European development of clofarabine as treatment for older patients with acute myeloid leukemia considered unsuitable for intensive chemotherapy.
Authors
Burnett, Alan KRussell, 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
Affiliation
Department of Haematology, Cardiff University School of Medicine, Cardiff CF14 4XN, United Kingdom. burnettak@cardiff.ac.ukIssue Date
2010-05-10
Metadata
Show full item recordAbstract
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.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 OncolJournal
Journal of Clinical OncologyDOI
10.1200/JCO.2009.26.4242PubMed ID
20385984Type
ArticleLanguage
enISSN
1527-7755ae974a485f413a2113503eed53cd6c53
10.1200/JCO.2009.26.4242