Clofarabine doubles the response rate in older patients with acute myeloid leukemia but does not improve survival

Burnett, Alan Kenneth, Russell, N. H., Hunter, A. E., Milligan, D., Knapper, Steven ORCID: https://orcid.org/0000-0002-6405-4441, Wheatley, K., Yin, J., McMullin, M. F., Ali, S., Bowen, D. and Hills, Robert Kerrin ORCID: https://orcid.org/0000-0003-0166-0062 2013. Clofarabine doubles the response rate in older patients with acute myeloid leukemia but does not improve survival. Blood 122 (8) , pp. 1384-1394. 10.1182/blood-2013-04-496596

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Abstract

Better treatment is required for older patients with acute myeloid leukemia (AML) not considered fit for intensive chemotherapy. We report a randomized comparison of low-dose Ara-C (LDAC) vs the novel nucleoside, clofarabine, in untreated older patients with AML and high-risk myelodysplastic syndrome (MDS). A total of 406 patients with de novo (62%), secondary disease (24%), or high-risk MDS (>10% marrow blasts) (15%), median age 74 years, were randomized to LDAC 20 mg twice daily for 10 days every 6 weeks or clofarabine 20 mg/m2 on days 1 to 5, both for up to 4 courses. These patients had more adverse demographics than contemporaneous intensively treated patients. The overall remission rate was 28%, and 2-year survival was 13%. Clofarabine significantly improved complete remission (22% vs 12%; hazard ratio [HR] = 0.47 [0.28-0.79]; P = .005) and overall response (38% vs 19%; HR = 0.41 [0.26-0.62]; P < .0001), but there was no difference in overall survival, explained by poorer survival in the clofarabine patients who did not gain complete remission and also following relapse. Clofarabine was more myelosuppressive and required more supportive care. Although clofarabine doubled remission rates, overall survival was not improved overall or in any subgroup. The treatment of patients of the type treated here remains a major unmet need. This trial was registered at www.clinicaltrials.gov as #ISRCTN 11036523.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > R Medicine (General) R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Publisher:	American Society of Hematology
ISSN:	0006-4971
Last Modified:	25 Oct 2022 08:06
URI:	https://orca.cardiff.ac.uk/id/eprint/51464

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