Phase II, multicenter, randomized trial of CPX‐351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML
Open accessAbstract
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. Cancer 2015;121:234–42. © 2014 American Cancer Society.
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VYEXOS/CPX-351 is a combination therapy that encapsulates a synergistic ratio of two anticancer drugs (cytarabine and daunorubicin).
“For example, VYEXOS/CPX‐351 is a combination therapy that encapsulates a synergistic ratio of two anticancer drugs (cytarabine and daunorubicin).349”
From Smart nanoparticles for cancer therapy (2023) · cites this paper as [349]
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- Authors
- Cortes, J. E., Goldberg, S. L., Feldman, E. J., Rizzeri, D. A., Hogge, D. E., Larson, M., Pigneux, A., Recher, C., Schiller, G., Warzocha, K., Kantarjian, H., Louie, A. C., & Kolitz, J. E.
- Affiliations
- The MD Anderson Cancer Center Houston Texas
- Hackensack University Medical Center (US)
- NewYork–Presbyterian Hospital (US)
- Duke Medical Center (US)
- BC Cancer Agency (CA)
- Rush University Medical Center (US)
- Haut‐Lévêque, Bordeaux France
- Hopital Purpan, Toulouse France
- University of California, Los Angeles (US)
- Instytut Hematologii i Transfuzjologi (PL)
- The University of Texas MD Anderson Cancer Center (US)
- Celator Pharmaceuticals, Inc Princeton New Jersey
- Northwell Health (US)
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2014-09-15
- Volume
- 121
- Issue
- 2
- Pages
- 234-242
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- PMC
- PMC5542857
- OpenAlex
- W1568498224
- Cited by
- 175
- References
- 19
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 10 · 2023: 10 · 2022: 12 · 2021: 16 · 2020: 22 · 2019: 18 · 2018: 28 · 2017: 20 · 2016: 18 · 2015: 8
- FWCI
- 10.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institutes of Health (CA016672)
- Topics
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinoids in leukemia and cellular processes
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Acute Lymphoblastic Leukemia research
- Keywords
- CPX-351, liposomal cytarabine, daunorubicin, acute myeloid leukemia, first relapse, salvage chemotherapy, poor-risk patients, event-free survival, overall survival, 60-day mortality
- MeSH terms
- Gemtuzumab, Adult, Aged, Aminoglycosides, Amsacrine, Antineoplastic Combined Chemotherapy Protocols, Cytarabine, Daunorubicin, Etoposide, Female, Humans, Injections, Liposomes, Male, Middle Aged, Mitoxantrone, Recurrence, Remission Induction, Vidarabine, Leukemia, Myeloid, Acute, Salvage Therapy, Treatment Outcome, Cladribine, Risk Assessment, Disease-Free Survival, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized
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