ALBERT

Description: Background: Patients with acute myeloid leukemia (AML) who achieve complete remission with induction therapy require consolidation therapy. The standard of care consolidation is HiDAC based on age and risk stratification. Consolidation therapy has historically been administered in the inpatient setting. The rising cost of inpatient care, alternative payment model implementation and patient preference has prompted institutions to consider shifting therapy to the outpatient setting. However, the safety and feasibility of outpatient high dose Cytarabine (HiDAC) consolidation therapy is not well established. The University of Arizona Cancer Center developed an Outpatient Program (OP) to facilitate administration of hematologic chemotherapy regimens in the outpatient setting. We hypothesized that OP administration of HiDAC consolidation therapy would be safe and efficacious and have large cost-savings implications under alternative payment model pilots, such as the oncology care model. Methods: We conducted a retrospective chart review on high-risk MDS/AML patients who were 18 years or older and received HiDAC consolidation therapy at UACC following induction therapy from November 1st 2013 to June 1st 2019. Interim data collection included age, risk stratification, treatment history, clinic visits, number of cycles received in the OP versus inpatient setting, supportive care, hospitalizations, and chemotherapy related adverse events. Our Outpatient HiDAC protocol consisted of a one-hour infusion for all cytarabine doses administered at 7:30am and 4:00pm, with neurologic checks prior to each dose. Growth factor support, if required was administered on the same day as the last dose of cytarabine Results: We evaluated 19 patients at our cancer center who received 52 total cycles of HiDAC consolidation therapy. The median patient age was 49.6 yrs with 21.1 % being over the age of 60. Thirty-three cycles were administered in the outpatient setting, with 19 cycles being administered inpatient. None of the patients who were administered HiDAC in either the IP or OP setting had reported clinically significant neurotoxicity (≥ grade III). Nine patients receive all of their cycles in the outpatient setting. 57.9% of our patients developed febrile neutropenia, with 47.4% of the patients requiring hospitalization for neutropenic fever. The average inpatient HiDAC length of stay was 6 days. Transitioning HiDAC to the outpatient setting led to a savings of 198 hospital days, with a corresponding cost reduction to our healthcare system of $529,650. Transitioning HiDAC to the outpatient setting also improved patient satisfaction. Conclusion: Outpatient administration of HiDAC consolidation therapy for AML patients is a safe and effective treatment option. In addition, transitioning HiDAC to the outpatient setting led to a reduced overall cost of care for AML treatment , under an OCM based practice model. Utilization of outpatient HiDAC for the outpatient setting provides a unique opportunity for select patients. Disclosures Maher: Agios: Consultancy. Anwer:Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; In-Cyte: Speakers Bureau. Campen:Coherus: Speakers Bureau; Teva: Speakers Bureau; Amgen: Consultancy. McBride:teva: Consultancy; Sandoz: Consultancy; Sanofi Genzyme: Consultancy.

Description: Introduction: Cancer patients who experienced a venous thromboembolism (VTE) are at high risk for poor clinical outcomes; hence VTE recurrence prevention is salient. Low molecular weight heparin (LMWH) has been the preferred treatment for cancer-related VTE; however, direct oral anticoagulants (DOACs) have been prescribed empirically in cancer due to patient convenience. Although the recent HOKUSAI and SELECT-D trials have confirmed the non-inferiority of DOACs to LMWH in the management of recurrent VTE in cancer patients, there remain a continued safety concern for major bleeds (MB). Recurrent VTE and MB complications during anticoagulation treatment of GI cancer (GICA) patients are increased as compared to other cancer types. The incremental health care costs associated with VTE recurrences and MB episodes are significant and steadily increasing. In this retrospective analysis, we aimed (1) to evaluate for differences in the VTE recurrence rate and MB events based on anticoagulation therapy (LMWH or DOAC) prescribed with a prior VTE and (2) to calculate the associated healthcare costs for six months of treatment. Methods: We reviewed the medical records of patients with biopsy-proven GICA and imaging documented VTE treated with DOAC or LMWH from November 2013 to February 2017. Patients were excluded if anticoagulation was given for another treatment indication or cancer diagnosis. Adverse events of recurrent VTE and MB criteria were defined per the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Costs of LMWH and DOAC t was sourced from Medicare Reimbursement 2018. Hospital admission and adjusted 6-month ambulatory cots were sourced from Economic Evaluations of Anticoagulation Outcomes in the U.S. by Amin et al 2015. Costs were inflation-adjusted to 2018 cost levels using the Medical Care component of the Consumer Price Index. The Chi-squared test was used for overall and the Fisher exact test for pairwise comparisons of the proportions of patients experiencing VTE and MB events. Results: Our analysis included 106 patients on enoxaparin (N=40), rivaroxaban (N=37) and apixaban (N=29). Recurrent VTE outcomes at 6 months were 3 (7.5%) for enoxaparin, 1 (2.7%) for rivaroxaban, and 2 (6.8%), for apixaban (all p=n.s.) (Table 1). Major bleeding events at 6 months were 2 (5%) for enoxaparin, 2 (6.8%) for apixaban, and a significantly higher 8 (21.6%) for rivaroxaban (overall p=0.048; v. LMWH pairwise p=0.042; all other p=n.s.). The estimated composite costs associated with the observed recurrent VTE event rates were $173,130 for enoxaparin, $57,710 for rivaroxaban, and $115,420 for apixaban. The estimated composite costs associated with the observed MB event rates were $117,146 for enoxaparin and apixaban, versus $468,558 for rivaroxaban. The estimated total 6-months healthcare costs for recurrent VTE, MB and prescriptions were $293,784 for enoxaparin, $529,336 for rivaroxaban, and $235,634 for apixaban. Conclusion: Our real-world retrospective analysis corroborates a non-inferiority of DOACs to LMWH in preventing recurrent VTE in GICA patients at 6 months but a higher incidence of MB in rivaroxaban v. LMWH treated patients. The higher MB rate for rivaroxaban mainly accounts for the higher overall costs of this DOAC v. LMWH and apixaban. In absolute total costs, apixaban prevails over LMWH and rivaroxaban, and LMWH prevails over rivaroxaban in cost-efficiency in this analysis of anticoagulation in selected high-risk GICA patients. Rivaroxaban significantly increases medical costs, mainly driven by the total number of major bleed adverse events in GICA patients, confirming previously published evidence. The subpopulation of GICA patients at high risk of VTE/MB warrants an additional prospective clinical trial for primary safety major bleed outcomes of DOACs with an accompanying cost-effectiveness analysis. This may eventually reduce the healthcare economic burden. Disclosures Abraham: Sandoz: Consultancy.

Description: Abstract 2145 Poster Board II-122 Introduction: Plerixafor (AMD3100; PLX), a bicyclam molecule that reversibly inhibits binding of the CXCR4 chemokine receptor to stromal cell derived factor-1, is used clinically in combination with G-CSF for mobilization of hematopoietic stem cells. Although the effects of PLX plus G-CSF on mobilization of CD34+ cells have been well studied, the impact of PLX plus G-CSF on mobilization of lymphocytes and lymphocyte subsets remains unclear. Additionally, comparative effects of PLX on the content and subpopulations of lymphocytes in apheresis products from patients (pts) with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM) have not been previously reported. Patients and Methods: Thirteen pts (7 NHL, 6 MM) underwent autologous PBSC mobilization with subcutaneous (sq) G-CSF (10 micrograms/kg/day x 4 days) and sq PLX (0.24 mg/kg on the fourth day of G-CSF administration), followed by large-volume apheresis approximately 15 hr after PLX dose. Pts who did not attain target CD34+ collection on first day of apheresis (day 1) received up to 3 additional daily doses of PLX plus G-CSF and up to 3 additional days of apheresis. Aliquots of apheresis products were obtained after each collection for differential WBC count, from which the absolute lymphocyte count (ALC) was calculated, and for flow cytometric quantitation of lymphocyte subsets. Cell doses were expressed per kg of pt weight. A nonparametric (Mann-Whitney) tests was used for all statistical analyses. Results: Five pts (1 NHL, 4 MM) collected target CD34+ cell doses (median 7.46 × 106 cells/kg; range, 7.22-22.7 × 106 cells/kg) with 1 apheresis. The remaining 8 pts collected target CD34+ cell doses after a total of 2 (2 NHL, 2MM), 3 (3 NHL) or 4 (1 NHL) aphereses. Doses of CD34+ cells, ALC, CD4+ cells, CD19+ cells and CD56+ cells were significantly higher in day 1 PBSC apheresis products from MM pts than from NHL pts, but neither CD3+ nor CD8+ cell dose was significantly different in the two groups (Table 1). For the pts undergoing 2 or more aphereses, comparison of day 1 and day 2 apheresis products showed significantly decreased doses of ALC, CD3+, CD4+ and CD8+ cells, but no significant differences in doses of CD34+, CD19+ or CD56+ cells (Table 2). Conclusions: PLX plus G-CSF effectively mobilizes lymphocytes and lymphocyte subsets as well as CD34+ cells. Pts with MM had significantly higher doses of specific lymphocyte subsets, notably CD4+ and CD56+, than did pts with NHL, potentially reflecting differences in previous treatments (e.g., lenalidomide plus dexamethasone in MM pts compared with ICE or ESHAP in NHL pts). These findings are relevant to the understanding of the effects of infused lymphocyte subsets on outcomes of and immune reconstitution after autologous PBSC transplantation. Disclosures: No relevant conflicts of interest to declare.