Vosaroxin and vosaroxin plus low-dose Ara-C (LDAC) vs low-dose Ara-C alone in older patients with acute myeloid leukemia.

Dennis, Mike, Russell, Nigel, Hills, Robert K, Hemmaway, Claire, Panoskaltsis, Nicki, McMullin, Mary-Frances, Kjeldsen, Lars, Dignum, Helen, Thomas, Ian F, Clark, Richard E, Milligan, Don and Burnett, Alan K (2015) Vosaroxin and vosaroxin plus low-dose Ara-C (LDAC) vs low-dose Ara-C alone in older patients with acute myeloid leukemia. Blood, 125 (19). pp. 2923-32. ISSN 1528-0020. This article is accessible to all HEFT staff and students via NICE journals and databases http://www.nice.org.uk/about/what-we-do/evidence-services/journals-and-databases by using their HEFT Athens login IDs

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Abstract

The development of new treatments for older patients with acute myeloid leukemia is an active area, but has met with limited success. Vosaroxin, a quinolone-derived intercalating agent has several properties that could prove beneficial. Initial clinical studies showed it to be well-tolerated in older patients with relapsed/refractory disease. In vitro data suggested synergy with cytarabine (Ara-C). To evaluate vosaroxin, we performed 2 randomized comparisons within the "Pick a Winner" program. A total of 104 patients were randomized to vosaroxin vs low-dose Ara-C (LDAC) and 104 to vosaroxin + LDAC vs LDAC. When comparing vosaroxin with LDAC, neither response rate (complete recovery [CR]/complete recovery with incomplete count recovery [CRi], 26% vs 30%; odds ratio [OR], 1.16 (0.49-2.72); P = .7) nor 12-month survival (12% vs 31%; hazard ratio [HR], 1.94 [1.26-3.00]; P = .003) showed benefit for vosaroxin. Likewise, in the vosaroxin + LDAC vs LDAC comparison, neither response rate (CR/CRi, 38% vs 34%; OR, 0.83 [0.37-1.84]; P = .6) nor survival (33% vs 37%; HR, 1.30 [0.81-2.07]; P = .3) was improved. A major reason for this lack of benefit was excess early mortality in the vosaroxin + LDAC arm, most obviously in the second month following randomization. At its first interim analysis, the Data Monitoring and Ethics Committee recommended closure of the vosaroxin-containing trial arms because a clinically relevant benefit was unlikely.

Item Type:	Article
Additional Information:	This article is accessible to all HEFT staff and students via NICE journals and databases http://www.nice.org.uk/about/what-we-do/evidence-services/journals-and-databases by using their HEFT Athens login IDs
Subjects:	WH Haemic and lymphatic systems. Haematology
Divisions:	Planned IP Care > Oncology and Clinical Haematology
Related URLs:	http://www.ncbi.nlm.nih.gov/pubmed/?term...
Depositing User:	Mrs Yolande Brookes
Date Deposited:	16 Sep 2015 14:31
Last Modified:	16 Sep 2015 14:31
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/1030

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