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J Clin Oncol. 2018 Sep 10;36(26):2684-2692. doi: 10.1200/JCO.2017.77.6112. Epub 2018 Jul 19.

CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia.

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1
Jeffrey E. Lancet, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Geoffrey L. Uy, Washington University School of Medicine, St Louis, MO; Jorge E. Cortes, The University of Texas MD Anderson Cancer Center, Houston, TX; Laura F. Newell, Oregon Health & Science University, Portland, OR; Tara L. Lin, University of Kansas Medical Center, Kansas City, KS; Ellen K. Ritchie, Weill Cornell Medical College, New York; Jonathan E. Kolitz, Northwell Health System, Lake Success; Daniel H. Ryan, University of Rochester, Rochester, NY; Robert K. Stuart, Medical University of South Carolina, Charleston, SC; Stephen A. Strickland, Vanderbilt-Ingram Cancer Center, Nashville, TN; Donna Hogge, Leukemia/Bone Marrow Transplant Program of British Columbia, Vancouver, British Columbia, Canada; Scott R. Solomon, The Leukemia Program at Northside Hospital Cancer Center Institute, Atlanta, GA; Richard M. Stone, Dana-Farber Cancer Institute, Boston, MA; Dale L. Bixby, University of Michigan, Grass Lake, MI; Gary J. Schiller, University of California-Los Angeles, Los Angeles; Matthew J. Wieduwilt, University of California-San Diego, La Jolla; Kamalika Banerjee, Michael Chiarella, Arthur C. Louie, Jazz Pharmaceuticals, Palo Alto; Bruno C. Medeiros, Stanford University School of Medicine, Stanford, CA; and Antje Hoering, Cancer Research and Biostatistics, Seattle, WA.

Abstract

Purpose CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin that delivers a synergistic 5:1 drug ratio into leukemia cells to a greater extent than normal bone marrow cells. Prior clinical studies demonstrated a sustained drug ratio and exposure in vivo and prolonged survival versus standard-of-care cytarabine plus daunorubicin chemotherapy (7+3 regimen) in older patients with newly diagnosed secondary acute myeloid leukemia (sAML). Patients and Methods In this open-label, randomized, phase III trial, 309 patients age 60 to 75 years with newly diagnosed high-risk/sAML received one to two induction cycles of CPX-351 or 7+3 followed by consolidation therapy with a similar regimen. The primary end point was overall survival. Results CPX-351 significantly improved median overall survival versus 7+3 (9.56 v 5.95 months; hazard ratio, 0.69; 95% CI, 0.52 to 0.90; one-sided P = .003). Overall remission rate was also significantly higher with CPX-351 versus 7+3 (47.7% v 33.3%; two-sided P = .016). Improved outcomes were observed across age-groups and AML subtypes. The incidences of nonhematologic adverse events were comparable between arms, despite a longer treatment phase and prolonged time to neutrophil and platelet count recovery with CPX-351. Early mortality rates with CPX-351 and 7+3 were 5.9% and 10.6% (two-sided P = .149) through day 30 and 13.7% and 21.2% (two-sided P = .097) through day 60. Conclusion CPX-351 treatment is associated with significantly longer survival compared with conventional 7+3 in older adults with newly diagnosed sAML. The safety profile of CPX-351 was similar to that of conventional 7+3 therapy.

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