Safety and Efficacy of Total Dose Infusion of Low Molecular Weight (LMW) Iron Dextran in a Large Population of Anemic Patients Across a Broad Spectrum of Diagnoses Associated with Iron Lack
Abstract Background: Physicians are reluctant to recommend high dose intravenous (IV) iron infusion for iron deficient (ID) patients due to concerns of adverse events (AEs) including anaphylaxis. This retrospective analysis evaluates efficacy and AEs with LMW iron dextran (ID) total dose infusion (TDI) in patients with iron deficiency. Methods: We retrospectively evaluated the Electronic Medical Records of 468 consecutive patients with iron deficient anemia (IDA) who received IV LMW ID between 01/2008 and 07/2011 in an ambulatory infusion center. Diagnostic parameters for IDA included hemoglobin [Hgb] <11 g/dL, transferrin saturation [TSAT] 19%, ferritin <100 ng/mL. The majority had documented intolerance of or inadequate response to oral iron. All received TDI of LMW ID (1130 ± 217 mg) over 1 hour after a test dose of 25 mg. Pre-medication was not used. Patients were closely monitored for AEs during and immediately after infusions. Laboratory data for baseline and repeat hematological parameters within 8 weeks following infusions were analyzed. End points were safety and efficacy. Safety data was available for all 468 patients. Follow-up data at 8 weeks was available on 315. Figure 1 Figure 1. Results: There were 103 males and 365 female patients. Most common diagnoses were GI bleed, chemotherapy, menorrhagia and chronic kidney disease. At baseline, mean Hgb was 9.8 g/dL, ferritin 92.08ng/mL, and TSAT 12.37%. At 8 weeks the mean hemoglobin increased to 10.97 g/dL (p =0.0001), Ferritin 279.63 ng/mL (p =0.0001), and TSAT 21.85% (p=0.0001). All tolerated the infusion well. There were no incidents of fever, chills, wheezing, hypotension, stridor, periorbital edema, anaphylaxis or death. One complained of chest tightness, but completed the infusion after several minutes and the administration of diphenhydramine and steroids. One developed a rash. Fatigue and myalgia were reported in 17.31% and 8.33% of patients respectively. Conclusions: This study demonstrates TDI of LMW ID can be given safely and conveniently over 1 hour in an outpatient setting without premedication to ID patients. Easily manageable minor reactions did not affect the therapeutic plan. No allergic or anaphylactic reactions were observed. This study demonstrated TDI of LMW ID improved hemoglobin levels more than 1 g/dL within 8 weeks. Consistent with the preponderance of published evidence TDI of LMW ID should be considered an important therapeutic option for iron replacement in patients with IDA. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
Disparities in the Upfront Use of Hematopoietic Stem Cell Transplant Among Patients with Acute Myeloid Leukemia
Abstract Background: The incidence for acute myelogenous leukemia (AML) is on the rise in the United States (US). Roughly 20,000 new AML patients are expected to occur in 2016 in the US (data from Surveillance Epidemiology and End Results Program). It is mainly a disease of older individuals with median age of 67 years. Unfortunately, most patients are not cured. Recent data suggest that early referral for hematopoietic stem cell transplant (HSCT) leads to more favorable outcomes, particularly those with non-good risk cytogenetics compared to alternate therapies. The objective of our study was to assess the use of upfront HSCT among AML patients with a focus on patients with non-good risk cytogenetics and determine disparity in its access based on sociodemographic and regional considerations. Methods: We analyzed data obtained from National Cancer Data Base (NCDB) Participant User Files for patients diagnosed with AML between 2004 and 2013 using the International Classification of Diseases for Oncology version 3 (ICD-O-3) codes 9840-9861, 9865-9874, 9891-9931. The data is collected prospectively by joint program of Commission on Cancer (CoC) and American Cancer Society. It covers nationwide oncology outcome from more than 1,500 CoC-accredited hospitals. Over 70% of all newly diagnosed cancer cases in the US are captured by NCDB. Since unique ICD-O-3 codes exist for the good-risk but not for intermediate- or poor-risk AML, we categorized the AML subtypes as good risk or non-good risk for analytic purposes. We considered patients with t(15;17), inv(16) and t(8;21) with corresponding ICD-O codes of 9871, 9896, and 9866, as good-risk patients. All others were considered non-good risk. Proportion of HSCT usage was estimated in various subgroups with 95% confidence intervals calculated using robust estimates of standard error. Results: We identified 80,087 patients who were diagnosed with AML between 2004 and 2013. Majority of these patients were Whites (85.9%), males (53.8%) and between the ages of 40 and 79 years (71.5%). The overall use of upfront HSCT increased consistently over time. This occurred predominantly among the non-good risk AML from a rate of 6.5% in 2004 to 12.5% in 2013 (Figure). Non-good risk patients who were Black, had Medicare insurance, with lower annual household income, and treated at facilities located in the East, South and Central parts of US ( AL, KY, MS, TN) had less access to HSCT (Table). Conclusion: The use of upfront HSCT in AML has almost doubled in the past decade, predominantly among those with non-good risk cytogenetics. Nevertheless, we found substantial disparity among sociodemographic and geographic subgroups. Future studies should try to understand and address how to bridge this gap. Disclosures No relevant conflicts of interest to declare.