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Poor progress on reducing alcohol consumption in Europe. 欧洲在减少酒精消费方面进展缓慢。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-01 DOI: 10.1016/S1470-2045(24)00435-2
Talha Burki
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引用次数: 0
Progress in NCD screening in Mongolia. 蒙古在非传染性疾病筛查方面取得的进展。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-16 DOI: 10.1016/S1470-2045(24)00454-6
Sharmila Devi
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引用次数: 0
Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup. 子宫内膜癌的临床研究:妇科癌症国际小组的共识建议。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00192-X
Carien L Creutzberg, Jae-Weon Kim, Gemma Eminowicz, Emma Allanson, Lauriane Eberst, Se Ik Kim, Remi A Nout, Jeong-Yeol Park, Domenica Lorusso, Linda Mileshkin, Petronella B Ottevanger, Alison Brand, Delia Mezzanzanica, Amit Oza, Val Gebski, Bhavana Pothuri, Tania Batley, Carol Gordon, Tina Mitra, Helen White, Brooke Howitt, Xavier Matias-Guiu, Isabelle Ray-Coquard, David Gaffney, William Small, Austin Miller, Nicole Concin, Matthew A Powell, Gavin Stuart, Michael A Bookman

The Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Consensus Conference on Clinical Research (ECCC) was held in Incheon, South Korea, Nov 2-3, 2023. The aims were to develop consensus statements for future trials in endometrial cancer to achieve harmonisation on design elements, select important questions, and identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and finalisation of 18 statements within four topic groups, addressing adjuvant treatment in high-risk disease; treatment for metastatic and recurrent disease; trial designs for rare endometrial cancer subgroups and special circumstances; and specific methodology and adaptation for trials in low-resource settings. In addition, eight areas of unmet need were identified. This was the first GCIG Consensus Conference to include patient advocates and an expert on inclusion, diversity, equity, and access to take part in all aspects of the process and output. Four early-career investigators were also selected for participation, ensuring that they represented different GCIG member groups and regions. Unanimous consensus was obtained for 16 of the 18 statements, with 97% concordance for the remaining two. Using the described methodology from previous Ovarian Cancer Consensus Conferences, this conference did not require even one minority statement. The high acceptance rate following active involvement in the preparation, discussion, and refinement of the statements by all representatives confirmed the consensus progress within a global academic setting, and the expectation that the ECCC will lead to greater harmonisation, actualisation, inclusion, and resolution of unmet needs in clinical research for individuals living with and beyond endometrial cancer worldwide.

妇科癌症国际小组(GCIG)子宫内膜癌临床研究共识会议(ECCC)于 2023 年 11 月 2 日至 3 日在韩国仁川举行。会议旨在为未来的子宫内膜癌试验制定共识声明,以统一设计要素、选择重要问题并确定未满足的需求。全球子宫内膜癌小组的所有 33 个成员小组都参与了四个专题小组 18 项声明的制定、完善和定稿工作,这些声明涉及高危疾病的辅助治疗、转移性和复发性疾病的治疗、罕见子宫内膜癌亚组和特殊情况下的试验设计,以及低资源环境下试验的具体方法和适应性。此外,还确定了八个尚未满足需求的领域。这是 GCIG 共识会议首次邀请患者权益倡导者和一位包容性、多样性、公平性和可及性方面的专家参与会议进程和成果的各个方面。会议还挑选了四位早期职业研究人员参加,确保他们代表不同的 GCIG 成员团体和地区。在 18 项声明中,有 16 项获得了一致同意,其余两项的同意率为 97%。采用以往卵巢癌共识会议的方法,本次会议甚至不需要一份少数人声明。所有代表都积极参与了声明的准备、讨论和完善工作,其较高的接受率证实了在全球学术环境中取得的共识进展,并期待 ECCC 将促进协调、实现、包容和解决全球子宫内膜癌患者和其他患者在临床研究中未得到满足的需求。
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引用次数: 0
Improving individualised therapies in localised gastro-oesophageal adenocarcinoma. 改进局部胃食管腺癌的个体化疗法。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00180-3
Magali Svrcek, Thibault Voron, Thierry André, Elizabeth C Smyth, Christelle de la Fouchardière

Despite our increased understanding of the biological and molecular aspects of gastro-oesophageal tumourigenesis, the identification of prognostic or predictive factors remains challenging. Patients with resectable gastric and oesophageal adenocarcinoma are often treated similarly after surgical resection, regardless of their tumour biology, clinical characteristics, and histological treatment response. Substantial progress has been made in the past 5 years in managing patients with gastric or oesophageal adenocarcinoma, including the use of immune checkpoint inhibitors and new targeted therapies, leading to substantial improvements in clinical outcomes. These advancements have primarily been established in advanced and metastatic disease, while the management framework for local and locoregional disease is just beginning to shift. We provide an overview of existing data on biomarkers and tumour-related and host-related factors that are relevant to stratify patients into low-risk and high-risk recurrence groups, both before and after surgery, paving the way for more personalised treatment approaches.

尽管我们对胃食管肿瘤发生的生物学和分子方面有了更多的了解,但确定预后或预测因素仍然具有挑战性。可切除的胃腺癌和食管腺癌患者在手术切除后通常会接受类似的治疗,无论其肿瘤生物学特性、临床特征和组织学治疗反应如何。过去 5 年中,在治疗胃或食管腺癌患者方面取得了重大进展,包括使用免疫检查点抑制剂和新型靶向疗法,从而大大改善了临床疗效。这些进展主要针对晚期和转移性疾病,而针对局部和局部区域疾病的管理框架才刚刚开始转变。我们概述了现有的生物标志物、肿瘤相关因素和宿主相关因素的数据,这些数据有助于在手术前后将患者分为低风险和高风险复发组,为更个性化的治疗方法铺平道路。
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引用次数: 0
Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study. 结合 PSMA-PET 和 PROMISE 重新定义前列腺癌患者的疾病分期和风险:一项多中心回顾性研究。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-29 DOI: 10.1016/S1470-2045(24)00326-7
Madeleine J Karpinski, Johannes Hüsing, Kevin Claassen, Lennart Möller, Hiltraud Kajüter, Florian Oesterling, Viktor Grünwald, Lale Umutlu, Jens Kleesiek, Tugce Telli, Anja Merkel-Jens, Anika Hüsing, Claudia Kesch, Ken Herrmann, Matthias Eiber, Sebastian Hoberück, Philipp T Meyer, Felix Kind, Kambiz Rahbar, Michael Schäfers, Andreas Stang, Boris A Hadaschik, Wolfgang P Fendler
<p><strong>Background: </strong>Prostate-specific membrane antigen (PSMA)-PET was introduced into clinical practice in 2012 and has since transformed the staging of prostate cancer. Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria were proposed to standardise PSMA-PET reporting. We aimed to compare the prognostic value of PSMA-PET by PROMISE (PPP) stage with established clinical nomograms in a large prostate cancer dataset with follow-up data for overall survival.</p><p><strong>Methods: </strong>In this multicentre retrospective study, we used data from patients of any age with histologically proven prostate cancer who underwent PSMA-PET at the University Hospitals in Essen, Münster, Freiburg, and Dresden, Germany, between Oct 30, 2014, and Dec 27, 2021. We linked a subset of patient hospital records with patient data, including mortality data, from the Cancer Registry North-Rhine Westphalia, Germany. Patients from Essen University Hospital were randomly assigned to the development or internal validation cohorts (2:1). Patients from Münster, Freiburg, and Dresden University Hospitals were included in an external validation cohort. Using the development cohort, we created quantitative and visual PPP nomograms based on Cox regression models, assessing potential PPP predictors for overall survival, with least absolute shrinkage and selection operator penalty for overall survival as the primary endpoint. Performance was measured using Harrell's C-index in the internal and external validation cohorts and compared with established clinical risk scores (International Staging Collaboration for Cancer of the Prostate [STARCAP], European Association of Urology [EAU], and National Comprehensive Cancer Network [NCCN] risk scores) and a previous nomogram defined by Gafita et al (hereafter referred to as GAFITA) using receiver operating characteristic (ROC) curves and area under the ROC curve (AUC) estimates.</p><p><strong>Findings: </strong>We analysed 2414 male patients (1110 included in the development cohort, 502 in the internal cohort, and 802 in the external validation cohort), among whom 901 (37%) had died as of data cutoff (June 30, 2023; median follow-up of 52·9 months [IQR 33·9-79·0]). Predictors in the quantitative PPP nomogram were locoregional lymph node metastases (molecular imaging N2), distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases), tumour volume (in L), and tumour mean standardised uptake value. Predictors in the visual PPP nomogram were distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases) and total tumour lesion count. In the internal and external validation cohorts, C-indices were 0·80 (95% CI 0·77-0·84) and 0·77 (0·75-0·78) for the quantitative nomogram, respectively, and 0·78 (0·75-0·82) and 0·77 (0·75-0·78) for the visual nomogram, respectively.
背景:前列腺特异性膜抗原(PSMA)-PET 于 2012 年被引入临床实践,自此改变了前列腺癌的分期。前列腺癌分子影像标准化评估(PROMISE)标准的提出旨在规范 PSMA-PET 的报告。我们的目的是在一个有总生存期随访数据的大型前列腺癌数据集中,比较PSMA-PET按PROMISE(PPP)分期与既有临床提名图的预后价值:在这项多中心回顾性研究中,我们使用了2014年10月30日至2021年12月27日期间在德国埃森、明斯特、弗莱堡和德累斯顿大学医院接受PSMA-PET检查的任何年龄的组织学证实的前列腺癌患者的数据。我们将患者医院记录子集与德国北莱茵威斯特法伦州癌症登记处的患者数据(包括死亡率数据)进行了链接。埃森大学医院的患者被随机分配到开发队列或内部验证队列(2:1)。明斯特、弗莱堡和德累斯顿大学医院的患者被纳入外部验证队列。利用开发队列,我们基于 Cox 回归模型创建了定量和直观的 PPP 直方图,评估总生存期的潜在 PPP 预测因子,并将总生存期的最小绝对缩小和选择操作者惩罚作为主要终点。在内部和外部验证队列中使用 Harrell's C-index 对性能进行了测量,并使用接收器操作特征曲线(ROC)和 ROC 曲线下面积(AUC)估算值与既定的临床风险评分(国际前列腺癌分期协作组 [STARCAP]、欧洲泌尿外科协会 [EAU] 和美国国立综合癌症网络 [NCCN] 风险评分)和 Gafita 等人之前定义的提名图(以下简称 GAFITA)进行了比较:我们分析了 2414 名男性患者(其中 1110 人纳入开发队列,502 人纳入内部队列,802 人纳入外部验证队列),截至数据截止日(2023 年 6 月 30 日;中位随访时间为 52-9 个月 [IQR 33-9-79-0]),其中 901 人(37%)已经死亡。定量PPP提名图中的预测因素包括局部淋巴结转移(分子影像学N2)、远处转移(骨盆外结节转移、骨转移[扩散或弥漫性骨髓受累]和器官转移)、肿瘤体积(以L计)和肿瘤平均标准化摄取值。可视化PPP提名图中的预测因子为远处转移(骨盆外结节转移、骨转移[扩散或弥漫性骨髓受累]和器官转移)和肿瘤病灶总数。在内部和外部验证队列中,定量提名图的C指数分别为0-80(95% CI 0-77-0-84)和0-77(0-75-0-78),视觉提名图的C指数分别为0-78(0-75-0-82)和0-77(0-75-0-78)。在联合开发和内部验证队列中,定量PPP提名图在患者初始分期时优于STARCAP风险评分(有分期数据的人数=139;AUC 0-73 vs 0-54;P=0-018),在生化复发时优于EAU风险评分(人数=412;0-69 vs 0-52;P解释:我们的PPP提名图能准确地对前列腺癌早期和晚期的高危和低危人群的总生存期进行分层,与已有的临床风险工具相比,预测准确率相当或更高。目前正在通过长期随访验证和改进提名图(NCT06320223):北莱茵威斯特伐利亚州癌症登记处。
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引用次数: 0
Defining the quality of interdisciplinary care for patients with brain metastases: modified Delphi panel recommendations. 确定脑转移患者跨学科治疗的质量:修改后的德尔菲小组建议。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00198-0
Camilo E Fadul, Jason P Sheehan, Julio Silvestre, Gloribel Bonilla, Joseph A Bovi, Manmeet Ahluwalia, Riccardo Soffietti, David Hui, Roger T Anderson

The value of interdisciplinary teams in improving outcomes and quality of care of patients with brain metastases remains uncertain, partly due to the lack of consensus on key indicators to evaluate interprofessional care. We aimed to obtain expert consensus across disciplines on indicators that evaluate the quality and value of brain metastases care. A steering committee of key opinion leaders curated relevant outcomes and process indicators from a literature review and a stakeholder needs assessment, and an international panel of physicians rated the outcomes and process indicators using a modified Delphi method. After three rounds, a consensus was reached on 29 indicators encompassing brain-directed oncological treatment, surgery, whole-brain radiotherapy, stereotactic radiosurgery, supportive or palliative care, and interdisciplinary team care. The Brain Metastases Quality-of-Care measure reflects the value and quality of brain metastases team-based care according to treatment modality and provides a benchmark of care for this under-studied patient population. The adoption, implementation, and sustainability of this set of indicators could help address the need expressed by patients with cancer, caregivers, and clinicians for more coordinated care across inpatient, outpatient, home, community, and tertiary academic settings.

跨学科团队在改善脑转移患者预后和护理质量方面的价值仍不确定,部分原因是对评估跨专业护理的关键指标缺乏共识。我们旨在就评估脑转移治疗质量和价值的指标达成跨学科专家共识。由关键意见领袖组成的指导委员会从文献综述和利益相关者需求评估中整理出相关的结果和过程指标,并由国际医生小组采用改良德尔菲法对结果和过程指标进行评分。经过三轮评定,最终就 29 项指标达成共识,这些指标包括脑定向肿瘤治疗、手术、全脑放疗、立体定向放射手术、支持性或姑息治疗以及跨学科团队护理。脑转移瘤护理质量衡量标准根据治疗方式反映了脑转移瘤团队护理的价值和质量,并为这一研究不足的患者群体提供了护理基准。这套指标的采用、实施和可持续性有助于满足癌症患者、护理人员和临床医生的需求,即在住院、门诊、家庭、社区和三级学术环境中提供更加协调的护理。
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引用次数: 0
Translating the theranostic concept to neuro-oncology: disrupting barriers. 将治疗概念转化为神经肿瘤学:打破障碍。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00145-1
Nathalie L Albert, Emilie Le Rhun, Giuseppe Minniti, Maximilian J Mair, Norbert Galldiks, Nelleke Tolboom, Asgeir S Jakola, Maximilian Niyazi, Marion Smits, Antoine Verger, Francesco Cicone, Michael Weller, Matthias Preusser

Theranostics integrate molecular imaging and targeted radionuclide therapy for personalised cancer therapy. Theranostic treatments have shown meaningful efficacy in randomised clinical trials and are approved for clinical use in prostate cancer and neuroendocrine tumours. Brain tumours represent an unmet clinical need and theranostics might offer effective treatment options, although specific issues need to be considered for clinical development. In this Policy Review, we discuss opportunities and challenges of developing targeted radionuclide therapies for the treatment of brain tumours including glioma, meningioma, and brain metastasis. The rational choice of molecular treatment targets is highlighted, including the potential relevance of different types of targeted radionuclide therapeutics, and the role of the blood-brain barrier and blood-tumour barrier. Furthermore, we discuss considerations for effective clinical trial design and conduct, as well as logistical and regulatory challenges for implementation of radionuclide therapies into neuro-oncological practice. Rational development will foster successful translation of the theranostic concept to brain tumours.

Theranostics 将分子成像和放射性核素靶向治疗整合在一起,用于个性化癌症治疗。治疗放射治疗在随机临床试验中已显示出显著疗效,并已获准用于前列腺癌和神经内分泌肿瘤的临床治疗。脑肿瘤是一项尚未满足的临床需求,治疗学可能提供有效的治疗方案,但临床开发需要考虑具体问题。在本政策综述中,我们将讨论开发放射性核素靶向疗法治疗脑肿瘤(包括胶质瘤、脑膜瘤和脑转移瘤)的机遇与挑战。我们强调了分子治疗靶点的合理选择,包括不同类型靶向放射性核素疗法的潜在相关性,以及血脑屏障和血瘤屏障的作用。此外,我们还讨论了有效设计和开展临床试验的注意事项,以及将放射性核素疗法应用于神经肿瘤实践所面临的后勤和监管挑战。合理的开发将促进治疗概念在脑肿瘤领域的成功转化。
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引用次数: 0
Trastuzumab deruxtecan in HER2-positive metastatic colorectal cancer: less is more? 曲妥珠单抗德鲁替康治疗 HER2 阳性转移性结直肠癌:少即是多?
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-05 DOI: 10.1016/S1470-2045(24)00397-8
Jeanine M L Roodhart, Miriam Koopman
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引用次数: 0
Cancer incidence and survival for 11 cancers in the Commonwealth: a simulation-based modelling study. 英联邦 11 种癌症的发病率和存活率:模拟建模研究。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-07 DOI: 10.1016/S1470-2045(24)00336-X
Zachary J Ward, Qassi Gaba, Rifat Atun
<p><strong>Background: </strong>The number of new cancer cases in Commonwealth countries rose by 35% between 2008 and 2018, but progress in cancer control has been slow in many low-income and lower-middle-income member states. We aimed to examine cancer outcomes and priority areas in the Commonwealth to provide insight and guidance on prioritisation of efforts to improve cancer survival and make the best use of scarce resources.</p><p><strong>Methods: </strong>We adapted a previously developed microsimulation model of global cancer survival for 11 cancer sites (oesophagus, stomach, colon, rectum, anus, liver, pancreas, lung, breast, cervix uteri, and prostate). All 56 Commonwealth countries were included and classified based on the 2020 World Bank Income groups (low-income, lower-middle-income, upper-middle-income, and high-income countries) and Commonwealth geographical areas. We modelled the number of incident cancer cases in each Commonwealth country in 2020, based on age group-specific estimates of incidence rates from GLOBOCAN 2020. We simulated 5-year net survival for each patient, accounting for the stage at diagnosis (I-IV), availability of specific treatment and imaging modalities, and quality of care (based on residual differences in expected versus observed survival after accounting for the availability and effectiveness of treatment and imaging modalities). We also simulated counterfactual policy scenarios, in which we scaled up various aspects of cancer care to the mean level of high-income countries to estimate the comparative effectiveness of different policies.</p><p><strong>Findings: </strong>Incident cancers in the Commonwealth accounted for an estimated 14·3% of global diagnosed cancer cases in 2020 among the 11 cancers modelled (1 610 000 Commonwealth cases [95% UI 1 556 000-1 674 000] of 11 227 000 global cases [11 069 000-11 406 000]) and are estimated to increase to 17·3% in 2050 due to population growth (3 330 000 [3 154 000-3 539 000] of 19 308 000 [18 706 000-19 911 000]). The 5-year net survival across 11 cancers combined in 2020 was 30·7% (95% UI 22·4-38·6) in Commonwealth countries, ranging from 4·1% (0·04-15·2) in low-income countries, 17·8% (3·7-30·9) in lower-middle-income countries, 33·1% (23·7-46·0) in upper-middle-income countries, to 59·0% (57·8-60·2) in high-income countries. Among single treatment policies, scaling up access to radiotherapy had the largest survival impact in low-income countries, surgery had the largest impact in lower-middle-income and upper-middle-income countries, and targeted therapy had the largest impact in high-income countries. By geographical area, improving radiotherapy availability was estimated to have the largest impact in Africa, surgery in Asia, targeted therapy in the Caribbean and the Americas and Europe, and quality of care in the Pacific Commonwealth countries. Comparing packages of scaling up the availability of all treatment modalities versus imaging modalities, expanding
背景:2008 年至 2018 年间,英联邦国家新发癌症病例增加了 35%,但许多低收入和中低收入成员国在癌症控制方面进展缓慢。我们旨在研究英联邦国家的癌症结果和优先领域,以便为改善癌症生存率和充分利用稀缺资源的优先工作提供见解和指导:我们对之前开发的全球癌症存活率微观模拟模型进行了调整,该模型适用于 11 种癌症(食道癌、胃癌、结肠癌、直肠癌、肛门癌、肝癌、胰腺癌、肺癌、乳腺癌、子宫颈癌和前列腺癌)。我们纳入了所有 56 个英联邦国家,并根据 2020 年世界银行收入分组(低收入国家、中低收入国家、中高收入国家和高收入国家)和英联邦地理区域进行了分类。我们根据 GLOBOCAN 2020 估算的特定年龄组发病率,模拟了 2020 年每个英联邦国家的癌症发病人数。我们模拟了每位患者的 5 年净存活率,其中考虑了诊断时的分期(I-IV 期)、特定治疗和成像方式的可用性以及护理质量(基于考虑治疗和成像方式的可用性和有效性后预期存活率与观察存活率之间的剩余差异)。我们还模拟了反事实政策情景,将癌症治疗的各个方面提高到高收入国家的平均水平,以估算不同政策的比较效果:在模拟的 11 种癌症中,英联邦的癌症发病率估计占 2020 年全球确诊癌症病例的 14-3%(英联邦病例 1 610 000 例 [95% UI 1 556 000-1 674 000] ,全球病例 11 227 000 例 [11 069 000-11 406 000]),由于人口增长,估计 2050 年将增至 17-3%(3 330 000 [3 154 000-3 539 000] ,全球病例 19 308 000 例 [18 706 000-19 911 000])。2020 年,英联邦国家 11 种癌症的 5 年净存活率合计为 30-7%(95% UI 22-4-38-6),其中低收入国家为 4-1%(0-04-15-2),中低收入国家为 17-8%(3-7-30-9),中上收入国家为 33-1%(23-7-46-0),高收入国家为 59-0%(57-8-60-2)。在单一治疗政策中,扩大放射治疗的可及性对低收入国家的生存率影响最大,手术治疗对中低收入和中高收入国家的影响最大,靶向治疗对高收入国家的影响最大。按地理区域划分,据估计,改善放射治疗的可用性对非洲的影响最大,手术对亚洲的影响最大,靶向治疗对加勒比地区、美洲和欧洲的影响最大,而医疗质量对太平洋英联邦国家的影响最大。比较扩大所有治疗方式与成像方式的一揽子方案,在高收入国家、加勒比地区、美洲、欧洲和太平洋地区,扩大成像的可获得性产生的效益最大,而在所有其他收入群体和地理区域,扩大治疗的可获得性产生的效益更大:我们发现 5 年净生存率存在很大差异,在英联邦国家中,不同收入群体的癌症生存率相差近 15 倍。努力改善治疗和成像模式的可用性以及护理质量对于缩小这些差距至关重要,不同环境下扩大政策的具体优先事项也各不相同。英联邦可以利用广泛的知识和资源,在支持成员国根据具体情况确定优先事项以改善癌症治疗效果方面发挥重要作用:哈佛大学陈博士公共卫生学院。
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引用次数: 0
Postoperative radiotherapy in women with early operable breast cancer (Scottish Breast Conservation Trial): 30-year update of a randomised, controlled, phase 3 trial. 早期可手术乳腺癌妇女的术后放疗(苏格兰乳房保护试验):随机对照 3 期试验的 30 年更新。
IF 41.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-08-07 DOI: 10.1016/S1470-2045(24)00347-4
Linda J Williams, Ian H Kunkler, Karen J Taylor, Joanna Dunlop, Tammy Piper, Jacqueline Caldwell, Wilma Jack, Joseph F Loane, Kenneth Elder, John M S Bartlett, J Michael Dixon, David A Cameron
<p><strong>Background: </strong>Breast-conserving surgery, adjuvant systemic therapy, and radiotherapy are the standard of care for most women with early breast cancer. There are few reports of clinical outcomes beyond the first decade of follow-up of randomised trials comparing breast-conserving surgery with or without radiotherapy. We present a 30-year update of the Scottish Breast Conservation Trial.</p><p><strong>Methods: </strong>In this randomised, controlled, phase 3 trial across 14 hospitals in Scotland, women aged younger than 70 years with early breast cancer (tumours ≤4 cm [T1 or T2 and N0 or N1]) were included. They underwent breast-conserving surgery (1 cm margin) with axillary node sampling or clearance. Oestrogen receptor (ER)-rich patients (≥20 fmol/mg protein) received 20 mg oral tamoxifen daily for 5 years. ER-poor patients (<20 fmol/mg protein) received chemotherapy (cyclophosphamide 600 mg/m<sup>2</sup>, methotrexate 50 mg/m<sup>2</sup>, and fluorouracil 600 mg/m<sup>2</sup> every 21 days intravenously in eight courses). Stratification was by menstrual status (within or more than 12 months from last menstrual period) and ER status (oestrogen concentration ≥20 fmol/mg protein, <20 fmol/mg protein, or unknown) and patients were randomly assigned (1:1) to high-dose (50 Gy in 20-25 fractions) local or locoregional radiotherapy versus no radiotherapy. No blinding was possible due to the nature of the treatment. We report the primary endpoint of the original trial, ipsilateral breast tumour recurrence, and the co-primary endpoint, overall survival. Clinical outcomes were compared by the log-rank test. Hazard ratios (HRs) are reported, with no radiotherapy as the reference group. Failures of the proportional hazards assumption are reported if significant. All analyses are by intention to treat.</p><p><strong>Findings: </strong>Between April 1, 1985, and Oct 2, 1991, 589 patients were enrolled and randomly assigned to the two treatment groups (293 to radiotherapy and 296 to no radiotherapy). After exclusion of four ineligible patients (two in each group), there were 291 patients in the radiotherapy group and 294 patients in the no radiotherapy group. Median follow-up was 17·5 years (IQR 8·4-27·9). Ipsilateral breast tumour recurrence was significantly lower in the radiotherapy group than in the no radiotherapy group (46 [16%] of 291 vs 107 [36%] of 294; HR 0·39 [95% CI 0·28-0·55], p<0·0001). Although there were differences in the hazard rate for ipsilateral breast tumour recurrence in the first decade after treatment (HR 0·24 [95% CI 0·15-0·38], p<0·0001), subsequent risks of ipsilateral breast tumour recurrence were similar in both groups (0·98 [0·54-1·79], p=0·95). There was no difference in overall survival between the two groups (median 18·7 years [95% CI 16·5-21·5] in the no radiotherapy group vs 19·2 years [16·9-21·3] in the radiotherapy group; HR 1·08 [95% CI 0·89-1 ·30], log-rank p=0·43).</p><p><strong>Interpretation: </strong
背景:保乳手术、辅助系统治疗和放疗是大多数早期乳腺癌患者的标准治疗方法。关于保乳手术加放疗或不加放疗的随机试验随访十年后的临床结果,目前还鲜有报道。我们对苏格兰保乳试验进行了 30 年的更新:在苏格兰 14 家医院开展的这项随机对照 3 期试验中,年龄小于 70 岁的早期乳腺癌(肿瘤小于 4 厘米 [T1 或 T2 和 N0 或 N1])女性被纳入其中。她们接受了保乳手术(边缘 1 厘米),并进行了腋窝结节取样或清除。雌激素受体(ER)丰富的患者(蛋白≥20 fmol/mg)每天口服20毫克他莫昔芬,持续5年。雌激素受体(ER)贫乏的患者(2,甲氨蝶呤 50 毫克/平方米,氟尿嘧啶 600 毫克/平方米,每 21 天静脉注射一次,共 8 个疗程)。根据月经状况(距上次月经期在 12 个月内或 12 个月以上)和雌激素状况(雌激素浓度≥20 fmol/mg 蛋白,结果)进行分层:1985年4月1日至1991年10月2日期间,589名患者被随机分配到两个治疗组(293名接受放射治疗,296名不接受放射治疗)。在排除了四名不符合条件的患者(每组两名)后,放射治疗组有 291 名患者,无放射治疗组有 294 名患者。中位随访时间为 17-5 年(IQR 8-4-27-9)。放疗组的同侧乳腺肿瘤复发率明显低于无放疗组(291 例中的 46 例 [16%] vs 294 例中的 107 例 [36%];HR 0-39 [95% CI 0-28-0-55], p解释:我们的研究结果表明,在早期乳腺癌保乳手术后十年或更长时间内,其生物学预示晚期复发的患者可能从辅助放疗中获益甚微:乳腺癌研究所(隶属于爱丁堡和洛锡安健康基金会)和 PFS 基因组学(现隶属于 Exact Sciences)。
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Lancet Oncology
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