Esther L Albuquerque, Justin G Horowitz, Grace C Lee
{"title":"Clinical safety of a 1-h infusion of cisplatin approach in a broad cancer population.","authors":"Esther L Albuquerque, Justin G Horowitz, Grace C Lee","doi":"10.1177/10781552251340630","DOIUrl":"https://doi.org/10.1177/10781552251340630","url":null,"abstract":"<p><p>IntroductionCisplatin has ubiquitous use throughout many cancer types and is incorporated in various regimens. Nephrotoxicity is a well-known side effect of cisplatin, occurring in up to one third of patients. Early clinical data showed elevated peak concentrations are correlated with increased incidence of nephrotoxicity, suggesting prolonging infusion duration may abate this known toxicity. A recent study showed there was no difference in rates of acute kidney injury (AKI) between rapid (1-h) and standard (3-h) infusions of cisplatin, however, cisplatin was administered inpatient with prolonged and aggressive hydration methods. Therefore, we aimed to compare outcomes in patients who received rapid-infusion vs. standard-infusion cisplatin in the outpatient setting at our institution.MethodsThis single center, pre-post intervention study evaluated outpatient visits between January 2022 and March 2024. Cisplatin was administered over 3-h at Mays Cancer Center, UT Health San Antonio, prior to an institutional practice change to 1-h (rapid infusion) that took place February 2023. The co-primary outcomes were the maximum decrease in eGFR from baseline and the incidence of stage 1 or higher AKI. Secondary outcomes included rates of treatment modification and rates of healthcare resource utilization.ResultsA total of 53 patients with a chemotherapy regimen containing cisplatin met study criteria. Baseline characteristics were similar for the standard (n = 28) and rapid infusion (n = 25) groups. The maximum decrease in eGFR in the standard infusion vs. rapid infusion group did not differ (15.2 vs 18.0 mL/min/1.73 m<sup>2</sup>, respectively; <i>p</i> = 0.89). The incidence of stage 1 or higher AKI was not significantly different between the standard and rapid infusion cohorts (<i>p</i> = 0.13). No differences were identified for the secondary outcomes including rates of regimen modifications or hospitalizations due to AKI or time to AKI in 120 days after the first cisplatin dose.ConclusionIn this pre-post intervention analysis neither occurrence nor severity of nephrotoxicity appeared to be affected by the infusion rate of cisplatin in the outpatient setting. Rapid infusion of cisplatin over 1-h appears to be a feasible option without increased safety risk for patients.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251340630"},"PeriodicalIF":1.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144030839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Using bispecific antibodies in a patient with peritoneal dialysis for relapsed multiple myeloma.","authors":"Heng Jiang, Yagya Ahlawat, Amir Steinberg","doi":"10.1177/10781552251341235","DOIUrl":"https://doi.org/10.1177/10781552251341235","url":null,"abstract":"<p><p>IntroductionBispecific antibodies (BsAbs) are a promising therapy for relapsed/refractory multiple myeloma (RRMM), but their efficacy in patients with end-stage renal disease (ESRD) on peritoneal dialysis (PD) remains unclear. Given the prevalence of renal impairment in MM, understanding BsAbs' use in this population is critical.Case ReportWe present a 72-year-old woman with ESRD on PD diagnosed with RRMM after developing a pathologic humeral fracture. Bone marrow biopsy confirmed lambda light chain multiple myeloma with extensive skeletal involvement.Management & OutcomeThe patient was treated with upfront radiation, and then received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), followed by carfilzomib, lenalidomide, and dexamethasone (KRd) upon progression. Due to limited response, teclistamab was initiated, achieving a significant but transient response, prompting a switch to talquetamab. Following relapse, she was transitioned to elotuzumab, pomalidomide, and dexamethasone, then selinexor as a bridge to chimeric antigen receptor T-cell (CAR-T) therapy.DiscussionThis case demonstrates that BsAbs may be effective in RRMM patients on PD, though responses were transient. Further research is needed to explore BsAbs' pharmacokinetics, optimal dosing, and long-term outcomes in dialysis-dependent MM patients.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251341235"},"PeriodicalIF":1.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sara Sarpas, Ding Quan Ng, Daniela Arcos, Alexandre Chan
{"title":"Pharmacist-led interventions associated with symptoms identified by electronic patient-reported outcome battery: A descriptive study.","authors":"Sara Sarpas, Ding Quan Ng, Daniela Arcos, Alexandre Chan","doi":"10.1177/10781552251340922","DOIUrl":"https://doi.org/10.1177/10781552251340922","url":null,"abstract":"<p><p>IntroductionAt the University of California Irvine (UCI) in Orange County California, we published an implementation study to evaluate the use of an electronic patient-reported outcome (ePRO) tool to guide pharmacist-led chemotherapy education in newly diagnosed cancer patients. The goal of this secondary analysis was to describe the types of pharmacist-led interventions performed in the implementation study.MethodsUsing a pre-configured ePRO battery, patients' symptoms were assessed in seven domains (cognitive impairment, physical impairment, pain, depression, anxiety, fatigue, nausea/vomiting) at each infusion visit. Other symptoms that were brought up during the visit were also documented. Based on symptom scores calculated in real-time, pharmacists implemented personalized patient care strategies and documented them in the clinical notes. Descriptive statistics were employed to evaluate the type of interventions employed for each symptom domain.ResultsAmong 250 patients enrolled, the average age of participants was 60 years old (SD = 14.6), with 129 (52%) being female, and 134 (54%) of participants identified as white. The preconfigured ePRO battery identified clinically important symptoms at 47.3% of the visits, and other clinically important symptoms were identified at 23.4% of the visits. Pharmacist education was performed for 311 (55%) of 564 visits examined throughout the study. The highest proportions of pharmacological interventions were performed to manage nausea/vomiting (51 visits), followed by gastrointestinal symptoms (21 visits), and pain (16 visits). Additional provider communication was performed for managing nausea/vomiting (14 visits), pain (9 visits), and neurological symptoms (9 visits).ConclusionWe observed a high rate of pharmacist-led education after the institution of ePRO to evaluate symptoms in patients undergoing anticancer treatment. Future studies should consider incorporating additional ePRO domains to include a wide range of patient-reported symptoms tailored to each type of anticancer treatment.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251340922"},"PeriodicalIF":1.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kasey Jackson, Kiera Roubal, Christopher Rangel, Frank Brescia
{"title":"Rechallenge of an alternative CDK 4/6 inhibitor after hepatotoxicity in the treatment of hormone-positive metastatic breast cancer.","authors":"Kasey Jackson, Kiera Roubal, Christopher Rangel, Frank Brescia","doi":"10.1177/10781552251340613","DOIUrl":"https://doi.org/10.1177/10781552251340613","url":null,"abstract":"<p><p>IntroductionCyclin Dependent Kinase (CDK) 4/6 inhibitors are changing the landscape of breast cancer treatment. These medications are generally well-tolerated, but incidences of hepatotoxicity have been reported in the literature.Case ReportIn this case, we present a 36-year-old Caucasian female who was diagnosed with hormone-receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer who initiated first line treatment with an aromatase inhibitor and a cyclin-dependent kinase (CDK) 4/6 inhibitor, ribociclib. Following treatment initiation, she experienced grade 4 hepatoxicity.Management and OutcomeRibociclib was discontinued due to probable cause of hepatotoxicity based on a Naranjo score of 7. Once her liver enzymes resolved to grade 1 toxicity, she was transitioned to another CDK 4/6 inhibitor, palbociclib. The patient has remained on palbociclib for 1 year of treatment with normalization of her liver function enzymes and stable disease.DiscussionThis case presents a successful rechallenge of an alternative CDK 4/6 inhibitor after grade 4 ribociclib-induced hepatotoxicity and reviews similar cases of ribociclib-induced hepatoxicity and management strategies.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251340613"},"PeriodicalIF":1.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143970619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Margot Vattaire-Hervé, Antoine Le Bozec, Justine Clarenne, Guillaume Cohet, Violaine Lepage, Chloé Gossery, Elise Michelet-Huot, Anne Quinquenel, Isabelle Madelaine, Eric Durot, Florian Slimano
{"title":"Predictive factors for delayed high-dose methotrexate elimination: A practical issue for diffuse large B-cell lymphoma patients.","authors":"Margot Vattaire-Hervé, Antoine Le Bozec, Justine Clarenne, Guillaume Cohet, Violaine Lepage, Chloé Gossery, Elise Michelet-Huot, Anne Quinquenel, Isabelle Madelaine, Eric Durot, Florian Slimano","doi":"10.1177/10781552251340000","DOIUrl":"https://doi.org/10.1177/10781552251340000","url":null,"abstract":"<p><p>PurposeThe high-dose methotrexate (HD-MTX) regimen (>1 g/m<sup>2</sup>) is the standard of care for preventing and managing central nervous system (CNS) invasion in diffuse large B-cell lymphoma (DLBCL). Delayed elimination of HD-MTX can lead to severe toxicity. Albumin is a suggested biological marker to predict delayed elimination. This study aims to evaluate whether serum albumin can be used as a predictive factor.MethodsThis retrospective bicentric study includes DLBCL patients, receiving HD-MTX from 06.30.2016 to 12.31.2023 using CHIMI0v5.9. Data collected included demographic, biological, clinical and therapeutic. Eligible patients were over 18 years, with DLBCL diagnosis, available serum albumin before HD-MTX, with therapeutic drug monitoring of plasma methotrexate available. Univariate and multivariate analysis compared patients with and without delayed elimination.ResultsA total of 68 patients were included, with 15 suffering delayed elimination. Univariate analysis showed that male and Body Surface Area ≥ 2 m² (BSA) patients were more likely to have delayed clearance (respectively p = 0.01; p = 0.05). The association with male sex was confirmed in multivariate analysis (p = 0.01). Most cases of hypoalbuminemia were classified as grade 1 or 2. Patients with hypoalbuminemia received lower doses of MTX. Serum albumin level was not significantly associated with delayed elimination (p = 0.8).ConclusionsOverall, mainly biometric factors are associated with delayed elimination, highlighting the problem of prescribing habits based on body surface area. Albuminemia's role remains debated, and this study does not provide a conclusion, as patients with hypoalbuminemia received lower HD-MTX doses. Studies should account factors related to inflammation, nutrition and specific biomarkers (prealbumin).</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251340000"},"PeriodicalIF":1.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthew Lei, Ryan D Nipp, Erica Tavares, Uvette Lou, Erica Grasso, Stephanie Mui, J Peter Marquardt, Till D Best, Emily E Van Seventer, Anurag Saraf, Ismail Tahir, Nora K Horick, Florian J Fintelmann, Eric J Roeland
{"title":"Artificial intelligence-based muscle analysis risk assessment of treatment-related toxicity in metastatic colorectal cancer.","authors":"Matthew Lei, Ryan D Nipp, Erica Tavares, Uvette Lou, Erica Grasso, Stephanie Mui, J Peter Marquardt, Till D Best, Emily E Van Seventer, Anurag Saraf, Ismail Tahir, Nora K Horick, Florian J Fintelmann, Eric J Roeland","doi":"10.1177/10781552251338048","DOIUrl":"https://doi.org/10.1177/10781552251338048","url":null,"abstract":"<p><p>IntroductionUp to 60% of adults with metastatic colorectal cancer (mCRC) receiving combination cytotoxic chemotherapy may experience loss of skeletal muscle mass and function. This study explores associations of artificial intelligence (AI)-based skeletal muscle assessment with hematologic toxicity and chemotherapy relative dose intensity (RDI) in adults with mCRC receiving standard combination chemotherapy.MethodsWe conducted a retrospective analysis of adults with mCRC receiving first-line FOLFOX or FOLFIRI over 6 months (≤12 cycles) from 1/2011 to 11/2018. We used a validated AI-based skeletal muscle assessment on baseline (prior to starting chemotherapy) computed tomography scans to determine skeletal muscle index (SMI, cm<sup>2</sup>/m<sup>2</sup>), categorizing low SMI using independent sex-specific cut-off values. We sought to evaluate the association between low SMI and the incidence of grade ≥3 (G ≥ 3) cytopenia over 6 months. Secondary endpoints included time to G ≥ 3 cytopenia and RDI.ResultsOverall, 126 adults met inclusion (median age = 61 years [range, 29-85]; 56 [44%] female) with a median BMI of 26.6 kg/m<sup>2</sup> (IQR, 24.1-30.5 kg/m<sup>2</sup>), including 59 (47%) with a low SMI. G ≥ 3 neutropenia incidence was higher in adults with low SMI (31% vs. 15%, p = 0.036). There was no difference for other G ≥ 3 cytopenias (39% vs 24%, p = 0.067) or median time to G ≥ 3 neutropenia (p = 0.053). Patients with a low SMI had a lower 5FU-bolus RDI (p = 0.045).ConclusionAdults with mCRC receiving first-line chemotherapy with low SMI experienced more G ≥ 3 neutropenia and decreased 5-FU bolus RDI.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251338048"},"PeriodicalIF":1.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144000713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Or Duchin, Bella Smolin, Hedva Sheinman, Natali Katsman, Shaked Ben Porat, Igal Louria-Hayon, Ayelet Shai
{"title":"Chronic cannabis use in breast cancer survivors: A questionnaire study of Israeli patients.","authors":"Or Duchin, Bella Smolin, Hedva Sheinman, Natali Katsman, Shaked Ben Porat, Igal Louria-Hayon, Ayelet Shai","doi":"10.1177/10781552251340329","DOIUrl":"https://doi.org/10.1177/10781552251340329","url":null,"abstract":"<p><p>IntroductionAs many as 90% of BC survivors suffer from long term sequelae, and many use or used cannabis during or after treatment to alleviate symptoms. Little is known about the effects of chronic cannabis use in this population. We aimed to study the patterns and effects of chronic cannabis use in BC survivors.Materials and methodsthis is a single center cohort study. Participants were patients aged 30-75, diagnosed with stage 1-3 BC and prescribed medical cannabis. Patients were included if they completed chemotherapy at least 6 months before study entry and did not experience disease recurrence during follow up. Patients were interviewed over the phone regarding the patterns and effects of cannabis use.ResultsTwenty-one patients were included. At the time of interview all patients increased their cannabis dose from 20 grams per month to an average of 47.6 grams per month. The positive effects reported were improved mood (76%), sleep (62%), pain (52%), neuropathy (29%) and appetite (5%). Adverse effects were increased appetite (10%), sleepiness (10%), cognitive adverse effects (10%), nausea (5%), mood adverse effects (5%) and gait problems (5%). Six patient (29%) reported themselves as being addicted to cannabis.ConclusionIn this cohort, long term cannabis use was associated with adverse effects, dose increments and risk of addiction. Further study is needed to better understand the safety of chronic cannabis use in BC survivors.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251340329"},"PeriodicalIF":1.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kyle Ritter, Malgorzata Strojny, Jane McCullough, Jenn Law
{"title":"Real-world efficacy and tolerability of axitinib + pembrolizumab in the treatment of renal cell carcinoma.","authors":"Kyle Ritter, Malgorzata Strojny, Jane McCullough, Jenn Law","doi":"10.1177/10781552251331576","DOIUrl":"https://doi.org/10.1177/10781552251331576","url":null,"abstract":"<p><p>Combination therapy with immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor tyrosine kinase inhibitors (VEGF TKIs) is standard of care for metastatic renal cell carcinoma (mRCC); however, no head-to-head trials have compared FDA-approved regimens. This project aims to provide real-world data on the safety and efficacy of axitinib + pembrolizumab in the treatment of mRCC and describe management of common treatment-related adverse events. This is a retrospective, observational, quality improvement project conducted at the Robert H Lurie Comprehensive Cancer Center of Northwestern University in Chicago, Illinois. Patients 18 years of age or older with stage IV RCC who received axitinib + pembrolizumab between April 2019 and February 2024 were included. Endpoints included progression-free survival (PFS), overall survival (OS), duration of treatment, subsequent therapies, and safety outcomes. Thirty-one patients received axitinib + pembrolizumab for mRCC. With a median follow-up time of 22.6 months, PFS was 37.4 months and OS was not reached. Ninety-four percent of patients experienced a treatment-related adverse event with 32.3% classified as grade 3 or higher. Fifty two percent of patients required axitinib dose reductions, 70.9% had at least one axitinib dose held, and 70.9% had at least one pembrolizumab dose held. Patients with axitinib dose reductions demonstrated improved OS at one year (92.9% vs. 80%). This retrospective study corroborates the findings of the KEYNOTE-426 trial and further demonstrates the effectiveness of axitinib + pembrolizumab combination therapy in the treatment of mRCC. Dose reductions and holds do not appear to impact treatment efficacy.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251331576"},"PeriodicalIF":1.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Access to current medicines in the treatment of Turkish melanoma patients.","authors":"Faruk Tas, Zubeyde Yolcu","doi":"10.1177/10781552251340008","DOIUrl":"https://doi.org/10.1177/10781552251340008","url":null,"abstract":"<p><p>Although the incidence of melanoma is increasing every year, the modern treatment modalities provided in recent years have led to significant gains in survival. However, there are difficulties in access to medicines in our country as well as in the world, especially due to the cost of medicines. In this study, we investigated to determine the access to drugs in our country. Our study was conducted using January 2025 data based on the Health Practice Circular of the Social Security Institution. In metastatic melanoma patients, BRAF/MEK inhibitor agents, vemurafenib-cobimetinib and dabrafenib-trametinib combination therapies, have been registered and reimbursed in the first-line treatment choice of the disease. Among immunotherapy drugs, ipilimumab and nivolumab as single agents have long been registered and reimbursed for the treatment of relapsed disease after chemotherapy, while pembrolizumab is still registered but not reimbursed. Ipilimumab-nivolumab is registered but still not imbursed. Talimogen laherparepvec and tebentafusp are still not registered. The dabrafenib-trametinib combination has been registered and reimbursed for the adjuvant treatment of stage 3. However, although both nivolumab and pembrolizumab are licensed as single agents, they are not covered by reimbursement. In the adjuvant treatment of stage 2 (2B/C) disease, pembrolizumab is licensed but not reimbursed, while nivolumab is not licensed. In conclusion, in our country, as in other parts of the world, there are difficulties and limitations in accessing the current treatment of melanoma. The significant survival benefits achieved with modern treatment of the disease are unfortunately hampered by difficulties in accessing treatment.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251340008"},"PeriodicalIF":1.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zoe Ngo, Scott Mayeda, Stacey Yu, Mark Danek, Austin Wang, Elyse A MacDonald, Ee Vonn Yong, Janjri Desai
{"title":"A novel decision tree for performing risk assessments of biologics in a health-system setting.","authors":"Zoe Ngo, Scott Mayeda, Stacey Yu, Mark Danek, Austin Wang, Elyse A MacDonald, Ee Vonn Yong, Janjri Desai","doi":"10.1177/10781552251338047","DOIUrl":"https://doi.org/10.1177/10781552251338047","url":null,"abstract":"<p><p>ObjectiveTo develop and implement a biological drug risk assessment decision tree that expands upon National Institute for Occupational Safety and Health (NIOSH) risk assessment evaluation procedures with the addition of molecular property parameters for exposure assessment.Data SourcesA literature review was performed using PubMed<sup>®</sup> (Keywords: peptide, protein, biologics, occupational exposure, risk assessment, molecular weight, molecular weight and penetration, skin, nasal absorption, ocular absorption, inhalation bioavailability. Period: 1991 to 2024).Data SummaryA thorough literature review showed a wide range of molecular weight cut-offs for absorption of biological drugs through various pathways (dermal, mucosal, inhalation). Large molecules greater than 1000 Daltons in size were found to have little to no bioavailability through these pathways, hence this weight was established as the size threshold within the risk assessment decision tree. Practical application of this decision tree by the investigational drug service in a large academic institution led to the reclassification of 89% of medications with previous hazardous designation.ConclusionsIn response to the increasing prevalence of biological drugs and limited guidelines on occupational handling, a protein-based biologics risk assessment decision tree, expanding on existing NIOSH evaluation procedures and incorporating molecular weight parameters was developed. Adoption of a risk assessment tool can help standardize and streamline biologics handling practice, which can improve operational efficiency without compromising staff safety.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251338047"},"PeriodicalIF":1.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}