Obinutuzumab Infusion-Related Reactions: Multicenter Retrospective Evaluation of Incidence, Severity, and Risk Factors.

Introduction: Despite standard prevention strategies, obinutuzumab carries a significant risk of infusion-related reactions (IRRs) for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Reported rates of IRRs vary in phase III clinical trials evaluating obinutuzumab-containing regimens. Although obinutuzumab has a higher rate of severe (grade 3 and higher) IRRs than rituximab, clinical risk factors predicting IRR have not been identified, and therefore strata informing patient-specific risk of IRR have not been applied in practice.

Advances in Myelofibrosis Management: New Janus Kinase Inhibitors Beyond Ruxolitinib.

Myelofibrosis is a myeloproliferative neoplasm characterized by the buildup of fibrous scar tissue in the bone marrow occurring secondary to the secretion of inflammatory cytokines, leading to cytopenias, dysfunctional hematopoiesis, and constitutional symptoms. One of the pathologic mechanisms that underlies myelofibrosis is aberrant activation of the Janus kinase (JAK)-STAT pathway. Targeting the JAK-STAT pathway via JAK inhibition can lead to significant improvements in spleen volume reduction and symptom improvement in intermediate- and high-risk myelofibrosis.

Incorporating pharmacoequity in the formulary review and evaluation process: Opportunities for health-system P&T committees to address health disparities and inequities.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes.

For patients with hematologic malignancies requiring allogeneic stem cell transplantation, alternative donor sources are needed when lacking access to a matched related or unrelated donor. Umbilical cord blood (UCB) has been an important alternative allograft donor source for these patients; however, several limitations exist. Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from UCB.

A second chance for avatrombopag in chemotherapy-induced thrombocytopenia.

Chemotherapy-induced thrombocytopenia (CIT) remains a common complication of cancer therapy with no approved available treatments in most of the world. Although a prior clinical trial of avatrombopag for CIT did not meet its primary end-point, a report from Galamaga and colleagues raises prospects for a second chance for avatrombopag in CIT, highlighting the differences between nadir and persistent CIT and the importance of patient selection in CIT treatment. Commentary on: Galamaga et al.

Oncology stewardship practice in the United States: A Hematology/Oncology Pharmacy Association national survey.

Introduction: The treatment of cancer is associated with high risk for toxicity and high cost. Strategies to enhance the value, quality, and safety of cancer care are often managed independently of one another. Oncology stewardship is a potential framework to unify these efforts and enhance outcomes.

Hemophagocytic lymphohistiocytosis induced by dabrafenib-trametinib in a patient with metastatic melanoma: a case report and pharmacovigilance analysis.

Hemophagocytic lymphohistiocytosis (HLH) has been reported rarely with BRAF/MEK inhibitor combinations, including dabrafenib/trametinib. Postmarketing pharmacovigilance analyses evaluating outcomes associated with dabrafenib/trametinib-induced HLH are also lacking. Herein, we report a case of dabrafenib/trametinib-induced HLH in a patient with metastatic melanoma.

Real-world clinical outcomes with fostamatinib for the treatment of refractory chronic immune thrombocytopenia: a single-center experience.

Fostamatinib is a spleen tyrosine kinase inhibitor indicated for the treatment of chronic immune thrombocytopenia (ITP) unresponsive to a previous treatment. Real-world studies evaluating the utilization and effectiveness of fostamatinib outside the context of a clinical trial are lacking. The objective of this analysis was to evaluate the effectiveness of fostamatinib for the treatment of ITP in a real-world cohort.

Real-World Impact of an In-House Dihydropyrimidine Dehydrogenase () Genotype Test on Fluoropyrimidine Dosing, Toxicities, and Hospitalizations at a Multisite Cancer Center.

Purpose: Fluoropyrimidine-related toxicity and mortality risk increases significantly in patients carrying certain genetic variants with standard dosing. We implemented genotyping at a multisite cancer center and evaluated its impact on dosing, toxicity, and hospitalization.

Methods: In this prospective observational study, patients receiving (reactive) or planning to receive (pretreatment) fluoropyrimidine-based chemotherapy were genotyped for five variants as standard practice per provider discretion.

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).

PD-1/PD-L1 inhibitor-induced immune thrombocytopenia: A pharmacovigilance study and systematic review.

Introduction: Programmed cell death-1 (PD-1) and programmed cell death ligand-1 (PD-L1) immune checkpoint inhibitors (ICIs) are used for a variety of cancers and are associated with a risk of developing immune-related adverse events, most commonly dermatitis, colitis, hepatitis, and pneumonitis. Immune-mediated hematologic toxicities have been reported, but are less well-described in the literature. Immune thrombocytopenia (ITP) is a rare autoimmune, hematologic adverse event that has been reported with PD-1/PD-L1 inhibitors.

Alpelisib-Induced Diabetic Ketoacidosis: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System and Review of the Literature.

Background: Alpelisib is a PI3K inhibitor indicated with fulvestrant for treatment of advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated breast cancer. In the phase III SOLAR-1 trial, grade 3/4 hyperglycemic events were reported in 36.6% of patients receiving alpelisib-fulvestrant compared to 0.

The Emerging Role of Reinforcement in the Clinician's Path from Continuing Education to Practice.

Introduction: Continuing education (CE) activities may affect clinicians' knowledge, skills, self-efficacy, and/or performance. Studies have suggested that self-efficacy may moderate or mediate the relationship between knowledge/competence and performance. Some results have shown that increases in knowledge/competence contributed to increases in self-efficacy.

Post-Transplant Cyclophosphamide for the Prevention of Graft-vs.-Host Disease in Allogeneic Hematopoietic Cell Transplantation: A Guide to Management for the Advanced Practitioner.

Cyclophosphamide remains a critical component to haploidentical transplant conditioning regimens. Post-transplant cyclophosphamide (PTCy) emerged as an effective component of graft-vs.-host disease (GVHD) prophylaxis in the nonmyeloablative haploidentical bone marrow transplant setting.

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.

Ocular toxicities associated with antibody drug conjugates and immunotherapy in oncology: clinical presentation, pathogenesis, and management strategies.

Introduction: The development of molecularly targeted anticancer therapies and immunotherapy continues to revolutionize the treatment of cancer. FDA accelerated approvals of novel targeted therapies allowed for introduction of these agents into the clinic at a rapid rate. On-and off-target ocular toxicities are prevalent treatment-related adverse events of newer therapies including antibody drug conjugates (ADCs) and immunotherapy.