Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes

Yun Gyoo Lee; Inho Kim; Sung Soo Yoon; Seonyang Park; June Won Cheong; Yoo Hong Min; Jeong Ok Lee; Soo Mee Bang; Hyeon Gyu Yi; Chul Soo Kim; Yong Park; Byung Soo Kim; Yeung Chul Mun; Chu Myoung Seong; Jinny Park; Jae Hoon Lee; Sung Yong Kim; Hong Ghi Lee; Yeo Kyeoung Kim; Hyeoung Joon Kim

doi:10.1111/bjh.12256

Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes

Yun Gyoo Lee, Inho Kim, Sung Soo Yoon, Seonyang Park, June Won Cheong, Yoo Hong Min, Jeong Ok Lee, Soo Mee Bang, Hyeon Gyu Yi, Chul Soo Kim, Yong Park, Byung Soo Kim, Yeung Chul Mun, Chu Myoung Seong, Jinny Park, Jae Hoon Lee, Sung Yong Kim, Hong Ghi Lee, Yeo Kyeoung Kim, Hyeoung Joon Kim

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

76 Scopus citations

Abstract

The present study aimed to directly compare the efficacy and safety of azacitidine and decitabine in patients with myelodysplastic syndromes (MDS). We compared the overall response rate (ORR) (complete responses, partial responses, marrow complete responses, and haematological improvements), overall survival (OS), event-free survival (EFS), time to leukaemic transformation, and adverse outcomes between azacitidine and decitabine. To minimize the effects of treatment selection bias in this observational study, adjustments were made using the propensity-score matching method. Among 300 patients, 203 were treated with azacitidine and 97 with decitabine. Propensity-score matching yielded 97 patient pairs. In the propensity-matched cohort, there were no significant differences between the azacitidine and decitabine groups regarding ORR (44% vs. 52%), OS (26 vs. 22·9 months), EFS (7·7 vs. 7·0 months), and rate of leukaemic transformation (16% vs. 22% at 1 year). In patients ≥65 years of age, survival was significantly better in the azacitidine group (P = 0·017). Patients who received decitabine experienced more frequent episodes of grade 3 or 4 cytopenia and infectious episodes. We found that azacitidine and decitabine showed comparable efficacy. Among patients ≥65 years of age, survival was significantly better in the azacitidine group (ClinicalTrials.gov Identifier: NCT01409070).

Original language	English
Pages (from-to)	339-347
Number of pages	9
Journal	British Journal of Haematology
Volume	161
Issue number	3
DOIs	https://doi.org/10.1111/bjh.12256
State	Published - May 2013

Bibliographical note

Funding Information:
The CUORE experiment (Cryogenic Underground Observatory for Rare Events, see [1, 2]) is a nuclear physics experiment funded by several agencies, among which the National Italian Institute of Nuclear Physics (INFN), the US Department of Energy (DOE) and the National Science Foundation (NSF, USA). The experiment is set up in the Gran Sasso National (Italian) Laboratory (LNGS), an underground facility in a highly seismic zone. In fact, the laboratory is located in a gallery beneath the Gran Sasso mountain, not far from the city of L’Aquila: that zone has been hit by a destructive earthquake in 2009 (MMS 6.3) and is currently involved in the earthquake swarm that follows the Amatrice earthquake (August 2016, MMS 6.2). In spite of the fact that the underground gallery seems to mitigate the seismic effects [3, 4], there is a major concern on the structural safety of all the experiments hosted by LNGS. The complexity of the structures, along with the strict requirements from the point of view of experimental physics, calls for the application of computational tools at the cutting-edge of technology.

Keywords

Azacitidine
Comparison
Decitabine
Myelodysplastic syndromes

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10.1111/bjh.12256

Cite this

Lee, Y. G., Kim, I., Yoon, S. S., Park, S., Cheong, J. W., Min, Y. H., Lee, J. O., Bang, S. M., Yi, H. G., Kim, C. S., Park, Y., Kim, B. S., Mun, Y. C., Seong, C. M., Park, J., Lee, J. H., Kim, S. Y., Lee, H. G., Kim, Y. K., & Kim, H. J. (2013). Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes. British Journal of Haematology, 161(3), 339-347. https://doi.org/10.1111/bjh.12256

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title = "Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes",

abstract = "The present study aimed to directly compare the efficacy and safety of azacitidine and decitabine in patients with myelodysplastic syndromes (MDS). We compared the overall response rate (ORR) (complete responses, partial responses, marrow complete responses, and haematological improvements), overall survival (OS), event-free survival (EFS), time to leukaemic transformation, and adverse outcomes between azacitidine and decitabine. To minimize the effects of treatment selection bias in this observational study, adjustments were made using the propensity-score matching method. Among 300 patients, 203 were treated with azacitidine and 97 with decitabine. Propensity-score matching yielded 97 patient pairs. In the propensity-matched cohort, there were no significant differences between the azacitidine and decitabine groups regarding ORR (44% vs. 52%), OS (26 vs. 22·9 months), EFS (7·7 vs. 7·0 months), and rate of leukaemic transformation (16% vs. 22% at 1 year). In patients ≥65 years of age, survival was significantly better in the azacitidine group (P = 0·017). Patients who received decitabine experienced more frequent episodes of grade 3 or 4 cytopenia and infectious episodes. We found that azacitidine and decitabine showed comparable efficacy. Among patients ≥65 years of age, survival was significantly better in the azacitidine group (ClinicalTrials.gov Identifier: NCT01409070).",

keywords = "Azacitidine, Comparison, Decitabine, Myelodysplastic syndromes",

author = "Lee, {Yun Gyoo} and Inho Kim and Yoon, {Sung Soo} and Seonyang Park and Cheong, {June Won} and Min, {Yoo Hong} and Lee, {Jeong Ok} and Bang, {Soo Mee} and Yi, {Hyeon Gyu} and Kim, {Chul Soo} and Yong Park and Kim, {Byung Soo} and Mun, {Yeung Chul} and Seong, {Chu Myoung} and Jinny Park and Lee, {Jae Hoon} and Kim, {Sung Yong} and Lee, {Hong Ghi} and Kim, {Yeo Kyeoung} and Kim, {Hyeoung Joon}",

note = "Funding Information: The CUORE experiment (Cryogenic Underground Observatory for Rare Events, see [1, 2]) is a nuclear physics experiment funded by several agencies, among which the National Italian Institute of Nuclear Physics (INFN), the US Department of Energy (DOE) and the National Science Foundation (NSF, USA). The experiment is set up in the Gran Sasso National (Italian) Laboratory (LNGS), an underground facility in a highly seismic zone. In fact, the laboratory is located in a gallery beneath the Gran Sasso mountain, not far from the city of L{\textquoteright}Aquila: that zone has been hit by a destructive earthquake in 2009 (MMS 6.3) and is currently involved in the earthquake swarm that follows the Amatrice earthquake (August 2016, MMS 6.2). In spite of the fact that the underground gallery seems to mitigate the seismic effects [3, 4], there is a major concern on the structural safety of all the experiments hosted by LNGS. The complexity of the structures, along with the strict requirements from the point of view of experimental physics, calls for the application of computational tools at the cutting-edge of technology.",

year = "2013",

month = may,

doi = "10.1111/bjh.12256",

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Lee, YG, Kim, I, Yoon, SS, Park, S, Cheong, JW, Min, YH, Lee, JO, Bang, SM, Yi, HG, Kim, CS, Park, Y, Kim, BS, Mun, YC, Seong, CM, Park, J, Lee, JH, Kim, SY, Lee, HG, Kim, YK & Kim, HJ 2013, 'Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes', British Journal of Haematology, vol. 161, no. 3, pp. 339-347. https://doi.org/10.1111/bjh.12256

TY - JOUR

T1 - Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes

AU - Lee, Yun Gyoo

AU - Kim, Inho

AU - Yoon, Sung Soo

AU - Park, Seonyang

AU - Cheong, June Won

AU - Min, Yoo Hong

AU - Lee, Jeong Ok

AU - Bang, Soo Mee

AU - Yi, Hyeon Gyu

AU - Kim, Chul Soo

AU - Park, Yong

AU - Kim, Byung Soo

AU - Mun, Yeung Chul

AU - Seong, Chu Myoung

AU - Park, Jinny

AU - Lee, Jae Hoon

AU - Kim, Sung Yong

AU - Lee, Hong Ghi

AU - Kim, Yeo Kyeoung

AU - Kim, Hyeoung Joon

N1 - Funding Information: The CUORE experiment (Cryogenic Underground Observatory for Rare Events, see [1, 2]) is a nuclear physics experiment funded by several agencies, among which the National Italian Institute of Nuclear Physics (INFN), the US Department of Energy (DOE) and the National Science Foundation (NSF, USA). The experiment is set up in the Gran Sasso National (Italian) Laboratory (LNGS), an underground facility in a highly seismic zone. In fact, the laboratory is located in a gallery beneath the Gran Sasso mountain, not far from the city of L’Aquila: that zone has been hit by a destructive earthquake in 2009 (MMS 6.3) and is currently involved in the earthquake swarm that follows the Amatrice earthquake (August 2016, MMS 6.2). In spite of the fact that the underground gallery seems to mitigate the seismic effects [3, 4], there is a major concern on the structural safety of all the experiments hosted by LNGS. The complexity of the structures, along with the strict requirements from the point of view of experimental physics, calls for the application of computational tools at the cutting-edge of technology.

PY - 2013/5

Y1 - 2013/5

N2 - The present study aimed to directly compare the efficacy and safety of azacitidine and decitabine in patients with myelodysplastic syndromes (MDS). We compared the overall response rate (ORR) (complete responses, partial responses, marrow complete responses, and haematological improvements), overall survival (OS), event-free survival (EFS), time to leukaemic transformation, and adverse outcomes between azacitidine and decitabine. To minimize the effects of treatment selection bias in this observational study, adjustments were made using the propensity-score matching method. Among 300 patients, 203 were treated with azacitidine and 97 with decitabine. Propensity-score matching yielded 97 patient pairs. In the propensity-matched cohort, there were no significant differences between the azacitidine and decitabine groups regarding ORR (44% vs. 52%), OS (26 vs. 22·9 months), EFS (7·7 vs. 7·0 months), and rate of leukaemic transformation (16% vs. 22% at 1 year). In patients ≥65 years of age, survival was significantly better in the azacitidine group (P = 0·017). Patients who received decitabine experienced more frequent episodes of grade 3 or 4 cytopenia and infectious episodes. We found that azacitidine and decitabine showed comparable efficacy. Among patients ≥65 years of age, survival was significantly better in the azacitidine group (ClinicalTrials.gov Identifier: NCT01409070).

AB - The present study aimed to directly compare the efficacy and safety of azacitidine and decitabine in patients with myelodysplastic syndromes (MDS). We compared the overall response rate (ORR) (complete responses, partial responses, marrow complete responses, and haematological improvements), overall survival (OS), event-free survival (EFS), time to leukaemic transformation, and adverse outcomes between azacitidine and decitabine. To minimize the effects of treatment selection bias in this observational study, adjustments were made using the propensity-score matching method. Among 300 patients, 203 were treated with azacitidine and 97 with decitabine. Propensity-score matching yielded 97 patient pairs. In the propensity-matched cohort, there were no significant differences between the azacitidine and decitabine groups regarding ORR (44% vs. 52%), OS (26 vs. 22·9 months), EFS (7·7 vs. 7·0 months), and rate of leukaemic transformation (16% vs. 22% at 1 year). In patients ≥65 years of age, survival was significantly better in the azacitidine group (P = 0·017). Patients who received decitabine experienced more frequent episodes of grade 3 or 4 cytopenia and infectious episodes. We found that azacitidine and decitabine showed comparable efficacy. Among patients ≥65 years of age, survival was significantly better in the azacitidine group (ClinicalTrials.gov Identifier: NCT01409070).

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KW - Comparison

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Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes

Abstract

Bibliographical note

Keywords

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