Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes

John F. Seymour; Pierre Fenaux; Lewis R. Silverman; Ghulam J. Mufti; Eva Hellström-Lindberg; Valeria Santini; Alan F. List; Steven D. Gore; Jay Backstrom; David McKenzie; C. L. Beach

doi:10.1016/j.critrevonc.2010.04.005

Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes

John F. Seymour, Pierre Fenaux, Lewis R. Silverman, Ghulam J. Mufti, Eva Hellström-Lindberg, Valeria Santini, Alan F. List, Steven D. Gore, Jay Backstrom, David McKenzie, C. L. Beach

Research output: Contribution to journal › Review article › peer-review

111 Scopus citations

Abstract

This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75mg/m²/daysubcutaneously×7 days every 28 days) (n=38) or CCR (n=49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; p=0.0193) and 2-year OS rates were 55% vs 15% (p<0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3-4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥75 years with good performance status and higher-risk MDS.

Original language	English
Pages (from-to)	218-227
Number of pages	10
Journal	Critical Reviews in Oncology/Hematology
Volume	76
Issue number	3
DOIs	https://doi.org/10.1016/j.critrevonc.2010.04.005
State	Published - Dec 2010

Keywords

AML
Acute myeloid leukemia
Azacitidine
Elderly
Low-dose ara-C
MDS
Myelodysplastic syndromes
Survival

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10.1016/j.critrevonc.2010.04.005

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Seymour, J. F., Fenaux, P., Silverman, L. R., Mufti, G. J., Hellström-Lindberg, E., Santini, V., List, A. F., Gore, S. D., Backstrom, J., McKenzie, D., & Beach, C. L. (2010). Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes. Critical Reviews in Oncology/Hematology, 76(3), 218-227. https://doi.org/10.1016/j.critrevonc.2010.04.005

@article{099f2c191e57459b9e85a14a3b64d3d2,

title = "Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes",

abstract = "This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75mg/m2/daysubcutaneously×7 days every 28 days) (n=38) or CCR (n=49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; p=0.0193) and 2-year OS rates were 55% vs 15% (p<0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3-4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥75 years with good performance status and higher-risk MDS.",

keywords = "AML, Acute myeloid leukemia, Azacitidine, Elderly, Low-dose ara-C, MDS, Myelodysplastic syndromes, Survival",

author = "Seymour, {John F.} and Pierre Fenaux and Silverman, {Lewis R.} and Mufti, {Ghulam J.} and Eva Hellstr{\"o}m-Lindberg and Valeria Santini and List, {Alan F.} and Gore, {Steven D.} and Jay Backstrom and David McKenzie and Beach, {C. L.}",

note = "Funding Information: The study was funded by Celgene Corporation . The paper was written by John F. Seymour and other co-authors who had access to all data and controlled all content. Sheila Truten, B.S. and Neil Malone, M.A., provided editorial assistance and Indrasiri Fernando, Ph.D., provided statistical support during manuscript development. ST is employed by MC2, Wynnewood, PA, and was compensated by Celgene Corporation; NM and IF are employed by Celgene Corporation, Summit, NJ. ",

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doi = "10.1016/j.critrevonc.2010.04.005",

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Seymour, JF, Fenaux, P, Silverman, LR, Mufti, GJ, Hellström-Lindberg, E, Santini, V, List, AF, Gore, SD, Backstrom, J, McKenzie, D & Beach, CL 2010, 'Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes', Critical Reviews in Oncology/Hematology, vol. 76, no. 3, pp. 218-227. https://doi.org/10.1016/j.critrevonc.2010.04.005

TY - JOUR

T1 - Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes

AU - Seymour, John F.

AU - Fenaux, Pierre

AU - Silverman, Lewis R.

AU - Mufti, Ghulam J.

AU - Hellström-Lindberg, Eva

AU - Santini, Valeria

AU - List, Alan F.

AU - Gore, Steven D.

AU - Backstrom, Jay

AU - McKenzie, David

AU - Beach, C. L.

N1 - Funding Information: The study was funded by Celgene Corporation . The paper was written by John F. Seymour and other co-authors who had access to all data and controlled all content. Sheila Truten, B.S. and Neil Malone, M.A., provided editorial assistance and Indrasiri Fernando, Ph.D., provided statistical support during manuscript development. ST is employed by MC2, Wynnewood, PA, and was compensated by Celgene Corporation; NM and IF are employed by Celgene Corporation, Summit, NJ.

PY - 2010/12

Y1 - 2010/12

N2 - This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75mg/m2/daysubcutaneously×7 days every 28 days) (n=38) or CCR (n=49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; p=0.0193) and 2-year OS rates were 55% vs 15% (p<0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3-4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥75 years with good performance status and higher-risk MDS.

AB - This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75mg/m2/daysubcutaneously×7 days every 28 days) (n=38) or CCR (n=49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; p=0.0193) and 2-year OS rates were 55% vs 15% (p<0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3-4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥75 years with good performance status and higher-risk MDS.

KW - AML

KW - Acute myeloid leukemia

KW - Azacitidine

KW - Elderly

KW - Low-dose ara-C

KW - MDS

KW - Myelodysplastic syndromes

KW - Survival

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U2 - 10.1016/j.critrevonc.2010.04.005

DO - 10.1016/j.critrevonc.2010.04.005

M3 - Review article

C2 - 20451404

AN - SCOPUS:77957021267

SN - 1040-8428

VL - 76

SP - 218

EP - 227

JO - Critical Reviews in Oncology/Hematology

JF - Critical Reviews in Oncology/Hematology

IS - 3

ER -

Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes

Abstract

Keywords

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