Multicenter comparison of high-dose cytarabine-based regimens versus liposomal daunorubicin and cytarabine (CPX-351) in patients with secondary acute myeloid leukemia

Abstract

Liposomal daunorubicin/cytarabine (CPX-351) gained FDA approval for secondary AML after demonstrating improved outcomes over daunorubicin and cytarabine (7 + 3). A number of study limitations prompted a comparison of safety/efficacy of CPX-351 against regimens containing a purine analogue and high-dose cytarabine (HIDAC). This retrospective study compared complete response rates with/without count recovery (CR/CRi) between HIDAC-based regimens and CPX-351 in 169 patients with newly diagnosed sAML. The CR/CRi rate was 62.7% in the HIDAC-based therapy arm vs. 47.9% in the CPX-351 arm (p = 0.002 [one-sided for non-inferiority]). Median time to absolute neutrophil and platelet count recovery was shorter after HIDAC-based therapy (18 and 23 days, respectively) compared to CPX-351 (36 and 38 days; p < 0.001). Median overall survival was 9.8 months in the HIDAC-based group and 9.14 months in the CPX-351 group. 30-day mortality was greater with CPX-351 (8.5%) compared to HIDAC-based (1.3%; p = 0.039). These results reveal comparable efficacy and favorable safety with HIDAC-based regimens.

Keywords:

• CPX-351
• cytarabine
• secondary AML
• Vyxeos
• FLAG
• oncology stewardship

Author contributions

All authors contributed to the study design, data collection and analysis, and preparation of the manuscript.

Disclosure statement

Jeff Klaus, PharmD serves on the speakers bureau for Jazz Pharmaceuticals and has attended an advisory board for Jazz Pharmaceuticals. Stephen Clark, PharmD is a consultant for Elliott Benson Research. Kristen Pettit, MD provides advising for the following companies: Kura Oncology, PharmaEssentia, CTI Biopharma. Tapan Kadia. No potential conflict of interest was reported by the author(s).

Additional information

Funding

MD reports personal fees from Novartis, personal fees from Agios, grants and personal fees from Pfizer, grants from BMS, grants and personal fees from Abbvie, grants and personal fees from Genentech, grants and personal fees from JAZZ, grants from Amgen, grants from AstraZeneca; Celgene: research grant; Incyte: research grant; Ascentage: research grant.