CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia
Autor: | Jeffrey E. Lancet, Daniel H. Ryan, Michael Chiarella, Robert K. Stuart, Geoffrey L. Uy, Jorge E. Cortes, Dale L. Bixby, Kamalika Banerjee, Richard Stone, Antje Hoering, Matthew J. Wieduwilt, Arthur C. Louie, Bruno C. Medeiros, Tara L. Lin, Donna E. Hogge, Laura F. Newell, Jonathan E. Kolitz, Scott R. Solomon, Ellen K. Ritchie, Stephen A. Strickland, Gary J. Schiller |
---|---|
Rok vydání: | 2018 |
Předmět: |
0301 basic medicine
Male Myeloid Cancer Research medicine.medical_specialty Daunorubicin medicine.medical_treatment Clinical Sciences Oncology and Carcinogenesis Enasidenib Acute Gastroenterology 03 medical and health sciences 0302 clinical medicine Internal medicine Neoplasms Antineoplastic Combined Chemotherapy Protocols Hematologic Malignancy Medicine Secondary Acute Myeloid Leukemia Humans Oncology & Carcinogenesis Aged Chemotherapy Leukemia business.industry Hazard ratio Cytarabine Neoplasms Second Primary Middle Aged medicine.disease Regimen Leukemia Myeloid Acute 030104 developmental biology Nanomedicine Second Primary Oncology 030220 oncology & carcinogenesis Liposomes Female business RAPID COMMUNICATION medicine.drug |
Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol 36, iss 26 Journal of Clinical Oncology |
Popis: | 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. |
Databáze: | OpenAIRE |
Externí odkaz: |