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Triplet vs doublet lenalidomide-containing regimens for the treatment of elderly patients with newly diagnosed multiple myeloma
V. Magarotto, S. Bringhen, M. Offidani, G. Benevolo, F. Patriarca, R. Mina, AP. Falcone, L. De Paoli, G. Pietrantuono, S. Gentili, C. Musolino, N. Giuliani, A. Bernardini, C. Conticello, S. Pulini, G. Ciccone, V. Maisnar, M. Ruggeri, R. Zambello,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
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- MeSH
- demografie MeSH
- Kaplanův-Meierův odhad MeSH
- kombinovaná farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom diagnóza farmakoterapie MeSH
- následné studie MeSH
- přežití bez známek nemoci MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- thalidomid škodlivé účinky analogy a deriváty terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Lenalidomide-dexamethasone improved outcome in newly diagnosed elderly multiple myeloma patients. We randomly assigned 662 patients who were age ≥65 years or transplantation-ineligible to receive induction with melphalan-prednisone-lenalidomide (MPR) or cyclophosphamide-prednisone-lenalidomide (CPR) or lenalidomide plus low-dose dexamethasone (Rd). The primary end point was progression-free survival (PFS) in triplet (MPR and CPR) vs doublet (Rd) lenalidomide-containing regimens. After a median follow-up of 39 months, the median PFS was 22 months for the triplet combinations and 21 months for the doublet (P = .284). The median overall survival (OS) was not reached in either arms, and the 4-year OS was 67% for the triplet and 58% for the doublet arms (P = .709). By considering the 3 treatment arms separately, no difference in outcome was detected among MPR, CPR, and Rd. The most common grade ≥3 toxicity was neutropenia: 64% in MPR, 29% in CPR, and 25% in Rd patients (P < .0001). Grade ≥3 nonhematologic toxicities were similar among arms and were mainly infections (6.5% to 11%), constitutional (3.5% to 9.5%), and cardiac (4.5% to 6%), with no difference among the arms. In conclusion, in the overall population, the alkylator-containing triplets MPR and CPR were not superior to the alkylator-free doublet Rd, which was associated with lower toxicity. This study was registered at www.clinicaltrials.gov as #NCT01093196.
Azienda Ospedaliera S Maria di Terni SC Oncoematologia Terni Italy
Clinica di Ematologia AOU Ospedali Riuniti di Ancona Ancona Italy
Department of Medicine Hematology and Clinical Immunology Padua School of Medicine Padua Italy
Division of Hematology Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy
Divisione di Medicina Interna ed Ematologia AOU San Luigi Gonzaga Orbassano Italy
Emat CTMO Ospedale R Binaghi Cagliari Cagliari Italy
Unità Operativa Complessa Ematologia Azienda Ospedaliera Universitaria G Martino Messina Italy
Citace poskytuje Crossref.org
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- $a Magarotto, Valeria $u Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino, Torino, Italy;
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- $a Lenalidomide-dexamethasone improved outcome in newly diagnosed elderly multiple myeloma patients. We randomly assigned 662 patients who were age ≥65 years or transplantation-ineligible to receive induction with melphalan-prednisone-lenalidomide (MPR) or cyclophosphamide-prednisone-lenalidomide (CPR) or lenalidomide plus low-dose dexamethasone (Rd). The primary end point was progression-free survival (PFS) in triplet (MPR and CPR) vs doublet (Rd) lenalidomide-containing regimens. After a median follow-up of 39 months, the median PFS was 22 months for the triplet combinations and 21 months for the doublet (P = .284). The median overall survival (OS) was not reached in either arms, and the 4-year OS was 67% for the triplet and 58% for the doublet arms (P = .709). By considering the 3 treatment arms separately, no difference in outcome was detected among MPR, CPR, and Rd. The most common grade ≥3 toxicity was neutropenia: 64% in MPR, 29% in CPR, and 25% in Rd patients (P < .0001). Grade ≥3 nonhematologic toxicities were similar among arms and were mainly infections (6.5% to 11%), constitutional (3.5% to 9.5%), and cardiac (4.5% to 6%), with no difference among the arms. In conclusion, in the overall population, the alkylator-containing triplets MPR and CPR were not superior to the alkylator-free doublet Rd, which was associated with lower toxicity. This study was registered at www.clinicaltrials.gov as #NCT01093196.
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- $a Offidani, Massimo $u Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy;
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- $a Benevolo, Giulia $u Struttura Complessa (SC) Ematologia, Dipartimento di Ematologia ed Oncologia, AOU Città della Salute e della Scienza di Torino, San Giovanni Battista, Torino, Italy;
- 700 1_
- $a Patriarca, Francesca $u Azienda Ospedaliera-Universitaria di Udine, Dipartimento Scienze Mediche, Sperimentali e Cliniche, Università di Udine, Udine, Italy;
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- 700 1_
- $a Falcone, Antonietta Pia $u Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Casa Sollievo della Sofferenza, Unità di Ematologia, San Giovanni Rotondo, Italy;
- 700 1_
- $a De Paoli, Lorenzo $u Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont and Maggiore Hospital, Novara, Italy;
- 700 1_
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- 700 1_
- $a Gentili, Silvia $u Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy;
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- 700 1_
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