Phase II, multicenter, randomized trial of CPX‐351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML. Issue 2 (15th September 2014)

• Record Type: Journal Article
• Authors: Cortes, Jorge E.; Goldberg, Stuart L.; Feldman, Eric J.; Rizzeri, David A.; Hogge, Donna E.; Larson, Melissa; Pigneux, Arnaud; Recher, Christian; Schiller, Gary; Warzocha, Krzysztof; Kantarjian, Hagop; Louie, Arthur C.; Kolitz, Jonathan E.
• Is Part Of: Cancer. Volume 121:Issue 2(2015)
• Page Start: 234
• Page End: 242
• Publication Date: 2014-09-15
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28974
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr28974-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>CPX‐351 is a liposome‐encapsulated fixed‐molar‐ratio formulation of cytarabine and daunorubicin that exploits molar ratio–dependent drug‐drug synergy to enhance antileukemic efficacy.</p> </sec> <sec id="cncr28974-sec-0002" sec-type="section"> <title>METHODS</title> <p>This phase II study randomized 125 patients 2:1 to CPX‐351 or investigators' choice of first salvage chemotherapy. Patients with acute myeloid leukemia (AML) in first relapse after initial Complete Remission (CR) lasting ≥1 month were stratified per the European Prognostic Index (EPI) into favorable, intermediate, and poor‐risk groups based on duration of first CR, cytogenetics, age, and transplant history. Control salvage treatment was usually based on cytarabine and anthracycline, often with 1 or more additional agents. Survival at 1 year was the primary efficacy end point.</p> </sec> <sec id="cncr28974-sec-0003" sec-type="section"> <title>RESULTS</title> <p>Patient characteristics were well balanced between the 2 study arms. Improvements in efficacy outcomes were observed following CPX‐351, but did not meet prospectively defined statistical criteria for 1‐year survival improvement in the overall population. Subset analyses of the EPI‐defined poor‐risk strata demonstrated higher response rates (39.3% vs 27.6%) and improvements in event‐free survival (HR, 0.63; <italic>P</italic> = .08) and overall survival (HR, 0.55; <italic>P</italic> = .02). Also, 60‐day mortality was lower in the CPX‐351 study arm for poor‐risk patients (16.1% vs 24.1%).</p> </sec> <sec id="cncr28974-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>Taken together, the data suggest possible improved outcomes in CPX‐351‐treated first relapse AML patients with EPI‐defined poor‐risk disease. <bold><italic>Cancer</italic> 2015;121:234–42</bold>. © <italic>2014 American Cancer Society</italic>.</p> </sec> </abstract>