A phase 1/2 study of NS-87/CPX-351 (cytarabine and daunorubicin liposome) in Japanese patients with high-risk acute myeloid leukemia.
Int J Hematol
; 119(6): 647-659, 2024 Jun.
Article
de En
| MEDLINE
| ID: mdl-38532078
ABSTRACT
OBJECTIVES:
NS-87/CPX-351 is a dual-drug liposomal encapsulation of cytarabine and daunorubicin. NS-87/CPX-351 exerts antileukemic action by maintaining a synergistic molar ratio of cytarabine to daunorubicin of 51 within the liposome while in circulation. Patients with high-risk acute myeloid leukemia (AML), which includes therapy-related AML and AML with myelodysplasia-related changes (AML-MRC), have poorer outcomes than those with other AML.METHODOLOGY:
This open-label phase 1/2 (P1/2) study was conducted in 47 Japanese patients aged 60-75 years with newly diagnosed high-risk AML to evaluate the pharmacokinetics, safety, and efficacy of NS-87/CPX-351.RESULTS:
In the 6 patients enrolled in the P1 portion, no dose-limiting toxicities (DLTs) were reported, and 100 units/m2 during the induction cycle was found to be acceptable. Cytarabine and daunorubicin had a long half-life in the terminal phase (32.8 and 28.7 h, respectively). In the 35 patients enrolled in the P2 portion, composite complete remission (CRc; defined as complete remission [CR] or CR with incomplete hematologic recovery [CRi]) was achieved in 60.0% (90% CI 44.7-74.0) of the patients. Adverse events due to NS-87/CPX-351 were well tolerated.OUTCOMES:
NS-87/CPX-351 can be considered as a frontline treatment option for Japanese patients with high-risk AML.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Leucémie aigüe myéloïde
/
Protocoles de polychimiothérapie antinéoplasique
/
Daunorubicine
/
Cytarabine
/
Liposomes
Limites:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Pays/Région comme sujet:
Asia
Langue:
En
Journal:
Int J Hematol
Sujet du journal:
HEMATOLOGIA
Année:
2024
Type de document:
Article
Pays d'affiliation:
Japon
Pays de publication:
Japon