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Introduction: To date, there is no adherence estimator to identify risk of nonadherence prior to initiating oral oncolytics. Methods: A workgroup was assembled through the National Community Oncology Dispensing Association and tasked with creating a tool to meet this need. Tool constructs were defined after a review of the literature identifying top barriers to adherence. A second literature search was conducted to identify questions targeting specific barriers from validated adherence questionnaires. Once a finalized draft was complete, the risk assessment tool was built into an electronic survey where a risk category can be automatically calculated for the patient. Results: The six most impactful factors affecting compliance to oral oncolytics were identified as patient's confidence, health literacy, perception of treatment, quality of life, social support, and complexity of chemotherapy regimen. A six-item questionnaire was created with five patient-directed questions and one clinician-directed question. Examples and descriptions were provided for clinicians to consider when categorizing complexity of a regimen. The tool was designed for responses to each question to be indexed into categories through a 10-point system. Results will be stratified into low, moderate, or high risk for nonadherence. Conclusion: The creation of a tool to predict nonadherence prior to starting therapy is an unmet need for patients initiating oral oncolytics. The aim of this tool is to meet those needs and better guide clinicians to provide patients with strategies to better manage nonadherence. Next steps include tool validation and piloting in clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: Luspatercept is approved for patients with very low-to intermediate-risk myelodysplastic syndrome (MDS). Dosing is based on pre-dose hemoglobin levels and transfusion requirements. This study aims to evaluate if a site with a pharmacist prospectively reviewing luspatercept doses achieves dose optimization, compared to a site that does not have a pharmacist prospectively reviewing doses. Methods: We performed a retrospective chart review involving patients age ≥18 years or older with MDS at a major academic medical center main campus, which does not have a pharmacist prospectively review luspatercept doses, and a satellite campus infusion center, which has a pharmacist prospectively reviewing doses. Patients included received at least one dose of luspatercept between January 1, 2017 through August 31, 2022. The primary endpoint is the percentage of off-label luspatercept doses not consistent with prescribing information (PI) recommended dose adjustments. Results: The study included 17 patients. Of the 162 doses evaluated, 37 (23%) were off-label. Off-label dosing at the main campus was more common than at a satellite location (29.6% vs. 2.4%; p < 0.003). More patients achieved transfusion independence at the satellite compared to the main campus (83.3% vs. 27.3% p < 0.39). Conclusions: There was a higher percentage of off-label dosing at a center without a pharmacist's prospective review vs. a center with a pharmacist's prospective review. On-label dose optimization may lead to a higher percentage of patients achieving transfusion independence. Enhancements in the current ordering and review process can be improved with the involvement of a pharmacist's prospective involvement at both centers. [ABSTRACT FROM AUTHOR]

Introduction: This study was designed to describe the landscape of oncology pharmacy practice at patient facing institutional healthcare organizations throughout the United States. Methods: The Hematology/Oncology Pharmacy Association (HOPA) Practice Outcomes and Professional Benchmarking Committee conducted a multi-organization, voluntary survey of HOPA members between March 2021 and January 2022. Four overarching domains were targeted: institutional description, job function, staffing, and training/certification. Data were evaluated using descriptive statistics. Results: A total of 68 responses were analyzed including 59% and 41% who self-identified their organization as academic and community centers, respectively. The median number of infusion chairs and annual infusion visits were 49 (interquartile range (IQR): 32–92) and 23,500 (IQR: 8300–300,000), respectively. Pharmacy departments reported to a business leader, physician leader, and nursing leader 57%, 24%, and 10% of the time, respectively. The median oncology pharmacy full-time equivalents was 16 (IQR: 5–60). At academic centers, 50% (IQR: 26–60) of inpatient and 30% (IQR: 21–38) of ambulatory pharmacist FTEs were dedicated to clinical activities. At community centers, 45% (IQR: 26–65) of inpatient and 50% (IQR: 42–58) of ambulatory pharmacist FTEs were dedicated to clinical activities. As many as 18% and 65% of organizations required or encouraged certification for oncology pharmacists, respectively. The median number of Board-Certified Oncology Pharmacists was 4 (IQR: 2–15). Conclusion: As the number of patients with cancer rises, the oncology workforce must grow to support this expanding population. These results describe the practice landscape of oncology pharmacy at US healthcare institutions to serve as a foundation for future research evaluating metrics and benchmarks. [ABSTRACT FROM AUTHOR]

Introduction: Tyrosine kinase inhibitor (TKI) use leads to near-normal life expectancy in patients with chronic myeloid leukemia (CML); unfortunately for some patients, adverse drug effects (ADEs) and medication burden associated with TKI therapy can lead to decreased quality of life. Additionally, TKIs have drug interactions that may negatively impact patients' management of co-morbidities or lead to increased ADEs. Case report: A 65-year-old female with a history of anxiety treated and controlled with venlafaxine experienced increased and resistant anxiety and insomnia after starting dasatinib for CML. Management and outcome: On dasatinib, the patient experienced worsening anxiety and insomnia. The stress of a new leukemia diagnosis, drug interactions, and ADEs from dasatinib were considered possible causes. Dose adjustments to dasatinib and venlafaxine were made to control the patient's symptoms. However, the patient's symptoms did not resolve. After being on dasatinib for 2.5 years, the patient discontinued TKI therapy due to being in a deep molecular remission and given ongoing challenges managing anxiety. Within 4 months of stopping dasatinib, the patient reported an improvement in anxiety and overall emotional wellbeing. She continues to feel better and remains in a complete molecular remission 20 months off treatment. Discussion: This case demonstrates a possible previously unknown drug interaction with dasatinib as well as a possible rarely reported ADE of dasatinib. Additionally, it highlights the difficulties patients with psychiatric disorders may face on TKI therapy and challenges providers may have in identifying rare psychiatric ADEs, thus emphasizing the need for documentation of these types of cases. [ABSTRACT FROM AUTHOR]

Introduction: In this study, we aim to determine the risk of bleeding or thrombosis with concurrent use of tyrosine kinase inhibitors (TKIs) used to treat CML, and serotonin reuptake inhibitors (SSRIs). Methods: We conducted a retrospective cohort study of patients with CP-CML cared for at Massachusetts General Hospital (MGH) between April 2016 to February 2021. Participants were included if diagnosed with CP-CML and began TKI treatment (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) after April 2016. Results: One hundred patients were evaluated, eighty of whom were taking TKIs only (median age 55, 40% female), and twenty were taking TKI and SSRI concomitantly (median age 53.5, 55% female). Baseline demographics between these groups were similar across all variables. Patients in the TKI only group had 9 bleeding events and 3 thrombotic events. Patients in the combination group had 6 bleeding events and 1 thrombotic event. There was no difference between overall rates of major bleeding (4% v. 10%, p = 0.26) or thrombotic events (4% v. 5%, p = 1). However, patients in the combination group were more likely to have major intracranial bleeding events (0% v. 10%, p = 0.04), and there was a trend to significance for minor bleeding events (7.5% v. 20%, p = 0.11). Conclusions: Concomitant use of TKIs and SSRIs does not appear to increase the total risk of bleeding or thrombotic events compared to patients on TKIs only. However, concomitant use of TKIs and SSRIs may increase risk of intracranial bleeding. Further work is needed to fully assess this risk. [ABSTRACT FROM AUTHOR]

Background Methicillin-susceptible Staphylococcus aureus (MSSA) is a common cause of bloodstream infection (BSI) in patients with febrile neutropenia, but treatment practices vary, and guidelines are not clear on the optimal regimen. Methods We conducted a multicenter retrospective cohort study of MSSA BSI in febrile neutropenia. We divided patients into 3 treatment groups: (1) broad-spectrum beta-lactams (ie, piperacillin-tazobactam, cefepime, meropenem); (2) narrow-spectrum beta-lactams (ie, cefazolin, oxacillin, nafcillin); and (3) combination beta-lactams (ie, both narrow- and broad-spectrum). We used multivariable logistic regression to compare 60-day mortality and bacteremia recurrence while adjusting for potential confounders. Results We identified 889 patients with MSSA BSI, 128 of whom had neutropenia at the time of the index culture: median age 56 (interquartile range, 43–65) years and 76 (59%) male. Of those, 56 (44%) received broad-spectrum beta-lactams, 30 (23%) received narrow-spectrum beta-lactams, and 42 (33%) received combination therapy. After adjusting for covariates, including disease severity, combination therapy was associated with a significantly higher odds for 60-day all-cause mortality compared with broad spectrum beta-lactams (adjusted odds ratio [aOR], 3.39; 95% confidence interval [CI], 1.29–8.89; P  = .013) and compared with narrow spectrum beta-lactams, although the latter was not statistically significant (aOR, 3.30; 95% CI,.80–13.61; P  = .071). Conclusions Use of combination beta-lactam therapy in patients with MSSA BSI and febrile neutropenia is associated with a higher mortality compared with treatment with broad-spectrum beta-lactam after adjusting for potential confounders. Patients in this study who transitioned to narrow-spectrum beta-lactam antibiotics did not have worse clinical outcomes compared with those who continued broad-spectrum beta-lactam therapy. [ABSTRACT FROM AUTHOR]

BACKGROUND: Chronic myeloid leukemia is a myeloproliferative neoplasm treated with long-term tyrosine kinase inhibitors (TKIs), including first-generation imatinib or second-generation TKIs (ie, dasatinib, nilotinib, or bosutinib). An uncommon adverse event of treatment with imatinib or with dasatinib is gynecomastia. Imatinib-induced gynecomastia has been well-described in the literature, but dasatinib-induced gynecomastia has been scarcely reported. DISCUSSION: We present 2 cases of dasatinib-induced gynecomastia and discuss the literature related to the mechanism of gynecomastia, treatment options, as well as patient education and monitoring. The 2 patients had very different onset of gynecomastia-one of these patients had symptoms after 2 months, and the other patient had symptoms after 4 years. The hormone levels were within normal limits in both patients. The postulated mechanisms for gynecomastia include the inhibition of platelet-derived growth factor and/or c-KIT, which contribute to testosterone production and secretion. The therapeutic approaches to gynecomastia include androgen support, tamoxifen, or switching to a different TKI. Both of our patients continued to use dasatinib without intervention, based on patient preference and the stable symptoms of gynecomastia. CONCLUSION: Based on the prevalence of low testosterone levels during imatinib and dasatinib therapy, it may be appropriate to monitor the patient's testosterone levels at baseline before starting dasatinib (or imatinib) therapy. Patients should be educated on the symptoms of low testosterone, including decreased libido, impotence, and hydrocele. [ABSTRACT FROM AUTHOR]

BACKGROUND: As medication experts, pharmacists play a critical role in educating and advising members of the cancer care team to optimize the use of oral anticancer agents, which can be convenient options for patients but are associated with novel adverse effects that are different from conventional cytotoxic chemotherapy. Because of increased demand for pharmacy services, including postgraduate year 2 (PGY2) oncology residents in these efforts may help expand pharmacy services. OBJECTIVE: To assess the feasibility and barriers to instituting a new PGY2 oncology pharmacy resident-led medication reconciliation and patient education service for patients with leukemia who are receiving oral anticancer therapy. METHODS: This single-center pilot study was conducted from September 1, 2019, to January 31, 2020, in a 1000-bed academic medical center and outpatient infusion clinic. Eligible inpatients and ambulatory patients with leukemia were identified through notification from the treating provider or the inpatient pharmacist, via e-mail from the prior authorization nurse, or via PGY2 oncology pharmacy resident chart review. Data collection included baseline demographics, diagnosis, patient identification method, oral anticancer therapies, interventions made, and the length of the encounter. Patients with altered mental status and those who declined patient education were excluded. RESULTS: Of the 28 patients identified during the pilot study period, 26 met the eligibility criteria and received the PGY2 oncology pharmacy resident-led pharmacy services. The PGY2 oncology pharmacy resident made a median of 3 interventions per patient. The interventions included medication reconciliation in all patients (N = 26; 100%), medication education (N = 26; 100%), identification of drug-drug interactions (N = 5; 19.2%), supportive care optimization (N = 5; 19.2%), and the identification of barriers to medication access (N = 1; 3.8%). The barriers to the implementation of this new PGY2 oncology pharmacy resident-led service included patient identification, time commitment, and complex coordination of care. CONCLUSION: The use of pharmacy extenders in a layered learning model can be an effective way to expand clinical pharmacy services and optimize patient care. Based on the experience gained in this pilot study, we are exploring restructuring the current full-time equivalents to expand the role of the pharmacist in the clinic. Further directions for expansion include telehealth services, longitudinal patient follow-up, and collaborative practice agreements to facilitate smoother workflow. [ABSTRACT FROM AUTHOR]

Background: Autologous hematopoietic stem cell transplant (HSCT) recipients are not uniformly considered as "high risk" enough to receive fluoroquinolone (FQ) prophylaxis. The risks versus benefits of FQ prophylaxis in autologous HSCT require further investigation. Methods: A retrospective chart review of patients > 19 years old who received an autologous HSCT at Nebraska Medicine analyzed two time periods (period 1: no prophylaxis [2013‐2015] versus period 2: levofloxacin prophylaxis [2015‐2016]) to characterize the clinical impact of levofloxacin prophylaxis on autologous HSCT recipients. Results: A total of 224 autologous HSCT were screened with 214 included. Febrile neutropenia (FN) developed in 101/113 (89%) versus 60/101 (59%) patients in the no prophylaxis (NPx) versus prophylaxis (Px) group (P <.01). Time to onset of FN was a median 6 versus 7 days (P =.01), and total bloodstream infections (BSI) were 33/113 (29%) versus 7/101 (7%) (P <.01) in NPx and Px groups, respectively. Gram‐negative BSI were absent in the Px group. Viridans group streptococci were the most common Gram‐positive BSI overall, with FQ‐resistance more common in Px recipients. Rates of Clostridium difficile infections, length of hospital stay, or death at 100 days post‐HSCT did not differ between the groups. Conclusion: Fluoroquinolone prophylaxis introduced into autologous HSCT care at our institution in 2015 resulted in prevention of Gram‐negative BSI, decreased rates of FN, microbiologically documented infections, and a delay in time to onset of FN compared with the prior NPx. FQ prophylaxis in autologous HSCT recipients should be evaluated per individual institution. [ABSTRACT FROM AUTHOR]

Background Patients with gynecologic malignancies are at an increased risk for venous thromboembolism. National guidelines recommend treatment of an acute venous thromboembolism with low molecular weight heparin for 5–10 days followed by long-term secondary prophylaxis with low molecular weight heparin for at least six months. Non-vitamin K oral anticoagulants are not currently recommended to be used in cancer patients for the management of venous thromboembolism because robust data on their efficacy and safety have yet to become available in cancer patients. The objectives of this study were to determine the proportion of gynecologic oncology patients with venous thromboembolism using rivaroxaban compared to warfarin or low molecular weight heparin as well as compare the safety and efficacy of these anticoagulants. Methods This study was a retrospective pilot analysis of adult patients with gynecologic malignancies who received either rivaroxaban, warfarin or low molecular weight heparin for treatment of venous thromboembolism at Augusta University Medical Center from 1 July 2013 to 30 June 2015. Statistical comparisons between the enoxaparin and rivaroxaban group were made using T-tests and Chi-square or Fisher's exact tests, where appropriate. Results Out of the 49 patients, 37% (18) patients were on rivaroxaban, 53% (26) on enoxaparin, and 10% (5) on warfarin. Only one patient (4%) in the enoxaparin group experienced a recurrent deep vein thrombosis while there were no cases of recurrent venous thromboembolism in the rivaroxaban and warfarin group. The incidence of major bleeding was 17% (n = 2), 20% (n = 1), and 8% (n = 2) in patients receiving rivaroxaban, enoxaparin, and warfarin, respectively. The rate of switching to a different anticoagulant than originally prescribed was 42% (n = 14) in the enoxaparin arm, and 5.5% (n = 1) in the rivaroxaban arm. Conclusion A high proportion of our gynecologic oncology patients received rivaroxaban for the management of venous thromboembolism. The sample size of this pilot analysis was too small to draw any conclusions regarding efficacy and safety of rivaroxaban compared with enoxaparin and warfarin. High rate of rivaroxaban use in gynecologic oncology patients at our institution highlights the need for larger, well-designed randomized controlled trials to confirm the safety and efficacy of its use in this population. [ABSTRACT FROM AUTHOR]

With the availability of BCR::ABL1 targeted tyrosine kinase inhibitors (TKIs), outcomes for most individuals with chronic phase chronic myeloid leukemia (CP-CML) are outstanding, with life expectancy similar to age-matched peers. Treatment-emergent adverse events (TEAEs) impair quality of life and many patients struggle with low-level chronic AEs, which for some individuals impact emotional well-being as well as social and work functioning. An emerging body of data supports that many TEAEs are related to therapy dose and can improve with dose reduction. However, it is critical that dose reductions do not alter current outcomes, especially in the rare patients who are at greater risk of losing response or transforming to acute leukemia. Organizations including the National Comprehensive Cancer Network have begun to address when dose reductions may be considered in patients with CP-CML. In this manuscript, we review retrospective and prospective data reporting outcomes in patients after dose reduction and review data supporting lower dose preemptive dosing in first-line and later-line therapy. Switching therapy for intolerance can result in improvements in symptoms and limit toxicity, but other TEAEs may occur. Additionally, emerging therapeutics such as the new class of BCR::ABL1 allosteric inhibitors are under evaluation with a goal of improving tolerability. However, with many TKIs on the cusp of becoming generic, dose reduction becomes an appealing and important cost-effective strategy to minimize TEAEs and improve quality of life while preserving outstanding outcomes in CP-CML.