Arsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/72637
Title:
Arsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study.
Authors:
Vey, Norbert; Bosly, Andre; Guerci, Agnes; Feremans, Walter; Dombret, Herve; Dreyfus, Francois; Bowen, David; Burnett, Alan K; Dennis, Michael; Ribrag, Vincent; Casadevall, Nicole; Legros, Laurence; Fenaux, Pierre
Abstract:
PURPOSE: Evaluation of the safety and efficacy of arsenic trioxide in patients with myelodysplastic syndromes (MDS). PATIENTS AND METHODS: MDS patients diagnosed according to standard French-American-British criteria received a loading dose of 0.3 mg/kg per day of arsenic trioxide for 5 days followed by a maintenance dose of 0.25 mg/kg arsenic trioxide twice weekly for 15 weeks. Patients were divided into two cohorts: lower-risk MDS (International Prognostic Scoring System risk category low or intermediate 1) and higher-risk MDS (International Prognostic Scoring System risk category intermediate 2 or high). Modified International Working Group criteria were used for response evaluation. RESULTS: Of 115 patients enrolled and treated in the study, 67% of patients were transfusion dependent at baseline; median age was 68 years. Most treatment-related adverse events were mild to moderate. The overall rate of hematologic improvement (intent-to-treat) was 24 (19%) of 115, including one complete and one partial response in the higher-risk cohort. The hematologic response rates were 13 (26%) of 50 and 11 (17%) of 64 in patients with lower-risk and higher-risk MDS, respectively. Major responses were observed in all three hematologic lineages; 16% of RBC transfusion-dependent patients and 29% of platelet transfusion-dependent patients became transfusion independent. At data cut off, the median response duration was 3.4 months, with responses ongoing in nine patients. CONCLUSION: Arsenic trioxide treatment consisting of an initial loading dose followed by maintenance therapy has moderate activity in MDS, inducing hematologic responses in both lower- and higher-risk patients. This activity combined with a manageable adverse effect profile warrants the additional study of arsenic trioxide, particularly in combination therapy, for the treatment of patients with MDS.
Affiliation:
Institut Paoli-Calmettes, Marseille, France. veyn@marseille.fnclcc.fr
Citation:
Arsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study. 2006, 24 (16):2465-71 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
1-Jun-2006
URI:
http://hdl.handle.net/10541/72637
DOI:
10.1200/JCO.2005.03.9503
PubMed ID:
16651646
Type:
Article
Language:
en
ISSN:
1527-7755
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorVey, Norbert-
dc.contributor.authorBosly, Andre-
dc.contributor.authorGuerci, Agnes-
dc.contributor.authorFeremans, Walter-
dc.contributor.authorDombret, Herve-
dc.contributor.authorDreyfus, Francois-
dc.contributor.authorBowen, David-
dc.contributor.authorBurnett, Alan K-
dc.contributor.authorDennis, Michael-
dc.contributor.authorRibrag, Vincent-
dc.contributor.authorCasadevall, Nicole-
dc.contributor.authorLegros, Laurence-
dc.contributor.authorFenaux, Pierre-
dc.date.accessioned2009-07-06T15:17:31Z-
dc.date.available2009-07-06T15:17:31Z-
dc.date.issued2006-06-01-
dc.identifier.citationArsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study. 2006, 24 (16):2465-71 J. Clin. Oncol.en
dc.identifier.issn1527-7755-
dc.identifier.pmid16651646-
dc.identifier.doi10.1200/JCO.2005.03.9503-
dc.identifier.urihttp://hdl.handle.net/10541/72637-
dc.description.abstractPURPOSE: Evaluation of the safety and efficacy of arsenic trioxide in patients with myelodysplastic syndromes (MDS). PATIENTS AND METHODS: MDS patients diagnosed according to standard French-American-British criteria received a loading dose of 0.3 mg/kg per day of arsenic trioxide for 5 days followed by a maintenance dose of 0.25 mg/kg arsenic trioxide twice weekly for 15 weeks. Patients were divided into two cohorts: lower-risk MDS (International Prognostic Scoring System risk category low or intermediate 1) and higher-risk MDS (International Prognostic Scoring System risk category intermediate 2 or high). Modified International Working Group criteria were used for response evaluation. RESULTS: Of 115 patients enrolled and treated in the study, 67% of patients were transfusion dependent at baseline; median age was 68 years. Most treatment-related adverse events were mild to moderate. The overall rate of hematologic improvement (intent-to-treat) was 24 (19%) of 115, including one complete and one partial response in the higher-risk cohort. The hematologic response rates were 13 (26%) of 50 and 11 (17%) of 64 in patients with lower-risk and higher-risk MDS, respectively. Major responses were observed in all three hematologic lineages; 16% of RBC transfusion-dependent patients and 29% of platelet transfusion-dependent patients became transfusion independent. At data cut off, the median response duration was 3.4 months, with responses ongoing in nine patients. CONCLUSION: Arsenic trioxide treatment consisting of an initial loading dose followed by maintenance therapy has moderate activity in MDS, inducing hematologic responses in both lower- and higher-risk patients. This activity combined with a manageable adverse effect profile warrants the additional study of arsenic trioxide, particularly in combination therapy, for the treatment of patients with MDS.en
dc.language.isoenen
dc.subjectHaematologic Diseasesen
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshArsenicals-
dc.subject.meshDisease-Free Survival-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshFemale-
dc.subject.meshHematologic Diseases-
dc.subject.meshHumans-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshMyelodysplastic Syndromes-
dc.subject.meshOxides-
dc.subject.meshPrognosis-
dc.subject.meshProspective Studies-
dc.subject.meshRisk Assessment-
dc.subject.meshRisk Factors-
dc.subject.meshSurvival Analysis-
dc.subject.meshTreatment Outcome-
dc.titleArsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study.en
dc.typeArticleen
dc.contributor.departmentInstitut Paoli-Calmettes, Marseille, France. veyn@marseille.fnclcc.fren
dc.identifier.journalJournal of Clinical Oncologyen

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