Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma

被引：877

作者：

McCarthy, Philip L. ^{[1
]}

Owzar, Kouros ^{[5
,6
]}

Hofmeister, Craig C. ^{[9
]}

Hurd, David D. ^{[7
]}

Hassoun, Hani ^{[3
]}

Richardson, Paul G. ^{[10
]}

Giralt, Sergio ^{[3
]}

Stadtmauer, Edward A. ^{[11
]}

Weisdorf, Daniel J. ^{[12
]}

Vij, Ravi ^{[13
]}

Moreb, Jan S. ^{[14
]}

Callander, Natalie Scott ^{[15
]}

Van Besien, Koen ^{[17
]}

Gentile, Teresa ^{[2
]}

Isola, Luis ^{[4
]}

Maziarz, Richard T. ^{[19
]}

Gabriel, Don A. ^{[8
]}

Bashey, Asad ^{[20
]}

Landau, Heather ^{[3
]}

Martin, Thomas ^{[21
]}

Qazilbash, Muzaffar H. ^{[22
]}

Levitan, Denise ^{[7
]}

McClune, Brian ^{[12
]}

Schlossman, Robert ^{[10
]}

Hars, Vera ^{[6
]}

Postiglione, John ^{[6
]}

Jiang, Chen ^{[6
]}

Bennett, Elizabeth ^{[6
]}

Barry, Susan ^{[6
]}

Bressler, Linda ^{[18
]}

Kelly, Michael ^{[18
]}

Seiler, Michele ^{[18
]}

Rosenbaum, Cara ^{[17
]}

Hari, Parameswaran ^{[16
]}

Pasquini, Marcelo C. ^{[16
]}

Horowitz, Mary M. ^{[16
]}

Shea, Thomas C. ^{[8
]}

Devine, Steven M. ^{[9
]}

Anderson, Kenneth C. ^{[10
]}

Linker, Charles ^{[21
]}

机构：

[1] Roswell Pk Canc Inst, BMT Program, Buffalo, NY 14263 USA

[2] SUNY Hlth Sci Ctr, Syracuse, NY 13210 USA

[3] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA

[4] Mt Sinai Med Ctr, BMT, New York, NY 10029 USA

[5] Duke Univ, Dept Biostat & Bioinformat, Durham, NC USA

[6] Duke Univ, Canc & Leukemia Grp B CALGB, Ctr Stat, Durham, NC USA

[7] Wake Forest Univ, Winston Salem, NC 27109 USA

[8] Univ N Carolina, Dept Med, Chapel Hill, NC USA

[9] Ohio State Univ, Div Hematol, Ctr Comprehens Canc, Columbus, OH 43210 USA

[10] Dana Farber Canc Inst, Dept Med Oncol, Jerome Lipper Multiple Myeloma Ctr, Boston, MA 02115 USA

[11] Univ Penn, Myeloma Program, Abramson Canc Ctr, Philadelphia, PA 19104 USA

[12] Univ Minnesota, Med Ctr, Dept Hematol & Oncol, Minneapolis, MN 55455 USA

[13] Washington Univ, Div Oncol, Sch Med, St Louis, MO 63130 USA

[14] Univ Florida, Bone Marrow Transplant Program, Gainesville, FL USA

[15] Univ Wisconsin, Dept Hematol, Madison, WI 53706 USA

[16] Med Coll Wisconsin, Dept Med, Ctr Int Blood & Marrow Transplant Res, Milwaukee, WI 53226 USA

[17] Univ Chicago Hosp, Dept Med, Chicago, IL 60637 USA

[18] Univ Chicago, CALGB, Chicago, IL 60637 USA

[19] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[20] BMT Grp Georgia, Atlanta, GA USA

[21] Univ Calif San Francisco, Dept Hematol & Oncol, San Francisco, CA 94143 USA

[22] Univ Texas MD Anderson Canc Ctr, Unit 423, Houston, TX 77030 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2012年 / 366卷 / 19期

关键词：

INTERGROUPE FRANCOPHONE; CONSOLIDATION THERAPY; RESPONSE CRITERIA; IMPROVES SURVIVAL; MAINTENANCE; THALIDOMIDE; BORTEZOMIB; DEXAMETHASONE; LEUKEMIA; PREDNISONE;

D O I：

10.1056/NEJMoa1114083

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Data are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma. Methods Between April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression. The starting dose of lenalidomide was 10 mg per day (range, 5 to 15). Results The study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group. At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide. At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died. The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001). A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03). More grade 3 or 4 hematologic adverse events and grade 3 non-hematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons). Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%). Conclusions Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma.

引用

页码：1770 / 1781

页数：12

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