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Overcome Daratumumab' severe reaction with desensitization in relapsed multiple myeloma. 在复发性多发性骨髓瘤中克服达拉单抗的严重反应和脱敏。
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-12-01 Epub Date: 2025-07-08 DOI: 10.1177/10781552251356918
Trang L Nguyen, Truc Phan, Mai T Vu, Kn Vy Huynh, Yi Hyeon Gyu, Tuan D Nguyen, Lan Q Phan, Tuan D Nguyen, Dinh V Nguyen

IntroductionDaratumumab, a monoclonal antibody that specifically targets the myeloma cells' CD38 antigen, is promisingly used in both monotherapy and combination therapy for relapsed patients with multiple myeloma. However, this approach had a significant challenge due to the high rate of infusion-related reaction in the first dosage (up to 38%) despite strict instructions on infusion rate and dilution volume. This study describes a patient who overcame severe infusion reaction after the first dosage by desensitization.Case reportA 60-year-old man with multiple myeloma was relapsed with multiple bone damage and elevated immunoglobulin D lambda after VTD (bortezomid, thalidomide, dexamethasone) regimen completion. After 60 min of initial Daratumumab dose with sufficient pre-medication, the patient manifested suspected grade 3 infustion reaction and was transported to the intensive care unit.Management and outcomeDaratumumab was immediately terminated; adrenaline, methylprednisolone, and diphenhydramine were started. Another regimen was performed. However, due to substantial progression of symptoms, a re-introduction of daratumumab was considered. Daratumumab prick and intradermal skin test was performed with negative result. Desensitization were sucessfull with the number of bags and steps gradually lowered with no adverse events observed. After three cycles, the patient achieved VGPR (Very Good Partial Response) without any symptomatic spinal cord compression.ConclusionDesensitization is a promising solution to overcome daratumumab's severe infusion reaction, opening the new approach for clinicians. To ensure success, it is important to have a multidisciplinary team with experienced allergist, hematologist, Intensive Care Init (ICU) team and oncology pharmacist to create a safe environment for desensitization.

daratumumab是一种特异性靶向骨髓瘤细胞CD38抗原的单克隆抗体,有望用于多发性骨髓瘤复发患者的单药和联合治疗。然而,尽管对输注速率和稀释体积有严格的说明,但由于第一次剂量的输注相关反应率高(高达38%),这种方法面临重大挑战。本研究描述了一位患者在第一次给药后通过脱敏克服了严重的输注反应。病例报告:一名60岁男性多发性骨髓瘤患者在完成VTD(硼替佐米、沙利度胺、地塞米松)治疗后,多发性骨损伤复发,免疫球蛋白D升高。在给予充分的达拉单抗初始剂量60分钟后,患者表现出疑似3级输液反应,并被送往重症监护病房。管理和结果:aratumumab立即终止;开始使用肾上腺素、甲基强的松龙和苯海拉明。进行另一种治疗方案。然而,由于症状的显著进展,考虑重新引入达拉单抗。达拉单抗点刺及皮内试验均为阴性。脱敏成功,袋数和步数逐渐减少,无不良事件发生。三个周期后,患者达到了VGPR(非常好的部分反应),没有任何症状性脊髓压迫。结论脱敏治疗是克服达拉单抗严重输液反应的有效方法,为临床医生开辟了新的途径。为了确保成功,重要的是要有一个多学科的团队,由经验丰富的过敏症专家、血液学家、重症监护(ICU)团队和肿瘤药剂师组成,为脱敏创造一个安全的环境。
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引用次数: 0
Overcoming language barriers to enhance pharmaceutical care: Design and validation of a pictogram-based tool for cancer patients. 克服语言障碍,加强药学服务:为癌症患者设计和验证一个基于象形文字的工具。
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-25 DOI: 10.1177/10781552251369421
Justine Clarenne, Marion Barrois, Audrey Durand, Léa Aubert, Claire Carlier, Kamelia Smati, Olivier Bouché, Florian Slimano

PurposeOncology Pharmacists providing care for cancer patients need access to medication history, act to prevent drug- / herb-drug interaction (HDI), educate patients on detection and management of adverse effects (AE) through proper use of supportive care. However, language barriers are common in case with less spoken languages, making communication challenging. We aimed to design and validate a set of illustrations addressing these key topics.MethodsThe design of the pictures was led by three pharmacists, focusing on three topics: general information (medication history), problems detection (AE of anticancer treatments, HDI) and the proper use of supportive care (e.g., mouthwash). Illustrations were created using Canva® (Canva Pty Ltd, Perth, Australia). Each card underwent a two-step validation process: an on-site evaluation (Wooclap® (Bruxelles, Belgium) for agreement/disagreement with recommendations), followed by a broader validation involving a multidisciplinary panel including oncologists, general practitioners, nurses, pharmacists, and patients- using a 9-point Likert scale on a Google® Form (Google, Mountain View, CA, USA).ResultsA total of 53 cards were initially evaluated by 19 pharmacists who fully approved 18 of them and provided recommendations for the others. Subsequently, a panel of 27 respondents rated the 53 cards. After the first round, the mean score was 7.37 ± 1.2, with all but five cards receiving a score >6 and being validated. The clarity of four cards (weight variation, HDI, dry skin, neuropathy) was improved while one (St John's wort) was ultimately removed. The four revised cards were then resubmitted and received approval.ConclusionsA final set of 52 validated cards will help enhance pharmaceutical care for cancer patients facing language barriers.

目的肿瘤药师为癌症患者提供护理,需要了解患者用药史,采取措施预防药物/草药相互作用(HDI),通过正确使用支持治疗,教育患者发现和管理不良反应(AE)。然而,语言障碍在口语较少的情况下很常见,这使得沟通具有挑战性。我们的目标是设计和验证一组解决这些关键主题的插图。方法图片设计由3名药师主导,围绕一般信息(用药史)、问题发现(抗癌治疗AE、HDI)和支持护理(如漱口水)的正确使用3个主题进行设计。插图使用Canva®(Canva Pty Ltd, Perth, Australia)创建。每张卡片都经过两步验证过程:现场评估(Wooclap®(布鲁塞尔,比利时)对建议的同意/不同意),然后是包括肿瘤学家、全科医生、护士、药剂师和患者在内的多学科小组进行更广泛的验证-使用谷歌®表格(谷歌,Mountain View, CA, USA)上的9分李克特量表。结果19名药师对53张卡片进行了初步评价,其中18张完全认可,并对其他卡片提出了建议。随后,一个由27名受访者组成的小组对这53张卡片进行了评分。第一轮结束后,平均得分为7.37±1.2,除5张牌外,其余牌得分均为bb0.6,并得到验证。四张卡片(体重变化、HDI、皮肤干燥、神经病变)的清晰度得到改善,而一张卡片(圣约翰草)最终被去除。然后重新提交四张修改后的卡片并获得批准。结论最终一套52张验证卡将有助于加强语言障碍癌症患者的药学服务。
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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 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-12-01 Epub 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 AimChronic 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 MethodsEighteen 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.ResultsOf 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.ConclusionIn 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。
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引用次数: 0
Comparison of granisetron and palonosetron in triplet anti-emetic prophylaxis in non-small cell lung cancer patients receiving cisplatin-based highly emetogenic chemotherapy. 比较格拉司琼和帕洛诺司琼在接受顺铂为基础的高致吐性化疗的非小细胞肺癌患者的三联止吐预防中的作用。
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-12-01 Epub Date: 2024-08-28 DOI: 10.1177/10781552241279537
Murat Araz, Ismail Beypinar, Fatih Inci, Lokman Koral, Mehmet Zahid Kocak, Mustafa Korkmaz, Aykut Demirkiran, Melek Karakurt Eryilmaz, Mehmet Artac

IntroductionWe compared the efficacy of first-generation granisetron and second-generation palonosetron in triplet anti-emetic prophylaxis in patients with non-small cell lung cancer (NSCLC) receiving cisplatin-based high emetogenic chemotherapy (HEC).MethodsThis prospective, multicenter, non-randomized, observational study was conducted between June 2018 and December 2021. Patients diagnosed with NSCLC who received triplet anti-emetic prophylactic treatment with aprepitant and dexamethasone plus granisetron or palonosetron before the first cycle of chemotherapy were included in the study. At the end of the first week after chemotherapy, the emesis scale was applied to the patients during the outpatient control. The primary endpoint was complete response (CR) and total control (TC).ResultsOne hundred twenty-one patients were included in the study. Sixty-one patients were in the granisetron group and 60 patients were in the palonosetron group. CR was higher with granisetron in the acute phase (70.5% vs. 58.3%, p = 0.16; respectively) and higher with palonosetron in the delayed phase (61.7% vs. 55.7%, p = 0.5; respectively), although not statistically significant. The TC rates were also not significantly different between the groups (54.1% vs.57.6%, p = 0.69).ConclusionsThere was no significant difference between granisetron and palonosetron in both acute and delayed control of emesis in NSCLC patients receiving cisplatin-based HEC.

简介我们比较了第一代格拉司琼和第二代帕洛诺司琼在接受顺铂为基础的高致吐化疗(HEC)的非小细胞肺癌(NSCLC)患者三联止吐预防中的疗效:这项前瞻性、多中心、非随机、观察性研究于2018年6月至2021年12月期间进行。研究纳入了确诊为NSCLC的患者,这些患者在第一周期化疗前接受了阿普瑞坦和地塞米松加格拉尼司琼或帕洛诺司琼的三联止吐预防治疗。化疗后第一周结束时,在门诊对照组中对患者进行催吐评分。研究的主要终点是完全反应(CR)和完全控制(TC):研究共纳入了121名患者。格拉司琼组 61 例,帕洛诺司琼组 60 例。急性期使用格拉司琼的 CR 更高(分别为 70.5% 对 58.3%,p = 0.16;),延迟期使用帕洛诺司琼的 CR 更高(分别为 61.7% 对 55.7%,p = 0.5;),但无统计学意义。各组的 TC 率也无明显差异(54.1% 对 57.6%,p = 0.69):结论:格拉司琼和帕洛诺司琼对接受顺铂为基础的 HEC 治疗的 NSCLC 患者在急性和延迟控制呕吐方面没有明显差异。
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引用次数: 0
Efficacy and safety of thalidomide for oncology-related uses approved in Brazil: An overview of systematic reviews. 巴西批准沙利度胺用于肿瘤相关用途的有效性和安全性:系统评价综述
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-12-01 Epub Date: 2025-06-18 DOI: 10.1177/10781552251348931
Paula Lana de Miranda Drummond, Cristine de Araújo Silva, Júlia Estevão de Souza, Bárbara Alice Rocha Magno, Giovanna Marchetti Battaglia, Raissa Carolina Fonseca Candido, Cristiane Aparecida Menezes de Pádua, Bruno Gonçalves Pereira

Objective: The aim of this overview was to summarize evidence of the efficacy and safety of thalidomide in the treatment of oncology-related diseases approved in Brazil, and to assess the quality of the available data. Methods: A literature search was performed in the Cochrane Library, PubMed, Embase, Lilacs, and SciELO databases. Studies must contain evidence of efficacy and/or safety of thalidomide use for multiple myeloma - MM, graft-versus-host disease - GVHD, and myelodysplastic syndrome - MDS. The extracted information were: authors, year, literature search, studies design, target population, studies sample, comparisons and thalidomide dose, funding, outcomes, results / pooled effect, heterogeneity, conclusion. Results: This overview showed the available data about efficacy and safety of thalidomide used in the treatment of oncology-related approved indications in Brazil. It also classified the methodological quality of studies according to Amstar 2 tool. Despite of the poor quality of the articles found, they supported the efficacy of thalidomide in MM treatment. The main adverse events reported were peripheral neuropathy, infections, hematological, thromboembolic, and gastrointestinal events. Evidence supported that the more drugs combined, the greater the efficacy, but there is also a greater risk of toxicity. For the indications of GVHD and MDS no systematic reviews and/or meta-analyses that met the inclusion criteria were found. Conclusions: The overview confirmed thalidomide's efficacy on MM. It is important to monitor and manage the occurrence of thalidomide-related adverse events. Strict control over its use must always be reinforced to maintain its safe use.

目的:本综述的目的是总结在巴西批准的沙利度胺治疗肿瘤相关疾病的有效性和安全性的证据,并评估现有数据的质量。方法:在Cochrane Library、PubMed、Embase、Lilacs和SciELO数据库中进行文献检索。研究必须包含沙利度胺用于多发性骨髓瘤(MM)、移植物抗宿主病(GVHD)和骨髓增生异常综合征(MDS)的有效性和/或安全性的证据。提取的信息包括:作者、年份、文献检索、研究设计、目标人群、研究样本、比较和沙利度胺剂量、资助、结局、结果/合并效应、异质性、结论。结果:本综述显示了沙利度胺在巴西用于治疗肿瘤相关经批准适应症的有效性和安全性的现有数据。并根据Amstar 2工具对研究的方法学质量进行了分类。尽管发现的文章质量较差,但它们支持沙利度胺治疗MM的疗效。报告的主要不良事件为周围神经病变、感染、血液学、血栓栓塞和胃肠道事件。有证据表明,联合使用的药物越多,疗效越好,但毒性风险也越大。对于GVHD和MDS的适应症,没有发现符合纳入标准的系统评价和/或荟萃分析。结论:综述证实了沙利度胺对MM的疗效,监测和管理沙利度胺相关不良事件的发生十分重要。必须始终加强对其使用的严格控制,以保持其安全使用。
{"title":"Efficacy and safety of thalidomide for oncology-related uses approved in Brazil: An overview of systematic reviews.","authors":"Paula Lana de Miranda Drummond, Cristine de Araújo Silva, Júlia Estevão de Souza, Bárbara Alice Rocha Magno, Giovanna Marchetti Battaglia, Raissa Carolina Fonseca Candido, Cristiane Aparecida Menezes de Pádua, Bruno Gonçalves Pereira","doi":"10.1177/10781552251348931","DOIUrl":"10.1177/10781552251348931","url":null,"abstract":"<p><p><b>Objective:</b> The aim of this overview was to summarize evidence of the efficacy and safety of thalidomide in the treatment of oncology-related diseases approved in Brazil, and to assess the quality of the available data. <b>Methods:</b> A literature search was performed in the Cochrane Library, PubMed, Embase, Lilacs, and SciELO databases. Studies must contain evidence of efficacy and/or safety of thalidomide use for multiple myeloma - MM, graft-versus-host disease - GVHD, and myelodysplastic syndrome - MDS. The extracted information were: authors, year, literature search, studies design, target population, studies sample, comparisons and thalidomide dose, funding, outcomes, results / pooled effect, heterogeneity, conclusion. <b>Results:</b> This overview showed the available data about efficacy and safety of thalidomide used in the treatment of oncology-related approved indications in Brazil. It also classified the methodological quality of studies according to Amstar 2 tool. Despite of the poor quality of the articles found, they supported the efficacy of thalidomide in MM treatment. The main adverse events reported were peripheral neuropathy, infections, hematological, thromboembolic, and gastrointestinal events. Evidence supported that the more drugs combined, the greater the efficacy, but there is also a greater risk of toxicity. For the indications of GVHD and MDS no systematic reviews and/or meta-analyses that met the inclusion criteria were found. <b>Conclusions:</b> The overview confirmed thalidomide's efficacy on MM. It is important to monitor and manage the occurrence of thalidomide-related adverse events. Strict control over its use must always be reinforced to maintain its safe use.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"1277-1306"},"PeriodicalIF":0.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317163","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
Comparing relative dose intensity of weekly nab-paclitaxel regimens in early breast cancer: A retrospective study at a large academic outpatient cancer center. 早期乳腺癌每周nab-紫杉醇方案的相对剂量强度比较:一项大型学术门诊癌症中心的回顾性研究。
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-11-27 DOI: 10.1177/10781552251399901
Kendra Gee-Rodriguez, Jina Yun, Arianne Duong, Amy Indorf

IntroductionNational guidelines for breast cancer support substitution with nab-paclitaxel for paclitaxel or docetaxel due to medical necessity.1 This study aimed to assess for correlation between weekly nab-paclitaxel dose and relative dose intensity (RDI) amongst early breast cancer patients.MethodsThis single-center, retrospective cohort study included adult patients with early breast cancer who switched from weekly paclitaxel to nab-paclitaxel after hypersensitivity reaction. The primary outcome of RDI was assessed in patients receiving nab-paclitaxel 80 mg/m2 (NB80) or 100 mg/m2 (NB100) intravenously (IV) weekly. Secondary outcomes included adverse effects, incidence of nab-paclitaxel alterations, and growth factor (GCSF) administration for secondary prophylaxis.ResultsAmongst 26 patients, the median age was 43 years (range 33 to 71), with the majority (54%) having stage II or later disease. Median RDI with NB80 was 91% (range 69 to 100%) versus 86% (55 to 100%) with NB100. Fifty percent of all patients underwent dose reductions. Dose delays occurred in a higher proportion of patients on 50% with NB80 vs 33% with NB100. Early nab-paclitaxel discontinuations occurred more on NB100 (33% vs 10%). Incidence of chemotherapy-induced peripheral neuropathy (CIPN) was 80% vs 83% with NB80 and NB100, respectively, while grade 2 CIPN was more common on NB100 (50% vs 35%). A lower rate of neutropenia resulted from NB80 (60 vs 67% with NB100).ConclusionNab-paclitaxel dosed at 80 mg/m2 IV weekly, after switching due to paclitaxel hypersensitivity, may promote improved RDI and safety compared to nab-paclitaxel 100 mg/m2 weekly amongst early breast cancer patients.

国家乳腺癌支持替代指南:基于医疗需要,nab-紫杉醇替代紫杉醇或多西紫杉醇本研究旨在评估早期乳腺癌患者每周nab-紫杉醇剂量与相对剂量强度(RDI)的相关性。方法本研究为单中心、回顾性队列研究,纳入了在过敏反应后从每周紫杉醇转为nab-紫杉醇治疗的早期乳腺癌成年患者。RDI的主要结局是在每周静脉注射nab-紫杉醇80 mg/m2 (NB80)或100 mg/m2 (NB100)的患者中进行评估。次要结局包括不良反应、nab-紫杉醇改变发生率和生长因子(GCSF)用于二级预防。结果26例患者中位年龄为43岁(33 ~ 71岁),多数(54%)为II期或晚期。NB80组的中位RDI为91%(范围69 - 100%),NB100组为86%(范围55 - 100%)。50%的患者接受了减量治疗。50%的NB80患者出现剂量延迟的比例高于33%的NB100患者。早期nab-紫杉醇停药在NB100组发生率更高(33% vs 10%)。NB80组和NB100组化疗引起的周围神经病变(CIPN)的发生率分别为80%和83%,而NB100组2级CIPN更常见(50%和35%)。NB80组中性粒细胞减少率较低(60%比NB100组67%)。结论在早期乳腺癌患者中,与每周一次100 mg/m2的nab-紫杉醇相比,每周给药80 mg/m2的nab-紫杉醇可改善RDI和安全性。
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引用次数: 0
Physicochemical and microbiological evaluation of dexamethasone-based mouthwash formulations. 地塞米松漱口水配方的理化和微生物学评价。
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-11-25 DOI: 10.1177/10781552251399107
Nour Jegham, Rania Rassas, Sarra Mahfoudhi, Amine Trabelsi, Nesrine Kalboussi, Balsam Kacem

IntroductionOral mucositis is a common and painful side effect of chemotherapy and radiotherapy in cancer patients, significantly impairing their quality of life and adherence to treatment. Although dexamethasone is recognized for its anti-inflammatory properties, no commercial mouthwash formulation exists at a concentration of 0.1 mg/mL. This study aimed to formulate and evaluate the physicochemical and microbiological stability of hospital-prepared dexamethasone-based mouthwashes.MethodsNine different formulations were developed by varying the humectants, cosolvents and surfactants. Stability was assessed over 28 days by monitoring pH, viscosity, density, zeta potential and dexamethasone concentration using HPLC. Microbiological quality was also evaluated. Statistical analyses were conducted using Student's t-test and ANOVA.ResultsFormula F9, composed of sorbitol as humectant and propylene glycol as cosolvent, demonstrated optimal physicochemical stability, with non-significant variation in viscosity and acceptable pH levels. The dexamethasone content remained within 98.48% after 52 days. Microbiological analyses showed no contamination at Day 28.ConclusionThe F9 formulation appears to be a stable and safe candidate for clinical use as a dexamethasone-based mouthwash. The recommended dosage for adults and children over five years of age is 10 mL (swish and spit) four times daily, while for children under five years, the recommended dosage is 5 mL (swish and spit) twice daily. Further clinical studies are warranted to confirm its therapeutic benefits in the management of oral mucositis.

口腔黏膜炎是癌症患者化疗和放疗后常见且痛苦的副作用,严重影响患者的生活质量和治疗依从性。虽然地塞米松被认为具有抗炎特性,但市面上没有浓度为0.1 mg/mL的漱口水配方。本研究旨在制定和评价医院配制的地塞米松漱口水的理化和微生物稳定性。方法采用不同的湿润剂、助溶剂和表面活性剂制备不同的配方。通过高效液相色谱法监测pH、粘度、密度、zeta电位和地塞米松浓度来评估28天的稳定性。微生物质量也进行了评价。统计分析采用学生t检验和方差分析。结果以山梨醇为湿润剂,丙二醇为助溶剂的配方F9具有最佳的物理化学稳定性,粘度变化不显著,pH值可接受。52 d后地塞米松含量保持在98.48%以内。微生物分析显示第28天没有污染。结论F9是一种稳定、安全的地塞米松基漱口水制剂。成人和5岁以上儿童的推荐剂量为10毫升(漱口和吐槽),每天4次,而5岁以下儿童的推荐剂量为5毫升(漱口和吐槽),每天2次。需要进一步的临床研究来证实其治疗口腔黏膜炎的疗效。
{"title":"Physicochemical and microbiological evaluation of dexamethasone-based mouthwash formulations.","authors":"Nour Jegham, Rania Rassas, Sarra Mahfoudhi, Amine Trabelsi, Nesrine Kalboussi, Balsam Kacem","doi":"10.1177/10781552251399107","DOIUrl":"https://doi.org/10.1177/10781552251399107","url":null,"abstract":"<p><p>IntroductionOral mucositis is a common and painful side effect of chemotherapy and radiotherapy in cancer patients, significantly impairing their quality of life and adherence to treatment. Although dexamethasone is recognized for its anti-inflammatory properties, no commercial mouthwash formulation exists at a concentration of 0.1 mg/mL. This study aimed to formulate and evaluate the physicochemical and microbiological stability of hospital-prepared dexamethasone-based mouthwashes.MethodsNine different formulations were developed by varying the humectants, cosolvents and surfactants. Stability was assessed over 28 days by monitoring pH, viscosity, density, zeta potential and dexamethasone concentration using HPLC. Microbiological quality was also evaluated. Statistical analyses were conducted using Student's t-test and ANOVA.ResultsFormula F9, composed of sorbitol as humectant and propylene glycol as cosolvent, demonstrated optimal physicochemical stability, with non-significant variation in viscosity and acceptable pH levels. The dexamethasone content remained within 98.48% after 52 days. Microbiological analyses showed no contamination at Day 28.ConclusionThe F9 formulation appears to be a stable and safe candidate for clinical use as a dexamethasone-based mouthwash. The recommended dosage for adults and children over five years of age is 10 mL (swish and spit) four times daily, while for children under five years, the recommended dosage is 5 mL (swish and spit) twice daily. Further clinical studies are warranted to confirm its therapeutic benefits in the management of oral mucositis.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251399107"},"PeriodicalIF":0.9,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145604639","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
The impact of growth factor utilization on infection risk in patients receiving bispecific monoclonal antibodies. 使用生长因子对接受双特异性单克隆抗体患者感染风险的影响。
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-11-25 DOI: 10.1177/10781552251397884
Yong Jun Bae, Houry Leblebjian, Robert Redd, Victoria Yeung, Shahrier Hossain

BackgroundBispecific monoclonal antibodies (BsAbs) are utilized in patients with relapsed or refractory multiple myeloma (MM) and light chain amyloidosis (AL amyloidosis) but are associated with high rates of neutropenia and infection. Granulocyte colony stimulating factors (G-CSF) offer a potential means to mitigate infection risk and maintain BsAb treatment, however their use alongside BsAbs is not well defined.MethodsThis single-center, retrospective chart review included adult patients with MM or AL amyloidosis who received teclistamab, talquetamab, or elranatamab at Dana-Farber Cancer Institute from 2022 to 2025. The primary outcome was to assess the rate of infections in patients with or without concomitant G-CSF therapy. The secondary outcomes were to compare the infection characteristics and relative dose intensities of BsAbs in patients with or without concomitant G-CSF therapy and to describe the efficacy of G-CSF therapy.ResultsInfection rates were comparable in patients that received G-CSF (60% with G-CSF vs. 41% without; p=0.055). Relative BsAb dose intensity was similar in patients that received G-CSF (95.2% with G-CSF vs. 100% without; p=0.23). G-CSF was effective in resolving grade 3 (89%) and grade 4 (75%) neutropenia, with a median time to resolution of 7 days, and same day administration with BsAb occurred in 69% of patients.ConclusionsG-CSF administration resulted in comparable infection rates and treatment intensity relative to those not receiving G-CSF. G-CSF was effective in resolving neutropenia, often permitting same-day BsAb administration. These findings support the feasibility and utility of G-CSF during BsAb therapy to minimize infection-related complications and treatment deviations.

背景:双特异性单克隆抗体(BsAbs)用于复发或难治性多发性骨髓瘤(MM)和轻链淀粉样变性(AL淀粉样变性)患者,但与中性粒细胞减少和感染的高发率相关。粒细胞集落刺激因子(G-CSF)提供了一种降低感染风险和维持BsAb治疗的潜在手段,但它们与BsAb的使用还没有很好的定义。方法这项单中心、回顾性图表回顾纳入了2022年至2025年在丹娜-法伯癌症研究所接受特司他单抗、塔克他单抗或埃尔那他单抗治疗的MM或AL淀粉样变性成年患者。主要结局是评估接受或不接受G-CSF治疗的患者的感染率。次要结果是比较合并或未合并G-CSF治疗的患者bsab的感染特征和相对剂量强度,并描述G-CSF治疗的疗效。结果接受G-CSF治疗的患者感染率相当(60%接受G-CSF治疗vs 41%未接受G-CSF治疗;p=0.055)。在接受G-CSF的患者中,BsAb的相对剂量强度相似(95.2%接受G-CSF vs. 100%未接受G-CSF; p=0.23)。G-CSF可有效缓解3级(89%)和4级(75%)中性粒细胞减少症,平均缓解时间为7天,69%的患者当天服用BsAb。结论给予G-CSF组与未给予G-CSF组的感染率和治疗强度相当。G-CSF对解决中性粒细胞减少症有效,通常允许当日给药BsAb。这些发现支持了G-CSF在BsAb治疗中减少感染相关并发症和治疗偏差的可行性和实用性。
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引用次数: 0
FLAG-Ida-Venetoclax vs CLIA-venetoclax for relapsed and refractory AML during a fludarabine shortage: A single center experience. FLAG-Ida-Venetoclax与CLIA-venetoclax在氟达拉滨短缺期间治疗复发和难治性AML:单中心经验
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-11-20 DOI: 10.1177/10781552251396885
Jose Tinajero, Dat Ngo, Brian Lee, Hoim Kim, Brian Ball, Paul Koller, Idoroenyi Amanam, Hoda Pourhassan, Haris Ali, Salman Otoukesh, Amandeep Salhotra, Amanda Blackmon, Karamjeet Sandhu

ObjectiveIntensive chemotherapy combinations with venetoclax are being used more frequently for acute myeloid leukemia (AML). In May 2022, a critical shortage of fludarabine prompted cladribine substitution at several institutions in the United States. FLAG-Ida-Ven and CLIA-Ven are similar IC regimens using different purine analogues, potentially with different efficacy and toxicity. To describe the patient population, outcomes, and toxicities of patients receiving FLAG-Ida-Ven and CLIA-Ven.Data SourcesA retrospective analysis of patients over 18 years with AML who received FLAG-Ida-Ven or CLIA-Ven for relapsed/refractory AML (R/R AML) at the City of Hope between December 2020 and January 2023.Data SummaryThere were 31 patients who received FLAG-Ida-Ven; 8 patients received CLIA-Ven. Patients were identified using ICD-10 code for AML and documented administration of medications. Most patients included were male with de novo AML with ELN adverse risk AML. Median age was 53 years (20-78) for FLAG-Ida-Ven and 47.5 years (23-69) for CLIA-Ven. Prior exposure to venetoclax based therapy was common (61.3% vs 50%). The ORR (overall response rate) in FLAG-Ida-Ven and CLIA-Ven was 46.7% and 75%, of which 86% vs 83% were MRD negative, respectively. There were 42% (n = 13) and 50% (n = 4) of patients who were able to proceed to allogeneic stem cell transplant in the FLAG-Ida-Ven and CLIA-Ven with median time to transplant being 89 vs 132 days respectively.Regarding safety, CLIA-Ven had a higher incidence of grade 3 or 4 non-hematologic adverse events, 6% vs 50% respectively. Survival from therapy initiation at 6 months was 48.4% vs 75%.ConclusionConsistent with the literature, it appears that the activity between FLAG-Ida-Ven and CLIA-Ven are comparable, however FLAG-Ida-Ven may have a more tolerable safety profile.

目的:强化化疗联合venetoclax治疗急性髓性白血病(AML)的频率越来越高。2022年5月,氟达拉滨严重短缺,促使美国几家机构改用克拉宾。FLAG-Ida-Ven和CLIA-Ven是使用不同嘌呤类似物的类似IC方案,可能具有不同的疗效和毒性。描述接受FLAG-Ida-Ven和CLIA-Ven治疗的患者群体、结果和毒性。对2020年12月至2023年1月期间在希望之城接受FLAG-Ida-Ven或CLIA-Ven治疗复发/难治性AML (R/R AML)的18岁以上AML患者的回顾性分析。31例患者接受FLAG-Ida-Ven治疗;8例患者接受CLIA-Ven治疗。使用ICD-10 AML代码识别患者并记录药物管理。大多数纳入的患者为男性,伴有ELN不良风险的新发AML。FLAG-Ida-Ven的中位年龄为53岁(20-78岁),CLIA-Ven的中位年龄为47.5岁(23-69岁)。先前暴露于venetoclax为基础的治疗是常见的(61.3% vs 50%)。FLAG-Ida-Ven和CLIA-Ven的ORR(总缓解率)分别为46.7%和75%,其中MRD阴性分别为86%和83%。在FLAG-Ida-Ven和CLIA-Ven中,有42% (n = 13)和50% (n = 4)的患者能够进行同种异体干细胞移植,移植的中位时间分别为89天和132天。在安全性方面,CLIA-Ven具有更高的3级和4级非血液学不良事件发生率,分别为6%和50%。6个月开始治疗的生存率为48.4% vs 75%。结论与文献一致,FLAG-Ida-Ven和CLIA-Ven之间的活性似乎是相当的,但FLAG-Ida-Ven可能具有更耐受的安全性。
{"title":"FLAG-Ida-Venetoclax vs CLIA-venetoclax for relapsed and refractory AML during a fludarabine shortage: A single center experience.","authors":"Jose Tinajero, Dat Ngo, Brian Lee, Hoim Kim, Brian Ball, Paul Koller, Idoroenyi Amanam, Hoda Pourhassan, Haris Ali, Salman Otoukesh, Amandeep Salhotra, Amanda Blackmon, Karamjeet Sandhu","doi":"10.1177/10781552251396885","DOIUrl":"https://doi.org/10.1177/10781552251396885","url":null,"abstract":"<p><p>ObjectiveIntensive chemotherapy combinations with venetoclax are being used more frequently for acute myeloid leukemia (AML). In May 2022, a critical shortage of fludarabine prompted cladribine substitution at several institutions in the United States. FLAG-Ida-Ven and CLIA-Ven are similar IC regimens using different purine analogues, potentially with different efficacy and toxicity. To describe the patient population, outcomes, and toxicities of patients receiving FLAG-Ida-Ven and CLIA-Ven.Data SourcesA retrospective analysis of patients over 18 years with AML who received FLAG-Ida-Ven or CLIA-Ven for relapsed/refractory AML (R/R AML) at the City of Hope between December 2020 and January 2023.Data SummaryThere were 31 patients who received FLAG-Ida-Ven; 8 patients received CLIA-Ven. Patients were identified using ICD-10 code for AML and documented administration of medications. Most patients included were male with de novo AML with ELN adverse risk AML. Median age was 53 years (20-78) for FLAG-Ida-Ven and 47.5 years (23-69) for CLIA-Ven. Prior exposure to venetoclax based therapy was common (61.3% vs 50%). The ORR (overall response rate) in FLAG-Ida-Ven and CLIA-Ven was 46.7% and 75%, of which 86% vs 83% were MRD negative, respectively. There were 42% (n = 13) and 50% (n = 4) of patients who were able to proceed to allogeneic stem cell transplant in the FLAG-Ida-Ven and CLIA-Ven with median time to transplant being 89 vs 132 days respectively.Regarding safety, CLIA-Ven had a higher incidence of grade 3 or 4 non-hematologic adverse events, 6% vs 50% respectively. Survival from therapy initiation at 6 months was 48.4% vs 75%.ConclusionConsistent with the literature, it appears that the activity between FLAG-Ida-Ven and CLIA-Ven are comparable, however FLAG-Ida-Ven may have a more tolerable safety profile.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251396885"},"PeriodicalIF":0.9,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145564177","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
Lutetium Lu 177 vipivotide tetraxetan: A literature review.
IF 0.9 4区 医学 Q4 ONCOLOGY Pub Date : 2025-11-11 DOI: 10.1177/10781552251392083
Grace Morrison, Lisa M Holle

To review pharmacology, pharmacokinetics, therapeutic use, product safety/description and perspectives on use of lutetium Lu 177 vipivotide tetraxetan in patients with metastatic castration-resistant prostate cancer (mCRPC). Data sources: A literature search was conducted using PubMed/Dynamed (October 2013-May 2025), limited to English language, humans, clinical trials, case reports, and guidelines. Data summary: Lutetium Lu 177 vipivotide tetraxetan is comprised of the beta-emitting radioisotope lutetium Lu-177 linked to a peptide, vipivotide tetraxetan, which binds to cells expressing prostate-specific membrane antigen (PSMA), resulting in cell death from the radiation. Kidney excretion may result in increased renal toxicity in patients with reduced renal function. Based on 2 phase III clinical trials, lutetium Lu 177 vipivotide tetraxetan 7.4 GBq administered intravenously every 6 weeks for up to 6 doses is effective in patients with mCRPC and PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor and docetaxel therapy or an androgen receptor pathway inhibitor alone, by significantly improving radiographic progression-free survival. It is generally well tolerated, with asthenia/fatigue, dry mouth, mild nausea and low-grade anemia most commonly occurring. Severe adverse drug reactions are uncommon. It should only be administered by trained personnel in a designated clinical setting with existing radiation safety protocols. Patients must limit close contact, use precautions with using the bathroom and other daily activities in days following treatment. Patient education is necessary to ensure safe daily practices. Several ongoing trials are evaluating lutetium Lu 177 vipivotide tetraxetan in combination with other anticancer agents for treatment of mCRPC, using different dosing strategies, or in other settings (metastatic castration-sensitive prostate cancer and early-stage prostate cancer). Conclusion: Lutetium Lu 177 vipivotide tetraxetan is an effective and well tolerated treatment for patients with mCRPC, PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor ± docetaxel. Ongoing studies evaluating its use in earlier disease stages and with different dosing strategies, will better define the role of this therapy in the treatment of prostate cancer.

目的:综述lu177 vipivotide tetraxetan在转移性去势抵抗性前列腺癌(mCRPC)患者中的药理学、药代动力学、治疗用途、产品安全性/描述和应用前景。数据来源:使用PubMed/Dynamed(2013年10月- 2025年5月)进行文献检索,仅限于英语、人类、临床试验、病例报告和指南。数据摘要:Lutetium Lu 177 vipivotide tetraxetan是由释放β的放射性同位素Lutetium Lu-177与肽vipivotide tetraxetan连接而成,肽与表达前列腺特异性膜抗原(PSMA)的细胞结合,导致细胞因辐射死亡。肾脏排泄可能导致肾功能下降的患者肾毒性增加。基于2项III期临床试验,lutetium Lu 177 vipivotide tetraxetan 7.4 GBq每6周静脉注射最多6次,对于在雄激素受体途径抑制剂和多西他赛治疗或单独雄激素受体途径抑制剂治疗进展后的mCRPC和psm阳性转移患者有效,通过显着提高放射学无进展生存期。通常耐受性良好,最常见的症状是乏力/疲劳、口干、轻度恶心和低度贫血。严重的药物不良反应并不常见。它只能由训练有素的人员在指定的临床环境中按照现有的辐射安全规程进行管理。在治疗后的几天内,患者必须限制密切接触,使用浴室和其他日常活动时采取预防措施。患者教育是必要的,以确保安全的日常做法。一些正在进行的试验正在评估lutetium lu177 vipivotide tetraxetan与其他抗癌药物联合治疗mCRPC,使用不同的剂量策略,或在其他情况下(转移性去势敏感前列腺癌和早期前列腺癌)。结论:Lutetium Lu 177 vipivotide tetraxetan对于雄激素受体途径抑制剂±多西他赛进展后的mCRPC, psma阳性转移患者是一种有效且耐受性良好的治疗方法。正在进行的研究评估其在早期疾病阶段和不同剂量策略的使用,将更好地确定这种疗法在治疗前列腺癌中的作用。
{"title":"Lutetium Lu 177 vipivotide tetraxetan: A literature review.","authors":"Grace Morrison, Lisa M Holle","doi":"10.1177/10781552251392083","DOIUrl":"https://doi.org/10.1177/10781552251392083","url":null,"abstract":"<p><p>To review pharmacology, pharmacokinetics, therapeutic use, product safety/description and perspectives on use of lutetium Lu 177 vipivotide tetraxetan in patients with metastatic castration-resistant prostate cancer (mCRPC). <b>Data sources:</b> A literature search was conducted using PubMed/Dynamed (October 2013-May 2025), limited to English language, humans, clinical trials, case reports, and guidelines. <b>Data summary:</b> Lutetium Lu 177 vipivotide tetraxetan is comprised of the beta-emitting radioisotope lutetium Lu-177 linked to a peptide, vipivotide tetraxetan, which binds to cells expressing prostate-specific membrane antigen (PSMA), resulting in cell death from the radiation. Kidney excretion may result in increased renal toxicity in patients with reduced renal function. Based on 2 phase III clinical trials, lutetium Lu 177 vipivotide tetraxetan 7.4 GBq administered intravenously every 6 weeks for up to 6 doses is effective in patients with mCRPC and PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor and docetaxel therapy or an androgen receptor pathway inhibitor alone, by significantly improving radiographic progression-free survival. It is generally well tolerated, with asthenia/fatigue, dry mouth, mild nausea and low-grade anemia most commonly occurring. Severe adverse drug reactions are uncommon. It should only be administered by trained personnel in a designated clinical setting with existing radiation safety protocols. Patients must limit close contact, use precautions with using the bathroom and other daily activities in days following treatment. Patient education is necessary to ensure safe daily practices. Several ongoing trials are evaluating lutetium Lu 177 vipivotide tetraxetan in combination with other anticancer agents for treatment of mCRPC, using different dosing strategies, or in other settings (metastatic castration-sensitive prostate cancer and early-stage prostate cancer). <b>Conclusion:</b> Lutetium Lu 177 vipivotide tetraxetan is an effective and well tolerated treatment for patients with mCRPC, PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor ± docetaxel. Ongoing studies evaluating its use in earlier disease stages and with different dosing strategies, will better define the role of this therapy in the treatment of prostate cancer.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251392083"},"PeriodicalIF":0.9,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145489107","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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