSL della Romagna, Rimini, Italy; 16Hematology Unit, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy; 17U.O. Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy. 18SSD Ematologia, ASLTO4, Ospedali di Chivasso Cirié Ivrea, Italy; 19Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic and 20Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic
°AP is currently a GlaxoSmithKline AG employee.
ABSTRACT
In 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 mainte- nance treatment with lenalidomide alone or with prednisone continu- ously. 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-dexametha- sone 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 interme- diate-fit and 165 (25%) were frail. After induction, 402 patients were eli- gible 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 vs. 18.6 months with lenalido- mide (hazard ratio 0.85, P=0.14), with no differences across frailty sub- groups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients; P=0.001). Grade ≥3 non-hematologic adverse events were rare (<15%). In fit patients, melphalan-prednisone-lenalidomide significantly prolonged progression-free survival compared to cyclophosphamide-prednisone-
Correspondence:
SARA BRINGHEN
sarabringhen@yahoo.com
Received: May 20, 2019. Accepted: September 26, 2019. Pre-published: October 3, 2019.
doi:10.3324/haematol.2019.226407
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/105/7/1937
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