Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia

Jonathan E. Kolitz, Stephen A. Strickland, Jorge E. Cortes, Donna Hogge, Jeffrey E. Lancet, Stuart L. Goldberg, Kathleen F. Villa, Robert J. Ryan, Michael Chiarella, Arthur C. Louie, Ellen K. Ritchie, Robert K. Stuart

Research output: Contribution to journalArticle

Abstract

CPX-351 is a dual-drug liposomal encapsulation of cytarabine/daunorubicin. In a phase 3 study (ClinicalTrials.gov Identifier: NCT01696084), patients aged 60–75 years with newly diagnosed, high-risk/secondary AML received 1–2 induction cycles with CPX-351 or 7 + 3 chemotherapy; those achieving complete remission (including with incomplete platelet or neutrophil recovery) could receive up to 2 consolidation cycles with CPX-351 or 5 + 2 chemotherapy, respectively. In this exploratory analysis of the subgroup of patients who received consolidation, median overall survival was prolonged among patients receiving CPX-351 induction/consolidation versus 7 + 3/5 + 2 (25.43 vs. 8.53 months; HR = 0.44 [95% CI: 0.25–0.77]). The safety profile of CPX-351 consolidation was consistent with that of the overall study. Outpatient administration of CPX-351 consolidation occurred in 51%–61% of patients and did not diminish overall survival. These findings suggest consolidation with CPX-351 in this patient population contributed to the prolonged overall survival versus 7 + 3/5 + 2, building upon findings from the overall study population, and provide evidence that, with careful monitoring, some patients can successfully receive CPX-351 as outpatients.

Original languageEnglish (US)
JournalLeukemia and Lymphoma
DOIs
StateAccepted/In press - Jan 1 2019
Externally publishedYes

Fingerprint

Daunorubicin
Cytarabine
Acute Myeloid Leukemia
Survival
Outpatients
Drug Therapy
Physiologic Monitoring
Population
Neutrophils
Blood Platelets
Safety
Pharmaceutical Preparations

Keywords

  • acute myeloid leukemia
  • consolidation
  • CPX-351
  • cytarabine
  • daunorubicin

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia. / Kolitz, Jonathan E.; Strickland, Stephen A.; Cortes, Jorge E.; Hogge, Donna; Lancet, Jeffrey E.; Goldberg, Stuart L.; Villa, Kathleen F.; Ryan, Robert J.; Chiarella, Michael; Louie, Arthur C.; Ritchie, Ellen K.; Stuart, Robert K.

In: Leukemia and Lymphoma, 01.01.2019.

Research output: Contribution to journalArticle

Kolitz, JE, Strickland, SA, Cortes, JE, Hogge, D, Lancet, JE, Goldberg, SL, Villa, KF, Ryan, RJ, Chiarella, M, Louie, AC, Ritchie, EK & Stuart, RK 2019, 'Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia', Leukemia and Lymphoma. https://doi.org/10.1080/10428194.2019.1688320
Kolitz, Jonathan E. ; Strickland, Stephen A. ; Cortes, Jorge E. ; Hogge, Donna ; Lancet, Jeffrey E. ; Goldberg, Stuart L. ; Villa, Kathleen F. ; Ryan, Robert J. ; Chiarella, Michael ; Louie, Arthur C. ; Ritchie, Ellen K. ; Stuart, Robert K. / Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia. In: Leukemia and Lymphoma. 2019.
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