Unveiling Discrepant and Rare Dihydropyrimidine Dehydrogenase (DPYD) Results Using an In-House Genotyping Test: A Case Series.

Fluoropyrimidine chemotherapy is a primary component of many solid tumor treatment regimens, particularly those for gastrointestinal malignancies. Approximately one-third of patients receiving fluoropyrimidine-based chemotherapies experience serious adverse effects. This risk is substantially higher in patients carrying DPYD genetic variants, which cause reduced fluoropyrimidine metabolism and inactivation (ie, dihydropyridine dehydrogenase [DPD] deficiency). Despite the known relationship between DPD deficiency and severe toxicity risk, including drug-related fatalities, pretreatment DPYD testing is not standard of care in the United States. We developed an in-house DPYD genotyping test that detects 5 clinically actionable variants associated with DPD deficiency, and genotyped 827 patients receiving fluoropyrimidines, of which 49 (6%) were identified as heterozygous carriers. We highlight 3 unique cases: (1) a patient with a false-negative result from a commercial laboratory that only tested for the c.1905 + 1G>A (*2A) variant, (2) a White patient in whom the c.557A>G variant (typically observed in people of African ancestry) was detected, and (3) a patient with the rare c.1679T>G (*13) variant. Lastly, we evaluated which DPYD variants are detected by commercial laboratories offering DPYD genotyping in the United States and found 6 of 13 (46%) did not test for all 5 variants included on our panel. We estimated that 20.4% to 81.6% of DPYD heterozygous carriers identified on our panel would have had a false-negative result if tested by 1 of these 6 laboratories. The sensitivity and negative predictive value of the diagnostic tests from these laboratories ranged from 18.4% to 79.6% and 95.1% to 98.7%, respectively. These cases underscore the importance of comprehensive DPYD genotyping to accurately identify patients with DPD deficiency who may require lower fluoropyrimidine doses to mitigate severe toxicities and hospitalizations. Clinicians should be aware of test limitations and variability in variant detection by commercial laboratories, and seek assistance by pharmacogenetic experts or available resources for test selection and result interpretation.

Sutimlimab: A Complement C1s Inhibitor for the Management of Cold Agglutinin Disease-Associated Hemolysis.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing and administration, and place in therapy of sutimlimab for the management of cold agglutinin disease (CAD)-associated hemolysis. DATA SOURCES: A literature search of PubMed (1966-October 2022) was conducted using the keywords sutimlimab, BIVV009, and cold agglutinin. Data were also obtained from prescribing information, meeting abstracts, and clinicaltrials.gov. STUDY SELECTION AND DATA EXTRACTION: All published prospective clinical trials, prescribing information, and meeting abstracts on sutimlimab for the treatment of CAD were reviewed. DATA SYNTHESIS: Sutimlimab is a first-in-class complement C1s inhibitor indicated for the treatment of CAD-associated hemolysis. This approval was based on the phase III CARDINAL trial, which evaluated sutimlimab in patients with CAD-associated hemolysis. The primary endpoint of achieving a hemoglobin of ≥12 g/dL or increase of ≥2 above baseline was achieved by 54% of patients with sutimlimab in the 26-week trial. The phase III CADENZA trial was a placebo-controlled trial in which sutimlimab has demonstrated a significant improvement in the composite endpoint of hemoglobin increase of ≥1.5 g/dL, avoidance of transfusion, and avoidance of additional CAD therapies (73% sutimlimab vs 15% placebo). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING DRUGS: Sutimlimab rapidly halts hemolysis, improves hemoglobin, and improves quality-of-life in patients with CAD. Safety issues with sutimlimab include infusion-related reactions and risk of serious infections with encapsulated bacteria. CONCLUSIONS: Sutimlimab provides an additional therapeutic option in the treatment of CAD-associated hemolysis that can lead to rapid improvement in hemoglobin and anemia-related symptoms.

Use of patient-reported outcome measures for oncology drugs receiving accelerated approval.

Patient-reported outcomes (PROs) represent an important evaluation of health-related quality of life that has become more commonly incorporated into oncology drug clinical trials. The frequency of PRO inclusion as an endpoint in oncology drug clinical trials leading to the initial accelerated approval of a new therapy is not yet known. We conducted a cross-sectional study evaluating all new drug applications submitted to the FDA over the past 10 years (2013-2022) that led to the initial approval of an oncology drug through the accelerated approval process. The objective was to assess whether the trials leading to such an approval included PROs. Between 2013 and 2022, the FDA approved 59 unique drugs for an oncology indication via the accelerated approval pathway, and 35 (59%) included a PRO assessment in the clinical trial. A median of 1 PRO measurement was used in each trial, with 23 different types of PRO assessment tools were used across the 59 new drug applications. In summary, we found that PRO measurements are inconsistently utilized in trials leading to initial accelerated approval of oncology drugs, and there seems to be a lack of harmonization of different PRO measurement tools used across trials.

Tafasitamab and lenalidomide for relapsed/refractory diffuse large B-cell lymphoma in a patient on chronic intermittent hemodialysis.

INTRODUCTION: Tafasitamab is an anti-CD19 monoclonal antibody indicated for the treatment of relapsed/refractory diffuse large B-cell lymphoma to be given in combination with lenalidomide. Experiences with tafasitamab in the setting of hemodialysis are limited and the efficacy and safety of this agent in this setting are unknown. CASE REPORT: We describe a patient with relapsed/refractory diffuse large B-cell lymphoma with hemodialysis-dependent end-stage renal disease who successfully received tafasitamab/lenalidomide. MANAGEMENT AND OUTCOME: Tafasitamab and reduced dose lenalidomide were initiated for relapsed diffuse large B-cell lymphoma. Tafasitamab was administered on non-dialysis days. Follow-up imaging for disease response assessment demonstrated a complete response. Therapy was well tolerated; the only major toxicity experienced was grade 4 neutropenia that resolved with dose adjustment to lenalidomide. Over a year from initiating therapy, the patient remains in a complete response. DISCUSSION/CONCLUSION: The combination of tafasitamab and dose-reduced lenalidomide produced a complete response in the treatment of relapsed/refractory diffuse large B-cell lymphoma in the setting of chronic intermittent hemodialysis.

Measuring the Impact of a Pharmacist-Driven Blood Factor Education Program: A Prospective, Single-Center Observational Study.

Introduction: Patients with bleeding disorders are best served by multidisciplinary teams. Pharmacists can play a critical role in the optimal management of patients with bleeding disorders through blood factor stewardship strategies and programs. An educational program was developed and implemented wherein a hematology pharmacist provided brief recorded lectures to an entire department of pharmacists in a multi-site health-system with the goal to improve the knowledge base and confidence among this population of general practitioners. Methods: The primary objective of this study was to evaluate the educational outcomes of a blood factor education program for pharmacists. The impact of the educational program was determined by measuring the difference in mean test scores between the pre- and post-program surveys. Results: The final analysis included 214 participants. The primary endpoint of mean competency test score was significantly improved in the post-test compared to pre-test (78.33% vs 52.83%; P < .0001). Any degree of test score improvement was observed in 99% (n = 212) of participants. Pharmacist confidence was significantly improved in all 20 domains of bleeding disorders and blood factor product verification and management. Conclusion: This program identified that most pharmacists in a large multi-site health-system were not familiar with bleeding disorders to a satisfactory degree, commonly because of the relative rare encounters with bleeding disorder-related orders, and that despite systems-based support there was an opportunity to improve practice through education. Such educational programming could be beneficial for the development of pharmacist-provided care and is a measure that could be implemented as part of blood factor stewardship initiatives.

Daratumumab for the Treatment of Multiple Myeloma: A Review of Clinical Applicability and Operational Considerations.

OBJECTIVE: To review the available data for the efficacy and safety of daratumumab in the treatment of multiple myeloma (MM), both in the newly diagnosed and relapsed/refractory settings, as well as provide additional guidance to clinicians on operational, safety, and supportive care considerations. DATA SOURCES: A literature search of PubMed (1966 to October 2021) was conducted using the keywords daratumumab, Darzalex, and myeloma. Data were also obtained from prescribing information and unpublished abstracts from meetings. STUDY SELECTION AND DATA EXTRACTION: All relevant published articles, prescribing information, and unpublished meeting abstracts on daratumumab for the treatment of MM were reviewed. DATA SYNTHESIS: Daratumumab is an anti-CD38 monoclonal antibody indicated for the treatment of MM. The addition of daratumumab to proteasome inhibitor and immunomodulatory drug-based regimens has led to a consistent improvement in progression-free survival and response rates in relapsed/refractory MM as per the POLLUX, CASTOR, APOLLO, and CANDOR trials. The ALCYONE and MAIA phase III trials have demonstrated an overall survival benefit when adding daratumumab to frontline regimens for transplant-ineligible patients with newly diagnosed MM. In transplant-eligible patients, daratumumab-based quadruplet regimens have improved depth of response in the CASSIOPIEA and GRIFFIN trials. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Operational and safety considerations that clinicians need to account for do exist, including different administration and infusion strategies, infusion-related reactions, increased risk for infectious complications, and interference with blood transfusion management. CONCLUSIONS: Daratumumab has led to a shift in the treatment paradigm of both newly diagnosed and relapsed/refractory MM, leading to improvements in outcomes such as response rates, depth of response, and progression-free survival.

Eptacog Beta for Bleeding Treatment and Prevention in Congenital Hemophilia A and B With Inhibitors: A Review of Clinical Data and Implications for Clinical Practice.

OBJECTIVE: To review the pharmacology, dosing and administration, safety, clinical efficacy, and role of eptacog beta in the treatment of congenital hemophilia with inhibitors. DATA SOURCES: A literature search of PubMed (1966 to August 2021) was conducted using the keywords eptacog beta, recombinant FVII, and hemophilia. STUDY SELECTION AND DATA EXTRACTION: All relevant published articles and prescribing information on eptacog beta for the treatment of congenital hemophilia with inhibitors were reviewed. DATA SYNTHESIS: Eptacog beta is a novel recombinant activated factor VII (rVIIa) product that demonstrated efficacy in controlling bleeding and associated pain in patients with hemophilia A or B with inhibitors. Eptacog beta has limited Food and Drug Administration-approved and off-label indications compared with other bypassing agents (BPAs; activated prothrombin complex concentrates [aPCC; eptacog alfa]). Eptacog beta costs less than eptacog alfa, but still more than aPCCs. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review provides insight into the role of eptacog beta for treatment of congenital hemophilia with inhibitors and reviews important health system formulary considerations for available BPAs. CONCLUSIONS: Eptacog beta is more cost-effective than eptacog alfa and, as such, may become the preferred rVIIa formulary product. However, eptacog alfa availability remains necessary for the treatment of disorders where eptacog beta has limited data. aPCC should remain the first-line BPA for the treatment of bleeding in patients with inhibitors with no contraindications to use because of its equivocal efficacy and safety and in light of the magnitude of cost savings associated with this strategy.

Risk factors associated with palbociclib-induced neutropenia in patients with metastatic breast cancer.

BACKGROUND: Neutropenia is the most common adverse event with palbociclib, an oral cyclin-dependent kinase 4/6 inhibitor, with grade 3/4 neutropenia occurring in up to 67% of patients in phase III trials evaluating this agent in metastatic breast cancer. This retrospective chart review assessed characteristics of patients on palbociclib to evaluate for risk factors in the development of grade 3/4 neutropenia. PATIENTS AND METHODS: Patients with metastatic breast cancer who received palbociclib were included. Patient demographics collected included age, gender, race, body mass index, breast cancer treatment history, palbociclib starting dose, baseline absolute neutrophil count, baseline platelet count, concomitant hormonal therapy, concomitant use of denosumab, and use of concomitant strong CYP3A4 inhibitors/inducers. Events of interest occurring within 30 days of initiation of palbociclib were also noted including antibiotic and corticosteroid use, mucosal conditions, open wounds, or surgery. The incidence and potential risk factors for grade 3/4 neutropenia in the first 6 months of treatment were analyzed. RESULTS: A total of 257 patients were included in the analysis with 206 patients (80.2%) and 139 patients (54.1%) experiencing all-grade neutropenia and grade 3/4 neutropenia, respectively. Multivariate analysis found baseline myelosuppression and recent antibiotic use to be independent predictors of grade 3/4 neutropenia. Normal weight patients had an increased risk for grade 3/4 neutropenia compared to obese patients by multivariate analysis. CONCLUSION: The results of this study showed baseline myelosuppression and recent antibiotic use within 30 days of palbociclib initiation were predictive of a higher incidence of grade 3/4 neutropenia. Obese patients were less likely to develop grade 3/4 neutropenia compared to normal weight patients.

Impact of obesity on safety outcomes and treatment modifications with ado-trastuzumab emtansine in breast cancer patients.

INTRODUCTION: Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate indicated for the treatment of HER2-positive breast cancer. The 2012 American Society of Clinical Oncology guidelines on chemotherapy dosing in obesity recommend using full weight-based cytotoxic chemotherapy doses to treat obese patients with cancer. These guidelines were published prior to the advent of anticancer antibody-drug conjugates. There is a need to investigate the safety of T-DM1 in obese patients. METHODS: This retrospective chart review included adult patients with breast cancer receiving T-DM1. The primary endpoint was a composite of the incidence of T-DM1 treatment modifications secondary to an adverse event. Secondary outcomes included the incidence of dose reductions, dose delays, treatment discontinuations, and adverse events. RESULTS: A total of 119 patients with HER2-positive breast cancer who received T-DM1 therapy were included in this study: 44 obese patients and 75 non-obese patients. The composite outcome of treatment modifications due to toxicity was significantly higher in obese patients compared to non-obese patients (45% vs 25%, p = 0.024). Treatment delays were significantly higher in obese patients (36% vs 16%, p = 0.011). All-grade adverse events with a higher incidence in obese patients included left ventricular ejection fraction decrease (11% vs 5%), bilirubin increase (32% vs 12%), thrombocytopenia (61% vs 55%), and peripheral neuropathy (34% vs 27%). CONCLUSIONS: This study suggests obese patients receiving T-DM1 may require more treatment modifications secondary to adverse events compared to non-obese patients. Larger studies are needed to determine if obese patients are at higher risk for specific T-DM1-induced adverse events.

Implementation, utilization, and evaluation of a pharmacist-driven romiplostim dosing service for patients with immune thrombocytopenia at a multisite cancer centre.

INTRODUCTION: Romiplostim is a thrombopoietin receptor agonist approved for the treatment of patients with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immune globulin, or splenectomy. Dose adjustments of romiplostim are based on platelet counts and follow a dosing schema that requires frequent monitoring. As a quality improvement initiative to increase clinical efficiency and promote clinical pharmacy services at our institution, we developed a collaborative practice agreement and implemented a novel pharmacist-driven romiplostim dosing protocol. METHODS: A retrospective chart review was conducted to evaluate the acceptance, utilization, and impact of the pharmacist-driven romiplostim dosing service. The primary outcome of our analysis was the adoption rate by providers of the romiplostim pharmacist dosing service. Secondary endpoints were focused on patients newly initiating romiplostim on the dosing service and included platelet responses and number of dose adjustments by a pharmacist. RESULTS: A total of 54 patients received romiplostim in our analysis: 25 patients who had already been receiving romiplostim and 29 patients who newly initiated romiplostim during the study period. Of the 29 patients newly initiating romiplostim, 27 (93%) had their dosing managed by a pharmacist Twenty-one patients (84%) and 18 patients (75%) achieved an initial and durable response with romiplostim, respectively. Pharmacists made a median of 3 dose adjustments to romiplostim per patient. CONCLUSION: The implementation of a pharmacist-driven romiplostim dosing service led to a significant adoption and utilization by physicians at our health system.

New and emerging therapies for the treatment of relapsed/refractory diffuse large B-cell lymphoma.

Diffuse large B-cell lymphoma (DLBCL) is the most common form of aggressive non-Hodgkin lymphoma. Approximately 40% of patients with DLBCL will experience disease relapse or will be refractory to first line chemoimmunotherapy, necessitating second-line salvage therapy. This has historically consisted of platinum-based chemotherapy regimens followed by autologous hematopoietic stem cell transplantation with curative intent for transplant-eligible patients or palliative chemotherapy for transplant-ineligible patients. In recent years there have been several new therapeutic agents approved for the treatment of relapsed/refractory DLBCL, thereby expanding the therapeutic landscape. These agents include polatuzumab vedotin, tafasitamab, loncastuximab tesirine, selinexor, and anti-CD19 chimeric antigen receptor T-cell therapies such as axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. This review summarizes the pharmacology, efficacy, safety, dosing, and administration of new agents recently approved for the treatment of relapsed/refractory DLBCL.

Comparative Utilization and Efficacy of Thrombopoietin Receptor Agonists in Relapsed/Refractory Immune Thrombocytopenia.

BACKGROUND: The thrombopoietin (TPO) agonists, eltrombopag and romiplostim, stimulate the production of platelets and offer an effective treatment option in relapsed/refractory immune thrombocytopenia (ITP). Recently published 2019 ITP guidelines recommend the TPO agonists as second-line therapy following corticosteroids; however, little data offer insights into comparative efficacy and tolerability. STUDY QUESTION: Is there a difference in the efficacy between romiplostim and eltrombopag in relapsed/refractory ITP? STUDY DESIGN: We conducted a single-center, retrospective chart review of patients with ITP treated with romiplostim or eltrombopag. MEASURES AND OUTCOMES: The primary objective was a sustained platelet response, defined as platelets greater than 50,000/µL in more than 66% of clinic visits over a 6-month period. Secondary objectives sought to evaluate response to and tolerability of TPO agonists. RESULTS: The study included 107 consecutive patients, 67 (63%) on romiplostim and 40 (37%) on eltrombopag. Previous corticosteroids and rituximab were used in 95% and 50% of patients, respectively. There was no difference identified in platelet responses between the TPO-RAs, 72% romiplostim versus 65% eltrombopag (P = 0.520). In addition, no differences were identified in secondary measures of response. CONCLUSIONS: In our experience with romiplostim and eltrombopag for ITP, we did not identify a difference in the efficacy of these agents. Further larger and prospective evaluations should be considered.

Bruton tyrosine kinase inhibitors for Waldenström macroglobulinemia: A review.

OBJECTIVE: The objective of this review is to evaluate the available evidence for the Bruton tyrosine kinase inhibitors in the treatment of Waldenström macroglobulinemia. DATA SOURCES: A search of the PubMed database was conducted using the following search terms: ibrutinib, PCI-32765, acalabrutinib, ACP-196, zanubrutinib, BGB-3111, and Waldenström macroglobulinemia. Prospective clinical trials evaluating the efficacy and safety of ibrutinib, acalabrutinib, and zanubrutinib in patients with Waldenström macroglobulinemia were evaluated. Abstracts from the American Society of Hematology and American Society of Clinical Oncology annual meetings were reviewed as well as the prescribing information for each drug. DATA SUMMARY: The first-generation Bruton tyrosine kinase inhibitor ibrutinib received Food and Drug Administration approval for Waldenström macroglobulinemia in 2015; this was the first drug approved for this rare condition. Ibrutinib has been evaluated as monotherapy and in combination with rituximab for the treatment of Waldenström macroglobulinemia. Since then, second-generation Bruton tyrosine kinase inhibitors, acalabrutinib and zanubrutinib, have been evaluated in prospective clinical trials for the treatment of Waldenström macroglobulinemia. All three agents have demonstrated high overall response rates and durable responses. CONCLUSION: Bruton tyrosine kinase inhibitors have demonstrated significant clinical activity in the treatment of Waldenström macroglobulinemia, both in treatment naïve as well as the relapsed/refractory patient populations.

Evaluation of a pharmacist-driven rapid infusion rituximab conversion protocol at a multisite cancer center.

INTRODUCTION: Infusion-related reactions (IRR) are a common adverse event associated with rituximab, an anti-CD20 monoclonal antibody indicated for the treatment of B-cell lymphomas. IRR risk is highest with the first infusion, which is given by a slow titration over an average of 3.5 hours. Subsequent administrations can be given over an accelerated, rapid 90-minute infusion if patients meet specific criteria. To improve rapid infusion rituximab utilization, we developed and implemented a pharmacist-driven protocol which allows pharmacists to change the administration instructions to rapid infusion. METHODS: A retrospective chart review was conducted to evaluate patients age ≥18 years with B-cell lymphomas who were eligible to receive rapid infusion rituximab following protocol implementation. The primary outcome was the prevalence of the use of rapid infusion rituximab for eligible patients. Secondary outcomes included the frequency of pharmacist-initiated conversions to rapid infusion rituximab and incidence of IRR with rapid infusions. RESULTS: A total of 180 patients were included in this study; 89 patients in the pre-protocol group and 91 patients in the post-protocol group. Fifteen patients and 66 patients in the pre-protocol and post-protocol groups, respectively, received rapid infusion rituximab (17% vs. 73%, p < 0.00001). The pharmacist-driven protocol was used to convert 49 patients (54%) to rapid infusion. No IRR occurred in patients receiving rapid infusion rituximab. CONCLUSION: The implementation of a pharmacist-driven protocol led to a significant improvement in the use of rapid infusion rituximab and optimized chair time utilization at our institution.

Ibrutinib treatment via alternative administration in a patient with chronic lymphocytic leukemia and dysphagia.

INTRODUCTION: Ibrutinib is a small molecule inhibitor of Bruton's tyrosine kinase indicated for the treatment of a variety of B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, marginal zone lymphoma, and Waldenstrom's macroglobulinemia. These indolent hematologic malignancies are considered diseases of the elderly, a population that may have dysphagia leading to difficulty swallowing tablets and capsules. Ibrutinib is currently not available in a liquid oral dosage form. We report the utilization and clinical outcomes associated with alternative administration of ibrutinib capsules in a patient with chronic lymphocytic leukemia and significant dysphagia. CASE REPORT: An 86-year old female requiring chronic lymphocytic leukemia-directed therapy due to a rising absolute lymphocyte count and worsening, transfusion-dependent anemia with a past medical history of dementia and dysphagia, was initiated on ibrutinib. MANAGEMENT & OUTCOME: Due to the patient's significant inability to swallow, ibrutinib capsules were administered via an alternative method by opening them and sprinkling onto soft food or applesauce. With ibrutinib therapy, the patient has had a significant clinical response in her chronic lymphocytic leukemia as evidenced by her decreased absolute lymphocyte count and achieving transfusion independence with improvements in hemoglobin. DISCUSSION: Ibrutinib administration via this alternative method resulted in an initial clinical response in the treatment of our patient's chronic lymphocytic leukemia as evidenced by a decreasing absolute lymphocyte count and improved anemia that achieved transfusion independence. The patient has maintained this response to therapy after approximately 1 year at the time of manuscript preparation.

Publication rates of hematology/oncology abstracts presented at major pharmacy association meetings.

INTRODUCTION: Professional conferences are where research findings are initially presented. Studies suggest many research ideas presented at conferences are never published. Previous studies have demonstrated that the full publication rate of abstracts presented at pharmacy meetings is approximately 20%. The objective of this study was to determine the full publication rate of hematology/oncology abstracts presented at major pharmacy organization annual meetings. METHODS: A systematic search of PubMed and Google Scholar was performed. Publication status was evaluated for hematology/oncology abstracts presented at annual meetings for the following organizations: American College of Clinical Pharmacy Annual Meeting, American Society of Health-System Pharmacists Midyear Clinical Meeting, Hematology/Oncology Pharmacy Association Annual Meeting, and International Society of Oncology Pharmacy Practitioners Annual Meeting. Data collected included the meeting of abstract presentation, number of authors, abstract study type, country of origin, journal of publication, and type of publication. Abstracts presented as trainee research were excluded. RESULTS: Of 451 oncology abstracts evaluated, the most common topic categories included pharmacotherapy (n = 244; 54.1%), clinical pharmacy practice (n = 84; 18.6%), and operational/compounding (n = 69; 15.3%). The overall publication rate was 17.5% (n = 79). Abstracts were published as full manuscripts over a spread of 48 different journals. Factors associated with full publication included abstracts with more than 5 authors (OR 3.86, 95% CI 2.32-6.43; p < 0.0001) and abstracts presented at oncology-focused pharmacy meetings (OR 2.92, 95% CI 1.49-5.72; p = 0.0018). CONCLUSION: This study showed an overall publication rate of 17.5% for abstracts presented at pharmacy meetings, consistent with prior studies.

Retrospective Analysis of Clinical Outcomes Associated With the Use of Pegfilgrastim On-body Injector in Patients Receiving Chemotherapy Requiring Granulocyte Colony-Stimulating Factor Support.

Objectives: Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used as primary prophylaxis in patients receiving myelosuppressive chemotherapy regimens that have greater than 20% risk of developing febrile neutropenia (FN). Historically, pegfilgrastim has been administered 24 to 72 hours after chemotherapy, necessitating a return to clinic to receive the provider-administered injection. An alternative option is the pegfilgrastim on-body injector (OBI). With the OBI device, patients have their pegfilgrastim administered 27 hours after receiving chemotherapy while remaining at home, avoiding an additional clinic appointment. Concerns with pegfilgrastim OBI include lack of experience with the device in both the patient and provider, device-related failures, and the success of delivery. This study evaluates pegfilgrastim OBI failure rates through associated patient outcomes among cancer patients receiving chemotherapy requiring G-CSF. Methods: A retrospective electronic chart review was conducted of adult patients with cancer who received chemotherapy and pegfilgrastim OBI from July 1, 2016, to July 31, 2018. The primary objective of this study was the incidence of FN in patients receiving pegfilgrastim OBI. Results: There were no reported cases of hospitalization due to FN in patients who received pegfilgrastim OBI. Dose delays and dosage modifications were not observed in our review. The OBI device failure rate was found to be low (1.92%). Conclusion: The low device failure rate from this study suggests that the OBI is a viable option for administration of pegfilgrastim in patients receiving chemotherapy requiring G-CSF.

Mogamulizumab: An Anti-CC Chemokine Receptor 4 Antibody for T-Cell Lymphomas.

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing, and administration of mogamulizumab for the treatment of T-cell lymphomas. Data Sources: A literature search of PubMed (1966 to September 2019) was conducted using the keywords mogamulizumab, KW-0761, and lymphoma. Data were also obtained from package inserts and meeting abstracts. Study Selection and Data Extraction: All relevant published articles, package inserts, and unpublished meeting abstracts on mogamulizumab for the treatment of T-cell lymphomas were reviewed. Data Synthesis: Mogamulizumab is an anti-CC chemokine receptor 4 (CCR4) monoclonal antibody that has demonstrated activity in various T-cell lymphomas. It was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) who have been treated with at least 1 prior line of therapy. Mogamulizumab demonstrated significant improvement in progression-free survival compared with vorinostat in patients with relapsed or refractory MF or SS. Serious adverse events associated with mogamulizumab include infusion-related reactions, cutaneous drug eruption, and autoimmune complications. Mogamulizumab administration in the preallogeneic hematopoietic stem cell transplant setting can increase the risk for severe posttransplant graft-versus-host disease. Relevance to Patient Care and Clinical Practice: Mogamulizumab is a first-in-class CCR4 inhibitor, providing a new option in the treatment of relapsed or refractory cutaneous T-cell lymphomas. Although not currently FDA approved for this indication, mogamulizumab may have some utility for the treatment of relapsed adult T-cell leukemia/lymphoma. Conclusion: The recent approval of mogamulizumab represents an important addition to the armamentarium of pharmacotherapies for T-cell lymphomas.

Vonicog alfa for the management of von Willebrand disease: a comprehensive review and single-center experience.

Von Willebrand Disease (VWD) is characterized by a qualitative or quantitative defect in von Willebrand factor that results in prolonged bleeding due to the inability to form a stable platelet plug. VWD is the most common inherited bleeding disorder. The mainstay of treatment of VWD includes desmopressin; with plasma-derived von Willebrand Factor concentrates reserved for patients with severe VWD or those with desmopressin intolerability. Although efficacious, plasma-derived factor concentrates can have risks associated with them including minimal risk of pathogenic transmission, potential to contain extraneous plasma proteins and cause severe allergic reactions, and a supply limited by plasma donor availability. Vonicog alfa is a recombinant von Willebrand Factor product. Two phase III trials evaluated the safety and efficacy of vonicog alfa in preventing perioperative bleeding and treating acute bleeding in patients with VWD. Beyond the clinical trials, there has been little real-world experience published regarding experiences with this medication. This article comprehensively reviews the efficacy, safety, pharmacokinetics, and pharmacodynamics of vonicog alfa. These points will be discussed using institutional experiential data from the University of Virginia (UVA) Health System in relation to the clinical studies. The goal of this review article is to offer insights to clinical directions, discuss operational challenges, and offer guidance for future studies and formulary decisions.

Implementation of a pilot electronic stroke outcome reporting system for emergency care providers.

INTRODUCTION: Emergency department (ED) providers and clinicians find that feedback on acute stroke patients is rewarding, valuable to professional development, and helpful for practice improvement. However, feedback is rarely provided, particularly for patients with stroke. Here we describe the implementation of an electronic stroke outcome reporting tool for providing feedback to ED providers. METHODS: We sought to evaluate the implementation of an electronic stroke outcome reporting tool at 3 Nashville hospitals. ED staff and providers voluntarily enrolled to receive de-identified reports of clinical (e.g., survival) and operational (e.g., timeliness) outcomes of patients with acute ischemic stroke and were offered free continuing education (CE) credits for following up on patients. We evaluated the implementation of this system through a descriptive evaluation of the feasibility, use of the system and CE, and perceived usefulness of the reports. RESULTS: We enrolled 232 ED providers, including 107 (46%) nurses and 57 (25%) attending physicians and transmitted 55 stroke outcome reports. Reports took 30-60 min to compile and were viewed by a mean of 2.6 (SD 1.5) registered providers; 97.1% found the reports useful and 36.2% reported likelihood to change practice. Continuing education credits were initiated or claimed by 22 providers. CONCLUSIONS: An electronic stroke outcome reporting tool was used and liked by ED staff and providers but the time to compile the reports is the major challenge to scalability. Future research should address the effectiveness of this reporting tool as a source of provider education and its impact on clinical and operational outcomes.