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Implementation of a pharmacist-guided pharmacogenomics dosing service at a rural NCI-designated comprehensive cancer center. 在国家癌症研究所指定的一家农村综合癌症中心实施药剂师指导的药物基因组学配药服务。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-04 DOI: 10.1177/10781552241281936
Jenna K Green, Laura J Hackett, Donald C Green, Sophie J Deharvengt, Gabriel A Brooks, Wahab A Khan, Gregory J Tsongalis, Lionel D Lewis, Parth S Shah

Introduction: The goal of pharmacogenetic testing is to identify genetic variants with significant implications on drug safety and efficacy. Several professional organizations and institutions have demonstrated the value of pharmacist involvement in the implementation of pharmacogenomic services. Therefore, we aimed to establish a pharmacist-guided model for interpretation of pharmacogenetic results for all oncology patients seen at the Dartmouth Cancer Center (DCC) in Lebanon, NH.

Methods: A pilot of a pharmacist-guided pharmacogenomics dosing service was implemented at the DCC. Pharmacy services included review of results from a next generation sequencing panel for DPYD, TPMT, NUDT15, and UGT1A1 variants. The pharmacist wrote a note in the electronic health record (EHR) detailing actionable drug-gene interactions and drug-dosing guidance, which was then routed to the treating oncologist. Outcomes collected included highlighting actionable mutations and defining pharmacist interventions. In addition, time spent formulating and documenting patient-specific drug-dosing recommendations was collected.

Results: From February 2024 through May 2024, a total of 71 patients with pharmacogenetic results, provided by the clinical molecular laboratory at Dartmouth Health, were reviewed by the pharmacist. The majority of patients tested were diagnosed with a malignancy of gastrointestinal origin. Twenty-one patients were found to have actionable variants in at least one of the four genes evaluated, and five of the 21 identified patients had active treatment plans for which dose changes were then implemented.

Conclusions: Implementation of a pharmacist-guided pharmacogenomics based dosing service aided in optimizing drug therapy and has positioned Dartmouth Health for further expansion of pharmacogenomics and personalized patient care.

导言:药物基因检测的目的是确定对药物安全性和有效性有重大影响的基因变异。一些专业组织和机构已经证明了药剂师参与实施药物基因组服务的价值。因此,我们的目标是为新罕布什尔州黎巴嫩市达特茅斯癌症中心(DCC)的所有肿瘤患者建立一个药剂师指导的药物基因结果解释模式:方法:在 DCC 开展了药剂师指导下的药物基因组学剂量服务试点。药学服务包括对新一代测序板的 DPYD、TPMT、NUDT15 和 UGT1A1 变异结果进行审查。药剂师在电子病历 (EHR) 中撰写了一份说明,详细介绍了可操作的药物基因相互作用和用药指导,然后将其发送给主治肿瘤医生。收集到的结果包括突出可操作的基因突变和确定药剂师的干预措施。此外,还收集了制定和记录患者特定用药建议所花费的时间:从 2024 年 2 月到 2024 年 5 月,药剂师共审查了 71 名患者的药物基因检测结果,这些结果由达特茅斯健康中心的临床分子实验室提供。大多数接受检测的患者被诊断为胃肠道恶性肿瘤。结果发现,21 名患者的四个评估基因中至少有一个基因存在可操作的变异,在这 21 名被确认的患者中,有 5 名患者的治疗计划正在执行中,随后对其进行了剂量调整:结论:在药剂师指导下实施基于药物基因组学的用药服务有助于优化药物治疗,并为达特茅斯医疗中心进一步拓展药物基因组学和个性化患者护理奠定了基础。
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引用次数: 0
Assessment of drug-drug interactions among patients with hematologic malignancy: A clinical pharmacist-led study. 评估血液系统恶性肿瘤患者的药物相互作用:一项由临床药剂师主导的研究。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-02 DOI: 10.1177/10781552241281664
Sogol Zarrabi, Elham Hosseini, Kourosh Sadeghi, Mohammad Vaezi, Bita Shahrami

Introduction: Patients with hematologic malignancies often receive multiple medications, leading to potential drug-drug interactions (DDIs). Identifying and managing these DDIs is crucial for ensuring patient safety and effective care. This study aimed to identify and describe DDIs and associated factors in hematologic malignancy patients.

Methods: This prospective interventional study was conducted at a referral center and included hospitalized patients with hematologic malignancies who were receiving at least four concurrent medications. A pharmacist initially compiled a comprehensive list of all medications through patient interviews and medication reviews, and subsequently, identified and categorized potential DDIs using the Lexi-interact® and Micromedex® databases. The clinical pharmacist then evaluated the clinical impact of the identified DDIs in every individual patient and provided appropriate interventions to resolve them.

Results: A total of 200 patients met the inclusion criteria for the study, with 1281 DDIs identified across 337 distinct types. The majority of identified DDIs exhibited major severity (52.1%) and pharmacokinetic mechanisms (50.3%), with an unspecified onset (79.4%) and fair evidence (67%). Of the identified DDIs, 81.1% were considered clinically significant, prompting 1059 pharmacotherapy interventions by the clinical pharmacist. Additionally, a significant relationship was observed between the number of drugs used during hospitalization and the occurrence of DDIs (P < 0.001, r = 0.633).

Conclusion: DDIs are highly prevalent among hospitalized patients with hematologic malignancies, with their occurrence increasing alongside the number of medications administrated. The intervention of a clinical pharmacist is crucial to evaluate the clinical impact of these DDIs and implement effective interventions for their management.

简介:血液系统恶性肿瘤患者通常会接受多种药物治疗,从而导致潜在的药物相互作用(DDI)。识别和管理这些 DDIs 对于确保患者安全和有效治疗至关重要。本研究旨在识别和描述血液恶性肿瘤患者的 DDIs 及其相关因素:这项前瞻性干预研究在一家转诊中心进行,研究对象包括至少同时接受四种药物治疗的血液恶性肿瘤住院患者。药剂师首先通过患者访谈和药物回顾编制了一份所有药物的综合清单,随后使用 Lexi-interact® 和 Micromedex® 数据库对潜在的 DDIs 进行了识别和分类。然后,临床药剂师评估已确定的 DDIs 对每位患者的临床影响,并提供适当的干预措施来解决这些问题:共有 200 名患者符合研究的纳入标准,发现了 337 种不同类型的 1281 个 DDI。大多数已识别的 DDIs 表现出严重程度(52.1%)和药代动力学机制(50.3%),发病原因不明(79.4%),证据尚可(67%)。在已确定的 DDIs 中,81.1% 被认为具有临床意义,促使临床药师采取了 1059 次药物治疗干预措施。此外,住院期间使用药物的数量与 DDIs 的发生率之间存在明显的关系(P 结论:DDIs 在住院患者中非常普遍:DDIs 在血液系统恶性肿瘤住院患者中非常普遍,其发生率随着用药数量的增加而增加。临床药剂师的干预对于评估这些 DDIs 的临床影响和实施有效的干预管理至关重要。
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引用次数: 0
Successful desensitization to etoposide in a patient after cardiac arrest. 一名心脏骤停患者对依托泊苷成功脱敏。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-02 DOI: 10.1177/10781552241280723
S Pérez-Codesido, V Azzi Virgini, S Fertani, P Jandus

Introduction: Etoposide phosphate is a chemotherapeutic agent used to treat various malignant neoplasms. Hypersensitivity reactions may occur with its use, and in rare cases, an anaphylactic reaction can manifest. Available options for patients experiencing hypersensitivity reactions include premedication, changing treatment, or undergoing desensitization. Various pediatric desensitization protocols have been described, ranging from six to fifteen steps, while published adult cases are rare.

Case report: We report the case of a 61-year-old woman with small-cell lung cancer and brain metastases. In November 2019, she underwent the second cycle of cisplatin and etoposide phosphate treatment. While receiving etoposide phosphate, she experienced dyspnea and suffered a cardiorespiratory arrest, leading to cardiopulmonary resuscitation and subsequent admission to the Intensive Care Unit. Her acute tryptase levels were notably elevated at 18 µg/L (compared to a baseline tryptase level of 6,6 µg/L) during the reaction.

Case management: We implemented a 16-step desensitization protocol (without premedication) under close monitoring in an intermediate care unit. The protocol was successfully executed over three cycles until tumor progression mandated a modification in systemic treatment.

Discussion: To our knowledge, this is the first documented case of successful desensitization to etoposide phosphate in a patient who experienced cardiac arrest during a hypersensitivity reaction. Although protocols of varying lengths have been published, we emphasize the importance of individualizing each protocol to fit the severity of the reaction and the resources and experience of each unit.

简介磷酸依托泊苷是一种用于治疗各种恶性肿瘤的化疗药物。使用时可能会出现超敏反应,在极少数情况下会出现过敏反应。对于出现超敏反应的患者,可采用的方法包括预先用药、改变治疗方法或进行脱敏治疗。已有各种儿科脱敏方案,从 6 个步骤到 15 个步骤不等,而发表的成人病例却很少见:我们报告了一名患有小细胞肺癌和脑转移的 61 岁女性病例。2019 年 11 月,她接受了第二周期的顺铂和磷酸依托泊苷治疗。在接受磷酸依托泊苷治疗期间,她出现呼吸困难,心肺功能骤停,需要进行心肺复苏,随后被送入重症监护室。在反应期间,她的急性色氨酸酶水平明显升高,达到 18 µg/L(而色氨酸酶的基线水平为 6.6 µg/L):病例处理:在中级护理病房的严密监护下,我们实施了 16 步脱敏方案(无需预先用药)。该方案成功实施了三个周期,直到肿瘤进展要求改变全身治疗方案:据我们所知,这是第一例在超敏反应期间心脏骤停的患者成功对磷酸依托泊苷脱敏的病例。尽管已公布的治疗方案长短不一,但我们强调根据反应的严重程度以及各单位的资源和经验制定个性化治疗方案的重要性。
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引用次数: 0
Grade 3 cytolysis in a patient with metastatic colorectal cancer consuming a mushroom powder-based alternative therapy. 一名使用蘑菇粉替代疗法的转移性结直肠癌患者出现 3 级细胞溶解。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-02 DOI: 10.1177/10781552241280617
Geoffrey Strobbe, Margaux Jeanjacquot, Camille Potey, Aurélien Carnot, Guillaume Marliot

Introduction: The use of Complementary Alternative Medicine (CAM) in patients with cancer is increasing. CAM is associated with potential toxicity and drug interactions, particularly with chemotherapy. Here, we report a case of cytolysis and hepatic cholestasis in a patient who was self-medicated with a mushroom powder-based alternative therapy containing Agaricus blazei Murril (ABM) during cancer treatment.

Case report: A 43-year-old woman with metastatic colorectal cancer and hepatic metastases was admitted to our hospital for intravenous chemotherapy. Markers of hepatic grade 3 cytolysis and cholestasis were identified during the pretreatment consultation. The baseline results were within normal limits.

Management and outcome: The chemotherapy was immediately canceled, and further tests were performed. After the investigation, the patient reported taking three mushroom powder-based capsules per day since November 2023. The dietary supplement contained ABM and Hericium erinaceus (HE) powder. After Pharmaceutical analysis, treatment with the supplement was discontinued, and the patient has not resumed. The changes in liver function were also favorable.

Discussion: In our case, given the improvement in liver function after CAM discontinuation, hepatic cytolysis appeared to be linked to ABM consumption despite the patient's liver metastases. Pharmaceutical analysis of CAM is essential to ensure the safety and optimization of cancer treatments. Patients should also communicate their CAMs to healthcare professionals and be aware of the consequences of consuming these dietary supplements. Finally, collaboration between pharmaceutical teams and oncologists is essential for optimal management of cancer patients.

简介癌症患者使用补充替代医学(CAM)的情况日益增多。CAM 具有潜在的毒性和药物相互作用,尤其是与化疗的相互作用。在此,我们报告了一例在癌症治疗期间自行服用含有姬松茸的蘑菇粉替代疗法(ABM)的患者发生细胞溶解和肝胆汁淤积的病例:一名患有转移性结直肠癌并伴有肝转移的 43 岁女性入住我院接受静脉化疗。在治疗前的会诊中发现了肝3级细胞溶解和胆汁淤积的标志物。基线结果在正常范围内:立即取消了化疗,并进行了进一步检查。经过调查,患者称自 2023 年 11 月起每天服用三粒蘑菇粉胶囊。膳食补充剂中含有 ABM 和 Hericium erinaceus(HE)粉末。经药物分析后,患者停止了服用该补充剂,至今未恢复服用。肝功能的变化也很好:在我们的病例中,鉴于停用 CAM 后肝功能有所改善,尽管患者有肝转移,但肝细胞溶解似乎与服用 ABM 有关。对 CAM 进行药物分析对于确保癌症治疗的安全性和优化至关重要。患者也应将其服用的 CAM 告知医护人员,并了解服用这些膳食补充剂的后果。最后,制药团队和肿瘤学家之间的合作对于优化癌症患者的治疗至关重要。
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引用次数: 0
"The protective effect of nano curcumin supplementation on doxorubicin induced cardiotoxicity in breast cancer patients; a randomized, double-blind clinical trial". "纳米姜黄素补充剂对乳腺癌患者多柔比星诱发的心脏毒性的保护作用;随机双盲临床试验"。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-02 DOI: 10.1177/10781552241277958
Mehdi Tohidi, Abolghasem Allahyari, Sajjad Ataei Azimi, Hedieh Alimi, Sepideh Elyasi, Farid Qoorchi Moheb Seraj, Hasan Mehrad-Majd

Background: Anthracycline drugs play a fundamental role in breast cancer treatment; however, the cardiotoxicity side effects obscure the advantages of treatment. Curcumin has antioxidant and anti-inflammatory effects.

Materials and methods: In this study, we investigated the effect of nanocurcumin supplementation on Doxorubicin induced Cardiotoxicity. In this randomized clinical trial, a week before starting the doxorubicin regimen for breast cancer patients, the control group received placebo and curcumin group received 80 mg daily dosage of nano curcumin capsules for six months. Echocardiography parameter changes before chemotherapy and after six months were evaluated.

Results: 46 patients were included. Left ventricle (LV) ejection fraction significantly decreased and LV end diastolic volume significantly increased in control group but no significant changes were observed in the curcumin group (LVEF: 2.62 ± 59.35 to 4.23 ± 56.85, p-value: 0.014 vs 59.55 ± 1.91 to 58.46 ± 3.41, p-value:0.135; LVEDV: 77.09 ± 15.33 to 80.65 ± 14.54, p-value:0.023 vs 72.41 ± 15.34 74.00 ± 14.25, p-value: 0.294). Additionally, LVEF, LV end systolic diameter (LVESD), and end diastolic diameter (LVEDD) insignificantly more decreased in control group versus curcumin group (LVEF: 4.13 ± 2.50- vs 3.36 ± 1.08-, p-value: 0.223; LVESD: 0.27 ± 0.06-vs 0.120.45 ±, p-value:0.110; LVEDD: -0.44 ± 0.33 vs 0.070.33 ±, p-value:0.269). Furthermore, symptomatic cardiomyopathy and ejection fraction ratio less than 53% were not observed. The LVEF reduction >15% was observed was also high in the control group, (p-value = 0.020).

Conclusion: This study shows the possible effect of nanocurcumin capsules to reduce the cardiotoxicity of anthracycline chemotherapy medications.

背景:蒽环类药物在乳腺癌治疗中起着基础性作用,但其心脏毒性副作用掩盖了治疗的优势。姜黄素具有抗氧化和抗炎作用:本研究探讨了纳米姜黄素补充剂对多柔比星诱导的心脏毒性的影响。在这项随机临床试验中,乳腺癌患者在开始接受多柔比星治疗前一周,对照组服用安慰剂,姜黄素组服用纳米姜黄素胶囊,每天服用 80 毫克,为期六个月。对化疗前和化疗后六个月的超声心动图参数变化进行评估:结果:共纳入 46 名患者。对照组患者的左心室射血分数明显降低,左心室舒张末期容积明显增加,而姜黄素组未观察到明显变化(LVEF:2.62 ± 59.35到4.23±56.85,P值:0.014 vs 59.55±1.91到58.46±3.41,P值:0.135;LVEDV:77.09±15.33到80.65±14.54,P值:0.023 vs 72.41±15.34 74.00±14.25,P值:0.294)。此外,对照组与姜黄素组相比,LVEF、左心室收缩末期直径(LVESD)和舒张末期直径(LVEDD)显著下降(LVEF:4.13±2.50-vs3.36±1.08-,P值:0.223;LVESD:0.27±0.06-vs 0.120.45±,P值:0.110;LVEDD:-0.44±0.33 vs 0.070.33±,P值:0.269)。此外,未观察到有症状的心肌病和射血分数比小于 53% 的患者。在对照组中,观察到 LVEF 降低 >15% 的比例也很高(P 值 = 0.020):这项研究表明,纳米姜黄素胶囊可能具有减轻蒽环类化疗药物心脏毒性的作用。
{"title":"\"The protective effect of nano curcumin supplementation on doxorubicin induced cardiotoxicity in breast cancer patients; a randomized, double-blind clinical trial\".","authors":"Mehdi Tohidi, Abolghasem Allahyari, Sajjad Ataei Azimi, Hedieh Alimi, Sepideh Elyasi, Farid Qoorchi Moheb Seraj, Hasan Mehrad-Majd","doi":"10.1177/10781552241277958","DOIUrl":"https://doi.org/10.1177/10781552241277958","url":null,"abstract":"<p><strong>Background: </strong>Anthracycline drugs play a fundamental role in breast cancer treatment; however, the cardiotoxicity side effects obscure the advantages of treatment. Curcumin has antioxidant and anti-inflammatory effects.</p><p><strong>Materials and methods: </strong>In this study, we investigated the effect of nanocurcumin supplementation on Doxorubicin induced Cardiotoxicity. In this randomized clinical trial, a week before starting the doxorubicin regimen for breast cancer patients, the control group received placebo and curcumin group received 80 mg daily dosage of nano curcumin capsules for six months. Echocardiography parameter changes before chemotherapy and after six months were evaluated.</p><p><strong>Results: </strong>46 patients were included. Left ventricle (LV) ejection fraction significantly decreased and LV end diastolic volume significantly increased in control group but no significant changes were observed in the curcumin group (LVEF: 2.62 ± 59.35 to 4.23 ± 56.85, <i>p</i>-value: 0.014 vs 59.55 ± 1.91 to 58.46 ± 3.41, <i>p</i>-value:0.135; LVEDV: 77.09 ± 15.33 to 80.65 ± 14.54, <i>p</i>-value:0.023 vs 72.41 ± 15.34 74.00 ± 14.25, <i>p</i>-value: 0.294). Additionally, LVEF, LV end systolic diameter (LVESD), and end diastolic diameter (LVEDD) insignificantly more decreased in control group versus curcumin group (LVEF: 4.13 ± 2.50- vs 3.36 ± 1.08-, <i>p</i>-value: 0.223; LVESD: 0.27 ± 0.06-vs 0.120.45 ±, <i>p</i>-value:0.110; LVEDD: -0.44 ± 0.33 vs 0.070.33 ±, <i>p</i>-value:0.269). Furthermore, symptomatic cardiomyopathy and ejection fraction ratio less than 53% were not observed. The LVEF reduction >15% was observed was also high in the control group, (<i>p</i>-value = 0.020).</p><p><strong>Conclusion: </strong>This study shows the possible effect of nanocurcumin capsules to reduce the cardiotoxicity of anthracycline chemotherapy medications.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241277958"},"PeriodicalIF":1.0,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120094","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
Evaluation of contraception methods in chronic myeloid leukemia patients: A Turkish multicenter study. 慢性髓性白血病患者避孕方法评估:土耳其多中心研究。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-02 DOI: 10.1177/10781552241280615
Rafiye Çiftçiler, Cem Selim, Melda Cömert, Haydar Zengin, Yıldız İpek, Vildan Gürsoy, Esra Yıldızhan, Abdülkerim Yıldız, Samet Yaman, Tayfun Elibol, Serkan Güven, Eren Arslan Davulcu, Deniz Özmen, Atakan Tekinalp, Zehra Narlı Özdemir, Mehmet Baysal, Sinan Mersin, Zeynep Güven, İbrahim Ethem Pınar, Serhat Çelik, Ahmet Emre Eşkazan

Background and aim: Chronic myeloid leukemia (CML) incidence has recently increased in younger individuals. With time, given the nature of the disease and available therapies, as well as the existing paucity and inconsistency of advice, worries about fertility have surfaced. With all these clear unknowns, we designed this study to raise awareness among both physicians and CML patients about whether male and female patients of childbearing age were using contraception at the time of diagnosis, and if so, which methods they were using. In this context, this study aimed to evaluate the contraception methods in patients with CML.

Materials and methods: Eighteen centres from Turkey participated in the study. Male and female patients of childbearing age diagnosed with chronic and accelerated phase CML between the years 2000 and 2024 were evaluated retrospectively.

Results: Of the two hundred and thirty-two patients included, one hundred and twenty-five (53.9%) of these patients were female and 107 (46.1%) were male. At diagnosis, all female patients were in the childbearing age, and male patients were sexually active. The median age at diagnosis of the patients was 38 (range, 18-77) years. Eighty-six (68.8%) female patients were using any contraception method, while this was 53.2% (n = 57) among male patients.

Conclusion: In conclusion, since CML patients are diagnosed at an earlier age and the desire of these patients to have children, adequate information and evaluation should be provided regarding fertility and contraception issues, especially in female patients, from the moment of diagnosis.

背景和目的:最近,慢性髓性白血病(CML)在年轻人中的发病率有所上升。随着时间的推移,考虑到疾病的性质和现有的治疗方法,以及现有建议的匮乏和不一致,人们开始担心生育问题。鉴于所有这些明显的未知因素,我们设计了这项研究,以提高医生和 CML 患者对育龄男性和女性患者在确诊时是否采取避孕措施的认识,如果采取避孕措施,他们使用的是哪种方法。在此背景下,本研究旨在评估 CML 患者的避孕方法:来自土耳其的 18 个中心参与了这项研究。对 2000 年至 2024 年期间被诊断为慢性和加速期 CML 的育龄男女患者进行了回顾性评估:在纳入的 232 名患者中,125 名(53.9%)为女性,107 名(46.1%)为男性。确诊时,所有女性患者均处于育龄期,男性患者性生活活跃。患者确诊时的年龄中位数为 38 岁(18-77 岁)。86名(68.8%)女性患者采取了任何避孕措施,而男性患者采取避孕措施的比例为53.2%(57人):总之,由于慢性骨髓性白血病患者确诊年龄较早,而且这些患者希望生育,因此应从确诊开始就提供有关生育和避孕问题的充分信息和评估,尤其是女性患者。
{"title":"Evaluation of contraception methods in chronic myeloid leukemia patients: A Turkish multicenter study.","authors":"Rafiye Çiftçiler, Cem Selim, Melda Cömert, Haydar Zengin, Yıldız İpek, Vildan Gürsoy, Esra Yıldızhan, Abdülkerim Yıldız, Samet Yaman, Tayfun Elibol, Serkan Güven, Eren Arslan Davulcu, Deniz Özmen, Atakan Tekinalp, Zehra Narlı Özdemir, Mehmet Baysal, Sinan Mersin, Zeynep Güven, İbrahim Ethem Pınar, Serhat Çelik, Ahmet Emre Eşkazan","doi":"10.1177/10781552241280615","DOIUrl":"https://doi.org/10.1177/10781552241280615","url":null,"abstract":"<p><strong>Background and aim: </strong>Chronic myeloid leukemia (CML) incidence has recently increased in younger individuals. With time, given the nature of the disease and available therapies, as well as the existing paucity and inconsistency of advice, worries about fertility have surfaced. With all these clear unknowns, we designed this study to raise awareness among both physicians and CML patients about whether male and female patients of childbearing age were using contraception at the time of diagnosis, and if so, which methods they were using. In this context, this study aimed to evaluate the contraception methods in patients with CML.</p><p><strong>Materials and methods: </strong>Eighteen centres from Turkey participated in the study. Male and female patients of childbearing age diagnosed with chronic and accelerated phase CML between the years 2000 and 2024 were evaluated retrospectively.</p><p><strong>Results: </strong>Of the two hundred and thirty-two patients included, one hundred and twenty-five (53.9%) of these patients were female and 107 (46.1%) were male. At diagnosis, all female patients were in the childbearing age, and male patients were sexually active. The median age at diagnosis of the patients was 38 (range, 18-77) years. Eighty-six (68.8%) female patients were using any contraception method, while this was 53.2% (n = 57) among male patients.</p><p><strong>Conclusion: </strong>In conclusion, since CML patients are diagnosed at an earlier age and the desire of these patients to have children, adequate information and evaluation should be provided regarding fertility and contraception issues, especially in female patients, from the moment of diagnosis.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241280615"},"PeriodicalIF":1.0,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108436","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
Pembrolizumab-induced type 1 diabetes. Pembrolizumab 诱导的 1 型糖尿病。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-20 DOI: 10.1177/10781552241255699
Ariana Maia, Daniela M Soares, Sofia Azevedo, Teresa Pereira, Cláudia Amaral

Introduction: Immunotherapy has a crucial role in the current treatment of multiple malignancies. Albeit described as rare, new onset autoimmune diabetes is a potentially life-threatening complication of programmed cell death-1 (PD-1) inhibitors, such as pembrolizumab, and its predisposing factors and pathological mechanism are yet to be clarified.

Case report: We present a case of a 72-year-old man with a high-grade bladder carcinoma undergoing pembrolizumab treatment. He had no personal or family history of diabetes mellitus but was diagnosed with primary hypothyroidism four months after starting pembrolizumab. Two years after starting pembrolizumab, he presented in the emergency department due to abdominal pain, anorexia, polydipsia, polyuria and vomiting over the preceding five days and he met criteria for severe diabetic ketoacidosis (DKA). Three days prior to his admission, he had received prednisolone therapy for suspected hypersensitivity related to a contrast-enhanced imaging that he performed.

Management & outcome: Prompt treatment for DKA was started, with transition to insulin basal-bolus therapy after DKA resolution, with progressive glycaemic stabilization. Further investigation revealed low C-peptide levels (0.07 ng/dL, with a fasting blood glucose of 288 mg/dL), HbA1c 9.2% and positive anti-IA2 antibodies, which allowed the diagnosis of new-onset autoimmune diabetes. Pembrolizumab was transiently suspended, and the patient resumed treatment after glycaemic profile optimization under multiple daily insulin administrations two months later.

Discussion: This case highlights the importance of clinical suspicion and glycaemic monitoring as an integral part of treatment protocols in patients on pembrolizumab and other immune checkpoint inhibitors. Additional research and investigation into the underlying mechanisms of this condition are necessary to identify potential screening tests for individuals at higher risk of developing DM and to guide the implementation of management and preventive strategies for ketoacidosis complication.

简介免疫疗法在目前多种恶性肿瘤的治疗中发挥着至关重要的作用。尽管被描述为罕见,但新发自身免疫性糖尿病是程序性细胞死亡-1(PD-1)抑制剂(如 pembrolizumab)的一种潜在威胁生命的并发症,其诱发因素和病理机制尚未明确:我们报告了一例 72 岁男性高级别膀胱癌患者接受 pembrolizumab 治疗的病例。他没有个人或家族糖尿病史,但在开始使用 pembrolizumab 四个月后被诊断为原发性甲状腺功能减退症。在开始使用 Pembrolizumab 两年后,他因腹痛、厌食、多饮、多尿和呕吐而到急诊科就诊。入院前三天,他曾接受过泼尼松龙治疗,原因是怀疑他对造影剂过敏:及时开始治疗 DKA,DKA 缓解后转为胰岛素基础治疗,血糖逐渐稳定。进一步检查发现,患者的C肽水平较低(0.07纳克/分升,空腹血糖为288毫克/分升),HbA1c为9.2%,抗IA2抗体阳性,因此诊断为新发自身免疫性糖尿病。患者暂时停用了 Pembrolizumab,两个月后,在每天多次使用胰岛素的情况下,患者的血糖情况得到优化,并恢复了治疗:本病例强调了临床怀疑和血糖监测的重要性,这是使用 pembrolizumab 和其他免疫检查点抑制剂的患者治疗方案中不可或缺的一部分。有必要对这一病症的潜在机制进行更多的研究和调查,以确定对罹患糖尿病风险较高的个体进行筛查的可能性,并指导酮症酸中毒并发症的管理和预防策略的实施。
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引用次数: 0
Evaluation of proteinuria monitoring practice patterns and treatment implications in patients with cancer receiving bevacizumab products. 评估接受贝伐珠单抗产品治疗的癌症患者的蛋白尿监测实践模式和治疗意义。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2023-09-01 DOI: 10.1177/10781552231198779
Kuan Sturgill, Katie Dicke, Mark Zangardi, Kara Osborne

Introduction: Proteinuria is a well-known toxicity of bevacizumab which can lead to kidney injury or nephrotic syndrome. There is little guidance on the frequency of monitoring and management of those that experience bevacizumab-induced proteinuria. Previous literature has suggested routine monitoring with every dose has limited clinical significance. Currently, there is no standardization of proteinuria monitoring at OhioHealth.

Methods: This retrospective descriptive study included 100 adult patients who received at least 3 doses of a bevacizumab product for a malignant condition at any OhioHealth facility from April 15, 2022 to October 15, 2022. The primary outcome was to describe the average number of proteinuria tests ordered over the course of therapy.

Results: Of the 100 patients evaluated, 91 received proteinuria monitoring during treatment with bevacizumab. The overall average number of tests completed per patient per month based on treatment period of bevacizumab was 1.51. Twenty-two of 91 patients (24%) developed grade 2+ proteinuria. Average time to first grade 2+ proteinuria event was 5.7 months. A history of baseline renal dysfunction or chronic kidney disease was the only predefined factor found to be significantly associated with developing grade 2+ proteinuria. The most common treatment modification following a grade 2+ proteinuria result was a delay in therapy.

Conclusion: Proteinuria monitoring may not be necessary for short definitive courses of bevacizumab and closer monitoring should be considered in patients with baseline renal dysfunction or CKD. Future direction includes evaluating the cost of varying proteinuria tests and developing a recommendation for OhioHealth to standardize testing.

简介蛋白尿是贝伐珠单抗的一种众所周知的毒性,可导致肾损伤或肾病综合征。对于贝伐珠单抗引起的蛋白尿的监测频率和处理方法,目前几乎没有任何指导。以往的文献表明,对每次用药进行常规监测的临床意义有限。目前,俄亥俄州卫生部还没有对蛋白尿监测进行标准化:这项回顾性描述性研究纳入了 2022 年 4 月 15 日至 2022 年 10 月 15 日期间在俄亥俄州医疗机构接受至少 3 次贝伐单抗产品治疗的 100 名成年恶性肿瘤患者。主要结果是描述在治疗过程中接受蛋白尿检测的平均次数:在接受评估的 100 名患者中,有 91 人在贝伐珠单抗治疗期间接受了蛋白尿监测。根据贝伐珠单抗的治疗周期,每位患者每月完成检测的总平均次数为 1.51 次。91 名患者中有 22 人(24%)出现了 2+ 级蛋白尿。首次出现 2+ 级蛋白尿的平均时间为 5.7 个月。基线肾功能不全或慢性肾病史是唯一与出现 2+ 级蛋白尿显著相关的预定义因素。出现 2+ 级蛋白尿后最常见的治疗调整是延迟治疗:结论:贝伐珠单抗的短期疗程可能不需要监测蛋白尿,但对于基线肾功能障碍或慢性肾脏病患者,应考虑进行更严密的监测。未来的方向包括评估不同蛋白尿检测的成本,并为俄亥俄州卫生局制定标准化检测的建议。
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引用次数: 0
Adverse events associated with Pegaspargase biosimilar in pediatric patients with acute lymphoblastic leukemia: A prospective single-center study. 与急性淋巴细胞白血病儿科患者使用 Pegaspargase 生物类似物相关的不良事件:前瞻性单中心研究。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2023-07-27 DOI: 10.1177/10781552231190827
Bijoy Kumar Panda, Mahima Gaikwad, Vibha Bafna, Neela Vaidya, Vishal Aundhe, Angha Mhatre

Background: While Pegaspargase is an essential component of the treatment of acute lymphoid leukemia (ALL) in children, it causes adverse events (AEs) that sometimes make full use impossible.

Objective: The objective was to investigate the safety of Pegaspargase biosimilar in pediatric ALL patients undergoing treatment according to ICiCLe ALL-14 protocol.

Method and materials: A prospective study was carried out in a university teaching hospital located in the state of Maharashtra, India. Data on clinical factors and adverse reaction characteristics were gathered from hospital medical records. Suspected AEs were classified according to causality and severity.

Results: During the study period, 72 children had 52 suspicions of AEs during treatment with biosimilar Pegaspargase. The odds ratio of 1.11 (95%CI, 0.41-2.98) suggested that males and females were both equally likely to experience adverse drug events, despite the fact that the frequency of suspected AEs was higher in boys (66%) than in girls (33%). None of the patients experienced allergic reactions. The high-risk category had the highest number of suspected AEs (56%), followed by intermediate risk (20%) and standard risk (20%). These patients showed a high frequency of suspected AEs during the induction phase (43%) followed by the consolidation phase (26%). Sixty percent of the reactions were classified as grade 1 or 2. ALL cell type (p = 0.02), risk category (p = 0.04) and length of hospitalization (p = 0.003) were significantly correlated with suspected AEs.

Conclusion: Bio-similar Pegaspargase in combination with chemotherapy was safe and tolerable in the pediatric ALL patients treated according to ICiCLe ALL-14 protocol. Suspected AEs ranged from mild to moderate and hepatic failure and hyperglycemia being severe.

背景:尽管Pegaspargase是治疗儿童急性淋巴性白血病(ALL)的重要成分,但其引起的不良事件(AEs)有时会导致无法完全使用:目的:调查根据 ICiCLe ALL-14 方案接受治疗的儿童 ALL 患者使用 Pegaspargase 生物仿制药的安全性:在印度马哈拉施特拉邦的一所大学教学医院开展了一项前瞻性研究。有关临床因素和不良反应特征的数据来自医院病历。根据因果关系和严重程度对疑似不良反应进行分类:在研究期间,72 名儿童在使用生物仿制药 Pegaspargase 治疗期间发生了 52 例可疑 AE。1.11(95%CI,0.41-2.98)的几率比表明,男性和女性发生药物不良事件的可能性相同,尽管男孩发生可疑AE的频率(66%)高于女孩(33%)。没有一名患者出现过敏反应。高风险类别的疑似不良反应发生率最高(56%),其次是中度风险(20%)和标准风险(20%)。这些患者在诱导阶段(43%)和巩固阶段(26%)出现疑似 AE 的频率较高。60%的反应被列为1级或2级。ALL细胞类型(p = 0.02)、风险类别(p = 0.04)和住院时间(p = 0.003)与疑似AEs显著相关:结论:根据ICiCLe ALL-14方案治疗的儿童ALL患者,生物类似物Pegaspargase联合化疗是安全和可耐受的。疑似不良反应从轻度到中度不等,肝功能衰竭和高血糖是严重不良反应。
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引用次数: 0
Optimizing cyclosporine A dose post allogeneic hematopoietic stem cell transplantation in paediatric cancer patients. 优化儿科癌症患者异基因造血干细胞移植后的环孢素 A 剂量。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2023-08-01 DOI: 10.1177/10781552231192516
Mennatallah Elnaggar, Hanafy Hafez, Amr Abdallah, Mahmoud Hamza, Marwa M Khalaf, Alaa El-Haddad

Background/objectives: Cyclosporine A (CSA) dosing has been complicated by considerable intra-patient and inter-patient variability in pharmacokinetics, which is affected by different factors. We aimed to assess the various factors that might affect the CSA dose and its plasma level.

Patients and methods: This retrospective study included paediatric cancer patients who underwent allogeneic hematopoietic stem cell transplant at the Children's Cancer Hospital Egypt 57357 from matched related donors with CSA as graft versus host disease prophylaxis. The CSA initial dose was 1.5 mg/kg IV Q12H. Then, it was titrated according to the level and drug toxicity. Cyclosporine A trough levels were assessed two to three times per week using the Emit 2000 cyclosporine-specific assay. Moreover, factors that may affect cyclosporine levels, such as age, sex, weight and the antifungal used, were analyzed to determine their effect on CSA plasma levels.

Results: There were 119 patients included in the study. The median age was 10 years; and 43% of them used voriconazole as a prophylactic antifungal. The multivariate analysis revealed that female patients, those >9 years or on voriconazole reached the target level at low initial CSA doses. A higher probability (93%) of reaching the desired plasma level with doses 1.5 mg/kg IV Q12H was observed among patients >9 years, and on voriconazole. While those who were ≤9 years and not on voriconazole required doses >1.5 mg/kg IV Q12H, with an 89% probability of reaching the desired level.

Conclusion: This study suggests that the initial CSA dose should consider the patient's age and the antifungal used. Patients >9 years and/or on voriconazole may require lower initial CSA doses and could start with 1.5 mg/kg IV Q12H.

背景/目的:环孢菌素 A(CSA)的药代动力学受不同因素的影响,在患者体内和患者之间存在相当大的变异性,这使得环孢菌素 A 的给药变得复杂。我们旨在评估可能影响 CSA 剂量及其血浆水平的各种因素:这项回顾性研究纳入了在埃及 57357 儿童癌症医院接受异体造血干细胞移植的儿童癌症患者,这些患者来自匹配的亲缘供体,并使用 CSA 作为移植物抗宿主疾病的预防措施。CSA 初始剂量为 1.5 mg/kg IV Q12H。然后,根据药物毒性水平滴定剂量。每周使用 Emit 2000 环孢素特异性分析仪评估两到三次环孢素 A 谷值水平。此外,还分析了可能影响环孢素水平的因素,如年龄、性别、体重和使用的抗真菌药物,以确定它们对 CSA 血浆水平的影响:共有 119 名患者参与研究。中位年龄为 10 岁,其中 43% 的患者使用伏立康唑作为预防性抗真菌药物。多变量分析显示,女性患者、年龄大于 9 岁或服用伏立康唑的患者在初始 CSA 剂量较低时就能达到目标水平。年龄大于 9 岁或服用伏立康唑的患者在使用 1.5 mg/kg IV Q12H 剂量时达到预期血浆水平的概率较高(93%)。而那些年龄小于 9 岁且未服用伏立康唑的患者则需要剂量大于 1.5 毫克/千克的静脉注射 Q12H,达到理想水平的概率为 89%:本研究表明,CSA 的初始剂量应考虑患者的年龄和所使用的抗真菌药物。年龄大于 9 岁和/或服用伏立康唑的患者可能需要较低的 CSA 初始剂量,可从 1.5 mg/kg IV Q12H 开始。
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引用次数: 0
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Journal of Oncology Pharmacy Practice
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