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2015 ; 32
(11
): 1140-59
Nephropedia Template TP
gab.com Text
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English Wikipedia
Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An
Open-Label, Phase-3b Study
#MMPMID26568466
Wu D
; Du X
; Jin J
; Xiao Z
; Shen Z
; Shao Z
; Li X
; Huang X
; Liu T
; Yu L
; Li J
; Chen B
; He G
; Cai Z
; Liang H
; Li J
; Ruan C
Adv Ther
2015[Nov]; 32
(11
): 1140-59
PMID26568466
show ga
INTRODUCTION: The objective of this study was to evaluate the efficacy and safety
of decitabine in Chinese patients with myelodysplastic syndrome (MDS). METHODS:
Patients (?18 years) who had a de novo or secondary MDS diagnosis according to
French-American-British classification and an International Prognostic Scoring
System score ?0.5 were enrolled and randomized (1:1) to one of two decitabine
regimens: 3-day treatment (3-h intravenous infusion of 15 mg/m(2) given every 8 h
for three consecutive days/cycle/6 weeks) or 5-day treatment (1-h intravenous
infusion of 20 mg/m(2) once daily on days 1-5/cycle/4 weeks). After a minimum of
30 patients were assigned to 3-day schedule, the remaining were assigned to the
5-day schedule. The primary efficacy endpoint was the overall response rate
(ORR). Secondary outcome measures included hematologic improvement (HI),
cytogenetic response rate, the time to acute myeloid leukemia (AML) progression,
and overall survival (OS). RESULTS: In total, 132 of 135 enrolled patients (3-day
treatment, n = 36; 5-day treatment, n = 99) discontinued treatment (major reasons
included patient withdrawal/lack of efficacy, n = 48; adverse events, n = 23; and
disease progression, n = 22). During the study, 35 of 132 (26.5%) patients from
the intent-to-treat (ITT) group achieved significant (P < 0.001) ORR [3-day group
(n = 10, 29.4%), P = 0.003; 5-day group (n = 25, 25.5%), P < 0.001]. The HI rate
was similar between the 3-day (47.1%) and 5-day groups (48.0%). Cytogenetic
response was achieved in 20 of the 30 (66.7%) patients who had a baseline
cytogenetic abnormality. Fifty-three (40.2%) AML transformations or deaths
occurred and the median AML-free survival time was 23.8 months for all patients
from the ITT set; 24-month OS rate was 48.9%. Adverse events of
myelosuppression-related disorders (85.6%) and infections (43.2%) were commonly
reported. CONCLUSION: Decitabine treatment was efficacious in Chinese patients
with MDS with its safety profile comparable to the global studies of decitabine
conducted to date. FUNDING: Xian-Janssen Pharmaceutical Ltd. China (a company of
Johnson & Johnson). TRIAL REGISTRATION: ClinicalTrials.gov identifier,
NCT01751867.
|Adolescent
[MESH]
|Adult
[MESH]
|Aged
[MESH]
|Antimetabolites, Antineoplastic/administration & dosage/adverse
effects/*therapeutic use
[MESH]
|Asian People
[MESH]
|Azacitidine/administration & dosage/adverse effects/*analogs &
derivatives/therapeutic use
[MESH]
free
free
free
