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

Journal of clinical oncology, 2018-09, Vol.36 (26), p.2684-2692 [Peer Reviewed Journal]

2018 by American Society of Clinical Oncology 2018 American Society of Clinical Oncology ;ISSN: 0732-183X ;EISSN: 1527-7755 ;DOI: 10.1200/JCO.2017.77.6112 ;PMID: 30024784

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  • Title:
    CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia
  • Author: Lancet, Jeffrey E ; Uy, Geoffrey L ; Cortes, Jorge E ; Newell, Laura F ; Lin, Tara L ; Ritchie, Ellen K ; Stuart, Robert K ; Strickland, Stephen A ; Hogge, Donna ; Solomon, Scott R ; Stone, Richard M ; Bixby, Dale L ; Kolitz, Jonathan E ; Schiller, Gary J ; Wieduwilt, Matthew J ; Ryan, Daniel H ; Hoering, Antje ; Banerjee, Kamalika ; Chiarella, Michael ; Louie, Arthur C ; Medeiros, Bruno C
  • Subjects: RAPID COMMUNICATION
  • Is Part Of: Journal of clinical oncology, 2018-09, Vol.36 (26), p.2684-2692
  • Description: 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.
  • Publisher: United States: American Society of Clinical Oncology
  • Language: English
  • Identifier: ISSN: 0732-183X
    EISSN: 1527-7755
    DOI: 10.1200/JCO.2017.77.6112
    PMID: 30024784
  • Source: GFMER Free Medical Journals
    Alma/SFX Local Collection
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