Assessment of rasburicase utilization for tumor lysis syndrome management in pediatric and adult patients in the inpatient and outpatient settings

2020 ◽  
pp. 107815522094536
Author(s):  
Marin I Abousaud ◽  
Marie C Rush ◽  
Michelle Rockey
Keyword(s):  
Tumor Lysis Syndrome ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Outpatient Setting ◽  
Primary Objective ◽  
Adult Patients ◽  
Potential Cost ◽  
Tumor Lysis ◽  
Laboratory Values ◽  
Outpatient Settings

Introduction At Wake Forest Baptist Health, an adult tumor lysis syndrome pocket card was created in order to optimize management of tumor lysis syndrome and outline specific recommendations for the use of rasburicase. Due to the increased use of rasburicase at our institution and its cost, the purpose of this study was to evaluate the utilization of rasburicase for the management of tumor lysis syndrome in pediatric and adult patients in the inpatient and outpatient settings. Methods This was an observational, single-center, non-randomized, retrospective chart review conducted between September 2018 and August 2019. The primary objective was to evaluate the utilization of rasburicase and appropriateness for the management of tumor lysis syndrome in pediatric and adult patients based on the Wake Forest Baptist Health tumor lysis syndrome pocket card. The secondary objectives were to assess response to prophylactic and treatment doses of rasburicase and to quantify drug cost versus expense of rasburicase utilization. Results Overall, 64 patients (57 adults and 7 pediatric patients) were included in the study. Rasburicase use for tumor lysis syndrome indication adhered to the pocket card 64% of the time. Appropriate fluids and/or allopurinol were initiated in only 34% of patients. For monitoring, 80% of patients had all necessary tumor lysis syndrome laboratory values collected after rasburicase administration. All 11 patients (17%) who received rasburicase in the outpatient setting did not have follow-up labs collected. Of the patients who had tumor lysis syndrome laboratory values collected post rasburicase, 39% were appropriately timed to accurately assess efficacy of rasburicase with the median time of laboratory monitoring after rasburicase being 6.5 h. Response was observed with rasburicase 3 mg (92%), 6 mg (100%), and weight-based dosing (100%). The wholesale acquisition cost per patient was $5203 (1101–10,406). The potential cost savings of using the 3 mg dose versus the 6 mg dose for the patients who did not meet tumor lysis syndrome treatment recommendations based on the Wake Forest Baptist Health pocket card was estimated to be $36,419.46. Conclusion There are several opportunities for improvement in tumor lysis syndrome management and rasburicase utilization at our institution. This study will lead to the implementation of formal restrictions for rasburicase use and selection of rasburicase dose. Updating the rasburicase order panel to include appropriate prophylaxis and require input of uric acid level, populating pertinent tumor lysis syndrome laboratory values on the order verification screen for pharmacists to appropriately assess if rasburicase meets the institution restriction criteria, and providing education to providers on the appropriate ordering and timing of labs.

Utilization, Complications, and Costs of Inpatient versus Outpatient Total Elbow Arthroplasty

Hand ◽  
2021 ◽  
pp. 155894472110306
Author(s):  
Natalie B. Baxter ◽  
Elissa S. Davis ◽  
Jung-Sheng Chen ◽  
Jeffrey N. Lawton ◽  
Kevin C. Chung
Keyword(s):  
Cost Savings ◽  
Outpatient Setting ◽  
Total Elbow Arthroplasty ◽  
Median Cost ◽  
Potential Cost ◽  
Elbow Arthroplasty ◽  
Hip And Knee Arthroplasty ◽  
Comorbidity Scores ◽  
Outpatient Settings ◽  
Surgical Setting

Background Although total hip and knee arthroplasty have largely moved to the outpatient setting, total elbow arthroplasty (TEA) remains a predominantly inpatient procedure. Currently, evidence on the safety and potential cost savings of outpatient TEA is limited. Therefore, we aimed to compare the costs and complications associated with performing TEA in the inpatient versus outpatient setting. Methods We identified patients who received elective TEA using the Truven Health MarketScan database. Outcomes of interest were 90-day complication rate, readmission rate, and procedure costs in the inpatient and outpatient settings. We used propensity score matching and logistic regression analysis to assess how patient comorbidities and surgical setting influenced complications and readmission rates. The median cost per patient was compared using the Mann-Whitney U test. Results We identified 307 outpatient and 414 inpatient TEA procedures over a 9-year period. Elixhauser comorbidity scores were higher for the inpatient cohort. The incidence of surgical complications was significantly higher in the inpatient than the outpatient cohort (27% vs 9%). The odds of 90-day readmissions were similar in the 2 groups (37% vs 25%). In terms of cost, the median inpatient TEA was more expensive than outpatient TEA ($26 817 vs $18 412). However, the median cost for occupational therapy within 90 days of surgery was higher for outpatient TEA patients ($687 vs $571). Conclusions The results of this study demonstrate that surgeons can consider a transition toward outpatient TEA for patients without significant comorbidities, as this will substantially reduce health care costs.

Clinical and Cost Comparison Evaluation of Inpatient Versus Outpatient Administration of EPOCH-Containing Regimens in Non-Hodgkin Lymphoma

2016 ◽  
Vol 30 (4) ◽  
pp. 400-405 ◽  
Author(s):  
Sarah S. Evans ◽  
Arpita S. Gandhi ◽  
Amber B. Clemmons ◽  
David L. DeRemer
Keyword(s):  
Chart Review ◽  
Hospital Admissions ◽  
Antiviral Agents ◽  
Cost Savings ◽  
Outpatient Setting ◽  
Primary Objective ◽  
Cost Comparison ◽  
Non Hodgkin Lymphoma ◽  
Institutional Review ◽  
Stimulating Factor

Background: Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-containing regimens are frequently utilized in non-Hodgkin’s lymphoma, however, the incidence of febrile neutropenia (FN) in patients receiving inpatient versus outpatient EPOCH has not been described. Additionally, no comparisons have been made regarding financial implications of EPOCH administration in either setting. This study’s primary objective was to compare hospital admissions for FN in patients receiving inpatient or outpatient EPOCH. Methods: A single-center, institutional review board-approved review was conducted for adults receiving EPOCH beginning January 2010. Clinical and financial data were collected through chart review and the institution’s financial department. Descriptive statistics were utilized for analysis. Results: A total of 25 patients received 86 cycles of an EPOCH-containing regimen (61 [70.9%] inpatient). Five (8.2%) inpatient cycles resulted in an admission for FN compared to 4 (16%) outpatient cycles. Prophylactic antifungal and antiviral agents were prescribed more often after inpatient cycles (>80%) compared to outpatient cycles (<50%). Overall, 27 (31.4%) of 86 cycles did not receive granulocyte colony-stimulating factor support. Outpatient EPOCH administration was associated with a cost savings of approximately US$141 116 for both chemotherapy costs and hospital day avoidance. Conclusion: EPOCH-containing regimens can be safely administered in the outpatient setting, which may result in cost savings for healthcare institutions.

Evaluation of the dosing strategies of biologic agents and the theoretical impact of dose rounding

2016 ◽  
Vol 24 (1) ◽  
pp. 47-55
Author(s):  
Savannah Lindsey ◽  
Laura Beth Parsons ◽  
Lindsay Rosenbeck Figg ◽  
Jill Rhodes
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Medical Center ◽  
Academic Medical Center ◽  
Wholesale Price ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Potential Cost ◽  
Cost Avoidance ◽  
The Cost

Introduction Monoclonal antibodies possess unique pharmacokinetic properties that permit flexible dosing. Increased use and high costs of these medications have led to the development of cost-containing strategies. This study aims to quantify the cost savings and clinical impact associated with dose rounding monoclonal antibodies to the nearest vial size. Methods This study was a single-arm, retrospective chart review assessing all monoclonal antibody doses dispensed at an outpatient community infusion center associated with an academic medical center between August 2014 and August 2015. All monoclonal antibody doses were reviewed to determine the cost of drug wasted using two methods. The waste-cost analysis described the amount of drug disposed of due to the use of partial vials. The theoretical dose savings described potential cost avoidance based on rounding the ordered dose to the nearest vial size. The theoretical rounded dose was compared to the actual ordered dose to explore clinical implications. Results A total of 436 doses were included. Of these, 237 were not rounded to the nearest vial size and included in the analysis. The cost of waste associated with these doses was $108,013.64 using actual wholesale price. The potential cost avoidance associated with the theoretical dose calculation was $83,595.53. Rounding these doses to the nearest vial size resulted in a median 6.7% (range, 1.4–20%) deviation from ordered dose. Conclusions Rounding monoclonal antibodies to the nearest vial size could lead to significant cost and waste savings with minimal deviation from the actual ordered dose.

scholarly journals Pharmacist-Driven Management of Chemotherapy Induced Nausea and Vomiting in Hospitalized Adult Oncology Patients. A Retrospective Comparative Study

2011 ◽  
Vol 2 (3) ◽  
Author(s):  
Ramy Elshaboury ◽  
Kathleen Green
Keyword(s):  
Practice Guidelines ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Standard Of Care ◽  
Nausea And Vomiting ◽  
P Value ◽  
Potential Cost

Chemotherapy-induced nausea and vomiting (CINV) is a major adverse event associated with cancer treatments. There are clinical practice guidelines that assist practitioners in managing CINV. Many cancer centers develop protocols for physicians and pharmacists to guide prophylaxis and breakthrough treatments of CINV based on published guidelines. The purpose of this study was to evaluate the outcome differences between pharmacist and physician -driven management of CINV in adult hospitalized cancer patients in a large academic medical center. This is a single center retrospective chart review study. The primary outcome of the study was the number of breakthrough antiemetic doses needed throughout the hospitalization. A total of 106 adult patients receiving inpatient chemotherapy were reviewed for CINV management. Fifty-five patients (52%) were managed according to the pharmacist-driven protocol, and fifty-one patients (48%) were managed by the physician. There was no difference between the two groups in the primary outcome. Patients in the pharmacist-managed group needed 6.4 breakthrough antiemetic doses; whereas, patients in the physician managed group needed 5.9 doses throughout the hospital stay (P-value = 0.7). No difference was seen when results were adjusted for length of hospitalization. There was a difference in adherence to the institution CINV guidelines favoring the pharmacist-driven approach (85% versus 33%, P < 0.0001). In conclusion, pharmacist-run protocol for CINV management was as effective as the standard of care. Protocols that are based on practice guidelines may offer the advantage of care standardization and potential cost savings.   Type: Student Project

scholarly journals A Comparison of Single Dose Rasburicase 3 Mg Versus 6 Mg for the Management of Tumor Lysis Syndrome

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4511-4511
Author(s):  
Sarah K Kraus ◽  
Catherine E Burdalski ◽  
Colleen Timlin ◽  
Tracy M Krause ◽  
Todd A Miano ◽  
...  
Keyword(s):  
Single Dose ◽  
Research Funding ◽  
Hematological Malignancies ◽  
Tumor Lysis Syndrome ◽  
Wholesale Price ◽  
Cost Savings ◽  
Urate Oxidase ◽  
Categorical Variables ◽  
Tumor Lysis ◽  
Dosing Strategies

Abstract Introduction: Rasburicase, a recombinant form of urate oxidase, is a highly effective treatment for tumor lysis syndrome (TLS). Although the FDA-approved dose for rasburicase is 0.2 mg/kg/day for up to five days, many centers have adopted alternative dosing strategies to decrease cost, the most common being a single 6 mg dose. We hypothesized that further reducing the dose to 3 mg would result in similar efficacy and yield significant cost savings compared to the 6 mg dose strategy. Methods: We conducted a retrospective cohort study to examine the comparative effectiveness of a single 3 mg dose of rasburicase versus a single 6 mg dose in 108 adults with hematological malignancies presenting with a baseline uric acid (UA) ≤ 12 mg/dL between June 2009 and February 2015. Prior to January 2012, our institutional policy recommended a single 6 mg dose for all patients who met criteria for rasburicase for TLS. In January 2012, the policy was amended to recommend a single 3 mg dose for patients with a baseline UA ≤ 12 mg/dL. Thus, the study included 56 patients with UA ≤ 12 who received a single 6 mg dose prior to the policy modification and 52 patients with UA ≤ 12 given the 3 mg dose after the amendment. The primary endpoint was the percentage of patients who achieved a UA ≤ 8 mg/dL (the upper limit of normal at our institution) 24 hours after a single dose of rasburicase. Fisher's exact test was used to analyze categorical variables and t-tests were used to analyze continuous variables. The a priori level of significance was set at α < 0.05. Results: The mean baseline UA was 9.3 mg/dL and 9.8 mg/dL in the 3 mg arm and 6 mg arm, respectively (P = .19). At 24 hours there was no difference in the percentage of patients who achieved a UA ≤ 8 mg/dL (92% vs. 98%; P = 0.36). In addition, there was no difference in the percentage of patients who achieved a UA ≤ 8 mg/dL at 48 hours (98% vs. 100%; P = 0.48). Six (11.5%) patients in the 3 mg arm and one (1.8%) patient in the 6 mg arm required a second dose of rasburicase to achieve a UA <8 mg/dL (P = 0.1). Of note, the 6 mg group had a greater percent reduction in UA from baseline compared to the 3 mg group at both 24 hours (-68.1% vs. -48.6%; P < .01) and 48 hours (-69.3% vs. -51.3%; P = 0.02) after rasburicase administration. There was no difference in the percent change of serum creatinine between the two dosing strategies at 24 hours (-6.5% vs. 0.1%; P = 0.11) or 48 hours (-4.5% vs. -2.5%; P = 0.22). In addition, no difference was observed with respect to the percent of patients who required renal replacement therapy within 7 days of rasburicase administration (8.9% vs. 9.6% P = 1.0). Based on the average wholesale price of $815 for one 1.5 mg vial of rasburicase, the single 3 mg dose was associated with approximately $1,500 cost savings per encounter compared to the 6 mg dose. Conclusion: A single 3 mg dose of rasburicase was as effective as 6 mg in normalizing UA within 24 hours. Our findings demonstrate that administering a single 3 mg dose of rasburicase is a cost-effective alternative for TLS management in patients with hematological malignancies presenting with a UA ≤ 12 mg/dL. Disclosures Svoboda: Immunomedics: Research Funding; Celgene: Research Funding; Seattle Genetics: Research Funding; Celldex: Research Funding. Ganetsky:Onyx: Speakers Bureau.

scholarly journals 1056. Safety and Tolerability of Dalbavancin in Vancomycin Allergic Patients – A Case Series

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S620-S620
Author(s):  
Kennedy J Freeman ◽  
Kerry O Cleveland ◽  
Christopher M Bland ◽  
Bruce M Jones
Keyword(s):  
Package Insert ◽  
Case Series ◽  
Panel Member ◽  
Retrospective Chart Review ◽  
Time Frame ◽  
Outpatient Setting ◽  
Primary Objective ◽  
Cross Sensitivity ◽  
Intravenous Line ◽  
Patient Reported

Abstract Background VVancomycin and dalbavancin, both in the glycopeptide class of antibiotics, are used in the treatment of Gram-positive infections, including methicillin-resistant Staphylococcus aureus. Antibiotics in this class contain a heptapeptide core that has potential for cross-sensitivity. Due to this risk, dalbavancin carries a warning in the package insert for use in patients with a glycopeptide allergy. Dalbavancin, a semi-synthetic derivative of vancomycin, has lipophilic side chains which reduce the risk of cross-sensitivity to vancomycin. This case series evaluated patients with a listed vancomycin allergy in their electronic health record who received dalbavancin as an outpatient infusion. Methods This study was a non-randomized, retrospective chart review of adult patients who had a documented vancomycin allergy and received dalbavancin between February 2016 and February 2021 for any indication in the outpatient setting. The primary objective was to evaluate dalbavancin tolerability in patients allergic to vancomycin. Patient characteristics and the specifics of dalbavancin infusion – dose, volume, infusion rate, intravenous line access, and receipt of premedication before infusion – were collected on each patient. Results 559 unique patients received dalbavancin over the time frame. Of these, ten had a documented, subjective vancomycin allergy. Patient-reported allergic reactions were rash (4), hives (3), anaphylaxis (2), red man syndrome (2), renal failure (2), and general malaise (1). Six patients had at least 1 additional subjective drug allergy. The various infections treated included cellulitis/abscess (8), osteomyelitis (1), and bacteremia (2). Most patients received 1500mg (2 received 1125mg) of dalbavancin in 300-500mL of dextrose 5% in water infused at either 600 or 1000mL/hr via a peripheral (6) or central (4) intravenous line. All patients tolerated the infusion with no adverse events reported and no receipt of premedication before administration. Conclusion Dalbavancin may be a reasonable treatment option in vancomycin allergic patients, despite possible cross-sensitivity. Further investigation into cross-sensitivity between vancomycin, dalbavancin, and other glycopeptide class agents is warranted. Disclosures Kerry O. Cleveland, M.D., AbbVie (Speaker’s Bureau)Merck (Speaker’s Bureau)Pfizer (Speaker’s Bureau) Bruce M. Jones, PharmD, BCPS, Abbvie (Consultant, Advisor or Review Panel member, Speaker’s Bureau)La Jolla (Speaker’s Bureau)Melinta (Consultant)Merck (Consultant)Paratek (Consultant, Speaker’s Bureau)

Evaluation of Direct Oral Anticoagulant Dosing and Monitoring in Two Geriatric Outpatient Clinics

2019 ◽  
Vol 34 (3) ◽  
pp. 192-205
Author(s):  
Michelle A. Howerton ◽  
Erin M. Suhrie ◽  
Amelia S. Gennari ◽  
Nancy Jones ◽  
Christine M. Ruby
Keyword(s):  
Medical Center ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Retrospective Chart Review ◽  
Office Visit ◽  
Outpatient Setting ◽  
Primary Objective ◽  
Improvement Project ◽  
Care Institute ◽  
Geriatric Center

OBJECTIVE: This study was conducted to evaluate direct oral anticoagulants (DOACs) prescribed to elderly patients in an outpatient setting, specifically evaluating if Food and Drug Administration (FDA) -approved dosing recommendations are followed.<br/> DESIGN: This study was a retrospective quality improvement project.<br/> SETTING: This study was conducted at geriatric hospital-based primary care clinics at the University of Pittsburgh Medical Center (UPMC), UPMC Senior Care Institute and UPMC Benedum Geriatric Center.<br/> PATIENTS: Subjects included were 65 years of age or older; had an office visit at UPMC Senior Care Institute or UPMC Benedum Geriatric Center from September 1, 2015, to August 31, 2017; and had a DOAC on their home medications.<br/> INTERVENTIONS: Data were obtained through retrospective chart review.<br/> MAIN OUTCOME MEASURE: The primary objective of the study was to evaluate the appropriateness of dosing of DOACs based on FDA-labeled recommendations.<br/> RESULTS: Of 232 patients included in analysis, 42.7% were found to have dosing inconsistent with FDAlabeled recommendations (47.3% apixaban, 35.8% rivaroxaban, and 31.6% dabigatran). No patients were prescribed edoxaban. The majority (72.7%) were dosed lower than FDA-recommended doses. Of all patients, the most frequent parameter (54.5%) for inappropriate dosing was patients meeting only 1 of 3 dose-reduction criteria when prescribed reduced-dose apixaban. Geriatrician and nongeriatrician prescribers had similar rates of prescribing DOACs with doses inconsistent with FDA-labeled recommendations (44.0% vs. 40.8%; P = 0.62).<br/> CONCLUSION: Results suggest that DOACs used in outpatient geriatric patients are frequently dosed inconsistent with FDA-approved dosing recommendations. Further research is needed regarding clinical outcomes in older patients receiving DOACs and in those with dose adjustments inconsistent with FDA-labeled recommendations.<br/>

scholarly journals Tumor Lysis Syndrome Risk in Outpatient Versus Inpatient Administration of Venetoclax and Hypomethlators for Acute Myeloid Leukemia

2021 ◽  
Author(s):  
Ari Pelcovits ◽  
Jozal Moore ◽  
Brianna Bakow ◽  
Rabin Niroula ◽  
Pamela Egan ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Tumor Lysis Syndrome ◽  
Outpatient Setting ◽  
Lymphocytic Leukemia ◽  
Inpatient Setting ◽  
Close Monitoring ◽  
Hypomethylating Agents ◽  
Tumor Lysis ◽  
Acute Myeloid

Abstract IntroductionVenetoclax along with hypomethylating agents (HMAs) is the new standard therapy for older patients with acute myeloid leukemia (AML) not fit for intensive frontline induction chemotherapy. Venetoclax is associated with fatal episodes of tumor lysis syndrome (TLS) in chronic lymphocytic leukemia (CLL), and recommendations are for its initiation for CLL and AML in the inpatient setting with close monitoring. Herein, we evaluated the safety of outpatient venetoclax ramp up when given in addition to HMAs for the treatment of AML. Methods We conducted a retrospective review of patients diagnosed with AML at our institution from 12/1/2016 until 7/1/2020. We identified patients who received HMAs and venetoclax for AML, either as frontline or relapsed/refractory therapy. Records were reviewed for evidence of laboratory or clinical tumor lysis episodes in all patients. Results Between 12/1/2016 and 7/1/2020 43 patients at our institution received venetoclax/HMA for the treatment of AML. Thirty-nine patients (91%) had venetoclax initiation and ramp up in the outpatient setting. One episode of laboratory TLS (2.5%) was identified. This patient required admission to the hospital for rasburicase and IV fluids with resolution of the laboratory effects without resultant clinical TLS. There were no episodes of clinical TLS in either group. 30-day mortality from venetoclax initiation was 0% in both groups. Conclusion Our experience with HMAs and venetoclax showed that outpatient ramp up of venetoclax is safe with a very low risk of laboratory TLS (2.5%) and no evidence of clinical TLS within our cohort.

scholarly journals Tumor Lysis Syndrome Risk in Outpatient Versus Inpatient Administration of Venetoclax and Hypomethlators for Acute Myeloid Leukemia

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 6-7
Author(s):  
Aryeh Pelcovits ◽  
Brianna Bakow ◽  
Jozal Waroich ◽  
Pamela C Egan ◽  
Rabin Niroula ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Uric Acid ◽  
Salvage Therapy ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Tumor Lysis Syndrome ◽  
Outpatient Setting ◽  
Tumor Lysis ◽  
Wbc Count ◽  
Acute Myeloid

Introduction Venetoclax (VEN), a BCL-2 inhibitor, along with hypomethylating agents (HMAs) has become standard therapy for older patients (pts) with acute myeloid leukemia (AML) not fit for intensive frontline therapy based on recent Phase 3 data reporting a median overall survival (OS) of 14.7 months. Initially used in CLL, VEN is associated with fatal episodes of tumor lysis syndrome (TLS). Package insert and expert opinion recommendations are for its initiation in the inpatient setting, with a dose escalation of 100mg day 1, 200mg day 2, and 400mg day 3 with IV hydration and close monitoring of TLS markers. In the initial phase 1b trial that resulted in its approval for use in pts with AML all pts were admitted to the hospital for initial venetoclax ramp up and received at least 72 hours of prior TLS prophylaxis, as well as initiation of venetoclax only if the white blood cell count was less than 25,000. No episodes of TLS were documented. Herein, we evaluated the safety of outpatient VEN ramp up when given in addition to HMAs for the treatment of AML. Methods We conducted a retrospective review of pts diagnosed with AML at our institution from 12/1/2016 until 7/1/2020. We identified pts who received HMAs and VEN, either as up-front treatment for newly diagnosed AML or as salvage therapy for relapsed or refractory disease, and stratified pts based on whether venetoclax was initiated in the inpatient or outpatient setting. We then examined baseline AML characteristics including initial blast count, cytogenetics and molecular profiles as well as baseline TLS markers prior to the initiation of VEN. Finally, using the Cairo-Bishop Criteria we examined the number of episodes of laboratory or clinical tumor lysis in all pts. Fisher's exact test and Wilcoxon rank-sum tests were performed to examine differences in categorical and continuous variables. Results Between 12/1/2016 and 7/1/2020 43 pts at received VEN in addition to an HMA for the treatment of AML (Table 1). 39 pts (91%) had VEN initiation and ramp up in the outpatient setting. Amongst all pts 24 received azacitadine, 11 decitabine, and 8 received both HMAs at some point during therapy. Twenty-two pts received HMA and VEN as frontline treatment while the other 21 received it as salvage therapy. There were 28 pts who received venetoclax within 28 days of starting the HMA, 25 of whom received it as an outpatient and 3 as an inpatient. Pretreatment labs were notable for median normal values of potassium, phosphate, uric acid, calcium and creatinine (Table 1). The median pretreatment creatinine levels between the two groups were not significantly different. Median pre-treatment WBC count was noted to be significantly higher in the inpatient cohort (37.9 vs 5.5, p-value of 0.01). Cytogenetic and molecular characteristics are included in the table with the only significant difference being a larger percentage of DNMT3A mutation in the inpatient group. While identification of TLS was somewhat limited by incomplete data on all pts, there was only one identified episode of laboratory TLS (2.5%) with an elevated phosphate and uric acid. This occurred in the outpatient group in a patient whose pretreatment WBC count was greater than 25,000. This pt required admission to the hospital for rasburicase and IV fluids with resolution of the laboratory effects without resultant clinical TLS. There were no episodes of clinical TLS in either group. 30-day mortality from starting VEN was 0% in both groups. While the Cairo-Bishop Criteria require the presence of 2 lab abnormalities to diagnose TLS we did a further analysis to evaluate for the presence of even a single lab abnormality associated with TLS. We identified 3 additional pts (7.5%) in the outpatient cohort who had the presence of only one lab abnormality associated with TLS within the 7 days after initiating treatment. None of these pts required any further TLS directed treatment or hospitalization. Conclusion Our experience with HMAs and VEN showed that outpatient ramp up of venetoclax is safe with a very low risk of laboratory TLS (2.5%) and no evidence of clinical TLS within our cohort. Even with an expanded definition of TLS we only identified 3 additional pts who developed laboratory abnormalities associated with TLS. Our results suggest that, in addition to HMA, VEN ramp up can be safely delivered with monitoring to pts with a WBC count less than 25,000 in the outpatient setting. Disclosures Olszewski: Genentech, Inc.: Research Funding; Spectrum Pharmaceuticals: Research Funding; TG Therapeutics: Research Funding; Adaptive Biotechnologies: Research Funding.

Sign in / Sign up

Export Citation Format

Share Document