Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: north American intergroup study swog s1117

Journal of Clinical Oncology

Volumn 35, Issue 24, 2017, Pages 2745-2753

  Sekeres, Mikkael A ^a,b   Othus, Megan ^d   List, Alan F ^a   Odenike, Olatoyosi ^f   Stone, Richard M ^h   Gore, Steven D ^j   Litzow, Mark R ^k   Buckstein, Rena ^l   Fang, Min ^s   Roulston, Diane ⁿ   Bloomfield, Clara D ^c   Moseley, Anna ^d   Nazha, Aziz ^b   Zhang, Yanming ^o   Velasco, Mario R ^g   Gaur, Rakesh ^p   Atallah, Ehab ^q   Attar, Eyal C ⁱ   Cook, Elina K ^m   Cull, Alyssa H ^m   Rauh, Michael J ^m   Appelbaum, Frederick R ^e   Erba, Harry P ^r   more..

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c OHIO STATE UNIVERSITY   (United States)

^d SWOG STATISTICAL CENTER   (United States)

^e Fred Hutchinson Cancer Research Center   (United States)

^f UNIVERSITY OF CHICAGO   (United States)

^g Cancer Care Specialists of Central Illinois   (United States)

^h DANA FARBER CANCER INSTITUTE   (United States)

ⁱ MASSACHUSETTS GENERAL HOSPITAL   (United States)

^j YALE UNIVERSITY   (United States)

^k Mayo Clinic   (Australia)

^l SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^m QUEEN S UNIVERSITY   (Canada)

ⁿ UNIVERSITY OF MICHIGAN   (United States)

^o MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^p Kansas City National Cancer Institute Community Oncology Research Program   (United States)

^q MEDICAL COLLEGE OF WISCONSIN   (United States)

^r UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^s University of Alabama ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

AZACITIDINE; LENALIDOMIDE; VORINOSTAT; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIMETABOLITE; HYDROXAMIC ACID; THALIDOMIDE;

ADULT; AGED; CANCER SURVIVAL; CHRONIC MYELOMONOCYTIC LEUKEMIA; CLINICAL OUTCOME; COHORT ANALYSIS; CONFERENCE PAPER; CONNECTIVE TISSUE DISEASE; CONTINUOUS INFUSION; CONTROLLED STUDY; CYTOGENETICS; DISEASE SEVERITY; DNMT3A GENE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GASTROINTESTINAL TOXICITY; GENE; GENE MUTATION; HEART DISEASE; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HIGH RISK PATIENT; HUMAN; INFECTION; INFESTATION; KIDNEY DISEASE; LEUKEMIA REMISSION; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; MYELODYSPLASTIC SYNDROME; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN DISEASE; SRSF2 GENE; THORAX DISEASE; TREATMENT DURATION; TREATMENT RESPONSE; URINARY TRACT DISEASE; VASCULAR DISEASE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; LEUKEMIA, MYELOMONOCYTIC, CHRONIC; MIDDLE AGED; MULTICENTER STUDY; MYELODYSPLASTIC SYNDROMES; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AZACITIDINE; HUMANS; HYDROXAMIC ACIDS; LEUKEMIA, MYELOMONOCYTIC, CHRONIC; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; THALIDOMIDE;

EID: 85028505702     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.66.2510     Document Type: Conference Paper

References (33)

1. Greenberg P, Cox C, LeBeau MM, et al: International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 89:2079-2088, 1997
2. Greenberg PL, Tuechler H, Schanz J, et al: Revised international prognostic scoring system for myelodysplastic syndromes. Blood 120:2454-2465, 2012
3. Sekeres MA, Cutler C: How we treat higher-risk myelodysplastic syndromes. Blood 123:829-836, 2014
4. Sekeres MA: Epidemiology, natural history, and practice patterns of patients with myelodysplastic syndromes in 2010. J Natl Compr Canc Netw 9:57-63, 2011
5. Kantarjian H, Issa JP, Rosenfeld CS, et al: Decitabine improves patient outcomes in myelodysplastic syndromes: Results of a phase III randomized study. Cancer 106:1794-1803, 2006
6. List A, Dewald G, Bennett J, et al: Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 355:1456-1465, 2006
7. Silverman LR, Demakos EP, Peterson BL, et al: Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: A study of the cancer and leukemia group B. J Clin Oncol 20: 2429-2440, 2002
8. Ebert BL, Pretz J, Bosco J, et al: Identification of RPS14 as a 5q- syndrome gene by RNA interference screen. Nature 451:335-339, 2008
9. Krönke J, Fink EC, Hollenbach PW, et al: Lenalidomide induces ubiquitination and degradation of CK1a in del(5q) MDS. Nature 523:183-188, 2015
10. Wei S, Chen X, Rocha K, et al: A critical role for phosphatase haplodeficiency in the selective suppression of deletion 5q MDS by lenalidomide. Proc Natl Acad Sci USA 106:12974-12979, 2009 [Erratum: Proc Natl Acad Sci USA 110:14504, 2013]
11. Santini V, Almeida A, Giagounidis A, et al: Randomized phase III study of lenalidomide versus placebo in RBC transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes and ineligible for or refractory to erythropoiesis-stimulating agents. J Clin Oncol 34:2988-2996, 2016
12. Mesa RA, Yao X, Cripe LD, et al: Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903. Blood 116:4436-4438, 2010
13. Quintás-Cardama A, Kantarjian HM, Manshouri T, et al: Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. J Clin Oncol 27: 4760-4766, 2009
14. Saunthararajah Y, Triozzi P, Rini B, et al: p53-Independent, normal stem cell sparing epigenetic differentiation therapy for myeloid and other malignancies. Semin Oncol 39:97-108, 2012
15. Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al: Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: A rando-mised, open-label, phase III study. Lancet Oncol 10: 223-232, 2009
16. Marks P, Rifkind RA, Richon VM, et al: Histone deacetylases and cancer: Causes and therapies. Nat Rev Cancer 1:194-202, 2001
17. Ruefli AA, Ausserlechner MJ, Bernhard D, et al: The histone deacetylase inhibitor and chemotherapeutic agent suberoylanilide hydroxamic acid (SAHA) induces a cell-death pathway characterized by cleavage of Bid and production of reactive oxygen species. Proc Natl Acad Sci USA 98:10833-10838, 2001
18. Silverman LR, Verma A, Odchimar-Reissig R, et al: A phase II trial of epigenetic modulators vorinostat in combination with azacitidine (azaC) in patients with the myelodysplastic syndrome (MDS): Initial results of study 6898 of the New York Cancer Consortium. Blood 122:386-393, 2013
19. Sekeres MA, List AF, Cuthbertson D, et al: Phase I combination trial of lenalidomide and azacitidine in patients with higher-risk myelodysplastic syndromes. J Clin Oncol 28:2253-2258, 2010
20. Sekeres MA, Tiu RV, Komrokji R, et al: Phase 2 study of the lenalidomide and azacitidine combination in patients with higher-risk myelodysplastic syndromes. Blood 120:4945-4951, 2012
21. Grinblatt DL, Sekeres MA, Komrokji RS, et al: Patients with myelodysplastic syndromes treated with azacitidine in clinical practice: The AVIDA registry. Leuk Lymphoma 56:887-895, 2015
22. Lyons RM, Cosgriff TM, Modi SS, et al: Hematologic response to three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes. J Clin Oncol 27:1850-1856, 2009
23. Cheson BD, Greenberg PL, Bennett JM, et al: Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood 108:419-425, 2006
24. Myelodysplastic Syndromes Foundation: MDS Centers of Excellence. https://www.mds-foundation.org/mds-centeres-of-excellence/
25. Bejar R, Stevenson KE, Caughey B, et al: Somatic mutations predict poor outcome in patients with myelodysplastic syndrome after hematopoietic stem-cell transplantation. J Clin Oncol 32:2691-2698, 2014
26. Walter MJ, Shen D, Shao J, et al: Clonal diversity of recurrently mutated genes in myelodysplastic syndromes. Leukemia 27:1275-1282, 2013
27. Sekeres MA, Schoonen WM, Kantarjian H, et al: Characteristics of US patients with myelodysplastic syndromes: Results of six cross-sectional physician surveys. J Natl Cancer Inst 100:1542-1551, 2008
28. Steensma DP, Komrokji RS, Stone RM, et al: Disparity in perceptions of disease characteristics, treatment effectiveness, and factors influencing treatment adherence between physicians and patients with myelodysplastic syndromes. Cancer 120: 1670-1676, 2014
29. Sekeres M, Swern A, List A, et al: Effect of lenalidomide (LEN) exposure on AML-free survival and overall survival in LEN-treated patients (pts) with IPSS Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) with del(5q). Blood 126:2870a, 2015
30. Bejar R, Lord A, Stevenson K, et al: TET2 mutations predict response to hypomethylating agents in myelodysplastic syndrome patients. Blood 124:2705-2712, 2014
31. Haferlach T, Nagata Y, Grossmann V, et al: Landscape of genetic lesions in 944 patients with myelodysplastic syndromes. Leukemia 28:241-247, 2014
32. Traina F, Visconte V, Elson P, et al: Impact of molecular mutations on treatment response to DNMT inhibitors in myelodysplasia and related neoplasms. Leukemia 28:78-87, 2014
33. Welch JS, Petti AA, Miller CA, et al: TP53 and decitabine in acute myeloid leukemia and myelodysplastic syndromes. N Engl J Med 375:2023-2036, 2016