Pub Date : 2024-07-08DOI: 10.1080/1120009X.2024.2376453
Mengyuan Xie, Manxue Jiang, Jian Xu, Yulin Zhu, Lingti Kong
The therapeutic range of voriconazole (VRC) is narrow, this study aimed to explore factors influencing VRC plasma concentrations > 5 mg/L and to construct a clinical risk score nomogram prediction model. Clinical data from 221 patients with VRC prophylaxis and treatment were retrospectively analyzed. The patients were randomly divided into a training cohort and a validation cohort at a 7:3 ratio. Univariate and binary logistic regression analysis was used to select independent risk factors for VRC plasma concentration above the high limit (5 mg/L). Four indicators including age, weight, CYP2C19 genotype, and albumin were selected to construct the nomogram prediction model. The area under the curve values of the training cohort and the validation cohort were 0.841 and 0.802, respectively. The decision curve analysis suggests that the nomogram model had good clinical applicability. In conclusion, the nomogram provides a reference for early screening and intervention in a high-risk population.
{"title":"Development and validation of a clinical risk score nomogram for predicting voriconazole trough concentration above 5 mg/L: a retrospective cohort study.","authors":"Mengyuan Xie, Manxue Jiang, Jian Xu, Yulin Zhu, Lingti Kong","doi":"10.1080/1120009X.2024.2376453","DOIUrl":"https://doi.org/10.1080/1120009X.2024.2376453","url":null,"abstract":"<p><p>The therapeutic range of voriconazole (VRC) is narrow, this study aimed to explore factors influencing VRC plasma concentrations > 5 mg/L and to construct a clinical risk score nomogram prediction model. Clinical data from 221 patients with VRC prophylaxis and treatment were retrospectively analyzed. The patients were randomly divided into a training cohort and a validation cohort at a 7:3 ratio. Univariate and binary logistic regression analysis was used to select independent risk factors for VRC plasma concentration above the high limit (5 mg/L). Four indicators including age, weight, <i>CYP2C19</i> genotype, and albumin were selected to construct the nomogram prediction model. The area under the curve values of the training cohort and the validation cohort were 0.841 and 0.802, respectively. The decision curve analysis suggests that the nomogram model had good clinical applicability. In conclusion, the nomogram provides a reference for early screening and intervention in a high-risk population.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"1-9"},"PeriodicalIF":1.9,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558860","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}
This study aimed to optimize nanosuspension of sorafenib tosylate (an anticancer hydrophobic drug molecule) using a central composite design. Nanosuspension was prepared using a nanoprecipitation-ultrasonication approach. FTIR and DSC analyses demonstrated that the drug and excipients were physicochemically compatible. X-ray powder diffraction analysis confirmed amorphous form of the payload in the formulation. The optimized formulation (batch NSS6) had a zeta potential of -18.1 mV, a polydispersity of 0.302, and a particle size of 97.11 nm. SEM analysis confirmed formation of rod-shaped particles. After 24 h, about 64.45% and 86.37% of the sorafenib tosylate was released in pH 6.8 and pH 1.2, respectively. The MTT assay was performed on HepG2 cell lines. IC50 value of the optimized batch was 39.4 µg/mL. The study concluded that sorafenib tosylate nanosuspension could be a promising approach in the treatment of hepatocellular cancer.
{"title":"Sorafenib tosylate-loaded nanosuspension: preparation, optimization, and <i>in vitro</i> cytotoxicity study against human HepG2 carcinoma cells.","authors":"Harpreet Kaur Khanuja, Rajendra Awasthi, Harish Dureja","doi":"10.1080/1120009X.2023.2273095","DOIUrl":"10.1080/1120009X.2023.2273095","url":null,"abstract":"<p><p>This study aimed to optimize nanosuspension of sorafenib tosylate (an anticancer hydrophobic drug molecule) using a central composite design. Nanosuspension was prepared using a nanoprecipitation-ultrasonication approach. FTIR and DSC analyses demonstrated that the drug and excipients were physicochemically compatible. X-ray powder diffraction analysis confirmed amorphous form of the payload in the formulation. The optimized formulation (batch NSS<sub>6</sub>) had a zeta potential of -18.1 mV, a polydispersity of 0.302, and a particle size of 97.11 nm. SEM analysis confirmed formation of rod-shaped particles. After 24 h, about 64.45% and 86.37% of the sorafenib tosylate was released in pH 6.8 and pH 1.2, respectively. The MTT assay was performed on HepG2 cell lines. IC<sub>50</sub> value of the optimized batch was 39.4 µg/mL. The study concluded that sorafenib tosylate nanosuspension could be a promising approach in the treatment of hepatocellular cancer.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"299-318"},"PeriodicalIF":1.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50161724","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}
Pub Date : 2024-07-01Epub Date: 2023-10-14DOI: 10.1080/1120009X.2023.2267896
Syed Tabish Rehman, Syeda Mahnoor Azeem, Areeba Akbar, Omer Shafiq, Syed Shehryar Azeem, Shabbir Hussain A Ali
Nivolumab is an anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody and was the first immune checkpoint inhibitor drug approved for use in advanced non-small cell lung cancer (NSCLC). In this report, we describe a rare case of Lambert-Eaton myasthenic syndrome (LEMS), which developed as a side effect of nivolumab in a patient with metastatic lung squamous cell carcinoma. Our patient, who was previously treated with nivolumab for metastatic squamous cell carcinoma of the lung, appeared with a headache, swollen face, dysarthria, asthenia, xerostomia, and drooping eyelid. Early testing indicated no thymomas or newly developing tumors in whole-body scans, and the blood workup was normal. We came to the conclusion that nivolumab-induced LEMS was the cause of the symptoms after performing nerve conduction investigations ruling out other differentials. We believe our clinical experience of this rare and unexpected adverse event should be shared.
{"title":"Nivolumab-induced Lambert-Eaton myasthenic syndrome: an immune-related adverse event in nonsmall cell lung cancer.","authors":"Syed Tabish Rehman, Syeda Mahnoor Azeem, Areeba Akbar, Omer Shafiq, Syed Shehryar Azeem, Shabbir Hussain A Ali","doi":"10.1080/1120009X.2023.2267896","DOIUrl":"10.1080/1120009X.2023.2267896","url":null,"abstract":"<p><p>Nivolumab is an anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody and was the first immune checkpoint inhibitor drug approved for use in advanced non-small cell lung cancer (NSCLC). In this report, we describe a rare case of Lambert-Eaton myasthenic syndrome (LEMS), which developed as a side effect of nivolumab in a patient with metastatic lung squamous cell carcinoma. Our patient, who was previously treated with nivolumab for metastatic squamous cell carcinoma of the lung, appeared with a headache, swollen face, dysarthria, asthenia, xerostomia, and drooping eyelid. Early testing indicated no thymomas or newly developing tumors in whole-body scans, and the blood workup was normal. We came to the conclusion that nivolumab-induced LEMS was the cause of the symptoms after performing nerve conduction investigations ruling out other differentials. We believe our clinical experience of this rare and unexpected adverse event should be shared.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"329-333"},"PeriodicalIF":1.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41202167","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}
Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been recommended as a first-line treatment of EGFR-positive non-small cell lung cancer (NSCLC). Skin rash is one of the most common side effects of osimertinib, and can have an impact on patients' quality of life and follow-up. However, there are few reports on the safety and efficacy of switching therapy with osimertinib and the other three generations of TKIs. In this paper, we present a case of NSCLC with an EGFR exon 19 deletion (19del) and MET gene amplification who developed a severe rash after 2 months of treatment with osimertinib that did not recur after switching to replacement therapy with aumonertinib. Our findings indicate that aumonertinib is as effective as osimertinib in treating EGFR19del, while also exhibiting a lower occurrence of adverse skin reactions. This may result in an improved quality of life for patients.
{"title":"Benefit from Almonertinib after Osimertinib treat EGFR 19 exon deletion NSCLC induced Severe rash: a case report.","authors":"Qichen Zhang, Peng Xie, Xiaoming Hou, Chengpeng Zhao, Ling Duan, Hui Qiao","doi":"10.1080/1120009X.2023.2276574","DOIUrl":"10.1080/1120009X.2023.2276574","url":null,"abstract":"<p><p>Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been recommended as a first-line treatment of EGFR-positive non-small cell lung cancer (NSCLC). Skin rash is one of the most common side effects of osimertinib, and can have an impact on patients' quality of life and follow-up. However, there are few reports on the safety and efficacy of switching therapy with osimertinib and the other three generations of TKIs. In this paper, we present a case of NSCLC with an EGFR exon 19 deletion (19del) and MET gene amplification who developed a severe rash after 2 months of treatment with osimertinib that did not recur after switching to replacement therapy with aumonertinib. Our findings indicate that aumonertinib is as effective as osimertinib in treating EGFR19del, while also exhibiting a lower occurrence of adverse skin reactions. This may result in an improved quality of life for patients.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"334-342"},"PeriodicalIF":1.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71424016","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}
Pub Date : 2024-07-01Epub Date: 2023-06-04DOI: 10.1080/1120009X.2023.2219592
Dongdong Zhang, Youhong Dong, Liling Zhang
{"title":"Bendamustine plus Rituximab versus R-miniCHOP: which is better for unfit patients with diffuse larger B-cell lymphoma?","authors":"Dongdong Zhang, Youhong Dong, Liling Zhang","doi":"10.1080/1120009X.2023.2219592","DOIUrl":"10.1080/1120009X.2023.2219592","url":null,"abstract":"","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"351-353"},"PeriodicalIF":1.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9572334","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}
Pub Date : 2024-07-01Epub Date: 2023-10-20DOI: 10.1080/1120009X.2023.2270833
Nour Faqeer, Rawaa Alrabie, Rand Al-Haddadin, Mohammad Ma'koseh
This retrospective study aimed to assess the characteristics and predictors of infusion-related reactions (IRRs) to rituximab in patients with B-cell non-Hodgkin lymphoma (B-NHL). The medical records of adult patients with B-NHL who received their first cycle of rituximab from August 2020 to August 2022 were reviewed. IRRs were defined as any signs experienced by patients during rituximab infusion and graded according to the Common Terminology Criteria for Adverse Events. During the study period, 334 patients were included; among them, 100 patients (30%) developed IRRs (mean age 54.7 (SD 13.2) years). Of the reported IRRs, 90% were grade II reactions, and 10% were grade III reactions. The multivariate analysis identified indolent lymphoma [OR 1.90, p = 0.025], no hydrocortisone as premedication [OR 3.03, p = 0.029], thrombocytopenia [OR 2.55, p = 0.009], and absolute lymphocyte count ≥ 2000 lymphocytes/microL [OR 1.74, p = 0.045] as independent predictors for IRRs.
{"title":"Characteristics and predictors of infusion-related reactions to rituximab in patients with B-cell non-Hodgkin lymphoma.","authors":"Nour Faqeer, Rawaa Alrabie, Rand Al-Haddadin, Mohammad Ma'koseh","doi":"10.1080/1120009X.2023.2270833","DOIUrl":"10.1080/1120009X.2023.2270833","url":null,"abstract":"<p><p>This retrospective study aimed to assess the characteristics and predictors of infusion-related reactions (IRRs) to rituximab in patients with B-cell non-Hodgkin lymphoma (B-NHL). The medical records of adult patients with B-NHL who received their first cycle of rituximab from August 2020 to August 2022 were reviewed. IRRs were defined as any signs experienced by patients during rituximab infusion and graded according to the Common Terminology Criteria for Adverse Events. During the study period, 334 patients were included; among them, 100 patients (30%) developed IRRs (mean age 54.7 (SD 13.2) years). Of the reported IRRs, 90% were grade II reactions, and 10% were grade III reactions. The multivariate analysis identified indolent lymphoma [OR 1.90, <i>p</i> = 0.025], no hydrocortisone as premedication [OR 3.03, <i>p</i> = 0.029], thrombocytopenia [OR 2.55, <i>p</i> = 0.009], and absolute lymphocyte count ≥ 2000 lymphocytes/microL [OR 1.74, <i>p</i> = 0.045] as independent predictors for IRRs.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"291-298"},"PeriodicalIF":1.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49677923","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}
Adjuvant chemotherapy improves the prognosis of patients with colorectal cancer (CRC) following radical resection. The aim of the present study is to review appropriate chemotherapeutic regimens for elderly patients. We examined 1138 Japanese patients who were operated for high-risk stage II or stage III CRC between July 2010 and June 2021 at our hospital. Patients were divided according to an age of 70 years. The efficacy of adjuvant therapy was analyzed in association with age and adjuvant chemotherapeutic regimens. A total of 507 patients (45%) were ≥70 years old. They were less likely to receive adjuvant chemotherapy (p < 0.001) or palliative chemotherapy after recurrence (p < 0.001) than patients aged <70 years. Cancer-specific survival (CSS) in stage III CRC patients was longer in the <70 years group than in the ≥70 years group (p = 0.006); however, CSS by regimens did not significantly differ between these groups. Adjuvant chemotherapy was associated with the longer relapse-free survival of stage III CRC patients in the <70 years group (p = 0.005). Although adjuvant chemotherapy was associated with a favourable CSS regardless of age, the implementation rate of adjuvant chemotherapy for elderly CRC patients was low, which may explain shorter CSS in stage III CRC patients the ≥70 years group than in the <70 years group.
辅助化疗可改善癌症根治术后患者的预后。本研究的目的是回顾适合老年患者的化疗方案。我们检查了2010年7月至2021年6月期间在我院接受高风险II期或III期CRC手术的1138名日本患者。患者按70岁年龄分组 年。根据年龄和辅助化疗方案分析辅助治疗的疗效。507名患者(45%)≥70 岁他们接受辅助化疗的可能性较小(p p p = 0.006);然而,不同方案的CSS在这些组之间没有显著差异。辅助化疗与第三期CRC患者的无复发生存期延长相关 = 0.005)。尽管无论年龄大小,辅助化疗都与良好的CSS相关,但老年CRC患者辅助化疗的实施率较低,这可能解释了III期CRC患者CSS较短(≥70 年组
{"title":"Adjuvant chemotherapy for elderly patients with colorectal cancer: a single-centre observational study in Japan.","authors":"Kazuaki Okamoto, Hiroaki Nozawa, Shigenobu Emoto, Koji Murono, Kazuhito Sasaki, Soichiro Ishihara","doi":"10.1080/1120009X.2023.2273096","DOIUrl":"10.1080/1120009X.2023.2273096","url":null,"abstract":"<p><p>Adjuvant chemotherapy improves the prognosis of patients with colorectal cancer (CRC) following radical resection. The aim of the present study is to review appropriate chemotherapeutic regimens for elderly patients. We examined 1138 Japanese patients who were operated for high-risk stage II or stage III CRC between July 2010 and June 2021 at our hospital. Patients were divided according to an age of 70 years. The efficacy of adjuvant therapy was analyzed in association with age and adjuvant chemotherapeutic regimens. A total of 507 patients (45%) were ≥70 years old. They were less likely to receive adjuvant chemotherapy (<i>p</i> < 0.001) or palliative chemotherapy after recurrence (<i>p</i> < 0.001) than patients aged <70 years. Cancer-specific survival (CSS) in stage III CRC patients was longer in the <70 years group than in the ≥70 years group (<i>p</i> = 0.006); however, CSS by regimens did not significantly differ between these groups. Adjuvant chemotherapy was associated with the longer relapse-free survival of stage III CRC patients in the <70 years group (<i>p</i> = 0.005). Although adjuvant chemotherapy was associated with a favourable CSS regardless of age, the implementation rate of adjuvant chemotherapy for elderly CRC patients was low, which may explain shorter CSS in stage III CRC patients the ≥70 years group than in the <70 years group.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"319-328"},"PeriodicalIF":1.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50161723","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}
<p><p>Through a Rapid Health Technology Assessment (RHTA), we evaluated the efficacy, safety and cost-effectiveness of baloxavir in the treatment of influenza, providing the necessary scientific information and evidence-based basis for healthcare professionals and health insurance decision-makers in making rational selections. Through systematic searches of <i>Pubmed</i>, <i>Embase</i>, <i>Web of Science</i>, <i>The Cochrane Register of Clinical Trials</i> database and the official website of Health Technology Assessment (HTA) agencies, we collected systematic reviews (SR)/Meta-analysis, cost-effectiveness evaluations and HTA reports of baloxavir for influenza, with a search time frame of date of database establishment to July 31, 2022. We then performed data extraction, literature screening and quality evaluation on the literature that met our selection criteria, after which the results of the studies were pooled and qualitatively described for analysis. 10 studies were included, including 6 SR/Meta-analysis, three economics studies, and 1 HTA report. In terms of efficacy, baloxavir had an advantage over oseltamivir for all three types of influenza patients (otherwise healthy patients, high-risk patients, and patients are not separated into groups with and without underlying health conditions) concerning change in virus titer from baseline at 24 and 48 h; about otherwise healthy patients and high-risk patients, baloxavir had an advantage over peramivir; pertaining to high-risk patients, baloxavir had an advantage over laninamivir; the above differences between groups were all statistically significant. In terms of safety, in otherwise healthy patients and patients are not separated into groups with and without underlying health conditions, baloxavir significantly reduced the incidence of DRAEs and nausea compared with oseltamivir, as well as significantly reduced the incidence of DRAEs compared with laninamivir; in patients are not separated into groups with and without underlying health conditions, baloxavir significantly reduced the incidence of AEs and diarrhoea compared with oseltamivir; the differences between the above groups were all statistically significant. Economically, in Japanese adult influenza patients and high-risk populations, the Quality-Adjusted Life Years (QALY) of baloxavir slightly triumphed over that of laninamivir (Δ = 0.000112 and 0.00209 QALY per 1 patient, respectively); moreover, the incremental cost-effectiveness ratio (ICER: 2,231,260 and 68,855 yen/QALY, respectively) was below the willingness-to-pay (WTP) threshold (5,000,000 yen/QALY); in Chinese adult influenza patients without underlying diseases and adult high-risk influenza patients, baloxavir had a higher QALY compared with oseltamivir (Δ = 0.000246 and 0.000186 respectively), however, their ICER (12,230 and 64,956 RMB/QALY) was above the local WTP threshold (10,000 RMB/QALY) and thus did not provide a cost-effectiveness advantage. Baloxavir had a favorable
通过快速健康技术评估(RHTA),我们评估了巴洛西韦治疗流感的疗效、安全性和成本效益,为医疗保健专业人员和健康保险决策者做出合理选择提供了必要的科学信息和循证依据。通过系统搜索Pubmed、Embase、Web of Science、Cochrane临床试验注册数据库和卫生技术评估(HTA)机构的官方网站,我们收集了巴洛西韦治疗流感的系统评价(SR)/Meta分析、成本效益评估和HTA报告,数据库建立的搜索时间框架为2022年7月31日。然后,我们对符合我们选择标准的文献进行了数据提取、文献筛选和质量评估,然后将研究结果汇总并进行定性描述以进行分析。包括10项研究,其中6项 SR/Meta分析、三项经济学研究和1份HTA报告。就疗效而言,巴洛沙韦对所有三种类型的流感患者(健康患者、高危患者和没有潜在健康状况的患者未分为两组)的病毒滴度在24和48时与基线相比的变化都优于奥司他韦 h;对于其他健康患者和高危患者,巴洛西韦比哌拉米韦有优势;对于高危患者,巴洛沙韦比拉那米韦有优势;上述各组间差异均有统计学意义。就安全性而言,在其他健康患者和没有潜在健康状况的患者中,与奥司他韦相比,巴洛西韦显著降低了DRAE和恶心的发生率,与拉那米韦相比,也显著降低了DRE的发生率;在没有将患者分为有和没有潜在健康状况的组的情况下,与奥司他韦相比,巴洛西韦显著降低了AE和腹泻的发生率;上述各组间差异均有统计学意义。在经济上,在日本成年流感患者和高危人群中,巴洛西韦的质量调整生命年(QALY)略高于拉那米韦(Δ分别为0.000112和0.00209 QALY/1名患者);此外,增量成本效益比(ICER:22231260和68855 日元/QALY)低于支付意愿阈值(5000000 日元/QALY);在没有基础疾病的中国成人流感患者和成人高危流感患者中,巴洛西韦的QALY高于奥司他韦(Δ分别为0.000246和0.000186),但其ICER(12230和64956元/QALY)高于当地的WTP阈值(10000元/QALY),因此没有提供成本效益优势。与神经氨酸酶抑制剂(NAI)相比,巴洛西韦具有良好的疗效和安全性,目前可用的证据表明,它仅在日本具有经济优势。
{"title":"Rapid health technology assessment of the novel endonuclease inhibitor baloxavir for the treatment of influenza.","authors":"Guangliang Huang, Yunfei Tian, Wenyan Cui, Xinhui Zhang, Yonghong Zhao, Xiuju Liu","doi":"10.1080/1120009X.2023.2263270","DOIUrl":"10.1080/1120009X.2023.2263270","url":null,"abstract":"<p><p>Through a Rapid Health Technology Assessment (RHTA), we evaluated the efficacy, safety and cost-effectiveness of baloxavir in the treatment of influenza, providing the necessary scientific information and evidence-based basis for healthcare professionals and health insurance decision-makers in making rational selections. Through systematic searches of <i>Pubmed</i>, <i>Embase</i>, <i>Web of Science</i>, <i>The Cochrane Register of Clinical Trials</i> database and the official website of Health Technology Assessment (HTA) agencies, we collected systematic reviews (SR)/Meta-analysis, cost-effectiveness evaluations and HTA reports of baloxavir for influenza, with a search time frame of date of database establishment to July 31, 2022. We then performed data extraction, literature screening and quality evaluation on the literature that met our selection criteria, after which the results of the studies were pooled and qualitatively described for analysis. 10 studies were included, including 6 SR/Meta-analysis, three economics studies, and 1 HTA report. In terms of efficacy, baloxavir had an advantage over oseltamivir for all three types of influenza patients (otherwise healthy patients, high-risk patients, and patients are not separated into groups with and without underlying health conditions) concerning change in virus titer from baseline at 24 and 48 h; about otherwise healthy patients and high-risk patients, baloxavir had an advantage over peramivir; pertaining to high-risk patients, baloxavir had an advantage over laninamivir; the above differences between groups were all statistically significant. In terms of safety, in otherwise healthy patients and patients are not separated into groups with and without underlying health conditions, baloxavir significantly reduced the incidence of DRAEs and nausea compared with oseltamivir, as well as significantly reduced the incidence of DRAEs compared with laninamivir; in patients are not separated into groups with and without underlying health conditions, baloxavir significantly reduced the incidence of AEs and diarrhoea compared with oseltamivir; the differences between the above groups were all statistically significant. Economically, in Japanese adult influenza patients and high-risk populations, the Quality-Adjusted Life Years (QALY) of baloxavir slightly triumphed over that of laninamivir (Δ = 0.000112 and 0.00209 QALY per 1 patient, respectively); moreover, the incremental cost-effectiveness ratio (ICER: 2,231,260 and 68,855 yen/QALY, respectively) was below the willingness-to-pay (WTP) threshold (5,000,000 yen/QALY); in Chinese adult influenza patients without underlying diseases and adult high-risk influenza patients, baloxavir had a higher QALY compared with oseltamivir (Δ = 0.000246 and 0.000186 respectively), however, their ICER (12,230 and 64,956 RMB/QALY) was above the local WTP threshold (10,000 RMB/QALY) and thus did not provide a cost-effectiveness advantage. Baloxavir had a favorable ","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"267-282"},"PeriodicalIF":1.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41134266","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}
Pub Date : 2024-07-01Epub Date: 2023-11-09DOI: 10.1080/1120009X.2023.2279831
Marissa Meegdes, Marleen G A M van der Velde, Sandra M E Geurts, Maartje A C E van Kats, M Wouter Dercksen, Vivianne C G Tjan-Heijnen
There is an ongoing clinical dilemma of how best to treat patients who present themselves with visceral crisis. The time needed to undo the state of visceral crisis is the most relevant outcome for this patient group. We describe four patients treated with CDK4/6 inhibitor plus endocrine therapy for HR+/HER2- metastatic breast cancer who presented themselves with a visceral crisis. Two of them are male and three of them had synchronous metastatic breast cancer. Two patients had lymphangitis carcinomatosis of the lungs, one extensive disease of the eye and one of the liver. Time to first clinical response was observed within a few weeks in three patients. For one patient a switch to chemotherapy was needed. These cases show that treatment with CDK4/6 inhibitors can achieve a rapid response in patients experiencing visceral crisis. We conclude that chemotherapy is not the sole possibility in visceral crisis, and that CDK4/6 inhibitors can be considered as well.
{"title":"Case series of metastatic breast cancer patients with visceral crisis treated with CDK4/6 inhibitors.","authors":"Marissa Meegdes, Marleen G A M van der Velde, Sandra M E Geurts, Maartje A C E van Kats, M Wouter Dercksen, Vivianne C G Tjan-Heijnen","doi":"10.1080/1120009X.2023.2279831","DOIUrl":"10.1080/1120009X.2023.2279831","url":null,"abstract":"<p><p>There is an ongoing clinical dilemma of how best to treat patients who present themselves with visceral crisis. The time needed to undo the state of visceral crisis is the most relevant outcome for this patient group. We describe four patients treated with CDK4/6 inhibitor plus endocrine therapy for HR+/HER2- metastatic breast cancer who presented themselves with a visceral crisis. Two of them are male and three of them had synchronous metastatic breast cancer. Two patients had lymphangitis carcinomatosis of the lungs, one extensive disease of the eye and one of the liver. Time to first clinical response was observed within a few weeks in three patients. For one patient a switch to chemotherapy was needed. These cases show that treatment with CDK4/6 inhibitors can achieve a rapid response in patients experiencing visceral crisis. We conclude that chemotherapy is not the sole possibility in visceral crisis, and that CDK4/6 inhibitors can be considered as well.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"343-350"},"PeriodicalIF":1.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72014402","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}
Pub Date : 2024-06-30DOI: 10.1080/1120009X.2024.2363105
M Bakri Hammami, Paola Gudino, Juan Diego Rodriguez Salazar, Charan Vegivinti, Asma Qasim, Anjali Acharya
Studies evaluating Cisplatin-induced nephrotoxicity in minorities are limited. We conducted a retrospective review of adult patients receiving cisplatin from 2019 to 2023 at an inner-city hospital. Renal indices were obtained at baseline and after cycles 1, 2, and 3 of Cisplatin. A total of 93 patients were included, 46% were male. Median age was 57 years. About 40% were Black, 13% White, and 42% Hispanic. About 54% were uninsured. About 16% of the patients developed AKI after cycle 1 of cisplatin, 5% after cycle 2%, and 17% after cycle 3. There was no statistically significant correlation between race, sex, BMI and development of cisplatin-induced AKI. Repeated measures ANOVA test indicated a statistically significant and cumulative rise in creatinine level following cisplatin therapy [Wilks' Lambda = 0.003, F(1,26)=13.7, η2 = 0.44]. Our study in a minority, low socioeconomic population highlights the progressive kidney injury following each cycle of cisplatin therapy. Further studies targeting this specific population are warranted to develop tailored interventions.
{"title":"Assessing the prevalence and severity of cisplatin-induced nephrotoxicity in a minority- low socioeconomic population in the Bronx, New York.","authors":"M Bakri Hammami, Paola Gudino, Juan Diego Rodriguez Salazar, Charan Vegivinti, Asma Qasim, Anjali Acharya","doi":"10.1080/1120009X.2024.2363105","DOIUrl":"https://doi.org/10.1080/1120009X.2024.2363105","url":null,"abstract":"<p><p>Studies evaluating Cisplatin-induced nephrotoxicity in minorities are limited. We conducted a retrospective review of adult patients receiving cisplatin from 2019 to 2023 at an inner-city hospital. Renal indices were obtained at baseline and after cycles 1, 2, and 3 of Cisplatin. A total of 93 patients were included, 46% were male. Median age was 57 years. About 40% were Black, 13% White, and 42% Hispanic. About 54% were uninsured. About 16% of the patients developed AKI after cycle 1 of cisplatin, 5% after cycle 2%, and 17% after cycle 3. There was no statistically significant correlation between race, sex, BMI and development of cisplatin-induced AKI. Repeated measures ANOVA test indicated a statistically significant and cumulative rise in creatinine level following cisplatin therapy [Wilks' Lambda = 0.003, F(1,26)=13.7, η<sup>2</sup> = 0.44]. Our study in a minority, low socioeconomic population highlights the progressive kidney injury following each cycle of cisplatin therapy. Further studies targeting this specific population are warranted to develop tailored interventions.</p>","PeriodicalId":15338,"journal":{"name":"Journal of Chemotherapy","volume":" ","pages":"1-6"},"PeriodicalIF":1.9,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468355","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}