Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

被引：18

作者：

Ossenkoppele, G. J. ^{[1
,49
]}

Breems, D. A. ^{[2
,33
]}

Stuessi, G. ^{[3
]}

Van Norden, Y. ^{[4
]}

Bargetzi, M. ^{[5
]}

Biemond, B. J. ^{[6
]}

A von dem Borne, P. ^{[7
]}

Chalandon, Y. ^{[8
,9
,44
]}

Cloos, J. ^{[1
]}

Deeren, D. ^{[10
]}

Fehr, M. ^{[11
,47
]}

Gjertsen, B. ^{[12
]}

Graux, C. ^{[13
,39
]}

Huls, G. ^{[14
,56
]}

Janssen, J. J. J. W. ^{[1
]}

Jaspers, A. ^{[15
]}

Jongen-Lavrencic, M. ^{[16
]}

De Jongh, E. ^{[17
]}

Klein, S. K. ^{[18
]}

Van der Klift, M. ^{[19
,50
]}

Van Marwijk Kooy, M. ^{[20
,63
]}

Maertens, J. ^{[21
]}

Micheaux, L. ^{[22
,23
]}

Van der Poel, M. W. M. ^{[24
]}

Van Rhenen, A. ^{[25
,62
]}

Tick, L. ^{[26
]}

Valk, P. ^{[15
]}

Vekemans, M. C. ^{[27
]}

Van der Velden, W. J. F. M. ^{[28
,61
]}

De Weerdt, O. ^{[29
,60
]}

Pabst, T. ^{[30
,31
]}

Manz, M. ^{[32
]}

Lowenberg, B. ^{[15
,16
]}

Havelange ^{[34
]}

Vekemans, M-C ^{[34
]}

Moors, I. ^{[35
]}

Van Obberg, F. ^{[36
]}

Maertens, J. A. ^{[37
]}

Hodossy, B. ^{[38
]}

Vansteenweghen, S. ^{[38
]}

Lammertijn, L. ^{[38
]}

Sonet, A. ^{[39
]}

Triffet, A. ^{[40
]}

Gjertsen, B. T. ^{[12
]}

Passweg, J. ^{[41
]}

Heim, D. ^{[41
]}

Giovanni, San ^{[42
]}

Stuessi, Georg ^{[42
]}

Betticher, D. ^{[43
]}

Chalandon, Y. ^{[8
,9
,44
]}

机构：

[1] Vrije Univ Amsterdam Med Ctr, Amsterdam Univ Med Cente, Amsterdam, Netherlands

[2] Netwerk Antwerpen, Antwerp, Belgium

[3] Bellinzona IOSI, Bellinzona, Switzerland

[4] Erasmus MC, Dept Hematol, HOVON Data Ctr, Rotterdam, Netherlands

[5] Aarau Kantonsspital, Aarau, Switzerland

[6] AMC, Amsterdam Univ Med Ctr, Amsterdam, Netherlands

[7] Leiden Univ, Med Ctr, Leiden, Netherlands

[8] Univ Hosp, Geneva, Switzerland

[9] Univ Geneva, Geneva, Switzerland

[10] Roeselare AZ Delta, Roeselare, Belgium

[11] St Gallen Kantonnsspital, St Gallen, Switzerland

[12] Haukeland Hosp, Bergen, Norway

[13] Yvoir MontGodinne, Yvoir, Belgium

[14] Univ Med Ctr Groningen, Groningen, Netherlands

[15] Hop Citadelle, Liege, Belgium

[16] Erasmus MC, Rotterdam, Netherlands

[17] Dordrecht ASZ, Dordrecht, Netherlands

[18] Meander Med Ctr, Amersfoort, Netherlands

[19] Amphia Breda, Breda, Netherlands

[20] Isala Hosp, Zwolle, Netherlands

[21] Hosp Gasthuisberg, Leuven, Belgium

[22] Katholieke Univ Leuven, Ctr Human Genet, Leuven, Belgium

[23] Univ Hosp Leuven, Leuven, Belgium

[24] Maastricht Univ, Med Ctr, Maastricht, Netherlands

[25] UMC Utrecht, Utrecht, Netherlands

[26] MaximaMC Eindhoven, Eindhoven, Netherlands

[27] Hop St Luc, Brussels, Belgium

[28] Radboudumc Nijmegen, Nijmegen, Netherlands

[29] St Antonius Hosp, Nieuwegein, Netherlands

[30] Inselspital Bern, Univ Hosp, Dept Oncol, Bern, Switzerland

[31] Univ Bern, Bern, Switzerland

[32] Univ Hosp, Zurich, Switzerland

[33] Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium

[34] Hop St LucV, Brussels, Belgium

[35] UZ Gent, Ghent, Belgium

[36] Hop St Paul Jolimont, Haine, Belgium

[37] Univ Hosp Gasthuisberg, Leuven, Belgium

[38] Citadelle, Liege, Belgium

[39] CHU UCLNamur Godinne, Yvoir, Belgium

[40] Charleroi CHU, Charleroi, Belgium

[41] Univ Hosp, Basel, Switzerland

[42] Osped San Giovanni Bellinzona, Bellinzona, Switzerland

[43] Kantonsspital, Fribourg, Switzerland

[44] Univ Hosp HUG, Geneva, Switzerland

[45] Univ Hosp, Lausanne, Switzerland

[46] Kantonsspital, Luzern, Switzerland

[47] Kantonsspital, St Gallen, Switzerland

[48] Univ Hosp, Zurich, Switzerland

[49] Vrije Univ Amsterdam Med Ctr, Univ Med Ctr, Amsterdam, Netherlands

[50] Amphia, Breda, Netherlands

来源：

LEUKEMIA | 2020年 / 34卷 / 07期

关键词：

ACUTE MYELOID-LEUKEMIA; HIGH-DOSE LENALIDOMIDE; THERAPY; ADULTS;

D O I：

10.1038/s41375-020-0725-0

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy ("3 + 7") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m(2) twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).

引用

页码：1751 / 1759

页数：9

共 50 条

[1] Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS
G. J. Ossenkoppele
D. A. Breems
G. Stuessi
Y. van Norden
M. Bargetzi
B. J. Biemond
P. A von dem Borne
Y. Chalandon
J. Cloos
D. Deeren
M. Fehr
B. Gjertsen
C. Graux
G. Huls
J. J. J. W. Janssen
A. Jaspers
M. Jongen-Lavrencic
E. de Jongh
S. K. Klein
M. van der Klift
M. van Marwijk Kooy
J. Maertens
L. Michaux
M. W. M. van der Poel
A. van Rhenen
L. Tick
P. Valk
M. C. Vekemans
W. J. F. M. van der Velden
O. de Weerdt
T. Pabst
M. Manz
B. Löwenberg
[J]. Leukemia, 2020, 34 : 1751 - 1759
[2] Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS
G. J. Ossenkoppele
D. A. Breems
G. Stuessi
Y. van Norden
M. Bargetzi
B. J. Biemond
P. A von dem Borne
Y. Chalandon
J. Cloos
D. Deeren
M. Fehr
B. Gjertsen
C. Graux
G. Huls
J. J. J. W. Janssen
A. Jaspers
M. Jongen-Lavrencic
E. de Jongh
S. K. Klein
M. van der Klift
M. van Marwijk Kooy
J. Maertens
L. Michaux
M. W. M. van der Poel
A. van Rhenen
L. Tick
P. Valk
M. C. Vekemans
W. J. F. M. van der Velden
O. de Weerdt
T. Pabst
M. Manz
B. Löwenberg
[J]. Leukemia, 2020, 34 : 2820 - 2820
[3] Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS (vol 66, pg 813, 2020)
Ossenkoppele, G. J.
Breems, D. A.
Stuessi, G.
van Norden, Y.
Bargetzi, M.
Biemond, B. J.
von dem Borne, P.
Chalandon, Y.
Cloos, J.
Deeren, D.
Fehr, M.
Gjertsen, B.
Graux, C.
Huls, G.
Janssen, J. J. J. W.
Jaspers, A.
Jongen-Lavrencic, M.
de Jongh, E.
Klein, S. K.
van der Klift, M.
van Marwijk Kooy, M.
Maertens, J.
Michaux, L.
van der Poel, M. W. M.
van Rhenen, A.
Tick, L.
Valk, P.
Vekemans, M. C.
van der Velden, W. J. F. M.
de Weerdt, O.
Pabst, T.
Manz, M.
Lowenberg, B.
[J]. LEUKEMIA, 2020, 34 (10) : 2820 - 2820
[4] Geriatric assessment:: a prospective study in older patients with AML and high-risk MDS
Deschler, B.
Ihorst, G.
Kuhn, M.
Rueter, B.
Luebbert, M.
[J]. CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, 2006, 60 : S26 - S27
[5] Determining Treatment for Older Patients with High-Risk MDS and AML: Which Factors Predict Optimal Quality of Life?
Tinsley-Vance, Sara M.
Small, Brent J.
McMillan, Susan C.
Komrokji, Rami S.
Lancet, Jeffrey E.
[J]. BLOOD, 2016, 128 (22)
[6] Inferior Outcome of Addition of the Aminopeptidase Inhibitor Tosedostat to Standard Intensive Treatment for Elderly Patients with AML and High Risk MDS
Janssen, Jeroen
Lowenberg, Bob
Manz, Markus
Bargetzi, Mario
Biemond, Bart
Borne, Peter von Dem
Breems, Dimitri
Brouwer, Rolf
Chalandon, Yves
Deeren, Dries
Efthymiou, Anna
Gjertsen, Bjorn-Tore
Graux, Carlos
Gregor, Michael
Heim, Dominik
Hess, Urs
Hoogendoorn, Mels
Jaspers, Aurelie
Jie, Asiong
Jongen-Lavrencic, Mojca
Klein, Saskia
van der Klift, Marjolein
Kuball, Jurgen
van Lammeren-Venema, Danielle
Legdeur, Marie-Cecile
van de Loosdrecht, Arjan
Maertens, Johan
Kooy, Marinus van Marwijk
Moors, Ine
Nijziel, Marten
van Obbergh, Florence
Oosterveld, Margriet
Pabst, Thomas
van der Poel, Marjolein
Sinnige, Harm
Spertini, Olivier
Terpstra, Wim
Tick, Lidwine
van der Velden, Walter
Vekemans, Marie-Christiane
Vellenga, Edo
de Weerdt, Okke
Westerweel, Peter
Stussi, Georg
van Norden, Yvette
Ossenkoppele, Gert
[J]. CANCERS, 2021, 13 (04) : 1 - 11
[7] Copy number profiles of high-risk MDS and AML patients
Ganster, C.
Braulke, F.
Shirneshan, K.
Schanz, J.
Neesen, J.
Salinas-Riester, G.
Platzbecker, U.
Haase, D.
[J]. ONKOLOGIE, 2013, 36 : 239 - 240
[8] A pilot study of bendamustine in elderly patients with high-risk MDS and AML
Strupp, C.
Knipp, S.
Hartmann, J.
Gattermann, N.
Haas, R.
Germing, U.
[J]. LEUKEMIA & LYMPHOMA, 2007, 48 (06) : 1161 - 1166
[9] An inexpensive way to treat elderly patients with high-risk MDS or AML
Kuendgen, Andrea
[J]. LEUKEMIA RESEARCH, 2011, 35 (08) : 985 - 986
[10] Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS
Huls, Gerwin
Chitu, Dana A.
Pabst, Thomas
Klein, Saskia K.
Stussi, Georg
Griskevicius, Laimonas
Valk, Peter J. M.
Cloos, Jacqueline
van de Loosdrecht, Arjan A.
Breems, Dimitri
van Lammeren-Venema, Danielle
van Zeventer, Isabelle
Boersma, Rinske
Jongen-Lavrencic, Mojca
Fehr, Martin
Hoogendoorn, Mels
Manz, Markus G.
Sohne, Maaike
Kooy, Rien van Marwijk
Deeren, Dries
van der Poel, Marjolein W. M.
Legdeur, Marie Cecile
Tick, Lidwine
Chalandon, Yves
Ammatuna, Emanuele
Blum, Sabine
Lowenberg, Bob
Ossenkoppele, Gert J.
[J]. BLOOD ADVANCES, 2020, 4 (18) : 4267 - 4277

← 1 2 3 4 5 →