Journal of Clinical Oncology, Vol 20, Issue 10
(May), 2002: 2429-2440
© 2002 American Society for Clinical Oncology
Randomized Controlled Trial of Azacitidine in Patients With the Myelodysplastic Syndrome: A Study of the Cancer and Leukemia Group B
By Lewis R. Silverman,
Erin P. Demakos,
Bercedis L. Peterson,
Alice B. Kornblith,
Jimmie C. Holland,
Rosalie Odchimar-Reissig,
Richard M. Stone,
Douglas Nelson,
Bayard L. Powell,
Carlos M. DeCastro,
John Ellerton,
Richard A. Larson,
Charles A. Schiffer,
James F. Holland
From the Mount Sinai School of Medicine and Memorial Sloan-Kettering Cancer Center, New York, and State University of New York School of Medicine at Syracuse, Syracuse, NY; Cancer and Leukemia Group B, Statistical Center, Duke University Medical Center, Durham, and Wake Forest University Bowman Gray School of Medicine, Winston-Salem, NC; Dana-Farber Cancer Institute, Boston, MA; University Medical Center–S. Nevada Community Clinical Oncology Program, Las Vegas, NV; University of Chicago, Chicago, IL; and Wayne State University, Detroit, MI.
Address reprint requests to Lewis R. Silverman, MD, Mount Sinai Medical Center, Division of Medical Oncology, Box 1129, One Gustave L. Levy Place, New York, NY 10029; email: lewis.silverman{at}mssm.edu
PURPOSE: Patients with high-risk myelodysplastic syndrome (MDS) have high mortality from bone marrow failure or transformation to acute leukemia. Supportive care is standard therapy. We previously reported that azacitidine (Aza C) was active in patients with high-risk MDS.
PATIENTS AND METHODS: A randomized controlled trial was undertaken in 191 patients with MDS to compare Aza C (75 mg/m2/d subcutaneously for 7 days every 28 days) with supportive care. MDS was defined by French-American-British criteria. New rigorous response criteria were applied. Both arms received transfusions and antibiotics as required. Patients in the supportive care arm whose disease worsened were permitted to cross over to Aza C.
RESULTS: Responses occurred in 60% of patients on the Aza C arm (7% complete response, 16% partial response, 37% improved) compared with 5% (improved) receiving supportive care (P < .001). Median time to leukemic transformation or death was 21 months for Aza C versus 13 months for supportive care (P = .007). Transformation to acute myelogenous leukemia occurred as the first event in 15% of patients on the Aza C arm and in 38% receiving supportive care (P = .001). Eliminating the confounding effect of early cross-over to Aza C, a landmark analysis after 6 months showed median survival of an additional 18 months for Aza C and 11 months for supportive care (P = .03). Quality-of-life assessment found significant major advantages in physical function, symptoms, and psychological state for patients initially randomized to Aza C.
CONCLUSION: Aza C treatment results in significantly higher response rates, improved quality of life, reduced risk of leukemic transformation, and improved survival compared with supportive care. Aza C provides a new treatment option that is superior to supportive care for patients with the MDS subtypes and specific entry criteria treated in this study.
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Silenced tumor suppressor genes reactivated by DNA demethylation do not return to a fully euchromatic chromatin state.
Cancer Res.,
April 1, 2006;
66(7):
3541 - 3549.
[Abstract]
[Full Text]
[PDF]
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C. Stresemann, B. Brueckner, T. Musch, H. Stopper, and F. Lyko
Functional diversity of DNA methyltransferase inhibitors in human cancer cell lines.
Cancer Res.,
March 1, 2006;
66(5):
2794 - 2800.
[Abstract]
[Full Text]
[PDF]
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M. Herranz, J. Martin-Caballero, M. F. Fraga, J. Ruiz-Cabello, J. M. Flores, M. Desco, V. Marquez, and M. Esteller
The novel DNA methylation inhibitor zebularine is effective against the development of murine T-cell lymphoma
Blood,
February 1, 2006;
107(3):
1174 - 1177.
[Abstract]
[Full Text]
[PDF]
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C. A. Schiffer
Clinical Issues in the Management of Patients with Myelodysplasia
Hematology,
January 1, 2006;
2006(1):
205 - 210.
[Abstract]
[Full Text]
[PDF]
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D. P. Steensma and J. M. Bennett
The Myelodysplastic Syndromes: Diagnosis and Treatment
Mayo Clin. Proc.,
January 1, 2006;
81(1):
104 - 130.
[Abstract]
[Full Text]
[PDF]
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D. M. B. Kerbauy, V. Lesnikov, N. Abbasi, S. Seal, B. Scott, and H. J. Deeg
NF-{kappa}B and FLIP in arsenic trioxide (ATO)-induced apoptosis in myelodysplastic syndromes (MDSs)
Blood,
December 1, 2005;
106(12):
3917 - 3925.
[Abstract]
[Full Text]
[PDF]
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L. R. Silverman, D. R. McKenzie, B. L. Peterson, R. M. Stone, B. L. Powell, C. Mayo, J. T. Backstrom, R. A. Larson, and The Cancer Leukemia Group B (CALGB)
Response Rates in Patients with Acute Myeloid Leukemia (AML), Treated with Azacitidine, Using WHO and International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS).
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
1848 - 1848.
[Abstract]
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R. Lyons, T. Cosgriff, S. Modi, L. Lintz, C.L. Beach, and J. T. Backstrom
Azacitidine (Vidaza(R)) Treatment Response Assessed Using Three Alternative Dosing Schedules in Patients with Myelodysplastic Syndromes (MDS).
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
2517 - 2517.
[Abstract]
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L. R. Silverman, D. R. McKenzie, B. L. Peterson, E. P. Demakos, J. F. Holland, R. R. Larson, and The Cancer Leukemia Group B (CALGB).
Analysis of Survival, AML Transformation, and Transfusion Independence in Patients with High-Risk Myelodysplastic Syndromes (MDS) Receiving Azacitidine Determined Using a Prognostic Model.
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
2523 - 2523.
[Abstract]
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L. R. Silverman, D. R. McKenzie, B. L. Peterson, E. P. Demakos, N. T. Malone, J. F. Holland, R. A. Larson, and The Cancer Leukemia Group B (CALGB).
Azacitidine Prolongs Survival and Time to AML Transformation in High-Risk Myelodysplastic Syndrome (MDS) Patients >= 65 Years of Age.
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
2524 - 2524.
[Abstract]
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L. R. Silverman, D. R. McKenzie, B. L. Peterson, R. Odchimar-Reissig, R. Hinkle, J. T. Backstrom, R. A. Larson, and The Cancer Leukemia Group B (CALGB).
Rates of Infection and Bleeding Are Not Increased in Patients with Myelodysplastic Syndromes (MDS) Treated with Azacitidine Compared with Supportive Care.
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
2525 - 2525.
[Abstract]
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L. R. Silverman, D. R. McKenzie, B. L. Peterson, C. M. De Castro, J. Ellerton, K. N. Knapp, C.L. Beach, R. A. Larson, and The Cancer Leukemia Group B (CALGB).
Response Rates Using International Working Group (IWG) Criteria in Patients with Myelodysplastic Syndromes (MDS) Treated with Azacitidine.
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
2526 - 2526.
[Abstract]
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L. R. Silverman, U. Germing, D. R. McKenzie, B. L. Peterson, R. A. Larson, and The Cancer Leukemia Group B (CALGB).
A New Validated Myelodysplastic Syndrome (MDS) Prognostic Model for Use When Cytogenetics Are Unavailable.
Blood (ASH Annual Meeting Abstracts),
November 16, 2005;
106(11):
2527 - 2527.
[Abstract]
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A. Sternberg, S. Killick, T. Littlewood, C. Hatton, A. Peniket, T. Seidl, S. Soneji, J. Leach, D. Bowen, C. Chapman, et al.
Evidence for reduced B-cell progenitors in early (low-risk) myelodysplastic syndrome
Blood,
November 1, 2005;
106(9):
2982 - 2991.
[Abstract]
[Full Text]
[PDF]
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F. Lyko and R. Brown
DNA Methyltransferase Inhibitors and the Development of Epigenetic Cancer Therapies
J Natl Cancer Inst,
October 19, 2005;
97(20):
1498 - 1506.
[Abstract]
[Full Text]
[PDF]
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C. Mund, B. Hackanson, C. Stresemann, M. Lubbert, and F. Lyko
Characterization of DNA Demethylation Effects Induced by 5-Aza-2'-Deoxycytidine in Patients with Myelodysplastic Syndrome
Cancer Res.,
August 15, 2005;
65(16):
7086 - 7090.
[Abstract]
[Full Text]
[PDF]
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M. Sullivan, K. Hahn, and J. M. Kolesar
Azacitidine: A novel agent for myelodysplastic syndromes
Am. J. Health Syst. Pharm.,
August 1, 2005;
62(15):
1567 - 1573.
[Abstract]
[Full Text]
[PDF]
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W. E. Samlowski, S. A. Leachman, M. Wade, P. Cassidy, P. Porter-Gill, L. Busby, R. Wheeler, K. Boucher, F. Fitzpatrick, D. A. Jones, et al.
Evaluation of a 7-Day Continuous Intravenous Infusion of Decitabine: Inhibition of Promoter-Specific and Global Genomic DNA Methylation
J. Clin. Oncol.,
June 10, 2005;
23(17):
3897 - 3905.
[Abstract]
[Full Text]
[PDF]
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A. M. Melnick, K. Adelson, and J. D. Licht
The Theoretical Basis of Transcriptional Therapy of Cancer: Can It Be Put Into Practice?
J. Clin. Oncol.,
June 10, 2005;
23(17):
3957 - 3970.
[Abstract]
[Full Text]
[PDF]
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K. N. Bhalla
Epigenetic and Chromatin Modifiers As Targeted Therapy of Hematologic Malignancies
J. Clin. Oncol.,
June 10, 2005;
23(17):
3971 - 3993.
[Abstract]
[Full Text]
[PDF]
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E. Kaminskas, A. Farrell, S. Abraham, A. Baird, L.-S. Hsieh, S.-L. Lee, J. K. Leighton, H. Patel, A. Rahman, R. Sridhara, et al.
Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes
Clin. Cancer Res.,
May 15, 2005;
11(10):
3604 - 3608.
[Abstract]
[Full Text]
[PDF]
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G. Marcucci, L. Silverman, M. Eller, L. Lintz, and C. L. Beach
Bioavailability of Azacitidine Subcutaneous Versus Intravenous in Patients With the Myelodysplastic Syndromes
J. Clin. Pharmacol.,
May 1, 2005;
45(5):
597 - 602.
[Abstract]
[Full Text]
[PDF]
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D. P. Steensma and A. F. List
Genetic Testing in the Myelodysplastic Syndromes: Molecular Insights Into Hematologic Diversity
Mayo Clin. Proc.,
May 1, 2005;
80(5):
681 - 698.
[Abstract]
[PDF]
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E. Kaminskas, A. T. Farrell, Y.-C. Wang, R. Sridhara, and R. Pazdur
FDA Drug Approval Summary: Azacitidine (5-azacytidine, VidazaTM) for Injectable Suspension
Oncologist,
March 1, 2005;
10(3):
176 - 182.
[Abstract]
[Full Text]
[PDF]
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R. Schneider-Stock, M. Diab-Assef, A. Rohrbeck, C. Foltzer-Jourdainne, C. Boltze, R. Hartig, P. Schonfeld, A. Roessner, and H. Gali-Muhtasib
5-aza-Cytidine Is a Potent Inhibitor of DNA Methyltransferase 3a and Induces Apoptosis in HCT-116 Colon Cancer Cells via Gadd45- and p53-Dependent Mechanisms
J. Pharmacol. Exp. Ther.,
February 1, 2005;
312(2):
525 - 536.
[Abstract]
[Full Text]
[PDF]
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A.-M. Tsimberidou, F. J. Giles, I. Khouri, C. Bueso-Ramos, S. Pilat, D. A. Thomas, J. Cortes, and R. Kurzrock
Low-dose interleukin-11 in patients with bone marrow failure: update of the M. D. Anderson Cancer Center experience
Ann. Onc.,
January 1, 2005;
16(1):
139 - 145.
[Abstract]
[Full Text]
[PDF]
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E. Hellstrom-Lindberg
Update on Supportive Care and New Therapies: Immunomodulatory Drugs, Growth Factors and Epigenetic-Acting Agents
Hematology,
January 1, 2005;
2005(1):
161 - 166.
[Abstract]
[Full Text]
[PDF]
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L. Sigalotti, E. Fratta, S. Coral, S. Tanzarella, R. Danielli, F. Colizzi, E. Fonsatti, C. Traversari, M. Altomonte, and M. Maio
Intratumor Heterogeneity of Cancer/Testis Antigens Expression in Human Cutaneous Melanoma Is Methylation-Regulated and Functionally Reverted by 5-Aza-2'-deoxycytidine
Cancer Res.,
December 15, 2004;
64(24):
9167 - 9171.
[Abstract]
[Full Text]
[PDF]
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J. Gilbert, S. D. Gore, J. G. Herman, and M. A. Carducci
The Clinical Application of Targeting Cancer through Histone Acetylation and Hypomethylation
Clin. Cancer Res.,
July 15, 2004;
10(14):
4589 - 4596.
[Abstract]
[Full Text]
[PDF]
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C. S. Cutler, S. J. Lee, P. Greenberg, H. J. Deeg, W. S. Perez, C. Anasetti, B. J. Bolwell, M. S. Cairo, R. P. Gale, J. P. Klein, et al.
A decision analysis of allogeneic bone marrow transplantation for the myelodysplastic syndromes: delayed transplantation for low-risk myelodysplasia is associated with improved outcome
Blood,
July 15, 2004;
104(2):
579 - 585.
[Abstract]
[Full Text]
[PDF]
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J. E. Dowell and J. D. Minna
Cancer Chemotherapy Targeted at Reactivating the Expression of Epigenetically Inactivated Genes
J. Clin. Oncol.,
April 15, 2004;
22(8):
1353 - 1355.
[Full Text]
[PDF]
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A. T.C. Chan, Q. Tao, K. D. Robertson, I. W. Flinn, R. B. Mann, B. Klencke, W. H. Kwan, T. W.-T. Leung, P. J. Johnson, and R. F. Ambinder
Azacitidine Induces Demethylation of the Epstein-Barr Virus Genome in Tumors
J. Clin. Oncol.,
April 15, 2004;
22(8):
1373 - 1381.
[Abstract]
[Full Text]
[PDF]
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R. Kurzrock, M. Albitar, J. E. Cortes, E. H. Estey, S. H. Faderl, G. Garcia-Manero, D. A. Thomas, F. J. Giles, M. E. Ryback, A. Thibault, et al.
Phase II Study of R115777, a Farnesyl Transferase Inhibitor, in Myelodysplastic Syndrome
J. Clin. Oncol.,
April 1, 2004;
22(7):
1287 - 1292.
[Abstract]
[Full Text]
[PDF]
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R. M. Stone, M. R. O'Donnell, and M. A. Sekeres
Acute Myeloid Leukemia
Hematology,
January 1, 2004;
2004(1):
98 - 117.
[Abstract]
[Full Text]
[PDF]
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A. F. List, J. Vardiman, J.-P. J. Issa, and T. M. DeWitte
Myelodysplastic Syndromes
Hematology,
January 1, 2004;
2004(1):
297 - 317.
[Abstract]
[Full Text]
[PDF]
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G. C. Bagby, J. M. Lipton, E. M. Sloand, and C. A. Schiffer
Marrow Failure
Hematology,
January 1, 2004;
2004(1):
318 - 336.
[Abstract]
[Full Text]
[PDF]
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V. Gandhi, H. Kantarjian, S. Faderl, P. Bonate, M. Du, M. Ayres, M. B. Rios, M. J. Keating, and W. Plunkett
Pharmacokinetics and Pharmacodynamics of Plasma Clofarabine and Cellular Clofarabine Triphosphate in Patients with Acute Leukemias
Clin. Cancer Res.,
December 15, 2003;
9(17):
6335 - 6342.
[Abstract]
[Full Text]
[PDF]
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