Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma

被引：695

作者：

Benboubker, Lotfi ^{[1
]}

Dimopoulos, Meletios A. ^{[9
]}

Dispenzieri, Angela ^{[10
]}

Catalano, John ^{[11
]}

Belch, Andrew R. ^{[12
,13
]}

Cavo, Michele ^{[18
]}

Pinto, Antonello ^{[19
]}

Weisel, Katja ^{[20
]}

Ludwig, Heinz ^{[21
]}

Bahlis, Nizar ^{[14
]}

Banos, Anne ^{[2
]}

Tiab, Mourad ^{[3
]}

Delforge, Michel ^{[22
]}

Cavenagh, Jamie ^{[23
]}

Geraldes, Catarina ^{[24
]}

Lee, Je-Jung ^{[25
]}

Chen, Christine ^{[15
]}

Oriol, Albert ^{[26
]}

de la Rubia, Javier ^{[27
,28
]}

Qiu, Lugui ^{[29
,30
,31
]}

White, Darrell J. ^{[16
,17
]}

Binder, Daniel ^{[32
]}

Anderson, Kenneth ^{[33
]}

Fermand, Jean-Paul ^{[4
]}

Moreau, Philippe ^{[5
]}

Attal, Michel ^{[6
]}

Knight, Robert ^{[34
]}

Chen, Guang ^{[34
]}

Van Oostendorp, Jason ^{[34
]}

Jacques, Christian ^{[34
]}

Ervin-Haynes, Annette ^{[34
]}

Avet-Loiseau, Herve ^{[6
]}

Hulin, Cyrille ^{[7
]}

Facon, Thierry ^{[8
]}

机构：

[1] CHRU, Serv Hematol & Therapie Cellulaire, Hop Bretonneau, Tours, France

[2] Ctr Hosp Cote Basque, Bayonne, France

[3] Ctr Hosp Dept Oudairies, La Roche Sur Yon, France

[4] Hop St Louis, Paris, France

[5] CHU Nantes, Serv Hematol, F-44035 Nantes 01, France

[6] CHRU Hop Purpan, Toulouse, France

[7] CHU Nancy Brabois, Vandoeuvre Les Nancy, France

[8] Ctr Hosp Reg Univ, Serv Malad Sang, Hop Claude Huriez, F-59037 Lille, France

[9] Univ Athens, Sch Med, Athens, Greece

[10] Mayo Clin, Ctr Canc, Rochester, MN USA

[11] Monash Univ, Frankston Hosp, Frankston, Vic, Australia

[12] Univ Alberta, Edmonton, AB, Canada

[13] Cross Canc Inst, Edmonton, AB T6G 1Z2, Canada

[14] Univ Calgary, Calgary, AB, Canada

[15] Princess Margaret Canc Ctr, Dept Med Oncol & Hematol, Toronto, ON, Canada

[16] Dalhousie Univ, Halifax, NS, Canada

[17] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada

[18] Univ Bologna, Sch Med, Seragnoli Inst Hematol, Bologna, Italy

[19] Ist Ricovero & Cura Carattere Sci, Unita Operat Complessa Ematol Oncol, Ist Nazl Tumori Fdn G Pascale, Naples, Italy

[20] Univ Tubingen, Tubingen, Germany

[21] Wilhelminenspital Stadt Wien, Dept Internal Med 1, Ctr Oncol & Hematol, Vienna, Austria

[22] Univ Hosp Leuven, Leuven, Belgium

[23] Barts Hlth NHS Trust, Dept Haematol, St Bartholomews Hosp, London, England

[24] Coimbra Univ Hosp, Dept Clin Hematol, Coimbra, Portugal

[25] Chonnam Natl Univ, Hwasun Hosp, Dept Hematol & Oncol, Hwasun, Jeollanamdo, South Korea

[26] Inst Josep Carreras, Dept Clin Hematol, Inst Catal Oncol Hosp Germans Trias & Pujol, Barcelona, Spain

[27] Hosp Univ La Fe, Valencia, Spain

[28] Univ Catolica Valencia San Vicente Martir, Valencia, Spain

[29] Chinese Acad Med Sci, Inst Hematol, State Key Lab Expt Hematol, Tianjin, Peoples R China

[30] Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China

[31] Peking Union Med Coll, Tianjin, Peoples R China

[32] Kantonsspital Winterthur, Winterthur, Switzerland

[33] Dana Farber Canc Inst, Boston, MA 02115 USA

[34] Celgene, Summit, NJ USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2014年 / 371卷 / 10期

关键词：

PREDNISONE PLUS THALIDOMIDE; STEM-CELL TRANSPLANTATION; BORTEZOMIB-MELPHALAN-PREDNISONE; DIAGNOSED MULTIPLE-MYELOMA; QUALITY-OF-LIFE; ELDERLY-PATIENTS; RESPONSE CRITERIA; INITIAL TREATMENT; ORAL MELPHALAN; PHASE-III;

D O I：

10.1056/NEJMoa1402551

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

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.

引用

页码：906 / 917

页数：12

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