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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 (CROSBI ID 178993)

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Lübbert, M. ; ... ; Labar, Boris ; ... ; Wijermans, P.W. 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 Res // Journal of clinical oncology, 29 (2011), 15; 1987-1996. doi: 10.1200/JCO.2010.30.9245

Podaci o odgovornosti

Lübbert, M. ; ... ; Labar, Boris ; ... ; Wijermans, P.W.

engleski

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

Purpose was 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. 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. 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. 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.

decitabine; elderly; high risk MDS

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Podaci o izdanju

29 (15)

2011.

1987-1996

objavljeno

0732-183X

10.1200/JCO.2010.30.9245

Povezanost rada

Kliničke medicinske znanosti

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