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[Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice(2024 edition)]. [中国多学科专家关于在临床实践中合理使用舒伐替尼的共识(2024 年版)"。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20240524-00216

Neuroendocrine neoplasms are a group of heterogeneous tumors originating from the neuroendocrine system, which can occur in any part of the body. Pulmonary and gastroenteropancreatic neuroendocrine tumors are the most common. In recent years, the global incidence of neuroendocrine tumors has increased more significantly than other types of tumors, especially in the past 40 years. The drug treatment of neuroendocrine tumors includes somatostatin analogues, anti-angiogenesis targeting drugs, nuclide therapy and chemotherapy. Surufatinib is an oral tyrosine kinase receptor inhibitors that targets for vascular endothelial growth factor receptor (VEGFR1-3), fibroblast growth factor receptor 1 (FGFR1), and colony-stimulating factor-1 receptor (CSF-1R), has received approval in 2020 and 2021 for the treatment of locally advanced or metastatic, progressive nonfunctional, well-differentiated (G1, G2) neuroendocrine tumors (NETs) of both pancreatic and extrapancreatic origin that are unresectable. Ongoing exploratory studies are investigating its potential application in other tumor types. Common adverse reactions observed during surufatinib treatment include hypertension, proteinuria, bleeding events, and hepatic lab test abnormal and diarrhea. Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice (2024 edition) aims to provide standardized guidance for its rational use and enhance patient compliance to maximize therapeutic benefits.

神经内分泌肿瘤是一组起源于神经内分泌系统的异质性肿瘤,可发生在身体的任何部位。肺和胃肠胰神经内分泌肿瘤最为常见。近年来,全球神经内分泌肿瘤的发病率比其他类型的肿瘤有了更显著的增长,尤其是在过去 40 年中。神经内分泌肿瘤的药物治疗包括体生长激素类似物、抗血管生成靶向药物、核素治疗和化疗。舒罗伐替尼是一种口服酪氨酸激酶受体抑制剂,靶向血管内皮生长因子受体(VEGFR1-3)、成纤维细胞生长因子受体1(FGFR1)和集落刺激因子-1受体(CSF-1R)、已于 2020 年和 2021 年获得批准,用于治疗无法切除的局部晚期或转移性、进展性无功能、分化良好(G1、G2)的胰腺和胰腺外神经内分泌肿瘤(NET)。目前正在进行的探索性研究正在调查其在其他肿瘤类型中的潜在应用。在舒法替尼治疗期间观察到的常见不良反应包括高血压、蛋白尿、出血事件、肝脏实验室检查异常和腹泻。中国多学科专家共识(2024年版)》旨在为索非替尼的临床合理应用提供规范化指导,提高患者依从性,最大限度地提高治疗效果。
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引用次数: 0
[A case of primary giant gastrointestinal stromal tumor of the liver]. [肝脏原发性巨大胃肠道间质瘤一例]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20230809-00070
W L Wang, A Hu, G Luo, Y P Luo, Y M Ou
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引用次数: 0
[Clinical predictive value of PD-1/PD-L1-induced electrocardiogram changes for cardiotoxicity]. [PD-1/PD-L1诱导的心电图变化对心脏毒性的临床预测价值]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20231024-00230
N Xue, L L Peng, D W Wu, X J Li

Objective: To observe the electrocardiogram (ECG) changes of programmed death receptor 1 (PD-1)/programmed death receptor-ligand 1 (PD-L1) immune checkpoint inhibitors before and after immunotherapy of patients during clinical antitumor process, and to explore the occurrence and influencing factors of cardiotoxicity of immune checkpoint inhibitors. Methods: A total of 93 patients with locally advanced or metastatic solid tumors confirmed by pathological diagnosis in Cancer Hospital of Chinese Academy of Medical Sciences from October 1, 2019 to September 30, 2020 were selected and treated with PD-1/PD-L1 inhibitor monotherapy. Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The patients were monitored and followed up for 10 cycles. The ECG results of each group were recorded, and the correlation between ECG abnormality and cardiotoxicity was analyzed. Results: A total of 75 patients showed abnormal ECG that met the diagnostic criteria. There was no significant difference in abnormal ECG rate after immunotherapy in group A (P>0.05), while the incidence of adverse cardiac events increased after immunotherapy in group B (P<0.05), and the abnormal ECG rate increased significantly after chemotherapy in group C and group D. There was statistical difference before and after immunotherapy (P<0.001). The number of abnormal cases in group A (8 cases, 50.0%, 8/16) was significantly lower than that of group B (20 cases, 87.0%, 20/23). The number of abnormal cases in group C and group D was 24 (85.7%) and 23 (88.4%), respectively, without statistical difference (P>0.05), but their abnormal rates of ECG were higher than that in group A. The incidence of electrical adverse events in immunotherapy center of patients with underlying diseases was 1.93 times higher than that of patients without underlying diseases. The incidence of central electrical adverse events during immunotherapy in group B, C and D was 6.667, 6.000 and 7.667 times higher than that in group A, respectively. Conclusions: The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention.

目的观察临床抗肿瘤过程中患者免疫治疗前后程序性死亡受体1(PD-1)/程序性死亡受体配体1(PD-L1)免疫检查点抑制剂的心电图(ECG)变化,探讨免疫检查点抑制剂心脏毒性的发生及影响因素。研究方法选取中国医学科学院肿瘤医院2019年10月1日至2020年9月30日经病理诊断确诊的局部晚期或转移性实体瘤患者共93例,采用PD-1/PD-L1抑制剂单药治疗。根据免疫治疗方案进行分组:A组(药物代码:609A),16例患者给予1mg/kg的药物,治疗21天;B组(药物代码:HX008),23例患者给予200mg的药物,治疗21天;C组(药物代码:GB226),28例患者给予3mg/kg的药物,治疗14天;D组(药物代码:LP002),26例患者给予900mg的药物,治疗14天。对患者进行了 10 个周期的监测和随访。记录各组的心电图结果,并分析心电图异常与心脏毒性之间的相关性。结果共有 75 名患者的心电图异常符合诊断标准。A组免疫治疗后心电图异常率无明显差异(P>0.05),B组免疫治疗后心脏不良事件发生率增加(P<0.05),C组和D组化疗后心电图异常率明显增加,免疫治疗前后有统计学差异(P<0.001)。A 组异常病例数(8 例,50.0%,8/16)明显低于 B 组(20 例,87.0%,20/23)。C组和D组异常例数分别为24例(85.7%)和23例(88.4%),无统计学差异(P>0.05),但其心电图异常率均高于A组。B组、C组和D组免疫治疗期间中心电不良事件的发生率分别是A组的6.667倍、6.000倍和7.667倍。结论免疫检查点抑制剂诱发的早期心电图变化具有很高的灵敏度,可以及早预测相关的心脏毒性。有无合并基础疾病和药物剂量与心脏不良事件的发生相关,这些早期变化为临床治疗和预防提供了证据。
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引用次数: 0
[TRAF4 promotes lung cancer development by activating tyrosine kinase of EGFR]. [TRAF4通过激活表皮生长因子受体的酪氨酸激酶促进肺癌发展]
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20231024-00240
X M Nie, D F Dong, J F Lin, B Y Wu, G Cai
<p><p><b>Objective:</b> To explore the role of tumor necrosis factor receptor-associated factor 4 (TRAF4) in promoting the abnormal activation of epidermal growth factor receptor (EGFR) and its effect on lung cancer cell proliferation, migration and invasion. <b>Methods:</b> Tumor tissues from patients who underwent lung adenocarcinoma resection at The First Affiliated Hospital of Second Military Medical University, from January 2015 to May 2017 were collected, and the expressions of TRAF4 and Ki-67 in lung cancer tissues were detected by immunohistochemistry, the mRNA levels of Cyclin D and Vimentin were detected by real-time fluorescence quantitative PCR (qRT-PCR). The effect of TRAF4 on the tumor growth ability of lung cancer A549 cells was investigated by the xenograft model, the effect of TRAF4 or EGFR on the tumor proliferation ability was detected by using cell counting kit 8 (CCK8) and BrdU assay, and the migration and invasion abilities of tumor cells were detected by Transwell assay. Different structural domain deletion expression vectors of TRAF4 and EGFR were constructed to transfect cells, and the interaction mode of TRAF4 and EGFR was investigated by immunoprecipitation assay. <b>Results:</b> The expression of TRAF4 in non-small cell lung cancer (NSCLC) tissues was positively correlated with the expressions of Ki-67, cyclin D, and vimentin (<i>r</i><sup>2</sup>: 0.438, 0.695, and 0.736, respectively, all <i>P</i><0.01). Immunohistochemical assay of tumor tissues from NSCLC patients showed that tissues with high expression of TRAF4 were also high in Ki-67. Patients with high TRAF4 expression (TRAF4 positivity >30%) had a shorter progression-free survival (PFS) time than that of patients with low TRAF4 expression (TRAF4 positivity ≤30%) (median PFS of 12 and 19 months, respectively; <i>P</i>=0.034). Traf4<sup>-/-</sup> cells had a weakened proliferative capacity than <i>traf4</i><sup>+/+</sup> cells and formed tumors with smaller size (<i>P</i><0.05). The expression level of Ki-67 in the tumor tissues formed by <i>traf4<sup>-/-</sup></i> cells [(45.6±8.7)%] was lower than that in the tumor tissues formed by <i>traf4</i><sup>+/+</sup> cells [(62.3±10.3)%, <i>P</i>=0.015], the mRNA levels of cyclin D (1.01±0.15) and vimentin (1.01±0.12) in the <i>traf4<sup>-/-</sup></i> cells were lower than those of the <i>traf4</i><sup>+/+</sup> cells (3.41±0.32 and 3.12±0.18, respectively, both <i>P</i><0.05).The western blot results showed that, with the elevated intracellular expression level of TRAF4, phosphorylation level of EGFR was significantly increased in both wild-type EGFR and activation mutant EGFR-expression cells. The capacities of proliferation, migration and invasion of A549 cells was weakened after EGFR knockdown (all <i>P</i><0.01). Immunoprecipitation experiments showed that TRAF4 binds to the peptide segment of the near-membrane region of EGFR through the TRAF structural domain, and the mutual binding between EGFR molecules was en
目的探讨肿瘤坏死因子受体相关因子 4(TRAF4)在促进表皮生长因子受体(EGFR)异常活化中的作用及其对肺癌细胞增殖、迁移和侵袭的影响。研究方法收集2015年1月至2017年5月在第二军医大学第一附属医院接受肺腺癌切除术患者的肿瘤组织,采用免疫组化方法检测肺癌组织中TRAF4和Ki-67的表达,采用实时荧光定量PCR(qRT-PCR)方法检测细胞周期蛋白D和Vimentin的mRNA水平。异种移植模型研究了TRAF4对肺癌A549细胞肿瘤生长能力的影响,细胞计数试剂盒8(CCK8)和BrdU检测了TRAF4或EGFR对肿瘤增殖能力的影响,Transwell检测了肿瘤细胞的迁移和侵袭能力。构建了不同结构域缺失的TRAF4和EGFR表达载体转染细胞,并通过免疫沉淀实验研究了TRAF4和EGFR的相互作用模式。结果显示非小细胞肺癌(NSCLC)组织中TRAF4的表达与Ki-67、细胞周期蛋白D和波形蛋白的表达呈正相关(r2分别为0.438、0.695和0.736,均P<0.01)。对 NSCLC 患者肿瘤组织的免疫组化检测显示,TRAF4 高表达的组织 Ki-67 也高。TRAF4高表达(TRAF4阳性率>30%)患者的无进展生存期(PFS)比TRAF4低表达(TRAF4阳性率≤30%)患者短(中位PFS分别为12个月和19个月;P=0.034)。与Traf4+/+细胞相比,Traf4-/-细胞的增殖能力更弱,形成的肿瘤更小(P<0.05)。traf4-/-细胞形成的肿瘤组织中Ki-67的表达水平[(45.6±8.7)%]低于traf4+/+细胞形成的肿瘤组织中Ki-67的表达水平[(62.3±10.3)%,P=0.015],traf4-/-细胞中细胞周期蛋白D(1.01±0.15)和波形蛋白(1.01±0.12)的mRNA水平低于traf4+/+细胞(3.Western印迹结果显示,随着TRAF4在细胞内表达水平的升高,野生型表皮生长因子受体和活化突变型表皮生长因子受体表达细胞的表皮生长因子受体磷酸化水平均显著升高。敲除表皮生长因子受体后,A549细胞的增殖、迁移和侵袭能力减弱(均P<0.01)。免疫沉淀实验表明,TRAF4通过TRAF结构域与表皮生长因子受体近膜区的肽段结合,在TRAF4过表达条件下,表皮生长因子受体分子间的相互结合增强。TRAF4 表达的增加促进了表皮生长因子受体分子磷酸化和下游信号的激活。结论:TRAF4在NSCLC组织和肿瘤细胞中表达升高,促进肿瘤增殖、迁移和侵袭。TRAF4可直接与表皮生长因子受体分子结合,增强自身磷酸化,并通过促进表皮生长因子受体分子间的相互作用激活下游信号通路。
{"title":"[TRAF4 promotes lung cancer development by activating tyrosine kinase of EGFR].","authors":"X M Nie, D F Dong, J F Lin, B Y Wu, G Cai","doi":"10.3760/cma.j.cn112152-20231024-00240","DOIUrl":"10.3760/cma.j.cn112152-20231024-00240","url":null,"abstract":"&lt;p&gt;&lt;p&gt;&lt;b&gt;Objective:&lt;/b&gt; To explore the role of tumor necrosis factor receptor-associated factor 4 (TRAF4) in promoting the abnormal activation of epidermal growth factor receptor (EGFR) and its effect on lung cancer cell proliferation, migration and invasion. &lt;b&gt;Methods:&lt;/b&gt; Tumor tissues from patients who underwent lung adenocarcinoma resection at The First Affiliated Hospital of Second Military Medical University, from January 2015 to May 2017 were collected, and the expressions of TRAF4 and Ki-67 in lung cancer tissues were detected by immunohistochemistry, the mRNA levels of Cyclin D and Vimentin were detected by real-time fluorescence quantitative PCR (qRT-PCR). The effect of TRAF4 on the tumor growth ability of lung cancer A549 cells was investigated by the xenograft model, the effect of TRAF4 or EGFR on the tumor proliferation ability was detected by using cell counting kit 8 (CCK8) and BrdU assay, and the migration and invasion abilities of tumor cells were detected by Transwell assay. Different structural domain deletion expression vectors of TRAF4 and EGFR were constructed to transfect cells, and the interaction mode of TRAF4 and EGFR was investigated by immunoprecipitation assay. &lt;b&gt;Results:&lt;/b&gt; The expression of TRAF4 in non-small cell lung cancer (NSCLC) tissues was positively correlated with the expressions of Ki-67, cyclin D, and vimentin (&lt;i&gt;r&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt;: 0.438, 0.695, and 0.736, respectively, all &lt;i&gt;P&lt;/i&gt;<0.01). Immunohistochemical assay of tumor tissues from NSCLC patients showed that tissues with high expression of TRAF4 were also high in Ki-67. Patients with high TRAF4 expression (TRAF4 positivity &gt;30%) had a shorter progression-free survival (PFS) time than that of patients with low TRAF4 expression (TRAF4 positivity ≤30%) (median PFS of 12 and 19 months, respectively; &lt;i&gt;P&lt;/i&gt;=0.034). Traf4&lt;sup&gt;-/-&lt;/sup&gt; cells had a weakened proliferative capacity than &lt;i&gt;traf4&lt;/i&gt;&lt;sup&gt;+/+&lt;/sup&gt; cells and formed tumors with smaller size (&lt;i&gt;P&lt;/i&gt;<0.05). The expression level of Ki-67 in the tumor tissues formed by &lt;i&gt;traf4&lt;sup&gt;-/-&lt;/sup&gt;&lt;/i&gt; cells [(45.6±8.7)%] was lower than that in the tumor tissues formed by &lt;i&gt;traf4&lt;/i&gt;&lt;sup&gt;+/+&lt;/sup&gt; cells [(62.3±10.3)%, &lt;i&gt;P&lt;/i&gt;=0.015], the mRNA levels of cyclin D (1.01±0.15) and vimentin (1.01±0.12) in the &lt;i&gt;traf4&lt;sup&gt;-/-&lt;/sup&gt;&lt;/i&gt; cells were lower than those of the &lt;i&gt;traf4&lt;/i&gt;&lt;sup&gt;+/+&lt;/sup&gt; cells (3.41±0.32 and 3.12±0.18, respectively, both &lt;i&gt;P&lt;/i&gt;<0.05).The western blot results showed that, with the elevated intracellular expression level of TRAF4, phosphorylation level of EGFR was significantly increased in both wild-type EGFR and activation mutant EGFR-expression cells. The capacities of proliferation, migration and invasion of A549 cells was weakened after EGFR knockdown (all &lt;i&gt;P&lt;/i&gt;<0.01). Immunoprecipitation experiments showed that TRAF4 binds to the peptide segment of the near-membrane region of EGFR through the TRAF structural domain, and the mutual binding between EGFR molecules was en","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[CT measurement of blood perfusion in hepatocellular carcinoma: from basic principle, measurement methods to clinical application]. [肝细胞癌血液灌注 CT 测量:从基本原理、测量方法到临床应用]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20240605-00240
Y K Li, Q B Wang, Y B Liang, Y Ke

Hepatocellular carcinoma (HCC) is one of the common and fatal malignant tumors worldwide, and the burden of HCC is particularly severe in China. Physiologically, the blood supply to healthy liver is mainly from the portal vein, supplemented by the hepatic artery. While in the development of HCC, the main source of blood supply to HCC is changed from the portal vein to the hepatic artery. The characteristics of HCC vascularization are important for imaging, surgery, interventional therapy, targeted therapy, etc. Even in the future, with the development of radiation therapy technology, such as proton and heavy ion therapy and artificial intelligence technology, the dynamic changes in HCC blood perfusion can be used as a new biomarker of tumor activity to provide accurate information on the intensity modulation of radiotherapy, so that accurate measurements of HCC blood perfusion is of great significance in guiding the diagnosis and treatment of HCC. The technologies for measurement of HCC blood perfusion have developed from invasive techniques, such as inert gas scavenging, electromagnetic flowmeter, and radionuclide-labeled erythrocyte elution in the middle of the last century to the present non-invasive techniques of CT. With the development of CT imaging technology in the last 30 years, the CT-based imaging technology can assess the status of organ and tissue perfusion relatively easily and accurately. In this paper, the various CT measurement techniques of blood perfusion in HCC were categorized into three types: semi-quantitative technique, relative quantitative technique, and absolute quantitative technique. Their basic principle, scanning methods, and clinical applications were discussed to provide a reference for the diagnosis and treatment of HCC.

肝细胞癌(HCC)是全球常见的致命性恶性肿瘤之一,在中国的发病率尤为严重。从生理学角度讲,健康肝脏的血液供应主要来自门静脉,辅以肝动脉。而在 HCC 的发展过程中,HCC 的主要供血来源由门静脉转变为肝动脉。HCC 血管化的特点对于成像、手术、介入治疗、靶向治疗等都非常重要。甚至在未来,随着质子、重离子治疗等放射治疗技术和人工智能技术的发展,HCC 血液灌注的动态变化可作为肿瘤活性的新生物标志物,为放疗强度调控提供准确信息,因此准确测量 HCC 血液灌注对指导 HCC 的诊断和治疗具有重要意义。HCC 血液灌注测量技术从上世纪中期的惰性气体清除、电磁流量计、放射性核素标记红细胞洗脱等有创技术发展到现在的 CT 无创技术。随着近 30 年 CT 成像技术的发展,以 CT 为基础的成像技术可以比较容易和准确地评估器官和组织的灌注状况。本文将 HCC 血液灌注的各种 CT 测量技术分为三类:半定量技术、相对定量技术和绝对定量技术。并对其基本原理、扫描方法和临床应用进行了探讨,以期为 HCC 的诊断和治疗提供参考。
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引用次数: 0
[Results of the cancer screening program in urban areas in Shaanxi province of China, 2019-2020]. [2019-2020年中国陕西省城市地区癌症筛查项目结果]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20231020-00208
Y Chen, B H Song, G Li, P Chen, S P Huang, Z J Liao, R Xu, Y R Li

Objective: Analyze the cancer screening status of the cancer screening program in urban areas in Shaanxi province in 2019-2020. Methods: The early diagnosis and early treatment project for urban cancers carried out high-risk population screening for 5 types of high-incidence malignant tumors (breast cancer, lung cancer, upper gastrointestinal cancer, liver cancer, and colorectal cancer) in urban areas. Three prefecture-level cities in Shaanxi province with a population of over 1 million (Xi'an, Baoji, and Shangluo) were selected, and 4 communities with a relatively good working foundation were selected in each city. The general population aged 45-74 years was surveyed on the principles of informed consent and voluntariness, and high-risk groups identified through the questionnaire were further subjected to free endoscopy, ultrasound, CT, and other clinical screenings. The high-risk rates, screening compliance rates, and positive detection rates of the above 5 types of malignant tumors were analyzed. Results: A total of 19 632 people completed the survey effectively, with the proportion of male participants (40.0%) lower than that of females (60.0%). A total of 10 102 high-risk groups were identified, with an initial screening high-risk rate of 51.5%, and the high-risk rates for the 5 types of cancers were 24.1% for breast cancer, 28.6% for lung cancer, 9.1% for upper gastrointestinal cancer, 4.0% for liver cancer, and 20.0% for colorectal cancer. Among the 14 960 person-time initially assessed as high-risk, 5 129 person-time received clinical screening, with a screening compliance rate of 34.3%. The number of people receiving clinical screening and the screening compliance rates for the 5 types of cancers were 1 192 (41.9%) for breast cancer, 2 081 (37.1%) for lung cancer, 574 (32.0%) for upper gastrointestinal cancer, 404 (51.3%) for liver cancer, and 878 (22.3%) for colorectal cancer, with positive detection numbers and rates of 179 (15.0%) for breast, 289 (13.9%) for lung, 9 (1.6%) for upper gastrointestinal, 14 (3.5%) for suspected liver, and 67 (7.6%) for colorectal, respectively. Conclusion: The cancer screening status of the cancer screening program in urban areas in Shaanxi province is beneficial for the detection of precancerous lesions and early cancer patients, and improving the early diagnosis and treatment rate of patients, but the public participation rate is not high, and the project management model and technical plan need to be further improved.

目的分析2019-2020年陕西省城市地区癌症筛查项目的筛查情况。方法:开展城市癌症早诊早治项目:城市癌症早诊早治项目在城市地区开展5种高发恶性肿瘤(乳腺癌、肺癌、上消化道癌、肝癌、结直肠癌)高危人群筛查。选择陕西省三个人口超过 100 万的地级市(西安、宝鸡、商洛),每个城市选择 4 个工作基础较好的社区。本着知情同意和自愿的原则,对 45-74 岁的普通人群进行问卷调查,并对通过问卷调查确定的高危人群进一步进行免费的内镜、超声、CT 等临床筛查。对上述 5 种恶性肿瘤的高风险率、筛查符合率和阳性检出率进行了分析。结果显示共有 19 632 人有效完成了调查,其中男性参与者比例(40.0%)低于女性(60.0%)。共发现 10 102 名高风险人群,初筛高风险率为 51.5%,5 种癌症的高风险率分别为:乳腺癌 24.1%、肺癌 28.6%、上消化道癌 9.1%、肝癌 4.0%、结直肠癌 20.0%。在初步评估为高风险的 14 960 人次中,有 5 129 人次接受了临床筛查,筛查达标率为 34.3%。在 5 种癌症中,接受临床筛查的人数和筛查达标率分别为:乳腺癌 1 192 人(41.9%)、肺癌 2 081 人(37.1%)、上消化道癌 574 人(32.0%)、肝癌 404 人(51.3%)、结肠癌 8 人(34.3%)。阳性检出人数和阳性检出率分别为:乳腺癌 179 人(15.0%)、肺癌 289 人(13.9%)、上消化道癌 9 人(1.6%)、疑似肝癌 14 人(3.5%)和结直肠癌 67 人(7.6%)。结论陕西省城市地区癌症筛查项目的癌症筛查现状有利于发现癌前病变和早期癌症患者,提高患者的早诊早治率,但公众参与率不高,项目管理模式和技术方案有待进一步完善。
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引用次数: 0
[Expert consensus on BRAF inhibitors in the treatment of malignant solid tumors (2024 edition)]. [关于 BRAF 抑制剂治疗恶性实体瘤的专家共识(2024 年版)]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20240409-00142

The global aging population is leading to an increasing incidence of cancer, exacerbating the global burden of cancer. By 2040, the total number of cancer patients worldwide is projected to reach 28 million. With advancements in tumor molecular biology research and the widespread application of next-generation sequencing technology, precision treatment for cancer has made significant progress in clinical settings. Selective targeting of the Braf gene has emerged as one of the early successful cases of precision medicine for tumors. Braf gene mutations can result in unrestricted activation of downstream kinases in the mitogen-activated protein kinase (MAPK) cell signaling pathway, promoting rapid proliferation of tumor cells. BRAF inhibitors, either as monotherapy or in combination with MEK inhibitor, have been approved for various cancers, including melanoma, non-small cell lung cancer, thyroid cancer, colorectal cancer and glioma, among others. Clinical studies related to BRAF inhibitors are continuously exploring new applications. However, there is currently no consensus on the use of BRAF inhibitors in the diagnosis and treatment of multiple solid cancers in China. This article integrates clinical evidence of Braf mutations in multiple solid cancers to establish an expert consensus on the diagnosis and treatment of malignant solid cancers with Braf gene mutations. The goal is to promote and guide the standardized application of BRAF inhibitors.

全球人口老龄化导致癌症发病率不断上升,加剧了全球癌症负担。预计到 2040 年,全球癌症患者总数将达到 2800 万。随着肿瘤分子生物学研究的进步和新一代测序技术的广泛应用,癌症精准治疗在临床上取得了重大进展。Braf 基因的选择性靶向治疗已成为肿瘤精准医疗的早期成功案例之一。Braf 基因突变可导致丝裂原活化蛋白激酶(MAPK)细胞信号通路中的下游激酶不受限制地激活,促进肿瘤细胞快速增殖。BRAF 抑制剂可作为单一疗法或与 MEK 抑制剂联用,已被批准用于多种癌症的治疗,包括黑色素瘤、非小细胞肺癌、甲状腺癌、结直肠癌和胶质瘤等。与 BRAF 抑制剂相关的临床研究正在不断探索新的应用领域。然而,目前国内对于 BRAF 抑制剂在多种实体瘤诊治中的应用尚未达成共识。本文综合多种实体瘤BRAF基因突变的临床证据,就BRAF基因突变的恶性实体瘤的诊断和治疗达成专家共识。旨在促进和指导BRAF抑制剂的规范化应用。
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引用次数: 0
[International comparison and assessment of the quality of drug clinical trial implementation in China based on scientific regulatory system]. 【基于科学监管体系的中国药物临床试验实施质量国际比较与评估】。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20230805-00060
H Fang, Y R Hou, H Y Huang, D W Wu, S P Jia, Y Tang, N Li

Objective: To analyze the international status and level of clinical trial quality in China, and explore the advantages and value of scientific regulation of clinical research quality in China. Methods: The data is sourced from the relevant reports publicly released by the National Medical Products Administration (NMPA), the inspection reports and announcements published by the Center for Food and Drug Inspection of the NMPA, the inspection data displayed on the official website of the U.S. Food and Drug Administration (FDA), as well as clinical diagnosis and treatment guidelines issued by the National Comprehensive Cancer Network (NCCN) of United States and the Chinese Society of Clinical Oncology (CSCO) (data as of July 21, 2023). This data provides an analysis of the regulatory status of the implementation of clinical drug trials in China, inspection data, and the approval and market entry of new oncology drugs and feedback from their practical application. Results: The clinical trial quality inspection systems of China and the United States are generally aligned, with similar inspection subjects, focus areas, and public disclosure pathways. However, each has its characteristics in terms of inspection targets and types. The quality of clinical trial data in China has been continuously improving. Between 2009-2015 and 2016-July 2023, China underwent 25 and 20 FDA Bioresearch Monitoring (BIMO) inspections, respectively. The inspection results showing "No Action Indicated" (NAI) improved from 48.0% to 85.0%, while "Voluntary Action Indicated" (VAI) decreased from 44.0% to 15.0%. Official Action Indicated (OAI) measures were required in 2009 and 2012. Compared to the 2009-2015 period, there has been a clear upward trend in the quality of clinical trial data since 2016. From 2016 to July 2023, the number of new oncology drugs developed by Chinese pharmaceutical companies and included in professional guidelines has steadily increased. Specifically, 37 drugs (58.7%) were included in the 2022 edition of the CSCO guidelines, and 15 drugs (23.8%) were included in the 2023 edition of the NCCN guidelines, with 10 of these drugs featured in both guidelines. Conclusions: The implementation quality of clinical trials in China has gained a certain level of international recognition and competitiveness. This progress is attributed to national macro-level guidance, a unique institutional model, and clinical practices aligned with international standards. In the future, it will be necessary to further strengthen the scientific regulatory system and enhance clinical research capabilities to continue advancing the high-quality development of clinical trials.

随着中国临床研究的快速发展和创新能力的不断增强,中国科学监管体系下的临床研究质量受到了广泛关注。本研究评估了中国药物临床试验实施的质量结果,比较了中美临床研究质量的科学监管体系,分析了现实世界中通过临床试验批准抗肿瘤新药的临床应用,以分析中国临床试验实施质量在国际行业中的地位和水平,并通过收集中美监管机构披露的临床试验数据检查以及验证抗肿瘤新药批准信息,探索中国临床研究科学监管的优势和价值。
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引用次数: 0
[The 5-year relative survival rate among cancer patients in Henan province of China, 2015-2019]. [2015-2019年中国河南省癌症患者5年相对生存率]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20231024-00237
Q Chen, M X Zhang, L W Guo, L Y Zheng, C Y Liu, Y X Wang, Y Liu, H Wang, H F Xu, R H Kang, X Y Wang, S Z Liu, S K Zhang

Objective: To analyze the 5-year relative survival rate of cancer in Henan province based on cancer registration data. Methods: Cancer survival data were extracted from the cancer registration database of Henan province with the diagnosis date between January 1, 2010 and December 31, 2019 were included. The closing date of follow-up was set as December 31, 2019. The 5-year relative survival rate of cancer was calculated using the period survival analysis method and the Ederer II method in the R package "periodR", and the interest period was between 2015 and 2019. Results: During the period of 2015-2019, the overall 5-year relative survival rate of cancer patients in Henan province was 43.6%, and after age-standardization, it was 40.2%. The overall 5-year relative survival rate showed the characteristics of higher survival rate in females than males (45.9% vs 34.7%, Z=39.60, P<0.001) and higher survival rate in urban areas than rural areas (44.9% vs 39.1%, Z=12.97, P<0.001). The 5-year relative survival rate for cancer patients among children aged 0-14 was 60.2%, and for adults aged 15 and above, it was 43.5%, which was standardized to 40.2% after age adjustment. There are two types of cancers with a standardized 5-year relative survival rate exceeding 70% (thyroid cancer at 82.2% and breast cancer at 71.6%), and four cancers with a rate below 30% (pancreatic cancer at 18.2%, liver cancer at 19.6%, lung cancer at 24.0%, and gallbladder cancer at 26.6%). Conclusion: The cancer 5-year survival rate in Henan Province is lower than that of the national average, indicating the need for continued enhancement of cancer prevention and control measures.

目的根据癌症登记数据分析河南省癌症 5 年相对生存率。方法从河南省癌症登记数据库中提取确诊日期在 2010 年 1 月 1 日至 2019 年 12 月 31 日之间的癌症生存数据。随访结束日期定为 2019 年 12 月 31 日。采用R软件包 "periodR "中的周期生存分析方法和Ederer II方法计算癌症5年相对生存率,关注期为2015年至2019年。结果显示2015-2019年期间,河南省癌症患者总体5年相对生存率为43.6%,年龄标准化后为40.2%。总体5年相对生存率呈现女性高于男性(45.9% vs 34.7%,Z=39.60,P<0.001)、城市高于农村(44.9% vs 39.1%,Z=12.97,P<0.001)的特点。0-14岁儿童癌症患者的5年相对生存率为60.2%,15岁及以上成人癌症患者的5年相对生存率为43.5%,经年龄调整后标准化为40.2%。有两种癌症的标准化 5 年相对生存率超过 70%(甲状腺癌为 82.2%,乳腺癌为 71.6%),有四种癌症的标准化 5 年相对生存率低于 30%(胰腺癌为 18.2%,肝癌为 19.6%,肺癌为 24.0%,胆囊癌为 26.6%)。结论河南省的癌症 5 年生存率低于全国平均水平,表明需要继续加强癌症预防和控制措施。
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引用次数: 0
[Trends and age-period-cohort analysis of leukemia incidence in Qidong from 1972 to 2021]. [1972-2021年启东白血病发病趋势及年龄段队列分析]。
Q3 Medicine Pub Date : 2024-10-23 DOI: 10.3760/cma.j.cn112152-20240201-00061
J Zhu, Y S Chen, J Wang, Y H Zhang, L L Ding, Y Y Xu, Y F Yan, J G Chen, H Cai

Objective: To describe the epidemiological characteristics and trends of leukemia incidence in Qidong between 1972 and 2021, and provide guidelines for prevention and control measures and strategies. Methods: The cancer registry data was collected and analyzed on leukemia incidence during 1972-2021 in Qidong by sex, age and time. Crude incidence rate (CR), China age-standardized rate (ASRC), world age-standardized rate (ASRW), and average annual change percentage (AAPC) was calculated by Joinpoint software. Age-period-cohort (APC) model was used to analyze the influence of age, period and birth cohort on the changes in the incidence trend of leukemia patients. Results: From 1972 to 2021, there were 2 948 patients with leukemia in Qidong, accounting for 2.00% of all cancer new cases, CR of leukemia was 5.26/105, ASRC was 4.34/105, ASRW was 4.35/105. The truncated incidence of 35-64 years old was 5.29/105, the cumulative incidence rate between the ages of 0 and 74 years old was 0.40%, the cumulative risk was 0.40%. There were 1 608 male patients, the CR, ASRC, and the ASRW were 5.81/105, 4.88/105 and 4.85/105. The number of female patients were 1 340, and the CR, ASRC, and the ASRW were 4.71/105, 3.86/105 and 3.91/105, respectively. Temporal trends indicated significant upward trends in ASRC among both gender, males and females with AAPC values of 1.41% (P<0.001), 1.15% (P<0.001), and 1.73% (P<0.001), respectively. The results of the APC model showed that the average net drift value of leukemia incidence in all age groups was 1.57% (95% CI, 1.24%-1.89%), and the highest value of local drift was 3.20% (95% CI, 1.63%-4.78%) in the 80~ years old group. The incidence of leukemia increased with age. With the passage of time, the risk of leukemia incidence increased gradually compared with the rate ratio of leukemia incidence (risk ratio [RR], 1.00) in 1992-1996, the RR of leukemia incidence increased from 0.70 during 1972-1976 to 1.57 during 2017-2021. The later the cohort was born, the greater the risk of leukemia incidence compared with the relative risk of leukemia incidence (RR, 1.00) in 1952-1956 cohort, the RR of leukemia incidence increased from 0.24 in the 1892-1896 cohort to 2.73 in the 2017-2021 cohort. Conclusions: The incidence of the leukemia has presented a rising trend in the past fifty years. Leukemia incidence increased with age, and the period and cohort effects on the risk of incidence increase. Further research is needed to investigate the risk factors related to leukemia.

目的描述 1972 年至 2021 年期间启东地区白血病的流行病学特征和发病趋势,并为防控措施和策略提供指导。方法收集并分析启东市 1972-2021 年期间按性别、年龄和时间划分的白血病发病情况。用 Joinpoint 软件计算粗发病率(CR)、中国年龄标准化发病率(ASRC)、世界年龄标准化发病率(ASRW)和年均变化百分比(AAPC)。采用年龄-时期-队列(APC)模型分析年龄、时期和出生队列对白血病发病趋势变化的影响。结果显示从 1972 年到 2021 年,启东共有 2 948 名白血病患者,占所有癌症新发病例的 2.00%,白血病 CR 为 5.26/105,ASRC 为 4.34/105,ASRW 为 4.35/105。35-64 岁截断发病率为 5.29/105,0-74 岁累积发病率为 0.40%,累积风险为 0.40%。男性患者人数为 1 608 人,CR、ASRC 和 ASRW 分别为 5.81/105、4.88/105 和 4.85/105。女性患者人数为 1 340 人,CR、ASRC 和 ASRW 分别为 4.71/105、3.86/105 和 3.91/105。时间趋势显示,男性和女性的 ASRC 均呈明显上升趋势,AAPC 值分别为 1.41% (P<0.001)、1.15% (P<0.001) 和 1.73% (P<0.001)。APC模型结果显示,各年龄组白血病发病率的平均净漂移值为1.57%(95% CI,1.24%-1.89%),80~80岁组的局部漂移值最高,为3.20%(95% CI,1.63%-4.78%)。白血病的发病率随着年龄的增长而增加。随着时间的推移,白血病发病风险逐渐增加,与 1992-1996 年的白血病发病率比(风险比 [RR],1.00)相比,白血病发病率比从 1972-1976 年的 0.70 增加到 2017-2021 年的 1.57。与 1952-1956 年队列的白血病发病率相对风险(RR,1.00)相比,队列出生越晚,白血病发病风险越大,白血病发病率从 1892-1896 年队列的 0.24 增加到 2017-2021 年队列的 2.73。结论是在过去的五十年中,白血病的发病率呈上升趋势。白血病发病率随着年龄的增长而增加,而时期和队列对发病风险的影响也在增加。需要进一步研究与白血病相关的风险因素。
{"title":"[Trends and age-period-cohort analysis of leukemia incidence in Qidong from 1972 to 2021].","authors":"J Zhu, Y S Chen, J Wang, Y H Zhang, L L Ding, Y Y Xu, Y F Yan, J G Chen, H Cai","doi":"10.3760/cma.j.cn112152-20240201-00061","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20240201-00061","url":null,"abstract":"<p><p><b>Objective:</b> To describe the epidemiological characteristics and trends of leukemia incidence in Qidong between 1972 and 2021, and provide guidelines for prevention and control measures and strategies. <b>Methods:</b> The cancer registry data was collected and analyzed on leukemia incidence during 1972-2021 in Qidong by sex, age and time. Crude incidence rate (CR), China age-standardized rate (ASRC), world age-standardized rate (ASRW), and average annual change percentage (AAPC) was calculated by Joinpoint software. Age-period-cohort (APC) model was used to analyze the influence of age, period and birth cohort on the changes in the incidence trend of leukemia patients. <b>Results:</b> From 1972 to 2021, there were 2 948 patients with leukemia in Qidong, accounting for 2.00% of all cancer new cases, CR of leukemia was 5.26/10<sup>5</sup>, ASRC was 4.34/10<sup>5</sup>, ASRW was 4.35/10<sup>5</sup>. The truncated incidence of 35-64 years old was 5.29/10<sup>5</sup>, the cumulative incidence rate between the ages of 0 and 74 years old was 0.40%, the cumulative risk was 0.40%. There were 1 608 male patients, the CR, ASRC, and the ASRW were 5.81/10<sup>5</sup>, 4.88/10<sup>5</sup> and 4.85/10<sup>5</sup>. The number of female patients were 1 340, and the CR, ASRC, and the ASRW were 4.71/10<sup>5</sup>, 3.86/10<sup>5</sup> and 3.91/10<sup>5</sup>, respectively. Temporal trends indicated significant upward trends in ASRC among both gender, males and females with AAPC values of 1.41% (<i>P</i><0.001), 1.15% (<i>P</i><0.001), and 1.73% (<i>P</i><0.001), respectively. The results of the APC model showed that the average net drift value of leukemia incidence in all age groups was 1.57% (95% <i>CI</i>, 1.24%-1.89%), and the highest value of local drift was 3.20% (95% <i>CI</i>, 1.63%-4.78%) in the 80~ years old group. The incidence of leukemia increased with age. With the passage of time, the risk of leukemia incidence increased gradually compared with the rate ratio of leukemia incidence (risk ratio [<i>RR</i>], 1.00) in 1992-1996, the RR of leukemia incidence increased from 0.70 during 1972-1976 to 1.57 during 2017-2021. The later the cohort was born, the greater the risk of leukemia incidence compared with the relative risk of leukemia incidence (<i>RR</i>, 1.00) in 1952-1956 cohort, the RR of leukemia incidence increased from 0.24 in the 1892-1896 cohort to 2.73 in the 2017-2021 cohort. <b>Conclusions:</b> The incidence of the leukemia has presented a rising trend in the past fifty years. Leukemia incidence increased with age, and the period and cohort effects on the risk of incidence increase. Further research is needed to investigate the risk factors related to leukemia.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","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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