Identification of patients with heparin-induced thrombocytopenia is encumbered by false positive enzyme-linked immuno assay (ELISA) antibody results, therefore a serotonin release assay (SRA) is used for confirmation. Recently, several studies have demonstrated that increasing the optical density (OD) threshold (currently at 0.4) of the antibody test enhances the positive predictive value. The purpose of this study was to determine the frequency of patients who were ELISA antibody positive but SRA negative, and the costs and bleeding events associated with alternative anticoagulant treatment. We hypothesized that treating patients with a positive ELISA antibody OD value of <1.0 would result in increased cost and bleeding risk. This retrospective chart review was conducted on adult hospitalized patients from 2011 to 2013. Patients with positive ELISA antibodies (OD of 0.4-1.0) and an SRA result were included. Eighty-five patients were identified with positive antibodies (average OD of 0.66), 100 % of which were found to be SRA negative. A total of 59 patients (69 %) received alternative anticoagulants. The average duration of treatment was 3.1 days, and 4 patients (4.7 %) experienced a bleeding event. The cost of testing and laboratory monitoring was $36,346 and the cost of the alternative anticoagulants totaled $47,179. The total cost was $83,525, with an average total cost per patient of $982. This study adds to the body of literature suggesting treatment should only be initiated if the OD is one or greater. The high false positive rate caused increased cost and some bleeding events.
Background/purpose: Standard acute myeloid leukemia (AML) induction regimens have reduced response in elderly patients. As an alternative, hypomethylating agents have better tolerability, but poorer response rates. Venetoclax, an oral anti-apoptotic protein BCL-2 inhibitor, was approved in combination for the treatment of newly-diagnosed AML adults 75 years or older and is supported by NCCN guidelines in combination with hypomethylating agents or low dose cytarabine for special patient populations. This study evaluated the outcomes of AML induction regimens in unfavorable risk patients 60 years old or older that were candidates for intensive remission induction therapy. Methodology: This was an IRB-approved retrospective chart review of AML patients with unfavorable risk cytogenetics aged 60 or older admitted to the Baptist Hospital of Miami Oncology Unit between February 1st, 2018 and August 1st, 2019, an 18-month period. Patients were included if they received one of the following AML induction regimens: daunorubicin + cytarabine (7+3), liposomal daunorubicin/cytarabine (CPX-351), venetoclax + decitabine (VEN +DEC), venetoclax + azacitidine (VEN+ AZA), or venetoclax + low dose cytarabine (VEN + LoDAC). For the purpose of the study, the 7+3 and CPX-351 regimens were classified as high intensity, while the VEN+ DEC, VEN+AZA, and VEN+LoDAC regimens were classified as low intensity. The primary outcome assessed was the rate of complete morphologic remission (CR) and complete morphologic remission with incomplete count recovery (CRi). Additional secondary outcomes included rate of induction failure, relapse free survival (RFS), time to complete remission, transplant status and eligibility, length of stay (LOS), and incidence of any-grade treatment-related toxicities. Results: A total of 20 patients were identified. Of the 20 patients, 9 (45%) received induction with 7+3, 3 (15%) received CPX-351, 5 (20%) received VEN+DEC, and 3 (15%) received VEN +AZA, thus 12 (60%) received high intensity regimens, while 8 (40%) received low intensity. The primary outcome of CR/CRi rate was 75% in the high intensity group vs. 63% in the low intensity group (P=0.0922). Furthermore, the rate of induction failure, median time to CR/CRi, median LOS, and transplant eligibility were similar between the high and low intensity groups. The median RFS was 272 days in the high intensity groups vs. 223 days in the low intensity groups (P=0.1496). The median duration of neutropenia was 30 days in the high intensity group vs. 34 days in the low intensity group while the median duration of thrombocytopenia was 31 days in the high intensity groups vs. 32 days in the low intensity group. Finally, the rate of grade 3 and 4 toxicities was 100% in the high intensity group vs. 88% in the low intensity group (P=0.0003), with higher incidences of grade 3 febrile neutropenia, grade 4 thrombocytopenia, and grade 1 and 2 liver enzyme elevations noted in the high intensity group. Conclusion: There were no statistically significant differences between the CR/CRi rates and median RFS of the high and low intensity groups, while there were significantly less grade 3 and 4 toxicities noted in the low intensity group. Venetoclax-based regimens are an acceptable alternative to intensive induction therapy in unfavorable risk patients over the age of 60 due to similar outcomes and less toxicity. Disclosures No relevant conflicts of interest to declare.
e19347 Background: First-line treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor for HR+/HER2- postmenopausal metastatic breast cancer (mBC) is considered standard of care based on the compelling data across all landmark trials. Commission on Cancer (CoC) as well as the Quality Oncology Practice Initiative (QOPI) describe standards for cancer care; some of which include utilizing data for continuous quality improvement as well as using nationally recognized guidelines to drive treatment selection. Reducing unwarranted variations in care through tracking and reporting adherence to nationally-recognized guidelines can be one way to focus on improving quality metrics. We evaluate first-line real-world treatment patterns of HR+/HER2- mBC patients in three health care systems in south Florida and compare with national standards. Methods: A retrospective analysis utilizing pharmacy and medical claims data (commercial and governmental payers) was performed. The data source was the IQVIA anonymized patient longitudinal open claims data for patients treated at the south Florida health systems. Patients age ≥18 years with HR+/HER2- mBC were included. First-line treatment was defined as the first claim for a medication after the mBC diagnosis. Results: Characterization of treatment patterns in three cancer centers in south Florida showed an increased utilization of CDK4/6 inhibitors as compared to the national average across all groups (see table). Conclusions: These data provide a baseline assessment of the utilization of CDK4/6 inhibitors in the first-line treatment of HR+/HER2- mBC. These data are reassuring with respect to the appropriate treatment in south Florida patients. However, we anticipate that treatment patterns may vary in other geographic areas given the national data trends. We would recommend this data be evaluated in other systems to identify potential areas of improvement. Limitations of this evaluation are consistent with any methodology using claims data which include possible coding errors and missing data which may or may not be systematic. [Table: see text]
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