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589 Feasibility, Safety and Predictors of Outcomes of Patients with Newly Diagnosed Acute Myeloid Leukemia Discharged “Early” after Intensive Induction Therapy

Program: Oral and Poster Abstracts
Type: Oral
Session: 613. Acute Myeloid Leukemias: Clinical and Epidemiological: Real World Outcomes and Treatment Approaches
Hematology Disease Topics & Pathways:
Research, epidemiology, Clinical Research, health outcomes research
Sunday, December 10, 2023: 4:30 PM

Cameron Hunter1, Wei Cheng, PhD2*, Stephanie Halene, MD1, Lourdes Mendez, MD1*, Nikolai A. Podoltsev, MD, PhD3, Amer M. Zeidan, MBBS, MHS4, Lisa Barbarotta, APRN1* and Rory M. Shallis, MD5

1Section of Hematology, Department of Internal Medicine, Yale School of Medicine - Yale Cancer Center, New Haven, CT
2Department of Biostatistics, Yale School of Public Health, New Haven, CT
3Associate Professor of Medicine, Department of Hematology, Yale School of Medicine, New Haven, CT
4Section of Hematology, Department of Internal Medicine, Yale University School of Medicine - Yale Cancer Center, New Haven, CT
5Section of Hematology, Department of Internal Medicine, Yale School of Medicine and Yale Cancer Center, Killingworth, CT

Background: Patients (pts) treated with intensive induction therapy for newly diagnosed acute myeloid leukemia (AML) traditionally remain admitted until an absolute neutrophil count (ANC) >0.5 x 103/L. Although a small number of centers reported on pt discharge with ANC <0.5 x 103/L via an “early” discharge (DC) program (EDP) post-intensive induction, little is known about the safety and outcomes among this group of pts, including the rates and predictors of post-DC complications (e.g., febrile neutropenia (FN), microbiologically proven infection) and both early- and long-term outcomes. We sought to describe our experience with an EDP and identify predictors of differential outcomes.

Methods: We conducted a single-center, retrospective study of pts with newly-diagnosed AML admitted to Yale Cancer Center (YCC) for intensive induction during December 2014-January 2023. Re-induced patients were excluded. Patients were eligible for the EDP if they: 1) were afebrile x 7 days, 2) required no parenteral therapies, 3) required transfusion support less than daily, 4), lived within 60 minutes of YCC with “average” traffic, and 5) had a dedicated care giver available 24 hours per day with reliable transportation to/from clinic. Chi-square and Wilcoxon rank-sum tests were applied to categorical and continuous variables, respectively. Overall survival (OS) was estimated using the Kaplan-Meier method and was compared using log-rank test. Statistical significance was determined by p-value <0.05.

Results: A total of 188 pts were evaluated. Amongst this population, 99 (52.7%) pts were DC under the EDP, while 89 (47.3%) were not. To remove confounding from peri-DC ANC kinetics, we focused on pts DC with an ANC <0.1 x 103/L (n=53, “EDP pts”) and compared them with non-EDP pts (DC ANC >0.5 x 103/L). There were no significant differences in age, sex, ECOG performance status (PS), baseline LVEF on echocardiography or other comorbidities. With regards to disease-specific factors, there was no difference in pre-induction blood counts (e.g., WBC 7.2 vs. 8.1, p=0.610), serum creatinine, uric acid, lactate dehydrogenase, AML subtype, or disease biology e.g., karyotypic or molecular features (Table 1).

Pts received 7+3 without (47%) or with (27%) other therapy, while 22% received liposomal daunorubicin/cytarabine. There were no differences in the rates of regimens used between EDP and non-EDP pts. The incidence of induction-related complications like FN (81.1% vs 89.9%, p=0.220), DIC, TLS, and bleeding were similar between groups, although there was a trend toward more documented infection among non-EDP pts (48.3% vs 30.2%, p=0.052). Findings on the D14 marrow (performed in 79% of pts) were similar between groups (chemoablation, p=0.131; D14 blast %, p=0.546).

Median days admitted from induction to DC was nearly a week less for EDP pts (22 [interquartile range (IQR): 19-29] vs 28 days [IQR: 25-32], p<0.0001). Amongst EDP patients, 12 (22.6%) were re-admitted, 10 (83%) due to FN with 4 of these pts having an infectious source identified. The median duration of re-admission was 6.5 days (IQR: 4.5-13). When considering re-admissions prior to ANC/count recovery or initiation of consolidation, EDP pts still had lower time spent in hospital prior to eventual count recovery (24 vs 28, p<0.0001).

ANC at DC did not predict OS amongst the larger cohort (n=188, p=0.949), but was associated with re-admission amongst pts DC with ANC <0.5 in univariate analysis (p=0.02). Time to DC and ANC at DC were strongly associated amongst the larger cohort (n=188, p=0.01 from linear regression) and pts DC with ANC <0.5 (p<0.00001 from linear regression)(Figure 1).

Although non-EDP pts had a shorter time to first response (33 vs 36 days, p=0.020), there were no differences in rates of CR/CRi/CRh (73.0% vs 60.4%, p=0.167) when compared with EDP pts. Similarly, there were no differences in early (60- and 90-day) mortality, or median OS between EDP and non-EDP pts (32.3 vs 26.4 months, p=0.695)(Table and Figure 1).

Conclusions: Our study shows that pts treated intensively for newly-diagnosed AML and meeting several criteria can be safely DC prior to count recovery without detriment to early mortality or OS. EDP pts spent up to a week more out of hospital when compared with non-EDP counterparts. Healthcare utilization, cost effectiveness and patient satisfaction evaluations of the EDP are underway.

Disclosures: Mendez: Inventiva: Consultancy. Podoltsev: Cogent Biosciences: Other: IDMC Member; AI Therapeutics; Arog Pharmaceuticals; Astellas Pharma, Inc.; Astex Pharmaceuticals; Boehringer Ingelheim Pharmaceuticals, Inc.; Celgene Corporation; CTI BioPharma Corp.; Daiichi Sankyo, Inc.; Genentech, Inc.; Jazz Pharmaceuticals, Inc.; Kartos Therapeuti: Research Funding; AbbVie Inc.; Blueprint Medicines (former); Constellation Pharmaceuticals (former); CTI BioPharma Corp. (former); Incyte Corporation (former); Novartis (former); PharmaEssentia (former): Consultancy. Zeidan: Schrödinger: Consultancy, Honoraria; Syndax: Consultancy, Honoraria; Genentech: Consultancy, Honoraria; Astellas: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; ALX Oncology: Consultancy, Honoraria; Lox Oncology: Consultancy, Honoraria; Regeneron: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; BeyondSpring: Consultancy, Honoraria; Agios: Consultancy, Honoraria; Jazz: Consultancy, Honoraria; Notable: Consultancy, Honoraria; Orum: Consultancy, Honoraria; Kura: Consultancy, Honoraria; Chiesi: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Epizyme: Consultancy, Honoraria; Syros: Consultancy, Honoraria; Shattuck Labs: Research Funding; Otsuka: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Boehringer-Ingelheim: Consultancy, Honoraria; Servier: Consultancy, Honoraria; BioCryst: Consultancy, Honoraria; Zentalis: Consultancy, Honoraria; Geron: Consultancy, Honoraria; Ionis: Consultancy, Honoraria; Taiho: Consultancy, Honoraria; Tyme: Consultancy, Honoraria; Foran: Consultancy, Research Funding; Mendus: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Astex: Research Funding; Celgene/BMS: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Shallis: Bristol Myers Squibb: Consultancy; Curio Science: Consultancy; Servier: Consultancy; Rigel: Consultancy; Gilead Sciences: Consultancy.

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