2010
DOI: 10.18632/oncotarget.106
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Phase 2 clinical trial of 5-azacitidine, valproic acid, and all-trans retinoic acid in patients with high-risk acute myeloid leukemia or myelodysplastic syndrome

Abstract: ABSTRACT:In this Phase 2 study, we evaluated the efficacy of combination of 5-azacitidine (AZA), valproic acid (VPA), and all-trans retinoic acid (ATRA) in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Treatment consisted of six cycles of AZA and VPA for 7 days, followed by ATRA for 21 days. Sixty-five patients were enrolled (median age, 72 years; 55 AML including 13 relapsed/refractory patients, 10 MDS; 30 unfavorable karyotypes). Best responses included 14 CR and 3 P… Show more

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Cited by 115 publications
(54 citation statements)
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“…In the clofarabine CLASSIC II study [27 ], the complete remission rate was 38% and median OS was 9.5 months. In the azacitidine VIVEDEP study, the complete remission rate was 22% and the median OS reached 12.4 months [28]. At first sight, these median OS are in the same range than that reported after intensive chemotherapy.…”
Section: Most Promising Alternative Therapiesmentioning
confidence: 66%
“…In the clofarabine CLASSIC II study [27 ], the complete remission rate was 38% and median OS was 9.5 months. In the azacitidine VIVEDEP study, the complete remission rate was 22% and the median OS reached 12.4 months [28]. At first sight, these median OS are in the same range than that reported after intensive chemotherapy.…”
Section: Most Promising Alternative Therapiesmentioning
confidence: 66%
“…The previously established LM38-LP cell line (passage [15][16][17][18][19][20][21][22][23][24][25], derived from a BALB/c murine mammary papillary adenocarcinoma with tumourigenic and metastatic capacities [8], was used throughout this study. This cell line is composed of two main subpopulations, antigenically characterized as luminal epithelial (LEP) and myoephitelial (MEP), which remain up to the 30th passage [12].…”
Section: Cell Culturesmentioning
confidence: 99%
“…Due to their role in growth regulation and differentiation, natural and synthetic retinoids are widely evaluated in clinical trials for cancer treatment and prevention [18][19][20]. Besides, since retinoic acid is known to act as a key regulator of embryonic stem cell behaviour, retinoids may not only induce apoptosis, but also differentiation of cancer stem cells.…”
Section: Introductionmentioning
confidence: 99%
“…Azacitidine-based combinations have recently been investigated in early phase clinical trials in relapsing/refractory AML [76][77][78] and in retrospective cohorts of limited size [60,69,79,80]. Subgroups of relapsed/refractory patients likely to benefit from such azacitidine-based regimens have not been identified to date.…”
Section: Combinationmentioning
confidence: 99%