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Productivity and aseptic process evaluation during batch production simulation of intravenous medications using a semi-automated compounding device.
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-05 DOI: 10.1177/10781552241304009
Ana C Riestra, Jaione Grisaleña, Naiara Telleria, Gerardo Cajaraville

Introduction: Intravenous (IV) medications can be prepared using compounding devices to increase productivity, and reduce risks associated with aseptic compounding. This study evaluated the productivity and quality outcomes of the aseptic process for simulated batches of IV medications used in clinical practice produced using a semi-automated compounding device (Gri-fill; Grifols).

Methods: Simulated batches from 50 to 600 preparations were completed representing hazardous and non-hazardous drugs, including one-step single component (atropine sulfate, cisplatin) and multistep, multiple component (mitomycin C, piperacillin/tazobactam, trastuzumab, 5-fluorouracil and gemcitabine). Productivity, device autonomy, quality of the aseptic process (media-fill test) and sterility of the preparations were evaluated.

Results: A total of 2024 final preparations and 460 intermediate products were compounded during 78 working hours. For low and high complexity level preparations, median (minimum-maximum) production speed was 1.3 (0.6-1.7) and 3.7 (2.6-4.3) min per preparation, respectively. The longest process (36.2 min/bag) was the preparation of a simulated gemcitabine 3 L bulk solution bag, which included reconstitution of vials and filling the bulk bag. All operational errors (0.6%) were resolved autonomously by the user. None of the 883 media fill preparations showed microbiological growth and all 114 analyzed preparations passed the sterility test.

Conclusions: Using a semi-automated compounding device, preparation efficiency of IV medications ranged from 14 preparations/h for multicomponent preparations from vials requiring reconstitution, to 100 preparations/h for low complexity preparations using a bulk solution bag. The aseptic processes demonstrated the absence of microbial growth in all tested preparations.

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引用次数: 0
Patterns of prescription opioid use and opioid-related harms among adult patients with hematologic malignancies. 血液系统恶性肿瘤成年患者的处方阿片类药物使用模式和阿片类物质相关危害。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2023-11-09 DOI: 10.1177/10781552231210788
Nadia A Nabulsi, Lisa K Sharp, Karen I Sweiss, Pritesh R Patel, Gregory S Calip, Todd A Lee

Introduction: Treatment advances for hematologic malignancies (HM) have dramatically improved life expectancy, necessitating greater focus on long-term cancer pain management. This study explored real-world patterns of opioid use among patients with HM.

Methods: This retrospective cohort study identified adults diagnosed with HM from January 1, 2013 through December 31, 2019 using the Truven MarketScan Commercial Claims and Encounters database. Across several HM types, we described rates of high-risk opioid use (based on Pharmacy Quality Alliance measures) and opioid-related harms, including incident opioid use disorder (OUD) diagnoses and opioid-related hospitalizations or emergency department (ED) visits. We used multivariable Cox regression to generate adjusted hazard ratios and 95% confidence intervals comparing the risk of opioid-related harms between patients with versus without high-risk opioid use.

Results: Our sample included 43,190 patients with HM. Median age at HM diagnosis was 54 years (interquartile range  =  44-60). Most patients (61.9%) were diagnosed with lymphoma. Approximately half (49.2%) had an opioid dispensed in the follow-up period. Among all patients, 20.0% met criteria for high-risk opioid use, 0.9% had an OUD diagnosis, and 0.3% experienced an opioid-related hospitalization/ED visit in follow-up. High-risk opioid use increased the risk of an OUD diagnosis by 3.3 times (p < 0.0001) and an opioid-related hospitalization/ED visit 4.2 times (p < 0.0001).

Conclusion: High-risk opioid use was prevalent among patients with HM and significantly increased the risk of opioid-related harms. However, rates of opioid-related harms were low. These findings highlight the importance of continually monitoring pain and opioid use throughout HM survivorship to provide safe, effective HM pain management.

简介:血液系统恶性肿瘤(HM)的治疗进展显著提高了预期寿命,因此需要更多地关注长期癌症疼痛管理。这项研究探讨了HM患者阿片类药物使用的真实模式。方法:这项回顾性队列研究使用Truven MarketScan商业索赔和遭遇数据库确定了2013年1月1日至2019年12月31日期间诊断为HM的成年人。在几种HM类型中,我们描述了高风险阿片类药物使用率(基于药房质量联盟的衡量标准)和阿片类相关危害,包括阿片类使用障碍(OUD)的诊断和阿片相关住院或急诊科就诊。我们使用多变量Cox回归来生成调整后的危险比和95%置信区间,比较有和没有高风险阿片类药物使用的患者之间阿片类相关危害的风险。结果:我们的样本包括43190名HM患者。HM诊断的中位年龄为54岁(四分位间距  =  44-60)。大多数患者(61.9%)被诊断为淋巴瘤。大约一半(49.2%)的患者在随访期间服用了阿片类药物。在所有患者中,20.0%的患者符合高风险阿片类药物使用标准,0.9%的患者被诊断为OUD,0.3%的患者在随访中经历了与阿片类物质相关的住院/ED就诊。高风险阿片类药物使用使OUD诊断风险增加3.3倍(p 结论:高危阿片类药物使用在HM患者中普遍存在,并显著增加了阿片类相关危害的风险。然而,与阿片类药物相关的伤害率很低。这些发现强调了在HM生存期持续监测疼痛和阿片类药物使用的重要性,以提供安全、有效的HM疼痛管理。
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引用次数: 0
Development of oral oncolytic nonadherence estimator (ORACLE): A pretreatment nonadherence risk assessment for oral oncolytics. 口腔溶瘤不依从性估计器(ORACLE)的开发:口腔溶瘤药物预处理不依从性风险评估。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2023-10-30 DOI: 10.1177/10781552231208442
Jessie Signorelli, Thuy Tran, Marie E Sirek, Yarelis Díaz-Rohena, Jodi L Taraba, Benyam Muluneh, Nayanika Basu, Jennifer Lilly, Julianne Darling

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.

引言:到目前为止,还没有依从性评估器来确定在开始口服溶瘤药物之前不依从的风险。方法:通过国家社区肿瘤配药协会组建了一个工作组,负责创建一个工具来满足这一需求。工具结构是在对文献进行审查后确定的,确定了依从性的主要障碍。进行了第二次文献检索,以从经过验证的依从性问卷中确定针对特定障碍的问题。一旦最终草案完成,风险评估工具就被内置到电子调查中,可以自动计算患者的风险类别。结果:影响口服溶瘤药物依从性的六个最有影响的因素是患者的信心、健康素养、治疗感知、生活质量、社会支持和化疗方案的复杂性。创建了一份六项问卷,其中包括五个患者指导的问题和一个临床医生指导的问题。提供了示例和描述,供临床医生在对方案的复杂性进行分类时考虑。该工具旨在通过10分系统将每个问题的回答编入分类索引。结果将分为不依从性的低风险、中等风险或高风险。结论:对于开始口服溶瘤药物的患者来说,在开始治疗前创建一个预测不依从性的工具是一个未得到满足的需求。该工具的目的是满足这些需求,并更好地指导临床医生为患者提供更好地管理不依从性的策略。接下来的步骤包括工具验证和临床实践试点。
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引用次数: 0
Successful treatment of PD1-inhibitor induced psoriasiform dermatitis using IL-17 blockade without compromising immunotherapy efficacy. 使用 IL-17 阻断剂成功治疗 PD1 抑制剂诱发的银屑病皮炎,同时不影响免疫疗法的疗效。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2024-08-07 DOI: 10.1177/10781552241269712
Adina Greene, Scott Penner, Amanda Edmond, Monica Camou, Jiaxin Niu, Jordan Abbott

Introduction: Pembrolizumab is a monoclonal PD-1 inhibitor used in the treatment of lung cancer in addition to several other malignancies. Psoriasiform dermatitis is a well-documented adverse effect.

Case report: We present a 68 year-old-male with a 50-year smoking history and a 30-year remote history of plaque psoriasis, limited to the knees and elbows, who presented with metastatic non-small cell lung cancer. He was started on a chemotherapy regimen of carboplatin, paclitaxel, and pembrolizumab. One month later, he presented to dermatology with diffuse erythematous scaly papules coalescing into plaques on 80% of body surface area (BSA).

Management & outcome: Pembrolizumab treatment was paused. The patient was prescribed triamcinolone 0.1% twice daily, but still had significant BSA at one-month and was started on an Il-17 inhibitor, ixekizumab, clearing the psoriasiform dermatitis. He was rechallenged with pembrolizumab every 3 weeks and repeat PET/CT demonstrated excellent tumor response.

Discussion: This case prompted a literature review to further characterize the use of IL-17 inhibitors for psoriasiform dermatitis in the setting of ICI therapy. All six cases demonstrated improvement of psoriasiform dermatitis, with two cases showing partial response and four cases showing complete resolution. In three of the six cases, the patients exhibited clinical response to the primary malignancy after rechallenging with ICI, while remaining on an IL-17 inhibitor. Our case, in conjunction with the other reported cases, seems to suggest that IL-17 blockade can maintain a fine balance in this challenging clinical scenario by treating psoriasiform dermatitis without compromising the efficacy of immunotherapy.

简介Pembrolizumab是一种单克隆PD-1抑制剂,用于治疗肺癌和其他几种恶性肿瘤。牛皮癣样皮炎是一种有据可查的不良反应:我们为您介绍一位 68 岁的男性患者,他有 50 年的吸烟史和 30 年的远期斑块状银屑病史,局限于膝盖和肘部。他开始接受卡铂、紫杉醇和彭博利珠单抗的化疗方案。一个月后,他因弥漫性红斑鳞屑性丘疹在80%的体表面积(BSA)上凝聚成斑块而到皮肤科就诊:彭博利珠单抗治疗暂停。给患者开了0.1%曲安奈德,每天两次,但一个月后仍有明显的体表面积(BSA),于是开始使用Il-17抑制剂ixekizumab,清除了银屑病皮炎。他开始使用Il-17抑制剂ixekizumab,清除了银屑病皮炎,每3周再次使用pembrolizumab,重复PET/CT显示肿瘤反应良好:该病例促使我们回顾文献,进一步了解在 ICI 治疗中使用 IL-17 抑制剂治疗银屑病皮炎的特点。所有六个病例的银屑病皮炎均有改善,其中两个病例显示部分反应,四个病例显示完全缓解。在这六个病例中,有三个病例的患者在重新接受 ICI 治疗后,原发恶性肿瘤出现了临床反应,但仍在服用 IL-17 抑制剂。我们的病例以及其他已报道的病例似乎表明,IL-17 抑制剂可以在这种具有挑战性的临床情况下保持微妙的平衡,既能治疗银屑病皮炎,又不影响免疫疗法的疗效。
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引用次数: 0
Cellular therapy site-preparedness: Inpatient pharmacy implementation at a large academic medical center. 细胞疗法现场准备:一家大型学术医疗中心的住院药房实施情况。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2024-08-28 DOI: 10.1177/10781552241279025
Janine G Martino, Kim McConnell, Lorraine Greathouse, Brent Del Rosario, Jaclyn M Jaskowiak

Background: With the recent Food & Drug Administration (FDA) approval of cellular therapy that requires product manipulation prior to administration in combination with a short stability window, the need was identified for local dose preparation within the pharmacy rather than the off-site stem cell processing laboratory. This approval gave rise to assessment of regulatory standards surrounding cellular therapy, evaluation and revision of current standard operating procedures and policies with formal process validation, assessment of occupational exposure mitigation and safety considerations, and development of staff training and education.

Objective: To describe and provide insight into the stepwise process of FACT validation and onboarding of commercially available cellular therapy products that require sterile compounding manipulation within a pharmacy prior to administration.

Discussion: A multidisciplinary effort is required to attain FACT certification and implement pharmacist compounding of cellular therapy products.1 Local preparation within a pharmacy facilitates a sound operational workflow and provides a pathway to perform aseptic manipulations of cellular therapy products safely and efficiently.

Conclusion: Safe and successful administration of cellular therapies handled and compounded by pharmacy department staff along with program validation requires a preemptive review utilizing a multidisciplinary approach for process development. This manuscript will provide a foundation based on consistency and transparency in effective cellular therapy sterile compounding and aseptic manipulation, proper handling and disposal procedures, increased communication through creation and optimization of treatment plans and order-sets, standardized medical center staff education, and development of policies and standard operating procedures for the entire health care team.

背景:最近,美国食品和药物管理局(FDA)批准了细胞疗法,该疗法需要在给药前对产品进行操作,同时需要较短的稳定期。这项批准要求对有关细胞疗法的监管标准进行评估,评估和修订当前的标准操作程序和政策,并进行正式的流程验证,评估职业暴露缓解和安全考虑因素,以及开展员工培训和教育:目的:描述并深入探讨商业化细胞治疗产品在用药前需要在药房内进行无菌复方操作的FACT验证和入职的逐步过程:1 在药房内进行局部准备有助于建立健全的操作流程,并为安全、高效地对细胞治疗产品进行无菌操作提供了途径:结论:要安全、成功地使用由药剂科员工处理和配制的细胞疗法,并进行程序验证,就必须利用多学科方法对流程开发进行先期审查。本手稿将为有效的细胞疗法无菌复方制剂和无菌操作、正确的处理和处置程序、通过创建和优化治疗计划和医嘱集加强沟通、标准化医疗中心员工教育以及为整个医疗团队制定政策和标准操作程序提供一个基于一致性和透明度的基础。
{"title":"Cellular therapy site-preparedness: Inpatient pharmacy implementation at a large academic medical center.","authors":"Janine G Martino, Kim McConnell, Lorraine Greathouse, Brent Del Rosario, Jaclyn M Jaskowiak","doi":"10.1177/10781552241279025","DOIUrl":"10.1177/10781552241279025","url":null,"abstract":"<p><strong>Background: </strong>With the recent Food & Drug Administration (FDA) approval of cellular therapy that requires product manipulation prior to administration in combination with a short stability window, the need was identified for local dose preparation within the pharmacy rather than the off-site stem cell processing laboratory. This approval gave rise to assessment of regulatory standards surrounding cellular therapy, evaluation and revision of current standard operating procedures and policies with formal process validation, assessment of occupational exposure mitigation and safety considerations, and development of staff training and education.</p><p><strong>Objective: </strong>To describe and provide insight into the stepwise process of FACT validation and onboarding of commercially available cellular therapy products that require sterile compounding manipulation within a pharmacy prior to administration.</p><p><strong>Discussion: </strong>A multidisciplinary effort is required to attain FACT certification and implement pharmacist compounding of cellular therapy products.<sup>1</sup> Local preparation within a pharmacy facilitates a sound operational workflow and provides a pathway to perform aseptic manipulations of cellular therapy products safely and efficiently.</p><p><strong>Conclusion: </strong>Safe and successful administration of cellular therapies handled and compounded by pharmacy department staff along with program validation requires a preemptive review utilizing a multidisciplinary approach for process development. This manuscript will provide a foundation based on consistency and transparency in effective cellular therapy sterile compounding and aseptic manipulation, proper handling and disposal procedures, increased communication through creation and optimization of treatment plans and order-sets, standardized medical center staff education, and development of policies and standard operating procedures for the entire health care team.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1442-1449"},"PeriodicalIF":1.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dostarlimab: A promising new PD-1 inhibitor for cancer immunotherapy. 多斯他利单抗:用于癌症免疫疗法的前景广阔的新型 PD-1 抑制剂。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2024-07-26 DOI: 10.1177/10781552241265058
Zubaria Farzeen, Rana Rashad Mahmood Khan, Ayoub Rashid Chaudhry, Muhammad Pervaiz, Zohaib Saeed, Shahzad Rasheed, Behram Shehzad, Ahmad Adnan, Muhammad Summer

Objective: Dostarlimab, a humanized monoclonal PD-1 blocking antibody, is being tested as a cancer therapy in this review. Specifically, it addresses mismatch repair failure in endometrial cancer and locally progressed rectal cancer patients.

Data sources: A thorough database search found Dostarlimab clinical trials and studies. Published publications and ongoing clinical trials on Dostarlimab's efficacy as a single therapy and in conjunction with other medicines across cancer types were searched.

Data summary: The review recommends Dostarlimab for endometrial cancer mismatch repair failure, as supported by GARNET studies. The analysis also highlights locally advanced rectal cancer findings. In the evolving area of cancer therapy, immune checkpoint inhibitors including pembrolizumab, avelumab, atezolizumab, nivolumab, and durvalumab were discussed.

Conclusions: Locally advanced rectal cancer patients responded 100% to Dostarlimab. Many clinical trials, including ROSCAN, AMBER, IOLite, CITRINO, JASPER, OPAL, PRIME, PERLA, and others, are investigating Dostarlimab in combination treatment. This research sheds light on Dostarlimab's current and future possibilities, in improving cancer immunotherapy understanding.

目的:多斯他利单抗是一种人源化单克隆 PD-1 阻断抗体,本综述将其作为一种癌症疗法进行测试。具体来说,它可以解决子宫内膜癌和局部进展期直肠癌患者的错配修复失败问题:通过全面的数据库搜索发现了多司他利单抗的临床试验和研究。数据摘要:综述推荐多斯他利单抗用于治疗子宫内膜癌错配修复失败,GARNET 研究也支持这一观点。分析还强调了局部晚期直肠癌的研究结果。在不断发展的癌症治疗领域,讨论了包括pembrolizumab、avelumab、atezolizumab、nivolumab和durvalumab在内的免疫检查点抑制剂:结论:局部晚期直肠癌患者对多斯他利单抗的反应率为100%。许多临床试验,包括 ROSCAN、AMBER、IOLite、CITRINO、JASPER、OPAL、PRIME、PERLA 等,都在研究 Dostarlimab 在联合治疗中的应用。这项研究揭示了多斯他利单抗目前和未来在提高癌症免疫疗法认识方面的可能性。
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引用次数: 0
Impact of telephone follow-up on hepatocellular carcinoma patients receiving oral chemotherapy from an ambulatory-care setting. 电话随访对在门诊接受口服化疗的肝癌患者的影响。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2023-12-03 DOI: 10.1177/10781552231215427
Yukio Sakata, Hisanaga Nomura, Hirofumi Nakajima, Tomomi Kitajima, Yukiko Ito, Yoshiya Yamamoto

Introduction: In recent years, most molecular target drugs have been administered orally, as prescribed at ambulatory services in hospitals and at patients' homes. Telephone follow-up is increasingly being used in clinical practice for patients needing additional support post-discharge and for the prevention of hospital readmissions. The purpose of this study was to clarify the clinical benefits of telephone follow-up while administering oral anticancer drugs.

Methods: This was a single-center, observational, retrospective study. We evaluated hepatocellular carcinoma patients who received sorafenib or lenvatinib between March 2010 and February 2018. The primary endpoint was the incidence of adverse events.

Results: From the total of 130 patients, 83 patients received telephone follow-up and 47 did not. The incidence of hand-foot skin reactions significantly reduced in patients with telephone follow-up (odds ratio (OR) 3.69, 95% confidence interval (CI) 1.16-11.8, p = 0.020). The median durations (ranges) of adherence to oral chemotherapy were 259 days (15-1730) for the telephone follow-up group and 121 days (14-1105) for the no-telephone follow-up group (p < 0.001). Moreover, the disease control rate was significantly higher in the telephone follow-up group (OR 2.52, 95% CI 1.15-5.53, p = 0.020).

Conclusions: Remote interventions, such as telephone follow-up, are useful means of managing adverse events in patients receiving oral anticancer drugs and can lead to improved treatment results.

近年来,大多数分子靶向药物都是口服的,作为医院和患者家中门诊服务的处方。在临床实践中,电话随访越来越多地用于出院后需要额外支持的患者和预防再入院。本研究的目的是阐明在口服抗癌药物的同时进行电话随访的临床益处。方法:本研究为单中心、观察性、回顾性研究。我们评估了2010年3月至2018年2月期间接受索拉非尼或lenvatinib治疗的肝细胞癌患者。主要终点是不良事件的发生率。结果:130例患者中,83例接受电话随访,47例未接受电话随访。电话随访患者的手足皮肤反应发生率显著降低(优势比(OR) 3.69, 95%可信区间(CI) 1.16-11.8, p = 0.020)。电话随访组口服化疗坚持的中位持续时间(范围)为259天(15-1730),非电话随访组为121天(14-1105)(p p = 0.020)。结论:远程干预,如电话随访,是管理口服抗癌药物患者不良事件的有效手段,可以改善治疗效果。
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引用次数: 0
Assessment of adherence to routine vaccination schedules in oncology patients. 肿瘤患者对常规疫苗接种计划的依从性评估。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2023-10-17 DOI: 10.1177/10781552231208434
David C Sabatino, Peter Campbell, Jennifer Santamala

Introduction: Patients diagnosed with cancer are at an increased risk of infection. Vaccines remain one of the most critical public health strategies in limiting infectious diseases, with a heightened importance in cancer patients. Data across the general US population indicates that vaccine adherence rates are suboptimal across all adult vaccine schedules. This study aims to define vaccine adherence rates within the oncology population.

Methods: This retrospective cohort study includes adult patients with a new cancer diagnosis. Vaccine administrations for COVID-19 (SARS-CoV-2), influenza, pneumococcal, tetanus/diphtheria/pertussis (TDaP), herpes zoster (RZV), human papillomavirus (HPV), and hepatitis B (hepB) were assessed. The primary outcome was complete vaccine adherence.

Results: Two hundred and eighty-three oncology patients were included. The median age at diagnosis was 63 years old, and most subjects were females (60%). The two most common malignancies were gastrointestinal and breast cancer at 26.5% and 15.2%, respectively. Suboptimal vaccine adherence rates were observed across the entire oncology population. Complete adherence was observed in only 1.4% of patients. Vaccine specific adherence rates were as follows, SARS-CoV-2: 38.9%; influenza: 11.4%; pneumococcal: 12.7%; TDaP: 13.1%; RZV: 3.5%; HPV: 0%; and hepB: 34%. Among the vaccine schedules assessed, SARS-CoV-2 vaccination rates were the highest with 38.9% of patients being fully adherent and 73% receiving at least one dose.

Conclusion: Lower vaccine adherence rates were observed in oncology patients compared to currently published rates. Providers and pharmacists can play a role in assessing and counseling patients on the importance of vaccine adherence before chemotherapy is initiated and after a remission is obtained.

简介:被诊断为癌症的患者感染的风险增加。疫苗仍然是限制传染病的最关键的公共卫生策略之一,在癌症患者中尤为重要。美国普通人群的数据表明,在所有成人疫苗接种计划中,疫苗依从率都不理想。本研究旨在确定肿瘤人群中的疫苗依从率。方法:这项回顾性队列研究包括新诊断为癌症的成年患者。评估了新冠肺炎(SARS-CoV-2)、流感、肺炎球菌、破伤风/白喉/百日咳(TDaP)、带状疱疹(RZV)、人乳头瘤病毒(HPV)和乙型肝炎(hepB)的疫苗接种情况。主要结果是完全坚持接种疫苗。结果:纳入283名肿瘤患者。诊断时的中位年龄为63岁,大多数受试者为女性(60%)。两种最常见的恶性肿瘤是胃肠道和乳腺癌症,分别为26.5%和15.2%。在整个肿瘤学人群中观察到次优疫苗依从性。只有1.4%的患者观察到完全依从性。疫苗特异性依从率如下:严重急性呼吸系统综合征冠状病毒2型:38.9%;流感:11.4%;肺炎球菌:12.7%;TDaP:113.1%;RZV:3.5%;HPV:0%;hepB:34%。在评估的疫苗接种计划中,严重急性呼吸系统综合征冠状病毒2型疫苗接种率最高,38.9%的患者完全粘附,73%的患者至少接种了一剂。结论:与目前公布的疫苗接种率相比,肿瘤患者的疫苗接种依从率较低。提供者和药剂师可以在化疗开始前和缓解后评估和咨询患者疫苗依从性的重要性。
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引用次数: 0
Polypharmacy and drug-drug interactions in metastatic breast cancer patients receiving cyclin-dependent kinase (CDK) 4/6 inhibitors. 接受细胞周期蛋白依赖性激酶 (CDK) 4/6 抑制剂治疗的转移性乳腺癌患者的多重用药和药物间相互作用。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2023-12-10 DOI: 10.1177/10781552231218959
Tanju Kapagan, Nilufer Bulut, Gokmen Umut Erdem

Introduction: Cyclin-dependent kinase (CDK) 4/6 inhibitors have significantly changed the treatment strategy for patients with locally advanced or metastatic hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2) breast cancer. The purpose of the study was to determine the prevalence of drug-drug interactions (DDI) in breast cancer patients using CDK 4/6 inhibitors and the extent of DDI reflected in the clinic and to increase clinical awareness among physicians.

Method: The data of 115 metastatic breast cancer patients using CDK 4/6 inhibitors who were admitted to the Medical Oncology outpatient clinic between July 2021 and July 2023 were retrospectively reviewed. The Drugs.com® Drug Interaction Checker application was used for the interaction between the CDK 4/6 inhibitor and other drugs.

Results: Among patients included in the study, 97.3% had at least one additional drug use. We have identified a total of 170 potential DDI risks in 63.5 % of patients. Among these, 50.5% had a major potential DDI. In our study, there was a potential risk of QT prolongation in 45.2% of 170 DDI, an increase in the potential toxicity of the additional drug in 44.1%, an increase in the potential toxicity of the CDK 4/6 inhibitor in 5.3%, a decrease in the potential efficacy of the CDK 4/6 inhibitor in 2.9%, a decrease in the potential efficacy of the additional drug in 1.1%, and a serious potential infection risk in 1.1%. Most of the drug interactions were QT prolongation and increased toxicity of the additional drug. In terms of cardiovascular events, grade-2 and grade-3 QTc prolongation was found in 4.3% and 1.7% of these interactions, respectively. When evaluated in terms of CDK 4/6 inhibitor subtype, there was a potential risk of DDI at major level with Ribocilib and at moderate level with Palbociclib.

Conclusion: If CDK 4/6 inhibitors interact with concomitant drugs, they may cause an increase in the incidence of cardiac side effects and a decrease in the effect of the CDK 4/6 inhibitor or additional drug or an increase in toxicity. Increasing awareness of this issue will help to reduce the rates of side effects or toxicity and provide effective antitumour therapy.

简介:细胞周期蛋白依赖性激酶(CDK)4/6抑制剂极大地改变了局部晚期或转移性激素受体阳性(HR+)、人类表皮生长因子2阴性(HER2)乳腺癌患者的治疗策略。该研究旨在确定使用 CDK 4/6 抑制剂的乳腺癌患者中药物间相互作用(DDI)的发生率以及 DDI 在临床中的反映程度,并提高医生的临床意识:方法:回顾性分析肿瘤内科门诊在2021年7月至2023年7月期间收治的115名使用CDK 4/6抑制剂的转移性乳腺癌患者的数据。使用Drugs.com® Drug Interaction Checker应用程序检测CDK 4/6抑制剂与其他药物之间的相互作用:在纳入研究的患者中,97.3%的患者至少额外使用过一种药物。在 63.5% 的患者中,我们共发现了 170 种潜在的 DDI 风险。其中,50.5%的患者有严重的潜在DDI风险。在我们的研究中,170 例 DDI 中 45.2% 存在 QT 延长的潜在风险,44.1% 存在额外药物潜在毒性增加的风险,5.3% 存在 CDK 4/6 抑制剂潜在毒性增加的风险,2.9% 存在 CDK 4/6 抑制剂潜在疗效降低的风险,1.1% 存在额外药物潜在疗效降低的风险,1.1% 存在严重潜在感染风险。大多数药物相互作用是 QT 延长和附加药物毒性增加。在心血管事件方面,分别有 4.3% 和 1.7% 的药物相互作用导致 2 级和 3 级 QTc 延长。如果根据CDK 4/6抑制剂亚型进行评估,Ribocilib可能存在较大程度的DDI风险,Palbociclib可能存在中等程度的DDI风险:结论:如果CDK 4/6抑制剂与同时服用的药物发生相互作用,可能会导致心脏副作用的发生率增加、CDK 4/6抑制剂或附加药物的效果下降或毒性增加。提高对这一问题的认识将有助于降低副作用或毒性的发生率,并提供有效的抗肿瘤治疗。
{"title":"Polypharmacy and drug-drug interactions in metastatic breast cancer patients receiving cyclin-dependent kinase (CDK) 4/6 inhibitors.","authors":"Tanju Kapagan, Nilufer Bulut, Gokmen Umut Erdem","doi":"10.1177/10781552231218959","DOIUrl":"10.1177/10781552231218959","url":null,"abstract":"<p><strong>Introduction: </strong>Cyclin-dependent kinase (CDK) 4/6 inhibitors have significantly changed the treatment strategy for patients with locally advanced or metastatic hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2) breast cancer. The purpose of the study was to determine the prevalence of drug-drug interactions (DDI) in breast cancer patients using CDK 4/6 inhibitors and the extent of DDI reflected in the clinic and to increase clinical awareness among physicians.</p><p><strong>Method: </strong>The data of 115 metastatic breast cancer patients using CDK 4/6 inhibitors who were admitted to the Medical Oncology outpatient clinic between July 2021 and July 2023 were retrospectively reviewed. The Drugs.com® Drug Interaction Checker application was used for the interaction between the CDK 4/6 inhibitor and other drugs.</p><p><strong>Results: </strong>Among patients included in the study, 97.3% had at least one additional drug use. We have identified a total of 170 potential DDI risks in 63.5 % of patients. Among these, 50.5% had a major potential DDI. In our study, there was a potential risk of QT prolongation in 45.2% of 170 DDI, an increase in the potential toxicity of the additional drug in 44.1%, an increase in the potential toxicity of the CDK 4/6 inhibitor in 5.3%, a decrease in the potential efficacy of the CDK 4/6 inhibitor in 2.9%, a decrease in the potential efficacy of the additional drug in 1.1%, and a serious potential infection risk in 1.1%. Most of the drug interactions were QT prolongation and increased toxicity of the additional drug. In terms of cardiovascular events, grade-2 and grade-3 QTc prolongation was found in 4.3% and 1.7% of these interactions, respectively. When evaluated in terms of CDK 4/6 inhibitor subtype, there was a potential risk of DDI at major level with Ribocilib and at moderate level with Palbociclib.</p><p><strong>Conclusion: </strong>If CDK 4/6 inhibitors interact with concomitant drugs, they may cause an increase in the incidence of cardiac side effects and a decrease in the effect of the CDK 4/6 inhibitor or additional drug or an increase in toxicity. Increasing awareness of this issue will help to reduce the rates of side effects or toxicity and provide effective antitumour therapy.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1403-1410"},"PeriodicalIF":1.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138805091","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}
引用次数: 0
Interleukin-6 as a biomarker of hypersensitivity reactions in chemotherapeutics and monoclonal antibodies. 白细胞介素-6作为化学治疗和单克隆抗体中超敏反应的生物标志物。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-12-01 Epub Date: 2023-10-10 DOI: 10.1177/10781552231204367
Rosalaura V Villarreal-González, Sandra González-Díaz, Oscar Vidal-Gutiérrez, Carlos de la Cruz-de la Cruz, Diana C Pérez-Ibave, María L Garza-Rodríguez

Background: In recent years, a new type of immediate hypersensitivity reaction known as cytokine release began to emerge, and within this phenotype of reactions, interleukin-6 is the most frequently associated with the presence during drug administration. Chemotherapeutic agents (QT) and monoclonal antibodies.

Objective: Determine interleukin-6 levels in hypersensitivity reactions to QT and monoclonal antibodies.

Methods: Observational and prospective study that was carried out from March 1, 2021 to March 1, 2022 in a university hospital in northeastern Mexico. Symptoms, severity, interleukin-6 levels, and skin tests of hypersensitivity reaction were evaluated at QT and monoclonal antibodies.

Results: A total of 41 patients with oncological disease were included, the most frequent being ovarian cancer. Symptoms as initial hypersensitivity reaction were neuromuscular in taxanes and cutaneous in Platinums.41.5% presented elevation of interleukin-6, and it was found more frequently in presence of metastases. Positive skin tests were found more frequently in the carboplatin and doxorubicin groups. The most frequently presented phenotype was type I in paclitaxel, carboplatin, and doxorubicin, and mixed-reaction (type I and cytokine release) in oxaliplatin.

Conclusion: With the increasing prevalence of hypersensitivity reactions to biologic and antineoplastic therapies, interleukin-6 should be recognized as a biomarker in immediate hypersensitivity reactions to QT and monoclonal antibodies.

背景:近年来,一种被称为细胞因子释放的新型即时超敏反应开始出现,在这种表型的反应中,白细胞介素-6最常与给药过程中的存在有关。化学治疗剂(QT)和单克隆抗体。目的:测定QT和单克隆抗体超敏反应中白细胞介素-6水平。方法:2021年3月1日至2022年3月31日在墨西哥东北部一所大学医院进行的观察和前瞻性研究。QT和单克隆抗体评估超敏反应的症状、严重程度、白细胞介素-6水平和皮肤试验。结果:共有41例肿瘤患者被纳入,其中最常见的是卵巢癌症。最初的超敏反应症状是紫杉烷的神经肌肉和Platinums的皮肤。41.5%的患者出现白细胞介素-6升高,在有转移的情况下更常见。卡铂和阿霉素组的皮肤试验阳性率更高。最常见的表型是紫杉醇、卡铂和阿霉素的I型,以及奥沙利铂的混合反应(I型和细胞因子释放)。结论:随着对生物和抗肿瘤治疗的超敏反应日益普遍,白细胞介素-6应被认为是对QT和单克隆抗体的即时超敏反应的生物标志物。
{"title":"Interleukin-6 as a biomarker of hypersensitivity reactions in chemotherapeutics and monoclonal antibodies.","authors":"Rosalaura V Villarreal-González, Sandra González-Díaz, Oscar Vidal-Gutiérrez, Carlos de la Cruz-de la Cruz, Diana C Pérez-Ibave, María L Garza-Rodríguez","doi":"10.1177/10781552231204367","DOIUrl":"10.1177/10781552231204367","url":null,"abstract":"<p><strong>Background: </strong>In recent years, a new type of immediate hypersensitivity reaction known as cytokine release began to emerge, and within this phenotype of reactions, interleukin-6 is the most frequently associated with the presence during drug administration. Chemotherapeutic agents (QT) and monoclonal antibodies.</p><p><strong>Objective: </strong>Determine interleukin-6 levels in hypersensitivity reactions to QT and monoclonal antibodies.</p><p><strong>Methods: </strong>Observational and prospective study that was carried out from March 1, 2021 to March 1, 2022 in a university hospital in northeastern Mexico. Symptoms, severity, interleukin-6 levels, and skin tests of hypersensitivity reaction were evaluated at QT and monoclonal antibodies.</p><p><strong>Results: </strong>A total of 41 patients with oncological disease were included, the most frequent being ovarian cancer. Symptoms as initial hypersensitivity reaction were neuromuscular in taxanes and cutaneous in Platinums.41.5% presented elevation of interleukin-6, and it was found more frequently in presence of metastases. Positive skin tests were found more frequently in the carboplatin and doxorubicin groups. The most frequently presented phenotype was type I in paclitaxel, carboplatin, and doxorubicin, and mixed-reaction (type I and cytokine release) in oxaliplatin.</p><p><strong>Conclusion: </strong>With the increasing prevalence of hypersensitivity reactions to biologic and antineoplastic therapies, interleukin-6 should be recognized as a biomarker in immediate hypersensitivity reactions to QT and monoclonal antibodies.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1294-1301"},"PeriodicalIF":1.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41203700","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}
引用次数: 0
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Journal of Oncology Pharmacy Practice
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