A phase 1/2 study of NS-87/CPX-351 (cytarabine and daunorubicin liposome) in Japanese patients with high-risk acute myeloid leukemia
© 2024. The Author(s)..
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/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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
International journal of hematology - (2024) vom: 26. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Usuki, Kensuke [VerfasserIn] |
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| Links: |
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| Themen: |
Acute myeloid leukemia |
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| Anmerkungen: |
Date Revised 27.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1007/s12185-024-03733-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370216288 |
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| 100 | 1 | |a Usuki, Kensuke |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A phase 1/2 study of NS-87/CPX-351 (cytarabine and daunorubicin liposome) in Japanese patients with high-risk acute myeloid leukemia |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 27.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a OUTCOMES: NS-87/CPX-351 can be considered as a frontline treatment option for Japanese patients with high-risk AML | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Acute myeloid leukemia | |
| 650 | 4 | |a CPX-351 | |
| 650 | 4 | |a Cytarabine | |
| 650 | 4 | |a Daunorubicin | |
| 650 | 4 | |a Liposomal formulation | |
| 700 | 1 | |a Miyamoto, Toshihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Yamauchi, Takuji |e verfasserin |4 aut | |
| 700 | 1 | |a Ando, Kiyoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ogawa, Yoshiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Onozawa, Masahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Yamauchi, Takahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kiyoi, Hitoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Yokota, Akira |e verfasserin |4 aut | |
| 700 | 1 | |a Ikezoe, Takayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Katsuoka, Yuna |e verfasserin |4 aut | |
| 700 | 1 | |a Takada, Satoru |e verfasserin |4 aut | |
| 700 | 1 | |a Aotsuka, Nobuyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Morita, Yasuyoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ishikawa, Takayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Asada, Noboru |e verfasserin |4 aut | |
| 700 | 1 | |a Ota, Shuichi |e verfasserin |4 aut | |
| 700 | 1 | |a Dohi, Atsushi |e verfasserin |4 aut | |
| 700 | 1 | |a Morimoto, Kensaku |e verfasserin |4 aut | |
| 700 | 1 | |a Imai, Shunji |e verfasserin |4 aut | |
| 700 | 1 | |a Kishimoto, Umi |e verfasserin |4 aut | |
| 700 | 1 | |a Akashi, Koichi |e verfasserin |4 aut | |
| 700 | 1 | |a Miyazaki, Yasushi |e verfasserin |4 aut | |
| 700 | 0 | |a Study Group for NS-87/CPX-351 |e verfasserin |4 aut | |
| 700 | 1 | |a Kuroda, Junya |e investigator |4 oth | |
| 700 | 1 | |a Iida, Hiroatsu |e investigator |4 oth | |
| 700 | 1 | |a Sekiguchi, Naohiro |e investigator |4 oth | |
| 700 | 1 | |a Takenaka, Katsuto |e investigator |4 oth | |
| 700 | 1 | |a Kawakita, Toshiro |e investigator |4 oth | |
| 700 | 1 | |a Imada, Kazunori |e investigator |4 oth | |
| 700 | 1 | |a Suzuki, Takahiro |e investigator |4 oth | |
| 700 | 1 | |a Miyawaki, Shuichi |e investigator |4 oth | |
| 700 | 1 | |a Usui, Noriko |e investigator |4 oth | |
| 700 | 1 | |a Asou, Norio |e investigator |4 oth | |
| 700 | 1 | |a Muta, Masakazu |e investigator |4 oth | |
| 700 | 1 | |a Tsuruda, Kazuto |e investigator |4 oth | |
| 700 | 1 | |a Taniwaki, Masafumi |e investigator |4 oth | |
| 700 | 1 | |a Fujita, Masatoshi |e investigator |4 oth | |
| 700 | 1 | |a Makishima, Hideki |e investigator |4 oth | |
| 700 | 1 | |a Nakanishi, Yoko |e investigator |4 oth | |
| 700 | 1 | |a Tajima, Masaya |e investigator |4 oth | |
| 700 | 1 | |a Masutomi, Yutaka |e investigator |4 oth | |
| 700 | 1 | |a Chiba, Masahiro |e investigator |4 oth | |
| 700 | 1 | |a Hokazomo, Mayuna |e investigator |4 oth | |
| 700 | 1 | |a Hirooka, Shihomi |e investigator |4 oth | |
| 700 | 1 | |a Mikasa, Taisuke |e investigator |4 oth | |
| 700 | 1 | |a Okamoto, Moemi |e investigator |4 oth | |
| 700 | 1 | |a Kawase, Akitaka |e investigator |4 oth | |
| 700 | 1 | |a Yamada, Akane |e investigator |4 oth | |
| 700 | 1 | |a Shimizu, Yuto |e investigator |4 oth | |
| 700 | 1 | |a Isogaya, Kento |e investigator |4 oth | |
| 700 | 1 | |a Ichikawa, Tomohiko |e investigator |4 oth | |
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