A phase 1/2 study of NS-87/CPX-351 (cytarabine and daunorubicin liposome) in Japanese patients with high-risk acute myeloid leukemia

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 5:1 within the liposome while in circulation. Patients with high-risk acute myeloid leuke...

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Bibliographic Details
Published in:International journal of hematology 2024-06, Vol.119 (6), p.647-659
Main Authors: Usuki, Kensuke, Miyamoto, Toshihiro, Yamauchi, Takuji, Ando, Kiyoshi, Ogawa, Yoshiaki, Onozawa, Masahiro, Yamauchi, Takahiro, Kiyoi, Hitoshi, Yokota, Akira, Ikezoe, Takayuki, Katsuoka, Yuna, Takada, Satoru, Aotsuka, Nobuyuki, Morita, Yasuyoshi, Ishikawa, Takayuki, Asada, Noboru, Ota, Shuichi, Dohi, Atsushi, Morimoto, Kensaku, Imai, Shunji, Kishimoto, Umi, Akashi, Koichi, Miyazaki, Yasushi
Format: Article
Language:English
Subjects:
Acute myeloid leukemia
Aged
Anticancer properties
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Asian People
Cytarabine
Cytarabine - administration & dosage
Cytarabine - pharmacokinetics
Daunorubicin
Daunorubicin - administration & dosage
Daunorubicin - pharmacokinetics
East Asian People
Female
Hematology
Humans
Japan
Leukemia
Leukemia, Myeloid, Acute - drug therapy
Liposomes
Male
Medicine
Medicine & Public Health
Middle Aged
Myelodysplastic syndrome
Oncology
Original
Original Article
Pharmacokinetics
Remission
Remission (Medicine)
Risk
Treatment Outcome
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Description
Summary: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 5:1 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/m 2 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.
ISSN:0925-5710
1865-3774
1865-3774
DOI:10.1007/s12185-024-03733-z