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[Guidelines for managing adverse reactions to antibody-drug conjugates in breast cancer (2025 edition)]. [乳腺癌抗体-药物结合物不良反应管理指南(2025年版)]。
Q3 Medicine Pub Date : 2026-03-23 DOI: 10.3760/cma.j.cn112152-20251012-00502

Breast cancer is the most common malignancy among women worldwide, with its incidence continuing to rise, posing a serious threat to women's health. In recent years, with the widespread adoption of molecular subtyping in diagnosis and treatment, breast cancer therapy has entered an era of individualized precision medicine. Early-stage breast cancer is primarily managed with surgery, combined with chemotherapy, radiotherapy, endocrine therapy, and targeted therapies (such as trastuzumab and pertuzumab), significantly improving cure rates. However, for recurrent or metastatic breast cancer, particularly refractory subtypes such as triple-negative and HER2-positive breast cancer, the efficacy of traditional treatments remains limited, and patients still face a poor prognosis. Antibody-drug conjugates (ADCs), as an innovative targeted therapy strategy, combine the precise targeting of monoclonal antibodies with the potent cytotoxicity of payload drugs, delivering cytotoxic agents directly to tumors through targeted chemotherapy, achieving "precision delivery and efficient killing". ADCs represent a relatively novel class of highly targeted anticancer biologics. In the field of breast cancer treatment, ADCs have made groundbreaking progress. Agents such as T-DM1 and T-DXd have significantly prolonged progression-free survival and overall survival in HER2-positive patients, providing critical treatment options for advanced-stage patients, markedly improving survival outcomes, and are now being explored in earlier lines of therapy, reshaping the treatment landscape of breast cancer. Although ADCs are generally well-tolerated, their unique structure-comprising antibodies, cytotoxic payloads, linkers, and conjugation processes-leads to distinct adverse effects and heterogeneous safety profiles within the class. Based on the latest research advances in ADC therapy for breast cancer and incorporating clinical experience from both domestic and international settings, the Breast Cancer Professional Committee of China Anti-Cancer Association, along with Breast Cancer Prevention and Treatment Research Professional Committee of Maternal and Child Health Research Society of China have jointly developed the "Guidelines for managing adverse reactions to antibody-drug conjugates in breast cancer (2025 edition)". This guideline aims to provide healthcare professionals with practical guidance on the early identification, regular assessment, timely management, and follow-up monitoring of ADC-related adverse reactions or events.

乳腺癌是全世界妇女中最常见的恶性肿瘤,其发病率持续上升,对妇女健康构成严重威胁。近年来,随着分子分型在诊断和治疗中的广泛采用,乳腺癌治疗进入了个体化精准医学时代。早期乳腺癌主要通过手术治疗,结合化疗、放疗、内分泌治疗和靶向治疗(如曲妥珠单抗和帕妥珠单抗),显著提高治愈率。然而,对于复发或转移性乳腺癌,特别是难治性亚型,如三阴性和her2阳性乳腺癌,传统治疗方法的疗效仍然有限,患者仍然面临预后不良的问题。抗体-药物偶联物(Antibody-drug conjugates, adc)作为一种创新的靶向治疗策略,将单克隆抗体的精确靶向与有效载荷药物的强大细胞毒性相结合,通过靶向化疗将细胞毒性药物直接递送至肿瘤,实现“精准递送、高效杀伤”。adc是一类相对新颖的高靶向抗癌生物制剂。在乳腺癌治疗领域,adc取得了突破性进展。T-DM1和T-DXd等药物显著延长了her2阳性患者的无进展生存期和总生存期,为晚期患者提供了关键的治疗选择,显著改善了生存结果,目前正在早期治疗中进行探索,重塑了乳腺癌的治疗格局。尽管adc通常具有良好的耐受性,但其独特的结构(包括抗体、细胞毒性有效载荷、连接物和偶联过程)导致了该类药物不同的副作用和不同的安全性。基于ADC治疗乳腺癌的最新研究进展,结合国内外临床经验,中国抗癌协会抗癌药物临床研究专业委员会联合制定了《乳腺癌抗体-药物偶联物不良反应管理指南(2025版)》。本指南旨在为医疗保健专业人员提供早期识别、定期评估、及时管理和后续监测adc相关不良反应或事件的实用指导。
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引用次数: 0
[Omics analysis of the regulatory role of APOBEC in the immune microenvironment of head and neck squamous cell carcinoma with different HPV status]. [组学分析APOBEC对不同HPV状态头颈部鳞状细胞癌免疫微环境的调节作用]。
Q3 Medicine Pub Date : 2026-03-23 DOI: 10.3760/cma.j.cn112152-20250930-00494
Y G Xu, D X Li, C Wu

Objective: To investigate the differences in apolipoprotein B mRNA editing enzyme, catalytic polypeptide-like (APOBEC) between human papillomavirus (HPV)-positive and HPV-negative head and neck squamous cell carcinoma (HNSCC) patients, analyze its association with the immune microenvironment and the cGAS-STING pathway, and evaluate its predictive value for immunotherapy efficacy. Methods: Whole-exome sequencing data from HNSCC patients (from September 2017 to March 2020 at the Third Affiliated Hospital of Kunming Medical University) were collected for somatic mutation profiling. APOBEC enrichment scores were calculated and integrated with differentially expressed genes (DEGs) to perform Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis and Gene Set Enrichment Analysis (GSEA). Single-cell RNA sequencing (scRNA-seq) data were utilized to validate the relationship between APOBEC3 expression, immune cell composition, and cGAS-STING module activity. Furthermore, an immunotherapy cohort was analyzed to evaluate the association of APOBEC3 family gene expression with immune checkpoint genes and therapeutic outcomes. Results: APOBEC mutational signatures were prevalent in both HPV-negative and HPV-positive HNSCC patients, but their driving patterns differed significantly: HPV-positive patients were dominated by APOBEC3A mutations, whereas the HPV-negative group exhibited a synergistic effect of multiple family members, including APOBEC3A/3B/3C/3D/3F. Pathway analysis indicated that in HPV-negative HNSCC, APOBEC activity was significantly associated with the enhancement of the cGAS-STING pathway, interferon response, and inflammatory response. Single-cell analysis confirmed that tumors with high APOBEC3 expression had richer immune cell infiltration, and the activities of four functional modules of the cGAS-STING pathway (cGAS-STING, NF-κB, interferon stimulation, and antigen presentation) were significantly upregulated. In the immunotherapy cohort, patients with high APOBEC3 expression exhibited higher expression of immune checkpoint molecules, and their treatment response rates were significantly superior to those in the low-expression group. Conclusions: APOBEC exhibits distinct driving mechanisms in HNSCC depending on HPV status. Its activity is closely related to cGAS-STING pathway activation, enhanced immune infiltration, and improved immunotherapy efficacy, suggesting potential predictive and therapeutic value.

目的:探讨载脂蛋白B mRNA编辑酶催化多肽样蛋白(APOBEC)在人乳头瘤病毒(HPV)阳性和HPV阴性头颈部鳞状细胞癌(HNSCC)患者中的差异,分析其与免疫微环境和cGAS-STING通路的相关性,并评价其对免疫治疗疗效的预测价值。方法:收集2017年9月至2020年3月昆明医科大学第三附属医院HNSCC患者的全外显子组测序数据,进行体细胞突变分析。计算APOBEC富集分数,并将其与差异表达基因(DEGs)整合,进行京都基因与基因组百科全书(KEGG)通路分析和基因集富集分析(GSEA)。利用单细胞RNA测序(scRNA-seq)数据验证APOBEC3表达、免疫细胞组成和cGAS-STING模块活性之间的关系。此外,还分析了免疫治疗队列,以评估APOBEC3家族基因表达与免疫检查点基因和治疗结果的关系。结果:APOBEC突变特征在hpv阴性和hpv阳性HNSCC患者中均普遍存在,但其驱动模式存在显著差异:hpv阳性患者以APOBEC3A突变为主,而hpv阴性组则表现为APOBEC3A/3B/3C/3D/3F等多个家族成员的协同作用。通路分析表明,在hpv阴性的HNSCC中,APOBEC活性与cGAS-STING通路、干扰素反应和炎症反应的增强显著相关。单细胞分析证实,APOBEC3高表达的肿瘤具有更丰富的免疫细胞浸润,cGAS-STING通路的四个功能模块(cGAS-STING、NF-κB、干扰素刺激和抗原提呈)活性显著上调。在免疫治疗队列中,APOBEC3高表达的患者免疫检查点分子表达更高,治疗有效率明显优于低表达组。结论:APOBEC在HNSCC中表现出不同的驱动机制,这取决于HPV状态。其活性与cGAS-STING通路激活、增强免疫浸润、提高免疫治疗效果密切相关,具有潜在的预测和治疗价值。
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引用次数: 0
[Expert Consensus on Multidisciplinary Diagnosis and Treatment of Small Cell Carcinoma of the Esophagus (2026 Edition)]. [食道小细胞癌多学科诊治专家共识(2026版)]。
Q3 Medicine Pub Date : 2026-03-12 DOI: 10.3760/cma.j.cn112152-20251114-00570

Small cell carcinoma of the esophagus (SCEC) is a rare and highly aggressive neuroendocrine tumor with poor prognosis. The clinical manifestations are lack of specificity, and the diagnosis depends on gastroscopic biopsy pathology and immunohistochemistry. Ultrasonic gastroscope+-, enhanced CT or PET-CT, and brain MRI are recommended for accurate staging. The combination of American Joint Committee on Cancer - Tumor, Node, Metastasis (AJCC-TNM) staging system and Veterans Administration Lung Study Group (VALSG) staging systems is recommended to guide the treatment. The treatment emphasizes the multidisciplinary comprehensive mode of chemotherapy, radiotherapy and surgery. For the patients with limited disease, chemotherapy combined with local treatment (surgery or radiotherapy) is recommended. For operable patients, radical chemoradiotherapy or perioperative treatment combined with surgery is recommended. The unresectable patients were treated with radical chemoradiotherapy. Patients with extensive stage were treated with systemic chemotherapy. Etoposide combined with platinum is the first choice for chemotherapy. If systemic treatment was effective, additional local treatment could be performed for residual lesions, and symptomatic metastatic lesions are recommended for palliative care. There is still a lack of high-level evidence-based medical evidence for immunotherapy, and relevant clinical trials are recommended. This consensus aims to promote the standardization of diagnosis and treatment of SCEC and improve the quality of life and long-term survival of patients through multidisciplinary collaboration.

摘要食道小细胞癌是一种罕见且高度侵袭性的神经内分泌肿瘤,预后较差。临床表现缺乏特异性,诊断依赖于胃镜活检病理和免疫组织化学。建议采用超声胃镜+-、增强CT或PET-CT、脑MRI进行准确分期。美国癌症-肿瘤,淋巴结,转移联合委员会(AJCC-TNM)分期系统和退伍军人管理局肺研究小组(VALSG)分期系统被推荐用于指导治疗。治疗强调化疗、放疗、手术多学科综合模式。对于病情有限的患者,建议化疗联合局部治疗(手术或放疗)。对于可手术的患者,建议采用根治性放化疗或围手术期联合治疗。不能切除的患者行根治性放化疗。广泛分期患者行全身化疗。依托泊苷联合铂是化疗的首选。如果全身治疗有效,可以对残余病变进行额外的局部治疗,并建议对有症状的转移性病灶进行姑息治疗。免疫疗法目前仍缺乏高水平的循证医学证据,建议进行相关的临床试验。该共识旨在通过多学科合作,促进SCEC诊断和治疗的标准化,提高患者的生活质量和长期生存。
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引用次数: 0
[Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China (2026 edition)]. 【中国化疗性中性粒细胞减少症临床诊断、治疗和预防共识(2026年版)】。
Q3 Medicine Pub Date : 2026-03-09 DOI: 10.3760/cma.j.cn112152-20251009-00497

Chemotherapy-induced neutropenia (CIN) is a common hematological adverse event and dose-limiting toxicity of chemotherapy. CIN may lead to dose reduction or delay of chemotherapeutic agents, febrile neutropenia (FN), and severe infections, which results in increased treatment costs, reduced chemotherapy efficacy, and even life-threatening complications. Therefore, standardized assessment of the risk of CIN in cancer patients, timely identification and intervention of FN, and appropriate prevention and treatment are essential to reduce CIN-related complications, improve patients' quality of life, and enhance chemotherapy outcomes. Based on the "Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China (2023 edition)", the Committee of Medical Oncology and the Committee of Neoplastic Supportive-care of China Anti-Cancer Association have thoroughly reviewed and summarized the latest evidence and clinical practices worldwide. This update puts forward 11 recommendations regarding the definition, grading, risk assessment, prevention, and treatment strategies for CIN, aiming to provide more timely and standardized guidance for Chinese oncologists in the diagnosis, treatment, and prevention of CIN.

化疗引起的中性粒细胞减少症(CIN)是一种常见的血液学不良事件和化疗的剂量限制性毒性。CIN可能导致化疗药物的剂量减少或延迟,发热性中性粒细胞减少(FN)和严重感染,从而导致治疗费用增加,化疗效果降低,甚至危及生命的并发症。因此,规范评估肿瘤患者发生CIN的风险,及时发现和干预FN,进行适当的预防和治疗,对于减少CIN相关并发症,改善患者生活质量,提高化疗效果至关重要。根据《中国化疗性中性粒细胞减少症临床诊断、治疗和预防共识(2023版)》,中国抗癌协会肿瘤医学专业委员会和肿瘤支持治疗专业委员会对全球最新的证据和临床实践进行了全面的回顾和总结。本次更新从CIN的定义、分级、风险评估、预防和治疗策略等方面提出了11条建议,旨在为中国肿瘤学家在CIN的诊断、治疗和预防方面提供更及时、规范的指导。
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引用次数: 0
[Expert consensus on adverse reaction management of PAM pathway inhibitors in breast cancer (2026 edition)]. 【PAM通路抑制剂治疗乳腺癌不良反应管理专家共识(2026版)】。
Q3 Medicine Pub Date : 2026-02-23 DOI: 10.3760/cma.j.cn112152-20251110-00558

The phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway (PAM pathway) is a crucial signaling network regulating cell proliferation, survival, and metabolism, which plays a central role in the pathogenesis and progression of breast cancer. Targeting the PAM pathway with inhibitors provides a novel precision therapeutic option for cancer patients. However, the broad suppression of physiological PAM pathway functions in normal tissues, combined with the distinct characteristics of their molecular targets, leads to both the uniqueness of adverse reactions associated with these agents and heterogeneity within their safety profiles. Given the complexity of the adverse reaction spectrum and the specialized management requirements for PAM pathway inhibitors, Cancer Drug Clinical Research Committee of China Anti-Cancer Association and Standard Construction Committee of China Anti-Cancer Association jointly convened a multidisciplinary expert panel to develop this consensus. This document systematically synthesizes epidemiological features, pathological mechanisms, and risk factors of PAM pathway inhibitor-associated adverse reactions. It provides clinicians with evidence-based guidance on standardized prevention strategies, early warning systems, assessment frameworks, intervention protocols, and long-term monitoring pathways. The ultimate goals are to maximize medication safety, optimize treatment adherence, and ultimately enhance antitumor efficacy and patient quality of life.

磷脂酰肌醇3-激酶(PI3K)/蛋白激酶B (Akt)/哺乳动物雷帕霉素靶蛋白(mTOR)信号通路(PAM)是调控细胞增殖、存活和代谢的重要信号网络,在乳腺癌的发病和进展中起核心作用。用抑制剂靶向PAM通路为癌症患者提供了一种新的精确治疗选择。然而,正常组织中生理PAM通路功能的广泛抑制,再加上其分子靶点的独特特征,导致这些药物相关不良反应的独特性和安全性的异质性。鉴于PAM通路抑制剂不良反应谱的复杂性和管理的专业性要求,中国抗癌协会肿瘤药物临床研究委员会和中国抗癌协会标准建设委员会联合召集多学科专家组,形成这一共识。本文系统地综合了PAM通路抑制剂相关不良反应的流行病学特点、病理机制及危险因素。它为临床医生提供关于标准化预防战略、早期预警系统、评估框架、干预方案和长期监测途径的循证指导。最终目标是最大限度地提高用药安全性,优化治疗依从性,最终提高抗肿瘤疗效和患者生活质量。
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引用次数: 0
[Expert consensus on the management practice of CD19 CAR-T cell therapy for B-cell lymphoma in China (2025 edition)]. 【中国CD19 CAR-T细胞治疗b细胞淋巴瘤管理实践专家共识(2025年版)】。
Q3 Medicine Pub Date : 2025-12-23 DOI: 10.3760/cma.j.cn112152-20250626-00296

In recent years, the incidence of B-cell non-Hodgkin lymphoma (B-NHL) in China has shown a steady increase, accounting for approximately 85%-90% of all lymphomas. Although standard immunochemotherapy regimens such as R-CHOP have led to long-term remission in some patients, approximately 30%-40% still experience relapse or refractory disease, with dismal prognosis and a median survival of less than one year. For patients who fail multiple lines of therapy, conventional options such as chemotherapy, radiotherapy, or hematopoietic stem cell transplantation offer limited benefits, highlighting an urgent need for innovative treatments. Chimeric antigen receptor T-cell (CAR-T) therapy, a breakthrough form of adoptive cellular immunotherapy, modifies autologous T cells to specifically recognize and eliminate malignant B cells, thereby achieving significant survival improvement in patients with relapse or refractory B-NHL. The clinical research and clinical application of CAR-T in the treatment of hematological tumors in China are in a state of rapid development. At present, there are two targeting CD19 CAR-T cells for the treatment of B-cell lymphoma, which gradually changed the diagnosis and treatment practice of lymphoma in China. At the same time, the clinic is actively exploring and improving the whole-process management experience of CAR-T therapy in lymphoma patients. So the Lymphoma Quality Control Expert Committee of the National Cancer Quality Control Center organized experts to form the consensus through discussion and revision many times, aiming to provide better guidance for clinicians to standardize the whole-process management of CAR-T cell therapy for B-cell Lymphoma, and further improve the survival benefits of patients.

近年来,b细胞非霍奇金淋巴瘤(B-NHL)在中国的发病率稳步上升,约占所有淋巴瘤的85%-90%。尽管标准的免疫化疗方案(如R-CHOP)已导致一些患者的长期缓解,但仍有大约30%-40%的患者复发或难治性疾病,预后不佳,中位生存期不到一年。对于多线治疗失败的患者,传统的选择,如化疗、放疗或造血干细胞移植提供有限的益处,突出了迫切需要创新的治疗方法。嵌合抗原受体T细胞(CAR-T)疗法是一种突破性的过继细胞免疫疗法,通过修饰自体T细胞特异性识别和消除恶性B细胞,从而显著提高复发或难治性B- nhl患者的生存率。CAR-T治疗血液学肿瘤的临床研究和临床应用在国内处于快速发展状态。目前有两种靶向CD19 CAR-T细胞治疗b细胞淋巴瘤,逐渐改变了国内淋巴瘤的诊疗实践。同时,诊所正在积极探索和完善CAR-T治疗淋巴瘤患者的全过程管理经验。为此,国家肿瘤质控中心淋巴瘤质控专家委员会组织专家经过多次讨论和修订形成共识,旨在更好地指导临床医生规范CAR-T细胞治疗b细胞淋巴瘤的全过程管理,进一步提高患者的生存效益。
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引用次数: 0
[Trend analysis and prediction of cancer incidence and mortality in the labor force population of Zhejiang Province cancer registry areas]. 浙江省癌症登记区劳动力人口癌症发病率和死亡率趋势分析与预测
Q3 Medicine Pub Date : 2025-12-23 DOI: 10.3760/cma.j.cn112152-20250630-00300
H T Zhu, H Hu, L Q Xu, L Y Ying, F Zhang, H Z Li
<p><p><b>Objective:</b> To analyze the incidence and mortality of malignant tumors among the labor force in cancer registration areas of Zhejiang Province in 2021, as well as the trend from 2000 to 2021, and predict the burden in 2031, in order to provide reference for precise prevention and control. <b>Methods:</b> The data of malignant tumors among the population aged 15-64 in Zhejiang cancer registration areas from 2000 to 2021 were collected. The incidence and mortality rates by gender, age group, urban-rural region, and major cancer types were analyzed. The age-standardized incidence (mortality) rates were calculated using the 2000 China standard population composition and Segi's world population composition, respectively. The Joinpoint regression model was used to estimate the temporal trends and to calculate the average annual percentage change (AAPC), and the auto-regressive integrated moving average model (ARIMA) was applied to predict the burden in 2031. <b>Results:</b> In 2021, 60 152 new cases of malignant tumors were reported among the labor force in the cancer registration areas of Zhejiang Province, accounting for 51.6% of all newly diagnosed malignant tumors across all age groups, while 10 285 deaths were recorded, representing 25.4% of the total. The age-standardized incidence rates of China was 283.4/10<sup>5</sup>, and the age-standardized mortality rates of China was 39.5/10<sup>5</sup>. The incidence rate in urban areas was higher than that in rural areas, while the mortality rate was lower in urban areas. The male-to-female ratio of the age-standardized incidence rate of world was 0.64:1, and the ratio of the age-standardized mortality rate of world was 1.76∶1. The top three cancers by incidence rate were thyroid cancer, lung cancer and breast cancer in females, while the top three by mortality rate were lung cancer, liver cancer and breast cancer in females. From 2000 to 2021, the incidence rate of malignant tumors in this population showed a significant upward trend (AAPC=3.61%, <i>P</i><0.001), particularly accelerating after 2013; while the mortality rate exhibited a general downward trend (AAPC=-1.60%, <i>P</i><0.001). The upward trends were most pronounced for thyroid cancer and prostate cancer in males, with AAPCs of 15.62% and 15.30%, respectively, while thyroid cancer in females showed the most significant growth, with an AAPC of 15.59% (all <i>P</i><0.05). Cancers with concurrent increases in both incidence and mortality included prostate cancer and colorectal cancer in males, and cervical cancer and lymphoma in females. ARIMA model projections indicated that by 2031, the age-standardized incidence rate of world would rise to 438/10<sup>5</sup>, while the mortality rate would decline to 39/10<sup>5</sup>. <b>Conclusions:</b> From 2000 to 2021, malignant tumors among the labor force in cancer registration areas of Zhejiang Province exhibits an upward trend in incidence and a downward trend in mortality. Efforts shou
目的:分析浙江省2021年肿瘤登记区劳动力恶性肿瘤的发病率和死亡率,以及2000 - 2021年的趋势,预测2031年的负担,为精准防控提供参考。方法:收集浙江省肿瘤登记区2000 - 2021年15-64岁恶性肿瘤病例资料。按性别、年龄组、城乡地区和主要癌症类型分析发病率和死亡率。年龄标准化发病率(死亡率)分别采用2000年中国标准人口构成和Segi世界人口构成计算。采用Joinpoint回归模型估算时间趋势,计算年平均变化百分比(AAPC),采用自回归综合移动平均模型(ARIMA)预测2031年的负担。结果:2021年浙江省肿瘤登记区劳动力中报告恶性肿瘤新发病例60 152例,占各年龄组恶性肿瘤新发病例总数的51.6%;死亡病例10 285例,占总死亡病例的25.4%。中国年龄标准化发病率为283.4/105,中国年龄标准化死亡率为39.5/105。城市地区的发病率高于农村地区,而城市地区的死亡率较低。世界年龄标准化发病率的男女比为0.64:1,世界年龄标准化死亡率的男女比为1.76∶1。女性发病率前三位的癌症分别是甲状腺癌、肺癌和乳腺癌,女性死亡率前三位的癌症分别是肺癌、肝癌和乳腺癌。2000 - 2021年,该人群恶性肿瘤发病率呈明显上升趋势(AAPC=3.61%, P<0.001), 2013年以后上升速度加快;死亡率总体呈下降趋势(AAPC=-1.60%, P<0.001)。男性甲状腺癌和前列腺癌的AAPC上升趋势最为明显,分别为15.62%和15.30%,女性甲状腺癌的AAPC增长最为显著,为15.59%(均P<0.05)。发病率和死亡率同时上升的癌症包括男性的前列腺癌和结直肠癌,以及女性的宫颈癌和淋巴瘤。ARIMA模型预测表明,到2031年,世界年龄标准化发病率将上升到438/105,而死亡率将下降到39/105。结论:2000 - 2021年,浙江省肿瘤登记区劳动力恶性肿瘤发病率呈上升趋势,死亡率呈下降趋势。应继续努力促进肿瘤的早期发现和治疗、疫苗接种、体重管理和健康的生活方式。
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引用次数: 0
[Expert consensus on clinical application of whole nutritional oncology foods for special medical purposes (2025 edition)]. 【特殊医疗用全营养肿瘤食品临床应用专家共识(2025年版)】。
Q3 Medicine Pub Date : 2025-12-23 DOI: 10.3760/cma.j.cn112152-20250529-00246

Malnutrition and metabolic disorders occur in a high proportion of oncology patients, and malnutrition has a significant impact on both treatment and prognosis, resulting in a heavy disease and economic burden. In recent years, as awareness of the nutritional status of oncology patients has improved, especially the multiple negative effects of malnutrition, it has highlighted the lack of clinical treatment and insufficient knowledge of adverse effects, leading to the lack of special medical use foods for oncology patients as well as irregularities in their use. In order to further promote the clinical and family standardised application of special medical purpose foods for oncology patients, the expert group collects and collates high-quality evidence in recent years, and discusses and summarises the opinions on clinical application, and consolidates the consensus "Expert consensus on clinical application of whole nutritional oncology foods for special medical purposes (2025 edition)", aiming to promote the standardisation of oncology nutritional treatment, meet the special nutritional needs of oncology patients, improve the clinical knowledge on the application of special medical purpose foods for oncology, and provide detailed and practical guidance on clinical operation.

肿瘤患者中营养不良和代谢紊乱的比例很高,营养不良对治疗和预后都有重大影响,造成了沉重的疾病和经济负担。近年来,随着人们对肿瘤患者营养状况认识的提高,尤其是营养不良的多重负面影响,凸显出临床治疗的缺失和不良反应认识的不足,导致肿瘤患者专用医疗食品缺乏,使用不规范。为进一步促进肿瘤患者特殊医疗目的食品的临床和家庭规范化应用,专家组收集整理近年来高质量证据,讨论总结临床应用意见,巩固共识《肿瘤全营养特殊医疗目的食品临床应用专家共识(2025版)》。旨在促进肿瘤营养治疗的规范化,满足肿瘤患者的特殊营养需求,提高肿瘤专用医疗食品应用的临床知识,为临床操作提供详细、实用的指导。
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引用次数: 0
[Expert consensus on amivantamab clinical application and adverse reaction management (2025 edition)]. 【阿米万他单抗临床应用及不良反应管理专家共识(2025年版)】。
Q3 Medicine Pub Date : 2025-12-23 DOI: 10.3760/cma.j.cn112152-20250718-00348

Amivantamab is the first fully humanized bispecific antibody approved for the treatment of non-small cell lung cancer (NSCLC) in the world. Amivantamab can block epidermal growth factor receptor (EGFR) pathway and mesenchymal-epithelial transformation factor (MET) pathway simultaneously, trigger the internalization and degradation of EGFR and MET, and activate the antitumor immune response. Amivantamab has been approved by the National Medical Products Administration for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation, EGFR exon 19 deletion or exon 21 L858R substitution mutation, and is expected to be widely used in clinical practice soon. How to reasonably manage the adverse reactions related to amivantamab and maximize its efficacy is an urgent problem to be solved. Based on the existing medical evidence, combined with clinical experience, the expert group of this consensus finally formulated this "Expert consensus on amivantamab clinical application and adverse reaction management (2025 edition)" after multiple discussions. The contents of the consensus include the clinical use and management of adverse reactions of amivantamab. The recommendations focus on the prevention of infusion-related reactions, skin adverse reactions, venous thromboembolism, peripheral edema, oral mucositis, ocular toxicity and interstitial lung disease, amivantamab dose adjustment and treatment when adverse events occur, in order to provide guidance for clinicians to correctly use amivantamab and manage related adverse reactions.

Amivantamab是世界上第一个被批准用于治疗非小细胞肺癌(NSCLC)的完全人源化双特异性抗体。阿米万他单抗可同时阻断表皮生长因子受体(EGFR)通路和间充质上皮转化因子(MET)通路,触发EGFR和MET的内化和降解,激活抗肿瘤免疫应答。Amivantamab已获国家药品监督管理局批准用于治疗EGFR外显子20插入突变、EGFR外显子19缺失或外显子21 L858R替代突变的局部晚期或转移性NSCLC成年患者,有望很快广泛应用于临床。如何合理管理阿米万他单抗的不良反应,使其疗效最大化,是一个亟待解决的问题。本共识专家组在现有医学证据的基础上,结合临床经验,经过多次讨论,最终制定了本《阿米伐他单抗临床应用及不良反应管理专家共识(2025版)》。共识内容包括阿米万他单抗的临床应用及不良反应处理。建议重点关注输液相关反应、皮肤不良反应、静脉血栓栓塞、外周水肿、口腔黏膜炎、眼毒性和间质性肺疾病的预防、不良事件发生时阿米伐他单的剂量调整和处理,为临床医生正确使用阿米伐他单和管理相关不良反应提供指导。
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引用次数: 0
[Research on postoperative survival prediction model of intrahepatic cholangiocarcinoma guided by lymph node metastasis rate]. [以淋巴结转移率为指导的肝内胆管癌术后生存预测模型研究]。
Q3 Medicine Pub Date : 2025-12-23 DOI: 10.3760/cma.j.cn112152-20241107-00483
Y J Liu, X Li, X X Zhang, Q J Li

Objective: To analyze the predictive model of lymph node metastasis rate (LNR) in patients with intrahepatic cholangiocarcinoma and its relationship with prognosis. Methods: This study included clinical characteristics and prognostic information of 172 patients with intrahepatic cholangiocarcinoma. Receiver operating characteristic (ROC) curves were used to calculate the optimal cutoff values for groups. Kaplan Meier survival curves were plotted using R language, and critical factors affecting prognosis were determined by Cox regression analysis. A prognostic prediction model was constructed and visualized using nomogram, and this model was validated using the SEER database. Results: Through ROC curve analysis, with 3-year overall survival (OS) as the benchmark, an LNR of 0.15 was identified as the optimal cutoff value for predicting the prognosis of intrahepatic cholangiocarcinoma patients, with an area under the curve of 0.764 (95% CI: 0.690, 0.838). Patients were divided into a low LNR group (LNR<0.15, n=97) and a high LNR group (LNR≥0.15, n=75) based on the LNR value. Statistically significant differences were observed between the two groups in terms of carbohydrate antigen 19-9, tumor size, lymph node metastasis, tumor number, and stage (all P<0.05). The median survival time of the high LNR group was 20 months (95% CI: 13-23), significantly shorter than that of the low LNR group, which was 36 months (95% CI: 21-43) (P<0.001). Multivariate analysis revealed that a high LNR value (HR=0.55, 95% CI: 0.32-0.95, P=0.033), age>60 years (HR=0.53, 95% CI: 0.35-0.81, P=0.004), and tumor diameter>5.5 cm (HR=0.62, 95% CI: 0.41-0.93, P=0.022) were independent factors affecting OS. A prognostic prediction model was established based on these independent factors, and the predicted 1-year, 2-year, and 3-year survival rates were close to the actual observed values. Validation using the SEER database also demonstrated the high predictive accuracy of this model. Conclusion: The clinical prognostic model based on lymph node metastasis rate can effectively predict the postoperative survival of patients with intrahepatic cholangiocarcinoma and provide important basis for clinical decision.

目的:分析肝内胆管癌患者淋巴结转移率(LNR)的预测模型及其与预后的关系。方法:收集172例肝内胆管癌患者的临床特点及预后资料。采用受试者工作特征(ROC)曲线计算各组最佳截止值。采用R语言绘制Kaplan Meier生存曲线,Cox回归分析确定影响预后的关键因素。建立了预后预测模型,并采用nomogram可视化方法对模型进行了可视化,并利用SEER数据库对模型进行了验证。结果:通过ROC曲线分析,以3年总生存期(OS)为基准,确定LNR为0.15为预测肝内胆管癌患者预后的最佳截断值,曲线下面积为0.764 (95% CI: 0.690, 0.838)。根据LNR值将患者分为低LNR组(LNR<0.15, n=97)和高LNR组(LNR≥0.15,n=75)。两组患者碳水化合物抗原19-9、肿瘤大小、淋巴结转移、肿瘤数量、分期差异均有统计学意义(P<0.05)。高LNR组的中位生存时间为20个月(95% CI: 13-23),显著短于低LNR组的中位生存时间36个月(95% CI: 21-43) (P<0.001)。多因素分析显示,高LNR值(HR=0.55, 95% CI: 0.32 ~ 0.95, P=0.033)、年龄> ~ 60岁(HR=0.53, 95% CI: 0.35 ~ 0.81, P=0.004)、肿瘤直径> ~ 5.5 cm (HR=0.62, 95% CI: 0.41 ~ 0.93, P=0.022)是影响OS的独立因素。基于这些独立因素建立预后预测模型,预测的1年、2年、3年生存率与实际观察值接近。使用SEER数据库的验证也证明了该模型具有较高的预测精度。结论:基于淋巴结转移率的临床预后模型可有效预测肝内胆管癌患者的术后生存,为临床决策提供重要依据。
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中华肿瘤杂志
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