European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy.

2.50
Hdl Handle:
http://hdl.handle.net/10541/109478
Title:
European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy.
Authors:
Burnett, Alan K; Russell, Nigel; Kell, W Jonathan; Dennis, Michael; Milligan, Donald W; Paolini, Stefania; Yin, John A; Culligan, Dominic; Johnston, Peter; Murphy, John; McMullin, Mary-Frances; Hunter, Ann; Das-Gupta, Emma; Clark, Richard E; Carr, Robert; Hills, Robert K
Abstract:
PURPOSE: Treatment options for older patients with acute myeloid leukemia (AML) who are not considered suitable for intensive chemotherapy are limited. We assessed the second-generation purine nucleoside analog, clofarabine, in two similar phase II studies in this group of patients. PATIENTS AND METHODS: Two consecutive studies, UWCM-001 and BIOV-121, recruited untreated older patients with AML to receive up to four or six 5-day courses of clofarabine. Patients in UWCM-001 were either older than 70 years or 60 to 69 years of age with poor performance status (WHO > 2) or with cardiac comorbidity. Patients in BIOV-121 were >or= 65 years of age and deemed unsuitable for intensive chemotherapy. RESULTS: A total of 106 patients were treated in the two monotherapy studies. Median age was 71 years (range, 60 to 84 years), 30% had adverse-risk cytogenetics, and 36% had a WHO performance score >or= 2. Forty-eight percent had a complete response (32% complete remission, 16% complete remission with incomplete peripheral blood count recovery), and 18% died within 30 days. Interestingly, response and overall survival were not inferior in the adverse cytogenetic risk group. The safety profile of clofarabine in these elderly patients with AML who were unsuitable for intensive chemotherapy was manageable and typical of a cytotoxic agent in patients with acute leukemia. Patients had similar prognostic characteristics to matched patients treated with low-dose cytarabine in the United Kingdom AML14 trial, but had significantly superior response and overall survival. CONCLUSION: Clofarabine is active and generally well tolerated in this patient group. It is worthy of further evaluation in comparative trials and might be of particular use in patients with adverse cytogenetics.
Affiliation:
Department of Haematology, Cardiff University School of Medicine, Cardiff CF14 4XN, United Kingdom. burnettak@cardiff.ac.uk
Citation:
European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy. 2010, 28 (14):2389-95 J Clin Oncol
Journal:
Journal of Clinical Oncology
Issue Date:
10-May-2010
URI:
http://hdl.handle.net/10541/109478
DOI:
10.1200/JCO.2009.26.4242
PubMed ID:
20385984
Type:
Article
Language:
en
ISSN:
1527-7755
Appears in Collections:
All Christie Publications ; Haematology

Full metadata record

DC FieldValue Language
dc.contributor.authorBurnett, Alan Ken
dc.contributor.authorRussell, Nigelen
dc.contributor.authorKell, W Jonathanen
dc.contributor.authorDennis, Michaelen
dc.contributor.authorMilligan, Donald Wen
dc.contributor.authorPaolini, Stefaniaen
dc.contributor.authorYin, John Aen
dc.contributor.authorCulligan, Dominicen
dc.contributor.authorJohnston, Peteren
dc.contributor.authorMurphy, Johnen
dc.contributor.authorMcMullin, Mary-Francesen
dc.contributor.authorHunter, Annen
dc.contributor.authorDas-Gupta, Emmaen
dc.contributor.authorClark, Richard Een
dc.contributor.authorCarr, Roberten
dc.contributor.authorHills, Robert Ken
dc.date.accessioned2010-08-11T10:55:54Zen
dc.date.available2010-08-11T10:55:54Zen
dc.date.issued2010-05-10en
dc.identifier.citationEuropean development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy. 2010, 28 (14):2389-95 J Clin Oncolen
dc.identifier.issn1527-7755en
dc.identifier.pmid20385984en
dc.identifier.doi10.1200/JCO.2009.26.4242en
dc.identifier.urihttp://hdl.handle.net/10541/109478en
dc.description.abstractPURPOSE: Treatment options for older patients with acute myeloid leukemia (AML) who are not considered suitable for intensive chemotherapy are limited. We assessed the second-generation purine nucleoside analog, clofarabine, in two similar phase II studies in this group of patients. PATIENTS AND METHODS: Two consecutive studies, UWCM-001 and BIOV-121, recruited untreated older patients with AML to receive up to four or six 5-day courses of clofarabine. Patients in UWCM-001 were either older than 70 years or 60 to 69 years of age with poor performance status (WHO > 2) or with cardiac comorbidity. Patients in BIOV-121 were >or= 65 years of age and deemed unsuitable for intensive chemotherapy. RESULTS: A total of 106 patients were treated in the two monotherapy studies. Median age was 71 years (range, 60 to 84 years), 30% had adverse-risk cytogenetics, and 36% had a WHO performance score >or= 2. Forty-eight percent had a complete response (32% complete remission, 16% complete remission with incomplete peripheral blood count recovery), and 18% died within 30 days. Interestingly, response and overall survival were not inferior in the adverse cytogenetic risk group. The safety profile of clofarabine in these elderly patients with AML who were unsuitable for intensive chemotherapy was manageable and typical of a cytotoxic agent in patients with acute leukemia. Patients had similar prognostic characteristics to matched patients treated with low-dose cytarabine in the United Kingdom AML14 trial, but had significantly superior response and overall survival. CONCLUSION: Clofarabine is active and generally well tolerated in this patient group. It is worthy of further evaluation in comparative trials and might be of particular use in patients with adverse cytogenetics.en
dc.language.isoenen
dc.subjectAnticancerous Agentsen
dc.subjectAcute Myeloid Leukaemiaen
dc.subject.meshAdenine Nucleotidesen
dc.subject.meshAge Factorsen
dc.subject.meshAgeden
dc.subject.meshAged, 80 and overen
dc.subject.meshAntineoplastic Agentsen
dc.subject.meshArabinonucleosidesen
dc.subject.meshChi-Square Distributionen
dc.subject.meshFeasibility Studiesen
dc.subject.meshFemaleen
dc.subject.meshGreat Britainen
dc.subject.meshHumansen
dc.subject.meshItalyen
dc.subject.meshKaplan-Meiers Estimateen
dc.subject.meshLeukemia, Myeloid, Acuteen
dc.subject.meshMaleen
dc.subject.meshMedication Adherenceen
dc.subject.meshMiddle Ageden
dc.subject.meshOdds Ratioen
dc.subject.meshPatient Selectionen
dc.subject.meshProportional Hazards Modelsen
dc.subject.meshRisk Assessmenten
dc.subject.meshRisk Factorsen
dc.subject.meshTime Factorsen
dc.subject.meshTreatment Outcomeen
dc.titleEuropean development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy.en
dc.typeArticleen
dc.contributor.departmentDepartment of Haematology, Cardiff University School of Medicine, Cardiff CF14 4XN, United Kingdom. burnettak@cardiff.ac.uken
dc.identifier.journalJournal of Clinical Oncologyen

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