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Lenalidomide Maintenance with or without Prednisone in Newly Diagnosed Myeloma Patients: A Pooled Analysis.
Bonello, Francesca; Pulini, Stefano; Ballanti, Stelvio; Gentile, Massimo; Spada, Stefano; Annibali, Ombretta; Omedé, Paola; Ronconi, Sonia; Cangialosi, Clotilde; Podda, Luigi; Palmas, Angelo; Malfitano, Alessandra; Rivoli, Giulia; Belotti, Angelo; Ciambelli, Fabrizio; Vincelli, Iolanda Donatella; Cafro, Anna Maria; Innao, Vanessa; Palumbo, Antonio; Sonneveld, Pieter; Spencer, Andrew; Hájek, Roman; Boccadoro, Mario; Gay, Francesca.
Afiliación
  • Bonello F; Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126 Torino, Italy.
  • Pulini S; U.O. Ematologia Clinica, Dipartimento di Ematologia, Ospedale Civile "Spirito Santo", 65124 Pescara, Italy.
  • Ballanti S; Ematologia con TMO, Ospedale Santa Maria della Misericordia, 06129 Perugia, Italy.
  • Gentile M; UOC di Ematologia, AO Cosenza, 87100 Cosenza, Italy.
  • Spada S; Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126 Torino, Italy.
  • Annibali O; Unit of Hematology, Stem Cell Transplantation, University Campus Bio Medico, 00128 Rome, Italy.
  • Omedé P; Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126 Torino, Italy.
  • Ronconi S; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
  • Cangialosi C; Divisione Ematologia UTMO, Azienda Ospedaliera Villa Sofia Cervello, 90146 Palermo, Italy.
  • Podda L; Ematologia, Azienda Ospedaliero-Universitaria Sassari, 07100 Sassari, Italy.
  • Palmas A; Ematologia, Ospedale S. Francesco, 08100 Nuoro, ATS Sardegna, Italy.
  • Malfitano A; Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126 Torino, Italy.
  • Rivoli G; Haematology Clinic, Department of Internal Medicine (DiMI), University of Genoa, Policlinico San Martino, IRCCS per l'Oncologia, 16132 Genova, Italy.
  • Belotti A; Division of Hematology-ASST Spedali Civili di Brescia, 25123 Brescia, Italy.
  • Ciambelli F; Sc Ematologia, ASST Valle Olona, 21052 Busto Arsizio, Italy.
  • Vincelli ID; Divisione di Ematologia, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, 89124 Reggio Calabria, Italy.
  • Cafro AM; Department of Oncology and Hematology, Niguarda Ca'Granda Hospital, 20162 Milano, Italy.
  • Innao V; Division of Hematology, Department of Human Pathology and the Adult Developmental, Faculty of Medicine, Messina University, 98122 Messina, Italy.
  • Palumbo A; Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126 Torino, Italy.
  • Sonneveld P; Department of Hematology, Erasmus MC Cancer Institute, 3015 GD Rotterdam, The Netherlands.
  • Spencer A; Department of Haematology, Alfred Health-Monash University, Melbourne, VIC 3004, Australia.
  • Hájek R; Department of Haematooncology, University Hospital Ostrava, 70852 Ostrava, Czech Republic.
  • Boccadoro M; Faculty of Medicine, University of Ostrava, 70300 Ostrava, Czech Republic.
  • Gay F; Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, via Genova 3, 10126 Torino, Italy.
Cancers (Basel) ; 11(11)2019 Nov 05.
Article en En | MEDLINE | ID: mdl-31694338
: We conducted a pooled analysis of two phase III trials, RV-MM-EMN-441 and EMN01, to compare maintenance with lenalidomide-prednisone vs. lenalidomide in newly diagnosed transplant-eligible and -ineligible myeloma patients. Primary endpoints were progression-free survival, progression-free survival 2 and overall survival with both regimens. A secondary aim was to evaluate the impact of duration of maintenance on overall survival and on outcome after relapse. A total of 625 patients (lenalidomide-prednisone arm, n = 315; lenalidomide arm, n = 310) were analyzed. The median follow-up was 58 months. Median progression-free survival (25 vs. 19 months; p = 0.08), progression-free survival 2 (56 vs. 49 months; p = 0.9) and overall survival (73 months vs. NR; p = 0.08) were not significantly different between the two arms. Toxicity profiles of lenalidomide-prednisone and lenalidomide were similar, with the exception of neutropenia that was higher in the lenalidomide arm (grade ≥ 3: 9% vs. 19%, p < 0.001), without an increase in the rate of infections. Overall survival (median NR vs. 49 months, p < 0.001), progression-free survival from relapse (median 35 vs. 24 months, p = 0.004) and overall survival from relapse (median not reached vs. 41 months, p = 0.002) were significantly longer in patients continuing maintenance for ≥2 years. We showed that the addition of prednisone at 25 or 50 mg every other day (eod) to lenalidomide maintenance did not induce any significant advantage.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Diagnostic_studies Idioma: En Revista: Cancers (Basel) Año: 2019 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Diagnostic_studies Idioma: En Revista: Cancers (Basel) Año: 2019 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza