Phase I dose escalation study of bortezomib in combination with lenalidomide in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)

被引:32
作者
Attar, Eyal C. [1 ]
Amrein, Philip C. [1 ]
Fraser, James W. [1 ]
Fathi, Amir T. [1 ]
McAfee, Steven [1 ]
Wadleigh, Martha [2 ]
DeAngelo, Daniel J. [2 ]
Steensma, David P. [2 ]
Stone, Richard M. [2 ]
Foster, Julia [1 ]
Neuberg, Donna [3 ]
Ballen, Karen K. [1 ]
机构
[1] Massachusetts Gen Hosp, Ctr Canc, Ctr Leukaemia, Boston, MA USA
[2] Dana Farber Canc Inst, Adult Leukemia Program, Boston, MA 02115 USA
[3] Dana Farber Canc Inst, Dept Biostat & Computat Biol, Boston, MA 02115 USA
关键词
Bortezomib and lenalidomide in MDS and AML; ACUTE MYELOGENOUS LEUKEMIA; INTERNATIONAL WORKING GROUP; RESPONSE CRITERIA; STEM-CELLS; KAPPA-B; THERAPY; RISK; CYTARABINE; INDUCTION; DELETION;
D O I
10.1016/j.leukres.2013.05.011
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
We conducted a phase I dose escalation study to determine the maximal tolerated dose of bortezomib that could be combined with standard dose lenalidomide in patients with MDS or AML. Treatment consisted of bortezomib (IV) on Days 1, 4, 8, and 11 and lenalidomide 10 mg daily (PO) days 1-21 in 28 day cycles for up to 9 cycles. 23 patients (14 MDS/CMML, 9 AML) were enrolled. The maximally tested dose of bortezomib, 1.3 mg/m(2), was tolerable in this regimen. Responses were seen in patients with MDS and AML. Further testing of this regimen is planned. (C) 2013 Elsevier Ltd. All rights reserved.
引用
收藏
页码:1016 / 1020
页数:5
相关论文
共 19 条
[1]
Erythroid response and decrease of WT1 expression after proteasome inhibition by bortezomib in myelodysplastic syndromes [J].
Alimena, Giuliana ;
Breccia, Massimo ;
Musto, Pellegrino ;
Cilloni, Daniela ;
D'Auria, Fiorella ;
Latagliata, Roberto ;
Sanpaolo, Grazia ;
Gottardi, Enrico ;
Saglio, Giuseppe ;
Mandelli, Franco .
LEUKEMIA RESEARCH, 2011, 35 (04) :504-507
[2]
Phase I and pharmacokinetic study of bortezomib in combination with idarubicin and cytarabine in patients with acute myelogenous leukemia [J].
Attar, Eyal C. ;
De Angelo, Daniel J. ;
Supko, Jeffrey G. ;
D'Amato, Ferdinando ;
Zahrieh, David ;
Sirulnik, Andres ;
Wadleigh, Martha ;
Ballen, Karen K. ;
McAfee, Steve ;
Miller, Kenneth B. ;
Levine, James ;
Galinsky, Ilene ;
Trehu, Elizabeth G. ;
Schenkein, David ;
Neuberg, Donna ;
Stone, Richard M. ;
Amrein, Philip C. .
CLINICAL CANCER RESEARCH, 2008, 14 (05) :1446-1454
[3]
Bortezomib Added to Daunorubicin and Cytarabine During Induction Therapy and to Intermediate-Dose Cytarabine for Consolidation in Patients With Previously Untreated Acute Myeloid Leukemia Age 60 to 75 Years: CALGB (Alliance) Study 10502 [J].
Attar, Eyal C. ;
Johnson, Jeffrey L. ;
Amrein, Philip C. ;
Lozanski, Gerard ;
Wadleigh, Martha ;
DeAngelo, Daniel J. ;
Kolitz, Jonathan E. ;
Powell, Bayard L. ;
Voorhees, Peter ;
Wang, Eunice S. ;
Blum, William ;
Stone, Richard M. ;
Marcucci, Guido ;
Bloomfield, Clara D. ;
Moser, Barry ;
Larson, Richard A. .
JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (07) :923-929
[4]
Dose Escalation of Lenalidomide in Relapsed or Refractory Acute Leukemias [J].
Blum, William ;
Klisovic, Rebecca B. ;
Becker, Heiko ;
Yang, Xiaoxia ;
Rozewski, Darlene M. ;
Phelps, Mitch A. ;
Garzon, Ramiro ;
Walker, Alison ;
Chandler, Jason C. ;
Whitman, Susan P. ;
Curfman, John ;
Liu, Shujun ;
Schaaf, Larry ;
Mickle, Jon ;
Kefauver, Cheryl ;
Devine, Steven M. ;
Grever, Michael R. ;
Marcucci, Guido ;
Byrd, John C. .
JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (33) :4919-4925
[5]
Braun T, 2006, BLOOD, V107, P1156
[6]
A Phase II Study of Lenalidomide Alone in Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes With Chromosome 5 Abnormalities [J].
Chen, Yiming ;
Kantarjian, Hagop ;
Estrov, Zeev ;
Faderl, Stefan ;
Ravandi, Farhad ;
Rey, Kristy ;
Cortes, Jorge ;
Borthakur, Gautam .
CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, 2012, 12 (05) :341-344
[7]
Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia [J].
Cheson, BD ;
Bennett, JM ;
Kopecky, KJ ;
Büchner, T ;
Willman, CL ;
Estey, EH ;
Schiffer, CA ;
Döhner, H ;
Tallman, MS ;
Lister, TA ;
LoCocco, F ;
Willemze, R ;
Biondi, A ;
Hiddemann, W ;
Larson, RA ;
Löwenberg, B ;
Sanz, MA ;
Head, DR ;
Ohno, R ;
Bloomfield, CD .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (24) :4642-4649
[8]
Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia [J].
Cheson, Bruce D. ;
Greenberg, Peter L. ;
Bennett, John M. ;
Lowenberg, Bob ;
Wijermans, Pierre W. ;
Nimer, Stephen D. ;
Pinto, Antonio ;
Beran, Miloslav ;
de Witte, Theo M. ;
Stone, Richard M. ;
Mittelman, Moshe ;
Sanz, Guillermo F. ;
Gore, Steven D. ;
Schiffer, Charles A. ;
Kantarjian, Hagop .
BLOOD, 2006, 108 (02) :419-425
[9]
A phase 2 study of high-dose lenalidomide as initial therapy for older patients with acute myeloid leukemia [J].
Fehniger, Todd A. ;
Uy, Geoffrey L. ;
Trinkaus, Kathryn ;
Nelson, Alissa D. ;
Demland, Jeffery ;
Abboud, Camille N. ;
Cashen, Amanda F. ;
Stockerl-Goldstein, Keith E. ;
Westervelt, Peter ;
DiPersio, John F. ;
Vij, Ravi .
BLOOD, 2011, 117 (06) :1828-1833
[10]
Nuclear factor-κB is constitutively activated in primitive human acute myelogenous leukemia cells [J].
Guzman, ML ;
Neering, SJ ;
Upchurch, D ;
Grimes, B ;
Howard, DS ;
Rizzieri, DA ;
Luger, SM ;
Jordan, CT .
BLOOD, 2001, 98 (08) :2301-2307