| A phase 2 randomized multicenter study of 2 extended dosing schedules of oral ezatiostat in low to intermediate-1 risk myelodysplastic syndrome. | |
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MedLine Citation:
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PMID: 21887679 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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BACKGROUND: Ezatiostat is a glutathione analog prodrug glutathione S-transferase P1-1 (GSTP1-1) inhibitor. This study evaluated 2 extended dose schedules of oral ezatiostat in 89 heavily pretreated patients with low to intermediate-1 risk myelodysplastic syndrome (MDS). METHODS: Patients were randomized by 1 stratification factor-baseline cytopenia (anemia only vs anemia with additional cytopenias)-to 1 of 2 extended dosing schedules. Multilineage hematologic improvement (HI) responses were assessed by International Working Group 2006 criteria. RESULTS: Overall, 11 of 38 (29%) red blood cell (RBC) transfusion-dependent patients had HI-Erythroid (HI-E) response. The median duration of HI-E response was 34 weeks. Multilineage responses were observed. There was 1 cytogenetic complete response in a del (5q) MDS patient. An important trend was the effect of prior therapy on response. A 40% HI-E rate (6 of 15 patients) was observed in patients who had prior lenalidomide and no prior hypomethylating agents (HMAs), with 5 of 11 (45%) patients achieving significant RBC transfusion reduction and 3 of 11 (27%) achieving transfusion independence. A 28% HI-E rate (5 of 18 patients) was observed in patients who were both lenalidomide and HMA naive, with 4 of 8 (50%) patients achieving clinically significant RBC transfusion reductions. Most common ezatiostat-related adverse events were grade 1 and 2 gastrointestinal including: nausea (45%, 17%), diarrhea (26%, 7%), and vomiting (30%, 12%). CONCLUSIONS: Ezatiostat is the first GSTP1-1 inhibitor shown to cause clinically significant and sustained reduction in RBC transfusions, transfusion independence, and multilineage responses in MDS patients. The tolerability and activity profile of ezatiostat may offer a new treatment option for patients with MDS. Cancer 2011. © 2011 American Cancer Society. |
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Authors:
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Azra Raza; Naomi Galili; Scott E Smith; John Godwin; Ralph V Boccia; Han Myint; Daruka Mahadevan; Deborah Mulford; Mark Rarick; Gail L Brown; Dale Schaar; Stefan Faderl; Rami S Komrokji; Alan F List; Mikkael Sekeres |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-9-1 |
Journal Detail:
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Title: Cancer Volume: - ISSN: 1097-0142 ISO Abbreviation: - Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-9-2 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0374236 Medline TA: Cancer Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 American Cancer Society. |
Affiliation:
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Columbia University Medical Center, New York, New York. azra.raza@columbia.edu. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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