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Cited by 552

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

Low-Dose Decitabine Versus Best Supportive Care in Elderly Patients With Intermediate- or High-Risk Myelodysplastic Syndrome (MDS) Ineligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group

Lübbert, Michael, Suciu, Stefan, Baila, Liliana, Rüter, Björn Hans, Platzbecker, Uwe, Giagounidis, Aristoteles, Selleslag, Dominik, Labar, Boris, Germing, Ulrich, Salih, Helmut R., Beeldens, Filip, Muus, Petra, Pflüger, Karl-Heinz, Coens, Corneel, Hagemeijer, Anne, Eckart Schaefer, Hans, Ganser, Arnold, Aul, Carlo, de Witte, Theo, Wijermans, Pierre W.·2011·Journal of Clinical Oncology
DOI 10.1200/jco.2010.30.9245
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Abstract

Purpose: To compare low-dose decitabine to best supportive care (BSC) in higher-risk patients with myelodysplastic syndrome (MDS) age 60 years or older and ineligible for intensive chemotherapy. Patients and Methods: Two-hundred thirty-three patients (median age, 70 years; range, 60 to 90 years) were enrolled; 53% had poor-risk cytogenetics, and the median MDS duration at random assignment was 3 months. Primary end point was overall survival (OS). Decitabine (15 mg/m 2) was given intravenously over 4 hours three times a day for 3 days in 6-week cycles. Results: OS prolongation with decitabine versus BSC was not statistically significant (median OS, 10.1 v 8.5 months, respectively; hazard ratio [HR], 0.88; 95% CI, 0.66 to 1.17; two-sided, log-rank P = .38). Progression-free survival (PFS), but not acute myeloid leukemia (AML) –free survival (AMLFS), was significantly prolonged with decitabine versus BSC (median PFS, 6.6 v 3.0 months, respectively; HR, 0.68; 95% CI, 0.52 to 0.88; P = .004; median AMLFS, 8.8 v 6.1 months, respectively; HR, 0.85; 95% CI, 0.64 to 1.12; P = .24). AML transformation was significantly (P = .036) reduced at 1 year (from 33% with BSC to 22% with decitabine). Multivariate analyses indicated that patients with short MDS duration had worse outcomes. Best responses with decitabine versus BSC, respectively, were as follows: complete response (13% v 0%), partial response (6% v 0%), hematologic improvement (15% v 2%), stable disease (14% v 22%), progressive disease (29% v 68%), hypoplasia (14% v 0%), and inevaluable (8% v 8%). Grade 3 to 4 febrile neutropenia occurred in 25% of patients on decitabine versus 7% of patients on BSC; grade 3 to 4 infections occurred in 57% and 52% of patients on decitabine and BSC, respectively. Decitabine treatment was associated with improvements in patient-reported quality-of-life (QOL) parameters. Conclusion: Decitabine administered in 6-week cycles is active in older patients with higher-risk MDS, resulting in improvements of OS and AMLFS (nonsignificant), of PFS and AML transformation (significant), and of QOL. Short MDS duration was an independent adverse prognosticator.

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Metadata

Authors
Lübbert, M., Suciu, S., Baila, L., Rüter, B. H., Platzbecker, U., Giagounidis, A., Selleslag, D., Labar, B., Germing, U., Salih, H. R., Beeldens, F., Muus, P., Pflüger, K.-H., Coens, C., Hagemeijer, A., Eckart Schaefer, H., Ganser, A., Aul, C., de Witte, T., & Wijermans, P. W.
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2011-05-20
Volume
29
Issue
15
Pages
1987-1996
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2010.30.9245
OpenAlex
W2106082819
Cited by
552
References
24
FWCI
28.11
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Low-Dose Decitabine Versus Best Supportive Care in Elderly Patients With Intermediate- or High-Risk Myelodysplastic Syndrome (MDS) Ineligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. https://app.cochat.ai/papers/10.1200/jco.2010.30.9245
The paper
Lübbert, M., Suciu, S., Baila, L., Rüter, B. H., Platzbecker, U., Giagounidis, A., Selleslag, D., Labar, B., Germing, U., Salih, H. R., Beeldens, F., Muus, P., Pflüger, K.-H., Coens, C., Hagemeijer, A., Eckart Schaefer, H., Ganser, A., Aul, C., de Witte, T., & Wijermans, P. W. (2011). Low-Dose Decitabine Versus Best Supportive Care in Elderly Patients With Intermediate- or High-Risk Myelodysplastic Syndrome (MDS) Ineligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2010.30.9245

Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.