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Evidence-based expert consensus on clinical management of safety of Bruton’s tyrosine kinase inhibitors(2024)

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chinese journal of Cancer Research 2024年第3期36卷 240-256页

作者： Zaiwei Song Dan Jiang Lingling Yu Yixuan Chen Daobin Zhou Yue Li Depei Wu Lingli Zhang Liyan Miao Jun Ma Jun Zhu Hongmei Jing Rongsheng Zhao the Steering Committee,the Consensus Panel and the Evidence Synthesis Group Evidence-based Pharmacy Professional Committee of chinese Pharmaceutical Association(CPA) Hospital Pharmacy Professional Committee of chinese Pharmaceutical Association(CPA) Division of Therapeutic Drug Monitoring of chinese Pharmacological Society(CPS) Expert Committee on Lymphoma of chinese Society of clinical oncology(CSCO) Expert Committee on Leukemia of chinese Society of clinical oncology(CSCO) Society of Integrative Cardio-oncology of China Anti-Cancer Association(CACA) chinese Society of Hematology of chinese Medical Association(CMA) Hospital Pharmacy Professional Committee of Cross-Straits Medicine Exchange Association(SMEA) Department of Pharmacy Peking University Third HospitalBeijing 100191China Institute for Drug Evaluation Peking University Health Science CenterBeijing 100191China Therapeutic Drug Monitoring and clinical Toxicology Center Peking UniversityBeijing 100191China Department of Pharmacy Administration and clinical Pharmacy School of Pharmaceutical SciencesPeking UniversityBeijing 100191China Department of Hematology Peking Union Medical College HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100005China Department of Cardiology the First Affiliated HospitalHarbin Medical UniversityHarbin 150001China Department of Hematology the First Affiliated Hospital of Soochow UniversitySuzhou 215006China Department of Pharmacy Evidence-based Pharmacy CenterWest China Second HospitalSichuan UniversityChengdu 610041China Department of Pharmacy the First Affiliated Hospital of Soochow UniversitySuzhou 215006China Department of Hematology and oncology Harbin Institute of Hematology and OncologyHarbin 150010China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of LymphomaPeking University Cancer Hospital&InstituteBeijing 100142China Department of Hematology Peking University Third HospitalBeijing 100191China 不详

Bruton’s tyrosine kinase inhibitors(BTKis)have revolutionized the treatment of B-cell ***,safety issues related to the use of BTKis may hinder treatment continuity and further affect clinical efficacy.A comprehensive and systematic expert consensus from a pharmacological perspective is lacking for safety issues associated with BTKi treatment.A multidisciplinary consensus working group was established,comprising 35 members from the fields of hematology,cardiovascular disease,cardio-oncology,clinical pharmacy,and evidencebased *** evidence-based expert consensus was formulated using an evidence-based approach and the Delphi *** Joanna Briggs Institute Critical Appraisal(JBI)tool and Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach were used to rate the quality of evidence and grade the strength of recommendations,*** consensus provides practical recommendations for BTKis medication based on nine aspects within three domains,including the management of common adverse drug events such as bleeding,cardiovascular events,and hematological toxicity,as well as the management of drug-drug interactions and guidance for special *** multidisciplinary expert consensus could contribute to promoting a multi-dimensional,comprehensive and standardized management of BTKis.

关键词： Consensus BTK inhibitors safety adverse drug events drug-drug interactions

chinese national clinical practice guideline on diagnosis and treatment of biliary tract cancers

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中华医学杂志(英文版) 2024年第19期137卷 2024 Sep 4页

作者： Wang Xu’an Bai Yongrui Chai Ningli Li Yexiong Linghu Enqiang Wang Liwei Liu Yingbin Society of Hepato-pancreatobiliary Surgery of chinese Research Hospital Association Society of Digestive Endoscopy of the chinese Medical Association chinese Medical journal clinical Practice Guideline Collaborative Department of Biliary and Pancreatic Surgery Renji Hospital Shanghai Jiao Tong University School of Medicine State Key Laboratory of Systems Medicine for Cancers Shanghai Cancer Institute Shanghai Key Laboratory for Cancer Systems Regulation and clinical Translation Shanghai China Department of Radiation oncology Renji Hospital School of Medicine Shanghai Jiao Tong University Shanghai China Department of Gastroenterology and Hepatology the First Medical Center Chinese People’s Liberation Army General Hospital Beijing China State Key Laboratory of Molecular oncology and Department of Radiation oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Beijing China State Key Laboratory of Oncogenes and Related Genes Shanghai Cancer Institute Department of oncology Renji Hospital School of Medicine Shanghai Jiao Tong University Shanghai China

Background: Biliary tract carcinoma (BTC) is relatively rare and comprises a spectrum of invasive tumors arising from the biliary tree. The prognosis is extremely poor. The incidence of BTC is relatively high in Asian countries, and a high number of cases are diagnosed annually in China owing to the large population. Therefore, it is necessary to clarify the epidemiology and high-risk factors for BTC in China. The signs associated with BTC are complex, often require collaborative treatment from surgeons, endoscopists, oncologists, and radiation therapists. Thus, it is necessary to develop a comprehensive chinese guideline for ***: This clinical practice guideline (CPG) was developed following the process recommended by the World Health Organization. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to assess the certainty of evidence and make recommendations. The full CPG report was reviewed by external guideline methodologists and clinicians with no direct involvement in the development of this CPG. Two guideline reporting checklists have been adhered to: Appraisal of Guidelines for Research and Evaluation (AGREE) and Reporting Items for practice Guidelines in Healthcare (RIGHT).Results: The guideline development group, which comprised 85 multidisciplinary clinical experts across China. After a controversies conference, 17 clinical questions concerning the prevention, diagnosis, and treatment of BTC were proposed. Additionally, detailed descriptions of the surgical principles, perioperative management, chemotherapy, immunotherapy, targeted therapy, radiotherapy, and endoscopic management were ***: The guideline development group created a comprehensive chinese guideline for the diagnosis and treatment of BTC, covering various aspects of epidemiology, diagnosis, and treatment. The 17 clinical questions have important reference value for the management of BTC.

关键词： Biliary tract carcinoma Etiology Diagnosis Treatment Surgery

BRAF抑制剂治疗恶性实体肿瘤专家共识(2024版)

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中华肿瘤杂志 2024年第10期46卷 919-929页

作者：中华医学会肿瘤学分会中国临床肿瘤学会罕见肿瘤委员会林桐榆焦顺昌不详电子科技大学附属肿瘤医院肿瘤内科、四川省肿瘤医院研究所、四川省癌症中心成都610041 中山大学肿瘤防治中心肿瘤内科广州510060 解放军总医院第一医学中心肿瘤内科北京100039

全球老龄化的背景下恶性肿瘤发病率不断提高,加剧了全球恶性肿瘤的疾病负担,预计2040年全球恶性肿瘤新发病例数将达2800万例。随着肿瘤分子生物学研究进展和二代测序技术的广泛应用,肿瘤精准治疗在临床上已取得了显著的进步。靶向BRAF... 详细信息

全球老龄化的背景下恶性肿瘤发病率不断提高,加剧了全球恶性肿瘤的疾病负担,预计2040年全球恶性肿瘤新发病例数将达2800万例。随着肿瘤分子生物学研究进展和二代测序技术的广泛应用,肿瘤精准治疗在临床上已取得了显著的进步。靶向BRAF治疗是肿瘤精准医疗成功的案例之一,BRAF基因突变可导致丝裂原活化蛋白激酶信号通路下游激酶的无限制激活,促进肿瘤细胞快速增殖。BRAF抑制剂单药或联合应用已在黑色素瘤、非小细胞肺癌、甲状腺癌、结直肠癌及脑胶质瘤等多个癌种中获批适应证,相关临床研究亦在不断探索中,但是国内尚无汇总BRAF抑制剂在恶性实体肿瘤中应用的共识。文章整合BRAF抑制剂在恶性实体肿瘤领域的临床证据,制定了BRAF抑制剂治疗恶性实体肿瘤专家共识以推进并指导BRAF抑制剂在恶性实体肿瘤领域的规范应用。

关键词：恶性肿瘤精准治疗 BRAF 不良反应

抗体药物偶联物治疗血液系统恶性肿瘤临床应用指导原则(2023年版)

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白血病．淋巴瘤 2024年第1期33卷 12-19页

作者：中国临床肿瘤学会(CSCO)淋巴瘤专家委员会中国临床肿瘤学会(CSCO)白血病专家委员会马军不详哈尔滨血液病肿瘤研究所哈尔滨150010

小分子靶向药物、单克隆抗体、抗体药物偶联物(ADC)、双特异性抗体、嵌合抗原受体T细胞等药物改善了血液系统肿瘤患者的预后。ADC将单克隆抗体的高特异性靶向能力和细胞毒活性小分子的高效杀伤作用相结合,实现了对肿瘤细胞的精准高效清... 详细信息

小分子靶向药物、单克隆抗体、抗体药物偶联物(ADC)、双特异性抗体、嵌合抗原受体T细胞等药物改善了血液系统肿瘤患者的预后。ADC将单克隆抗体的高特异性靶向能力和细胞毒活性小分子的高效杀伤作用相结合,实现了对肿瘤细胞的精准高效清除。目前全球范围内已有多款ADC药物获批用于治疗血液系统肿瘤,然而目前ADC药物在国内尚未普及应用,关于ADC药物在血液系统恶性肿瘤领域的应用与管理,临床医生亟需切实有效的建议和参考。现基于国内外指南共识及权威文献,结合国内该领域相关专家临床诊疗经验制定本指导原则,供临床医生和专业诊疗机构参考。

关键词：血液肿瘤白血病淋巴瘤多发性骨髓瘤抗体药物偶联物

埃普奈明治疗复发难治多发性骨髓瘤临床应用指导原则(2024年版)

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白血病．淋巴瘤 2024年第2期33卷 74-81页

作者：中国临床肿瘤学会(CSCO)白血病专家委员会中国临床肿瘤学会(CSCO)淋巴瘤专家委员会中国临床肿瘤学会(CSCO)骨髓瘤筹备委员会马军陈文明不详哈尔滨血液病肿瘤研究所哈尔滨150010 首都医科大学附属北京朝阳医院血液科北京100020

埃普奈明是重组环化变构的人肿瘤坏死因子相关凋亡诱导配体,通过激活死亡受体4/死亡受体5(DR4/DR5)诱导不依赖p53的细胞凋亡,是全球首个获批上市的DR4/DR5激动剂,用于治疗复发难治多发性骨髓瘤(RRMM)。RRMM患者接受埃普奈明单药或联合... 详细信息

埃普奈明是重组环化变构的人肿瘤坏死因子相关凋亡诱导配体,通过激活死亡受体4/死亡受体5(DR4/DR5)诱导不依赖p53的细胞凋亡,是全球首个获批上市的DR4/DR5激动剂,用于治疗复发难治多发性骨髓瘤(RRMM)。RRMM患者接受埃普奈明单药或联合用药治疗具有较好的疗效及安全性。鉴于目前我国临床医生缺乏对该药的临床应用经验,中国临床肿瘤学会(CSCO)组织国内专家制定了埃普奈明在RRMM中的临床应用指导原则,旨在为临床医生提供参考。

关键词：多发性骨髓瘤埃普奈明肿瘤坏死因子相关凋亡诱导配体死亡受体4 死亡受体5

RAS野生型转移性结直肠癌抗表皮生长因子受体单抗维持治疗中国专家共识(2024版)

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中华胃肠外科杂志 2024年第4期27卷 316-325页

作者：中国临床肿瘤学会结直肠癌专家委员会徐瑞华张东生不详中山大学肿瘤防治中心

对于接受标准一线治疗达到疾病控制的转移性结直肠癌(mCRC),后续治疗策略的制订应在维持疗效的同时注重改善患者生活质量。化疗联合抗表皮生长因子受体(EGFR)单抗是RAS野生型mCRC患者的标准一线治疗方案。当一线含抗EGFR单抗诱导治疗达... 详细信息

对于接受标准一线治疗达到疾病控制的转移性结直肠癌(mCRC),后续治疗策略的制订应在维持疗效的同时注重改善患者生活质量。化疗联合抗表皮生长因子受体(EGFR)单抗是RAS野生型mCRC患者的标准一线治疗方案。当一线含抗EGFR单抗诱导治疗达到最佳疗效、且处于疾病缓解或稳定状态时,含抗EGFR单抗维持治疗方案可在维持疗效获益的同时,降低毒副反应和提高患者生活质量。本共识基于循证医学和临床实践,进一步明确抗EGFR单抗维持治疗的应用时机、方案选择、不良反应管理和后续策略选择,为抗EGFR单抗维持治疗提供临床应用规范化标准和指导,以期使患者的治疗最大化获益。

关键词：结直肠肿瘤,转移性 RAS野生型抗EGFR单抗维持治疗

格菲妥单抗治疗弥漫大B细胞淋巴瘤临床用药指导原则(2024年版)

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白血病．淋巴瘤 2024年第5期33卷 257-264页

作者：中国临床肿瘤学会(CSCO)淋巴瘤专家委员会马军不详哈尔滨血液病肿瘤研究所哈尔滨150010

格菲妥单抗是一种2∶1结构、靶向CD20×CD3的新型双特异性抗体,单药或联合其他药物治疗复发或难治弥漫大B细胞淋巴瘤(DLBCL)可获得持续的缓解,并降低疾病进展或死亡风险,患者显著获益。格菲妥单抗是首个在全球范围内被批准用于DLBCL的... 详细信息

格菲妥单抗是一种2∶1结构、靶向CD20×CD3的新型双特异性抗体,单药或联合其他药物治疗复发或难治弥漫大B细胞淋巴瘤(DLBCL)可获得持续的缓解,并降低疾病进展或死亡风险,患者显著获益。格菲妥单抗是首个在全球范围内被批准用于DLBCL的双特异性抗体,在我国也新近获批用于治疗既往接受过至少二线系统性治疗的复发或难治DLBCL。专家组结合国内外相关研究和临床实践,制定了格菲妥单抗治疗DLBCL的临床用药指导原则,旨在为我国临床医师规范、合理用药提供参考。

关键词：淋巴瘤,大B细胞,弥漫性格菲妥单抗双特异性抗体

EGFR20外显子插入突变非小细胞肺癌规范化诊疗中国专家共识(2024版)

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中国肺癌杂志 2024年第7期27卷 485-494页

作者：中国临床肿瘤学会非小细胞肺癌专家委员会周彩存不详

表皮生长因子受体(epidermal growth factor receptor,EGFR)20外显子插入(exon 20 insertion,ex20ins)突变非小细胞肺癌(non-small cell lung cancer,NSCLC)的规范化诊疗在《EGFR 20外显子插入突变非小细胞肺癌规范化诊疗中国专家共识(2023版)》中进行了阐述,提高了临床医生对该罕见靶点的关注。随着疾病领域探索的深入及新型靶向药物的获批,EGFR ex20ins NSCLC的诊疗策略也随之更新。本共识在2023版中国专家共识的基础上进行更新,专家组通过参考国内外文献及临床数据并结合专家自身临床经验,分别从疾病认知、疾病检测、疾病治疗和新型靶向药物研发现状等方面更新共识性建议,以期更好地为临床医师提供用药参考。

关键词：肺肿瘤 EGFR20外显子插入突变规范化诊疗共识

常见原发性皮肤T细胞淋巴瘤诊疗中国专家共识(2024年版)

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白血病．淋巴瘤 2024年第6期33卷 321-328页

作者：中国临床肿瘤学会(CSCO)淋巴瘤专家委员会马军朱军赵东陆不详哈尔滨血液病肿瘤研究所哈尔滨150010 北京大学肿瘤医院哈尔滨血液病肿瘤研究所

原发性皮肤T细胞淋巴瘤(PCTCL)是一组原发于皮肤的罕见非霍奇金淋巴瘤, 最常见亚型为蕈样肉芽肿, 其次为原发性皮肤CD30阳性T细胞淋巴组织增生性疾病。虽然2022年第5版世界卫生组织造血淋巴肿瘤分类已将Sézary综合征从PCTCL中划除, 但... 详细信息

原发性皮肤T细胞淋巴瘤(PCTCL)是一组原发于皮肤的罕见非霍奇金淋巴瘤, 最常见亚型为蕈样肉芽肿, 其次为原发性皮肤CD30阳性T细胞淋巴组织增生性疾病。虽然2022年第5版世界卫生组织造血淋巴肿瘤分类已将Sézary综合征从PCTCL中划除, 但基于其与蕈样肉芽肿的密切相关性, 依然有必要一起讨论。PCTCL的早期确诊和及时治疗十分重要, 专家组成员结合PCTCL的诊治现状及国内外相关研究数据, 制定了该共识, 旨在为临床医生提供参考。

关键词：淋巴瘤 T细胞皮肤蕈样肉芽肿淋巴瘤原发性皮肤间变性大细胞 Sézary综合征淋巴瘤样丘疹病