Systemic therapy

全身治疗
  • 文章类型: Journal Article
    背景:局部晚期(不可切除)或转移性去分化脂肪肉瘤(DDLPS)是脂肪肉瘤的常见表现。尽管建立了DDLPS的诊断和治疗指南,关键的临床差距仍然由诊断挑战驱动,症状负担和缺乏针对性,安全有效的治疗方法。这项研究的目的是收集欧洲和美国对管理的专家意见,该疾病的临床试验设计以及无进展生存期(PFS)的价值未满足的需求和期望。其他目标包括提高认识和教育整个医疗保健系统的关键利益相关者。
    方法:招募了一个由12名肉瘤关键意见领袖(KOL)组成的国际小组。该研究包括两轮带有预定义陈述的调查。专家以9分的李克特量表对每个陈述进行评分。共识被定义为≥75%的专家对陈述评分≥7。在协商一致会议上讨论了订正声明。
    结果:关于疾病负担的55项预定义陈述中的43项达成了共识,治疗范式,未满足的需求,PFS的价值及其与总生存期(OS)的关系,和交叉试验设计。12个语句被取消优先级或与其他语句合并。没有专家不同意的陈述。
    结论:本研究构成了第一个关于DDLPS的国际Delphi小组。它旨在探索KOL对DDLPS中疾病负担和未满足需求的看法,PFS的值,以及它潜在的转化为操作系统的好处,以及DDLPS治疗交叉试验设计的相关性。结果表明,欧洲和美国在DDLPS管理方面保持一致,未满足的需求,和对临床试验的期望。提高对与DDLPS相关的关键临床差距的认识可以有助于改善患者预后并支持创新治疗方法的开发。
    BACKGROUND: Locally advanced (unresectable) or metastatic dedifferentiated liposarcoma (DDLPS) is a common presentation of liposarcoma. Despite established diagnostic and treatment guidelines for DDLPS, critical clinical gaps remain driven by diagnostic challenges, symptom burden and the lack of targeted, safe and effective treatments. The objective of this study was to gather expert opinions from Europe and the United States on the management, unmet needs and expectations for clinical trial design as well as the value of progression-free survival (PFS) in this disease. Other aims included raising awareness and educate key stakeholders across healthcare systems.
    METHODS: An international panel of 12 sarcoma key opinion leaders (KOLs) was recruited. The study consisted of two rounds of surveys with pre-defined statements. Experts scored each statement on a 9-point Likert scale. Consensus agreement was defined as ≥75% of experts scoring a statement with ≥7. Revised statements were discussed in a consensus meeting.
    RESULTS: Consensus was reached on 43 of 55 pre-defined statements across disease burden, treatment paradigm, unmet needs, value of PFS and its association with overall survival (OS), and cross-over trial design. Twelve statements were deprioritised or merged with other statements. There were no statements where experts disagreed.
    CONCLUSIONS: This study constitutes the first international Delphi panel on DDLPS. It aimed to explore KOL perception of the disease burden and unmet need in DDLPS, the value of PFS, and its potential translation to OS benefit, as well as the relevance of a cross-over trial design for DDLPS therapies. Results indicate an alignment across Europe and the United States regarding DDLPS management, unmet needs, and expectations for clinical trials. Raising awareness of critical clinical gaps in relation to DDLPS can contribute to improving patient outcomes and supporting the development of innovative treatments.
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  • 文章类型: Journal Article
    脑膜转移越来越被认为是可治疗的,但通常无法治愈,晚期癌症的并发症。由于现代癌症疗法延长了转移性癌症患者的生命,特别是在脑实质转移患者中,实体瘤软脑膜转移患者的治疗选择和临床研究方案也得到了类似的发展,以提高特定人群的生存率。最近临床研究的扩展,早期诊断,和药物开发引发了新的悬而未决的问题。这些包括软脑膜转移生物学和首选的动物模型,现代癌症人群的流行病学,确保新的软脑膜转移诊断的验证和可及性,多模式治疗方案的最佳临床实践,临床试验设计和反应评估标准化,以及值得进一步研究的途径。一个由多学科专家组成的国际小组,研究和管理软脑膜转移,由神经肿瘤学会和美国临床肿瘤学会支持,他们聚集在一起,就这些紧迫的话题达成共识,并为未来的方向提供路线图。我们希望这些建议将加速软脑膜转移领域的合作和进展,并作为进一步讨论和患者倡导的平台。
    Leptomeningeal metastases are increasingly becoming recognized as a treatable, yet generally incurable, complication of advanced cancer. As modern cancer therapeutics have prolonged the lives of patients with metastatic cancer, specifically in patients with parenchymal brain metastases, treatment options and clinical research protocols for patients with leptomeningeal metastases from solid tumors have similarly evolved to improve survival within specific populations. Recent expansion in clinical investigation, early diagnosis, and drug development have given rise to new unanswered questions. These include leptomeningeal metastasis biology and preferred animal modeling, epidemiology in the modern cancer population, ensuring validation and accessibility of newer leptomeningeal metastasis diagnostics, best clinical practices with multi-modality treatment options, clinical trial design and standardization of response assessments, and avenues worthy of further research. An international group of multi-disciplinary experts in the research and management of leptomeningeal metastases, supported by the Society for Neuro-Oncology and American Society of Clinical Oncology, were assembled to reach a consensus opinion on these pressing topics and provide a roadmap for future directions. Our hope is that these recommendations will accelerate collaboration and progress in the field of leptomeningeal metastases and serve as a platform for further discussion and patient advocacy.
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  • 文章类型: Journal Article
    “晚期乳腺癌国际共识会议”(ABC)的基本原理是使用循证方法将全球晚期或转移性乳腺癌患者的治疗标准化。目的还在于确保所有国家的患者根据当前的治疗建议和标准接受适当的治疗。第七届晚期乳腺癌国际共识会议(ABC7)于2023年11月9日至12日在葡萄牙里斯本举行。ABC7专注于转移性疾病以及局部晚期和炎性乳腺癌。专题包括治疗寡转移患者,软脑膜疾病,脑转移的治疗,和孕妇ABC。和往年一样,来自世界各地的患者倡导者参加了共识会议,并参与了决策。
    The rationale behind the \"International Consensus Conference for Advanced Breast Cancer\" (ABC) is to standardize the treatment of patients with advanced or metastatic breast cancer worldwide using an evidence-based approach. The aim is also to ensure that patients in all countries receive adequate treatment based on current treatment recommendations and standards. The 7th International Consensus Conference on Advanced Breast Cancer (ABC7) took place from November 9 to 12, 2023 in Lisbon/Portugal. ABC7 focused on metastatic disease as well as on locally advanced and inflammatory breast cancer. Special topics included the treatment of oligometastatic patients, leptomeningeal disease, treatment of brain metastases, and pregnant women with ABC. As in previous years, patient advocates from all over the world participated in the consensus conference and were involved in decision making.
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  • 文章类型: Journal Article
    美国皮肤病学会于2014年首次发布了一系列诊断和治疗特应性皮炎的指南。选择了12名临床医生进行审查,grade,并提供有关临床特征的可用数据的临床见解,症状学,病理生理学,教育,治疗,以及特应性皮炎(AD)的新兴临床研究。基于这些发现,AAD发布了一份指南,为医生简化特应性皮炎的信息,建议使用临床证据进行诊断,并首先用非药物疗法治疗以恢复天然皮肤屏障。建议采用局部药物治疗以改善瘙痒和炎症,并在临床相关的中度至重度病例中使用较新的全身性药物。与缺乏治疗数据的实践相比,强调了循证实践。为了突出特应性皮炎的新证据和药理学突破,AAD制定了一套更新的指南,对医生进行新药及其在治疗中的作用的教育.本章回顾了AAD指南作为管理特应性皮炎和保持最新疾病进展的工具。
    The American Academy of Dermatology first published a series of guidelines for diagnosing and managing atopic dermatitis in 2014. Twelve clinicians were selected to review, grade, and offer clinical insight on available data regarding the clinical features, symptomology, pathophysiology, education, treatment, and emerging clinical studies on atopic dermatitis (AD). Based on these findings, the AAD released a guideline to streamline information on atopic dermatitis for physicians, recommending using clinical evidence to diagnose and first treating with nonpharmacologic therapies to restore the natural skin barrier. Topical pharmacologic therapies were recommended for improving pruritus and inflammation and newer systemic agents for clinically relevant moderate-to-severe cases. Evidence-based practices were emphasized in comparison to those that lacked therapeutic data. To highlight the emerging evidence and pharmacologic breakthroughs in atopic dermatitis, the AAD produced an updated set of guidelines educating physicians on new agents and their role in treatment. This chapter reviews the AAD guidelines as a tool for managing atopic dermatitis and staying up to date on disease advancements.
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  • 文章类型: Journal Article
    “晚期乳腺癌国际共识会议”是在10多年前发起的。其理由是根据现有证据标准化晚期乳腺癌(ABC)的治疗,并确保全球所有ABC患者都能接受适当的治疗并获得新疗法。
    美国广播公司(ABC7)第七届国际共识会议于2023年11月9日至11日举行-与往年一样在里斯本/葡萄牙举行。ABC7不仅关注转移性疾病,还关注局部晚期和炎性乳腺癌。专题是寡转移疾病的管理,软脑膜疾病,脑转移瘤,和孕妇ABC。由于目前全球的形势,生活在冲突地区的病人特别感兴趣。和往年一样,来自世界各地的患者倡导者被纳入了ABC会议,并对共识提出了重要意见.
    德国乳腺癌专家小组就ABC7小组成员的投票结果与德国常规临床实践的相关性发表评论。与以前的会议一样,ABC7投票集中在修改或新的声明上。关于未经ABC7共识修改的声明,在2021年发表的手稿中对它们进行了讨论,德国专家在其中对ABC6共识进行了评论。德国的评论始终基于妇科肿瘤学工作组“乳房委员会”的当前建议(ArbeitsgemeinschaftGynäkologischeOnkologie,前妈妈)。
    UNASSIGNED: The \"International Consensus Conference for Advanced Breast Cancer\" was initiated more than 10 years ago. The rationale was to standardize treatment of advanced breast cancer (ABC) based on available evidence and to ensure that all ABC patients worldwide receive adequate treatment and access to new therapies.
    UNASSIGNED: The 7th International Consensus Conference for ABC (ABC7) took place from November 9 to 11, 2023 - as in previous years in Lisbon/Portugal. ABC7 focused not only on metastatic disease but also on locally advanced and inflammatory breast cancer. Special topics were the management of oligometastatic disease, leptomeningeal disease, brain metastases, and pregnant women with ABC. Due to the current situation worldwide, there was a special interest to patients living in conflict zones. As in previous years, patient advocates from around the world were integrated into the ABC conference and had a major input to the consensus.
    UNASSIGNED: A German breast cancer expert panel comments on the voting results of the ABC7 panelists regarding their relevance for routine clinical practice in Germany. As with previous meetings, the ABC7 votes focused on modified or new statements. Regarding the statements not modified for the ABC7 consensus, they are discussed in the published manuscript from 2021 in which the German experts commented on the ABC6 consensus. The German comments are always based on the current recommendations of the \"Breast Committee\" of the Gynecological Oncology Working Group (Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Mamma).
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  • 文章类型: Journal Article
    BACKGROUND: Renal cell carcinoma is the third most common tumor among urological tumors. In Germany more than 14,000 people are affected every year. The sex ratio is 2/3 men and 1/3 women.
    OBJECTIVE: The S3 guideline is intended to provide all disciplines dealing with renal cell carcinoma with the current status of diagnostics, therapy and follow-up care of the patients with this tumor.
    METHODS: The first version of the German guideline on renal cell carcinoma was published in 2015. The development was carried out at S3 level, which means that a structured, evidence-based literature search was carried out, recommendations and statements were developed in topic-related working groups and were approved by an interdisciplinary group of officials elected by the different medical societies. The chapters were gradually revised in 2017, 2020 and 2021 to reflect new aspects. This article provides information about the most important innovations of the most recent update from 2023.
    RESULTS: In the epidemiology subsection, the substance trichlorethene has been added as a risk factor for the development of renal cell carcinoma. While there were no new data on neoadjuvant therapy, the checkpoint inhibitor pembrolizumab was the first substance to demonstrate improved disease-specific and overall survival in the adjuvant situation. The combination nivolumab plus cabozantinib and lenvatinib plus pembrolizumab were included in the chapter on systemic therapy for metastatic clear cell renal cell carcinoma. New are the chapters on non-clear cell renal cell carcinoma and hereditary tumors.
    CONCLUSIONS: The S3 guideline provides a structured, evidence-based overview of all aspects of renal cell carcinoma.
    UNASSIGNED: HINTERGRUND: Das Nierenzellkarzinom (NCC) ist der dritthäufigste maligne Tumor unter den urologischen Tumoren. In Deutschland erkranken mehr als 14.000 Menschen pro Jahr. Das Geschlechterverhältnis beträgt zwei Drittel Männer und ein Drittel Frauen.
    UNASSIGNED: Die S3-Leitlinie soll allen mit dem NCC befassten Fachdisziplinen den aktuellen Stand zur Diagnostik, Therapie und Nachsorge des Tumors vermitteln.
    METHODS: Die Erstfassung der deutschen Leitlinie zum NCC erschien 2015. Die Erarbeitung erfolgte auf S3-Niveau, d. h. es erfolgte eine evidenzbasierte strukturierte Literaturrecherche. Die in themenbezogenen Kleingruppen erarbeiteten Empfehlungen und Statements wurden von der interdisziplinären Gruppe der Mandatsträger konsentiert. Als Living Guideline wurden 2017, 2020 und 2021 die Kapitel nach und nach entsprechend neuer Aspekte überarbeitet. Der vorliegende Artikel informiert über die wichtigsten Neuerungen der letzten Aktualisierung aus 2023.
    UNASSIGNED: Im Unterkapitel „Epidemiologie“ wurde die Substanz Trichlorethen neu als Risikofaktor für das Entstehen eines NCC aufgenommen. Während es zur neoadjuvanten Therapie keine neuen Daten gab, konnte mit dem Checkpoint-Inhibitor Pembrolizumab erstmals ein verbessertes krankheitsfreies und Gesamtüberleben in der adjuvanten Situation gezeigt werden. In das Kapitel zur Systemtherapie des metastasierten klarzelligen NCC wurden die Kombinationen Nivolumab und Cabozantinib sowie Lenvatinib und Pembrolizumab aufgenommen. Neu sind die Kapitel zu den nicht-klarzelligen NCC und den erblichen Tumoren.
    UNASSIGNED: Die S3-Leitlinie gibt einen strukturierten, evidenzbasierten Überblick über sämtliche Aspekte zum NCC.
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  • 文章类型: Journal Article
    日本乳腺癌学会乳腺癌临床实践指南,2022年版于2022年6月发布。该指南是在尽可能符合“2020年指南发展思想手册”的同时编写的。3.0.“由日本优质医疗保健委员会的思想手册发展委员会于2021年编辑。此外,2021年2月19日至3月4日,对日本乳腺癌协会成员进行了一项关于2018年版指南的调查.根据600多名成员的回应,进行了创新,以使指南更加用户友好。该指南的2018年版旨在为医生和患者提供使用共享决策的支持工具。2022年指南包括两卷:(1)“流行病学和诊断”部分,涵盖“筛查和诊断”,“放射学诊断”,和“病理诊断”,和(2)涵盖“手术治疗”的“治疗”部分,“放射治疗”,和“全身疗法”。我们相信,这份指南的简明摘要将对日本和海外的医生和研究人员有用。
    The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer, 2022 Edition was published in June 2022. The guidelines were prepared while conforming as much as possible to the \"Minds Manual for Guideline Development 2020 ver. 3.0.\" edited by the Minds Manual Development Committee of the Japan Council for Quality Health Care in 2021. In addition, a survey of Japanese Breast Cancer Society members on the 2018 edition of the guidelines was conducted from February 19 to March 4, 2021. Based on the responses from over 600 members, original innovations were made to make the guidelines more user-friendly. The 2018 edition of the guidelines was developed to provide support tools for physicians and patients to utilize shared decision-making. The 2022 guidelines consist of two volumes: (1) an \"Epidemiology and Diagnosis\" section covering \"Screening and Diagnosis\", \"Radiological diagnosis\", and \"Pathological diagnosis\", and (2) a \"Treatment\" section covering \"Surgical therapy\", \"Radiation therapy\", and \"Systemic therapy\". We believe that this concise summary of the guidelines will be useful to physicians and researchers in Japan and overseas.
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  • 文章类型: Journal Article
    加拿大老年人中乳腺癌的患病率正在增加。这些患者群体在乳腺癌的管理方面面临着独特的挑战,因为老年人通常有不同的生物学特征,社会心理,和治疗相关的考虑。本文提出了加拿大治疗景观的专家共识,重点关注优化老年人晚期乳腺癌系统治疗选择的关键考虑因素。本文旨在为参与老年人乳腺癌护理的医疗保健专业人员提供循证建议和实践指导。通过认识和解决老年人的具体需求,医疗保健提供者可以优化治疗结果并提高该人群的整体护理质量.
    The prevalence of breast cancer amongst older adults in Canada is increasing. This patient population faces unique challenges in the management of breast cancer, as older adults often have distinct biological, psychosocial, and treatment-related considerations. This paper presents an expert consensus of the Canadian treatment landscape, focusing on key considerations for optimizing selection of systemic therapy for advanced breast cancer in older adults. This paper aims to provide evidence-based recommendations and practical guidance for healthcare professionals involved in the care of older adults with breast cancer. By recognizing and addressing the specific needs of older adults, healthcare providers can optimize treatment outcomes and improve the overall quality of care for this population.
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  • 文章类型: Journal Article
    欧洲放射治疗和肿瘤学会(ESTRO)倡导建立指南,以优化精确放射治疗(RT)与当代癌症治疗方法的结合。RT(QART)的质量保证在影响治疗结果中起着关键作用。纳入QART方案的临床试验已经证明了提高的存活率和最小的相关毒性。尽管如此,在常规临床实践中,RT的适应症可能存在差异,剂量,分馏,和治疗计划,导致不确定性。在报告乳腺癌全身治疗结果的关键试验中,关于RT的信息有限,现代全身治疗和RT之间的潜在相互作用在很大程度上仍然未知。本文基于ESTRO认可的共识建议,由国际乳腺癌专家制定。通过修改后的德尔菲程序达成了共识,并在佛罗伦萨召开的一次国际会议上提出了共识,意大利,2023年6月这些建议被视为最佳和基本标准,后者旨在定义最低要求。已经设计了病例报告表(CRF)的模板,可用于所有涉及RT的临床乳腺癌试验。最佳要求包括遵守预定义的RT计划协议和集中式QART。基本要求旨在减少与RT指南的差异和偏差,即使RT不是试验的主要焦点。这些建议强调了在临床试验和日常临床例程中实施这些实践以生成高质量数据的重要性。
    The European Society for Radiotherapy and Oncology (ESTRO) has advocated the establishment of guidelines to optimise precision radiotherapy (RT) in conjunction with contemporary therapeutics for cancer care. Quality assurance in RT (QART) plays a pivotal role in influencing treatment outcomes. Clinical trials incorporating QART protocols have demonstrated improved survival rates with minimal associated toxicity. Nonetheless, in routine clinical practice, there can be variability in the indications for RT, dosage, fractionation, and treatment planning, leading to uncertainty. In pivotal trials reporting outcomes of systemic therapy for breast cancer, there is limited information available regarding RT, and the potential interaction between modern systemic therapy and RT remains largely uncharted. This article is grounded in a consensus recommendation endorsed by ESTRO, formulated by international breast cancer experts. The consensus was reached through a modified Delphi process and was presented at an international meeting convened in Florence, Italy, in June 2023. These recommendations are regarded as both optimal and essential standards, with the latter aiming to define the minimum requirements. A template for a case report form (CRF) has been devised, which can be utilised by all clinical breast cancer trials involving RT. Optimal requirements include adherence to predefined RT planning protocols and centralised QART. Essential requirements aim to reduce variations and deviations from the guidelines in RT, even when RT is not the primary focus of the trial. These recommendations underscore the significance of implementing these practices in both clinical trials and daily clinical routines to generate high-quality data.
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  • 文章类型: Journal Article
    尽管在其管理方面取得了相当大的进步,但肝细胞癌(HCC)仍面临着重大的治疗挑战。印度全国肝脏研究协会(INASL)于2014年首次发布了其指南,以帮助医疗保健专业人员诊断和治疗HCC。这些指南随后在2019年进行了更新。然而,INASL已经认识到,由于最近在HCC的诊断和管理方面的快速进步,需要在2023年修订其指南。特别是对于中级和高级阶段。目的是为医疗保健专业人员提供针对印度环境的循证建议。要做到这一点,成立了一个特别工作组,在普里举行了为期两天的圆桌讨论会,奥里萨邦.在这次活动中,各自领域的专家审议并最终确定了共识声明,以制定这些更新的准则。2023年INASL指南为诊断提供了一个全面的框架,分期,以及印度中晚期肝癌的管理。它们代表了在全国范围内规范临床实践方面向前迈出的重要一步,主要目标是确保HCC患者根据最新证据获得最佳治疗。该指南涵盖了与中晚期HCC相关的各种主题,包括攻击行为的生物标志物,分期,治疗方案,和后续护理。
    Hepatocellular carcinoma (HCC) presents significant treatment challenges despite considerable advancements in its management. The Indian National Association for the Study of the Liver (INASL) first published its guidelines to aid healthcare professionals in the diagnosis and treatment of HCC in 2014. These guidelines were subsequently updated in 2019. However, INASL has recognized the need to revise its guidelines in 2023 due to recent rapid advancements in the diagnosis and management of HCC, particularly for intermediate and advanced stages. The aim is to provide healthcare professionals with evidence-based recommendations tailored to the Indian context. To accomplish this, a task force was formed, and a two-day round table discussion was held in Puri, Odisha. During this event, experts in their respective fields deliberated and finalized consensus statements to develop these updated guidelines. The 2023 INASL guidelines offer a comprehensive framework for the diagnosis, staging, and management of intermediate and advanced HCC in India. They represent a significant step forward in standardizing clinical practices nationwide, with the primary objective of ensuring that patients with HCC receive the best possible care based on the latest evidence. The guidelines cover various topics related to intermediate and advanced HCC, including biomarkers of aggressive behavior, staging, treatment options, and follow-up care.
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