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Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma

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Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. / Benboubker, Lotfi; Dimopoulos, Meletios A; Dispenzieri, Angela; Catalano, John; Belch, Andrew R; Cavo, Michele; Pinto, Antonello; Weisel, Katja; Ludwig, Heinz; Bahlis, Nizar; Banos, Anne; Tiab, Mourad; Delforge, Michel; Cavenagh, Jamie; Geraldes, Catarina; Lee, Je-Jung; Chen, Christine; Oriol, Albert; de la Rubia, Javier; Qiu, Lugui; White, Darrell J; Binder, Daniel; Anderson, Kenneth; Fermand, Jean-Paul; Moreau, Philippe; Attal, Michel; Knight, Robert; Chen, Guang; Van Oostendorp, Jason; Jacques, Christian; Ervin-Haynes, Annette; Avet-Loiseau, Hervé; Hulin, Cyrille; Facon, Thierry; FIRST Trial Team.

in: NEW ENGL J MED, Jahrgang 371, Nr. 10, 04.09.2014, S. 906-17.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Benboubker, L, Dimopoulos, MA, Dispenzieri, A, Catalano, J, Belch, AR, Cavo, M, Pinto, A, Weisel, K, Ludwig, H, Bahlis, N, Banos, A, Tiab, M, Delforge, M, Cavenagh, J, Geraldes, C, Lee, J-J, Chen, C, Oriol, A, de la Rubia, J, Qiu, L, White, DJ, Binder, D, Anderson, K, Fermand, J-P, Moreau, P, Attal, M, Knight, R, Chen, G, Van Oostendorp, J, Jacques, C, Ervin-Haynes, A, Avet-Loiseau, H, Hulin, C, Facon, T & FIRST Trial Team 2014, 'Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma', NEW ENGL J MED, Jg. 371, Nr. 10, S. 906-17. https://doi.org/10.1056/NEJMoa1402551

APA

Benboubker, L., Dimopoulos, M. A., Dispenzieri, A., Catalano, J., Belch, A. R., Cavo, M., Pinto, A., Weisel, K., Ludwig, H., Bahlis, N., Banos, A., Tiab, M., Delforge, M., Cavenagh, J., Geraldes, C., Lee, J-J., Chen, C., Oriol, A., de la Rubia, J., ... FIRST Trial Team (2014). Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. NEW ENGL J MED, 371(10), 906-17. https://doi.org/10.1056/NEJMoa1402551

Vancouver

Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M et al. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. NEW ENGL J MED. 2014 Sep 4;371(10):906-17. https://doi.org/10.1056/NEJMoa1402551

Bibtex

@article{28d11c6cb5c84f35bafc32f2490ff466,
title = "Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma",
abstract = "BACKGROUND: The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches.METHODS: We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT.RESULTS: The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P<0.001 for both comparisons). Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points, including overall survival (at the interim analysis). Overall survival at 4 years was 59% with continuous lenalidomide-dexamethasone, 56% with 18 cycles of lenalidomide-dexamethasone, and 51% with MPT. Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT (70% vs. 78%). As compared with MPT, continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events, a moderate increase in infections, and fewer second primary hematologic cancers.CONCLUSIONS: As compared with MPT, continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival, with an overall survival benefit at the interim analysis, among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation. (Funded by Intergroupe, Francophone du My{\'e}lome and Celgene; FIRST ClinicalTrials.gov number, NCT00689936; European Union Drug Regulating Authorities Clinical Trials number, 2007-004823-39.).",
keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Lenalidomide, Male, Melphalan, Middle Aged, Multiple Myeloma, Prednisone, Thalidomide, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Lotfi Benboubker and Dimopoulos, {Meletios A} and Angela Dispenzieri and John Catalano and Belch, {Andrew R} and Michele Cavo and Antonello Pinto and Katja Weisel and Heinz Ludwig and Nizar Bahlis and Anne Banos and Mourad Tiab and Michel Delforge and Jamie Cavenagh and Catarina Geraldes and Je-Jung Lee and Christine Chen and Albert Oriol and {de la Rubia}, Javier and Lugui Qiu and White, {Darrell J} and Daniel Binder and Kenneth Anderson and Jean-Paul Fermand and Philippe Moreau and Michel Attal and Robert Knight and Guang Chen and {Van Oostendorp}, Jason and Christian Jacques and Annette Ervin-Haynes and Herv{\'e} Avet-Loiseau and Cyrille Hulin and Thierry Facon and {FIRST Trial Team}",
year = "2014",
month = sep,
day = "4",
doi = "10.1056/NEJMoa1402551",
language = "English",
volume = "371",
pages = "906--17",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "10",

}

RIS

TY - JOUR

T1 - Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma

AU - Benboubker, Lotfi

AU - Dimopoulos, Meletios A

AU - Dispenzieri, Angela

AU - Catalano, John

AU - Belch, Andrew R

AU - Cavo, Michele

AU - Pinto, Antonello

AU - Weisel, Katja

AU - Ludwig, Heinz

AU - Bahlis, Nizar

AU - Banos, Anne

AU - Tiab, Mourad

AU - Delforge, Michel

AU - Cavenagh, Jamie

AU - Geraldes, Catarina

AU - Lee, Je-Jung

AU - Chen, Christine

AU - Oriol, Albert

AU - de la Rubia, Javier

AU - Qiu, Lugui

AU - White, Darrell J

AU - Binder, Daniel

AU - Anderson, Kenneth

AU - Fermand, Jean-Paul

AU - Moreau, Philippe

AU - Attal, Michel

AU - Knight, Robert

AU - Chen, Guang

AU - Van Oostendorp, Jason

AU - Jacques, Christian

AU - Ervin-Haynes, Annette

AU - Avet-Loiseau, Hervé

AU - Hulin, Cyrille

AU - Facon, Thierry

AU - FIRST Trial Team

PY - 2014/9/4

Y1 - 2014/9/4

N2 - BACKGROUND: The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches.METHODS: We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT.RESULTS: The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P<0.001 for both comparisons). Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points, including overall survival (at the interim analysis). Overall survival at 4 years was 59% with continuous lenalidomide-dexamethasone, 56% with 18 cycles of lenalidomide-dexamethasone, and 51% with MPT. Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT (70% vs. 78%). As compared with MPT, continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events, a moderate increase in infections, and fewer second primary hematologic cancers.CONCLUSIONS: As compared with MPT, continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival, with an overall survival benefit at the interim analysis, among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation. (Funded by Intergroupe, Francophone du Myélome and Celgene; FIRST ClinicalTrials.gov number, NCT00689936; European Union Drug Regulating Authorities Clinical Trials number, 2007-004823-39.).

AB - BACKGROUND: The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches.METHODS: We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT.RESULTS: The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P<0.001 for both comparisons). Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points, including overall survival (at the interim analysis). Overall survival at 4 years was 59% with continuous lenalidomide-dexamethasone, 56% with 18 cycles of lenalidomide-dexamethasone, and 51% with MPT. Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT (70% vs. 78%). As compared with MPT, continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events, a moderate increase in infections, and fewer second primary hematologic cancers.CONCLUSIONS: As compared with MPT, continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival, with an overall survival benefit at the interim analysis, among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation. (Funded by Intergroupe, Francophone du Myélome and Celgene; FIRST ClinicalTrials.gov number, NCT00689936; European Union Drug Regulating Authorities Clinical Trials number, 2007-004823-39.).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Dexamethasone

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Lenalidomide

KW - Male

KW - Melphalan

KW - Middle Aged

KW - Multiple Myeloma

KW - Prednisone

KW - Thalidomide

KW - Comparative Study

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1056/NEJMoa1402551

DO - 10.1056/NEJMoa1402551

M3 - SCORING: Journal article

C2 - 25184863

VL - 371

SP - 906

EP - 917

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 10

ER -