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Clinical Trial
. 2015 Jan 15;121(2):234-42.
doi: 10.1002/cncr.28974. Epub 2014 Sep 15.

Phase II, multicenter, randomized trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML

Jorge E Cortes  1 , Stuart L Goldberg, Eric J Feldman, David A Rizzeri, Donna E Hogge, Melissa Larson, Arnaud Pigneux, Christian Recher, Gary Schiller, Krzysztof Warzocha, Hagop Kantarjian, Arthur C Louie, Jonathan E Kolitz
Affiliations
Clinical Trial

Phase II, multicenter, randomized trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML

Jorge E Cortes et al. Cancer. .

Abstract

Background: 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.

Methods: 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.

Results: 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; P = .08) and overall survival (HR, 0.55; P = .02). Also, 60-day mortality was lower in the CPX-351 study arm for poor-risk patients (16.1% vs 24.1%).

Conclusions: Taken together, the data suggest possible improved outcomes in CPX-351-treated first relapse AML patients with EPI-defined poor-risk disease.

Keywords: Acute Myeloid Leukemia; Chemotherapy Intervention; First Relapse; Phase II.

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Conflict of interest statement

Conflict of Interest: None

Figures

Figure 1
Figure 1
CONSORT diagram.
Figure 2
Figure 2
EFS and OS Kaplan-Meier curves.
See this image and copyright information in PMC

References

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