Title: Evaluation of Outcomes for HiDAC-135 Versus HiDAC-123
Investigators: Chelsea Hylton
Rachel Matthews
Darby Siler
Laura Beth Parsons
Practice site: Sarah Cannon Cancer Center at TriStar Centennial Medical Center
Background (464/600 words): Intermediate to high-dose cytarabine (IDAC/HiDAC) is a preferred consolidation chemotherapy regimen for patients with acute myeloid leukemia (AML) that have achieved remission [1]. IDAC/HiDAC is traditionally administered every 12 hours on days 1, 3, and 5 (HiDAC-135). Studies have explored administering cytarabine 3000 mg/m2 every 12 hours on days 1, 2, and 3 (HiDAC-123) to reduce the risk of neutropenia without compromising the clinical outcomes [2]. There was a significant difference in median overall survival of 79 months (HiDAC-123) versus 31 months (HiDAC-135) (P=0.031). HiDAC-135 was also associated with a longer course of hospitalization (P=0.008) and increase in transfusions (P=0.011) [2]. More recent studies have explored administering HiDAC-123 with or without granulocyte colony stimulating factors (G-CSF) to mitigate myelosuppression and relapse [3]. There was no statistically significant difference in overall survival and relapse-free survival, but there was a significant difference in the decreased duration of neutropenia (P<0.0001) [3].
This study compares HiDAC-135 and HiDAC-123 in a real-world setting.
Methods:This institutional review board (IRB)-approved, single center, retrospective chart review included patients with AML that received 2 or more cycles of IDAC/HiDAC consolidation on the adult hematology service line between 02/01/2023-01/31/2025. The institutional practice changed from HiDAC-135 to HiDAC-123 in January 2024. Patients were excluded if they were enrolled in a clinical trial or were treated on the pediatric service line. Outcomes were compared across groups. Descriptive statistics was used for baseline characteristics and outcomes. Data was collected from electronic medical records after running our pharmacy surveillance platform to include cytarabine orders during the study timeframe.
Results: A total of 132 patients were screened; 12 patients met inclusion criteria (HIDAC-135: n=8; HIDAC-123: n=2;HIDAC-135 to HIDAC-123: n=2). There was a wide variation in age in the HIDA-123 arm, with one patient being over age. Total cycle delays varied across treatment arms: HIDAC-135 at 43%, HIDAC-123 at 100%, and HIDAC-135 to HIDAC-123 at 67%. The median duration of hospitalization was 5 days for HIDAC-135, 3 days for HIDAC-123, and 4 days for HIDAC-135 to HIDAC-123. G-CSF administration was 36% in HIDAC-135, 100% in HIDAC-123, and 60% in HIDAC-135 to HIDAC-123. There was an incidence of hospital readmission for febrile neutropenia (FN) seen in 27.2% in HIDAC-135 and 60% in HIDAC-123, with no FN readmissions in the HIDAC-135 to HIDAC-123 arm. Of note, all three readmissions for FN in HIDAC-123 received G-CSF. Only one of the FN readmissions in the HIDAC-135 arm received G-CSF.
Conclusions/Discussion: Outcomes of this study comparing HIDAC-135 to HIDAC-123 were not consistent with previous studies. Insufficient data due to small patient numbers may have impacted study results and ability to conduct statistical analysis. Though not collected, some patients underwent hematopoietic stem cell transplant instead of receiving all four cycles of HIDAC consolidation. Further analysis is needed to compare results with HIDAC-123 at this institution.
References:1. Mayer RJ, Davis RB, Schiffer CA, et al. Intensive postremission chemotherapy in adults with acute myeloid leukemia.
N Engl J Med. 1994;331(14):896-903. doi:10.1056/NEJM199410063311402
2. Krayem B, Horesh N, Frisch A, Zuckerman T, Ofran Y. Hidac consolidation in aml: comparable outcomes with reduced toxicity using a three-day schedule(HiDAC-123).
Eur J Haematol. 2025;115(2):193-195. doi:10.1111/ejh.14432
3. Jaramillo, S - Blood Cancer J (2017) Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia.pdf
Contact information: Chelsea Hylton, PharmD
[email protected]