Clinical Lymphoma, Myeloma & Leukemia, Vol.21, Suppl.1 - September 2021

Abstracts Clinical Lymphoma, Myeloma & Leukemia September 2021 S284 and yearly variations were detected in all diagnosis except the APML. Keywords: acute lymphoblastic leukemia, acute myeloid leukemia, acute promyelocytic leukemia, aplastic anemia, immune thrombocytopenic purpura, seasonal variations AML-149 Efficacy and Safety of Azacytidine in Combination with Fludarabine and High-Dose Cytarabine with G-CSF (FLAG) in Relapsed/Refractory Acute Myeloid Leukemia: A Non- Randomized, Open-Label, Phase II Study Shaima Al Aoun*, Ibraheem Motabi, Maged Al Ammari, Nawal Al lshehry, Mohammed Marei, Bilal Albtoosh, Imran Tailor, Syed Altaf, Sayid Zaidi, Mansour Alfayez King Fahad Medical City, Riyadh, Saudi Arabia Objecti v e: The primary objective is overall response rate (CR/ CRi). D esig n : This is a single-institution, single-arm, phase II study of pre-treatment with azacytidine followed by FLAG for the treatment of relapsed or refractory AML. Setti n g: Salvage therapy in relapsed/refractory AML. Patie n ts or Other Participa n ts: Patients with relapsed or refractory AML, ECOG performance status  2, and patients with preserved organ function. Exclusion criteria: Patients with a diagnosis of acute promyelocytic leukemia (AML-M3), pregnant women, patients previously treated with fludarabine, and patients with uncontrolled intercurrent illness. Twenty-one patients were enrolled, and all were evaluable for toxicity and response. The median number of prior treatments was 1 (range: 1–3). Nine patients (43%) were refractory to the most recent treatment, while most other patients relapsed less than 6 months from the last treatment before enrollment. I n ter v e n tio n s: Azacytidine was given at 7 5 mg/m 2 per day for 5 days prior to the standard FLAG therapy. Mai n Outco m es Measures: Primary study endpoints were safety and ORR [ORR = CR, CRi, PR, morphologic leukemia-free state (MLFS) according to the International Working Group criteria], overall survival, and relapse-free survival. Results: Bone marrow suppression was the most common adverse event and was observed in all patients. The 30-day mortality was noted in 2 patients (10%), related to infection/septic shock with multi-organ failure. The combination was tolerated, and toxicities were as expected for patients receiving salvage intensive chemotherapy. The CR/CR with incomplete blood count recovery (CRi) rate was 53%. Of the 9 primary refractory patients, 5 (56%) achieved CR/CRi. Eight of 11 patients who achieved CR/CRi also attained minimal residual disease-negative status (<1.0% by flow cytometry), and 8 patients ( 7 3%) went for stem cell transplant. Of the 11 patients who achieved CR/CRi, 5 were still alive on the last follow-up. The overall survival for the entire cohort was 4.1 months, and relapse-free survival was 4. 7 months. Co n clusio n s: AZA FLAG combination is safe and does not seem to have an added benefit in response rate or survival. Keywords: AML, azacytidine, FLAG, adverse risk AML AML-157 Economic Burden of Hospitalizations for Acute Myeloid Leukemia (AML) in Remission in the United States: A Retrospective Analysis of an Administrative Claims Database Clara Chen 1 *, Eros Papademetriou 2 , Xing Liu 2 , Ravi Potluri 2 1 Bristol Myers Squibb, Princeton, NJ, United States, 2 SmartAnalyst Inc, New York, NY, United States Co n text: Healthcare resource utilization and costs of managing AML patients are substantial, with hospitalization being the main cost driver of AML care. In the Phase 3 QUAZAR AML-001 maintenance trial, lower rates and durations of hospitalization with oral azacitidine vs placebo corresponded with substantial reductions in hospitalization-related costs in patients with AML in remission. Objecti v e: Examine the impact of remission duration on the economic burden of hospitalizations among AML patients in a real-world setting. Methods: Adult patients with an AML diagnosis (ICD-9-CM/ICD-10-CM) who achieved remission after first-line induction chemotherapy were identified from an administrative claims health database (Optum ® Clinformatics ® Data Mart). Additional inclusion/exclusion criteria were applied to match the QUAZAR AML-001 trial population. Eligible patients were organized into cohorts based on their duration of remission (DOR): cohort A < median DOR, cohort B  median DOR. Hospitalization incidence and duration were analyzed between cohorts using an appropriate count model for hospitalizations. Hospitalization- related costs were compared using a generalized linear model with gamma distribution and log-link function. Results: Overall, median DOR was 125 days; cohorts A and B included 220 and 231 patients, respectively, with median times from remission to end of follow-up of 89 and 3 7 8 days. Baseline characteristics were comparable between cohorts (mean [SD] age 62.8 [14. 7 ] years, Charlson comorbidity index [CCI] 1. 7 [1.6]) except for sex (male: 59.5% vs 4 7 .6%). The number of hospitalizations (4. 7 1 vs 2.68 per patient per year [PPPY]) and total length of stays (43.88 vs 23.59 days PPPY) were higher in cohort A vs B, respectively; estimated hospitalization-related costs (2019 USD) were $242,511 vs $132,554 PPPY, respectively. Cumulative mean hospitalization cost per patient was $61,3 7 1 higher in Cohort A at 12 months and $108,593 higher at 24 months. When adjusted for confounding baseline variables (e.g., age, sex, CCI), the number, length, and cost of hospitalization were each significantly greater in cohort A than in cohort B (P<0.001 each). Co n clusio n s: In a real-world setting, prolonged remission was associated with significantly lower rates and durations of hospitalization in patients with AML in remission following induction chemotherapy, which were estimated to result in substantial cumulative cost savings. Keywords: oral azacitidine, acute myeloid leukemia, resource utilization, hospitalization, HEOR