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Multimodality imaging of a large incidental papillary fibroelastoma. 偶发巨大乳头状纤维瘤的多模式成像。
IF 41.6 1区 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00392-9
Wiaam Elkhatib, Prajwal Reddy
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引用次数: 0
Legacies of conflict and humanitarian crises on cancer care. 冲突和人道主义危机对癌症护理的影响。
IF 41.6 1区 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00453-4
The Lancet Oncology
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引用次数: 0
Measuring success of adjuvant treatment for patients with melanoma. 衡量黑色素瘤患者辅助治疗的成功率。
IF 41.6 1区 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY Pub Date : 2024-09-01 Epub Date: 2024-08-12 DOI: 10.1016/S1470-2045(24)00372-3
Brent O'Carrigan, Pippa G Corrie
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引用次数: 0
Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): primary results from a multicentre, randomised, phase 2 trial. 曲妥珠单抗德鲁司坦治疗 HER2 阳性晚期结直肠癌患者(DESTINY-CRC02):一项多中心、随机、2 期试验的初步结果。
IF 41.6 1区 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY Pub Date : 2024-09-01 Epub Date: 2024-08-05 DOI: 10.1016/S1470-2045(24)00380-2
Kanwal Raghav, Salvatore Siena, Atsuo Takashima, Takeshi Kato, Marc Van den Eynde, Filippo Pietrantonio, Yoshito Komatsu, Hisato Kawakami, Marc Peeters, Thierry Andre, Sara Lonardi, Kensei Yamaguchi, Jeanne Tie, Cristina Gravalos Castro, Hung-Chih Hsu, John H Strickler, Tae-You Kim, Yongjun Cha, Daniel Barrios, Qi Yan, Takahiro Kamio, Kojiro Kobayashi, Aislyn Boran, Makito Koga, John D Allard, Takayuki Yoshino
<p><strong>Background: </strong>Trastuzumab deruxtecan has shown encouraging activity in patients with treatment-refractory HER2-positive, RAS wild-type and BRAF wild-type metastatic colorectal cancer. Dose optimisation and further antitumour assessments in patients with RAS mutations and those with previous anti-HER2 therapy are warranted. We aimed to evaluate two doses of trastuzumab deruxtecan (5·4 mg/kg and 6·4 mg/kg) to establish the recommended dose in patients with pretreated HER2-positive, RAS wild-type or mutant metastatic colorectal cancer.</p><p><strong>Methods: </strong>DESTINY-CRC02 was a multicentre, randomised, two-stage, two-arm, phase 2 study done in 53 research hospitals and medical centres in Australia, Belgium, France, Italy, Japan, South Korea, Spain, Taiwan, the UK, and the USA. Eligible patients were aged 18 years and older or 20 years and older (depending on region) with pretreated pathologically documented, unresectable, recurrent, or metastatic HER2-positive, and RAS wild-type or mutant colorectal cancer. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and have received previous chemotherapy, and anti-EGFR, anti-VEGF, or anti-PD-L1 therapy, if clinically indicated. In stage 1, patients were randomly assigned (1:1), via a secure interactive response technology system, to receive 5·4 mg/kg or 6·4 mg/kg trastuzumab deruxtecan administered intravenously every 21 days. Stratification factors were ECOG performance status, HER2 status, and RAS status. In stage 2, patients were assigned into the 5·4 mg/kg treatment group only. The primary endpoint was confirmed objective response rate by blinded independent central review, assessed in all patients for whom treatment was assigned (full analysis set). Safety was assessed in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT04744831, and is ongoing (not recruiting).</p><p><strong>Findings: </strong>Between March 5, 2021, and March 29, 2022, 135 patients were centrally screened, 122 of whom were enrolled. In stage 1, 40 patients each were randomly assigned to receive trastuzumab deruxtecan 5·4 mg/kg and 6·4 mg/kg. In stage 2, an additional 42 patients were enrolled in the 5·4 mg/kg group. 64 (52%) participants were male and 58 (48%) were female. The median duration of follow-up was 8·9 months (IQR 6·7-10·5) in the 5·4 mg/kg group and 10·3 months (5·9-12·7) in the 6·4 mg/kg group. The confirmed objective response rate by blinded independent central review was 37·8% (31/82 [95% CI 27·3-49·2]) in the 5·4 mg/kg group and 27·5% (11/40 [14·6-43·9]) in the 6·4 mg/kg group. 34 (41%) of 83 patients in the 5·4 mg/kg group and 19 (49%) of 39 in the 6·4 mg/kg group had grade 3 or worse drug-related treatment-emergent adverse events. The most common grade 3 or worse drug-related treatment-emergent adverse events were neutrophil count decreased (13 [16%] of 83 patients), anaemia
背景:曲妥珠单抗德鲁司坦在治疗难治性 HER2 阳性、RAS 野生型和 BRAF 野生型转移性结直肠癌患者中显示出令人鼓舞的活性。有必要对RAS突变患者和既往接受过抗HER2治疗的患者进行剂量优化和进一步的抗肿瘤评估。我们旨在评估两种剂量的曲妥珠单抗德鲁司坦(5-4 mg/kg和6-4 mg/kg),以确定HER2阳性、RAS野生型或突变型转移性结直肠癌患者的推荐剂量:DESTINY-CRC02是一项多中心、随机、两阶段、两臂、二期研究,在澳大利亚、比利时、法国、意大利、日本、韩国、西班牙、台湾、英国和美国的53家研究医院和医疗中心进行。符合条件的患者年龄在 18 岁及以上或 20 岁及以上(视地区而定),病理记录显示为不可切除、复发或转移性 HER2 阳性、RAS 野生型或突变型结直肠癌。患者的东部合作肿瘤学组(ECOG)表现为 0 或 1,既往接受过化疗,并在有临床指征的情况下接受过抗 EGFR、抗 VEGF 或抗 PD-L1 治疗。在第一阶段,患者通过安全互动反应技术系统随机分配(1:1)接受每21天静脉注射5-4 mg/kg或6-4 mg/kg曲妥珠单抗。分层因素包括 ECOG 表现状态、HER2 状态和 RAS 状态。在第二阶段,患者仅被分配到5-4 mg/kg治疗组。主要终点是通过盲法独立中央审查确认的客观反应率,评估对象是所有接受治疗的患者(完整分析集)。对所有至少接受过一次治疗的患者进行了安全性评估。该试验已在 ClinicalTrials.gov 注册,编号为 NCT04744831,目前正在进行中(未招募):2021年3月5日至2022年3月29日期间,集中筛选了135名患者,其中122人被纳入。在第一阶段,随机分配40名患者分别接受5-4毫克/千克和6-4毫克/千克的曲妥珠单抗德鲁司坦治疗。在第二阶段,又有42名患者被纳入5-4毫克/千克组。64名参与者(52%)为男性,58名参与者(48%)为女性。5-4 mg/kg组的中位随访时间为8-9个月(IQR为6-7-10-5),6-4 mg/kg组为10-3个月(5-9-12-7)。经盲法独立中央审查确认的客观反应率为:5-4 mg/kg组37-8%(31/82 [95% CI 27-3-49-2]),6-4 mg/kg组27-5%(11/40 [14-6-43-9])。5-4 mg/kg组83名患者中有34名(41%)和6-4 mg/kg组39名患者中有19名(49%)出现了3级或更严重的药物相关治疗突发不良事件。在5-4毫克/千克组中,最常见的3级或更严重的药物相关治疗突发不良事件是中性粒细胞计数减少(83名患者中有13人[16%])、贫血(6人[7%])、恶心(6人[7%])和白细胞计数减少(5人[6%]);中性粒细胞计数减少(39 名患者中有 10 人[26%])、贫血(8 人[21%])、血小板计数减少(4 人[10%])和白细胞计数减少(4 人[10%])。在5-4毫克/千克组的83名患者中,有11人(13%)发生了与药物相关的严重不良事件;在6-4毫克/千克组的39名患者中,有6人(15%)发生了与药物相关的严重不良事件;在5-4毫克/千克组,最常见的不良事件是恶心(3人[4%]),在6-4毫克/千克组,最常见的不良事件是疲劳(2人[5%])、中性粒细胞减少(2人[5%])和血小板减少(2人[5%])。5-4毫克/千克组有一名(1%)患者发生了与药物相关的治疗突发不良事件,导致死亡(肝功能衰竭)。5-4毫克/千克组有7名患者(8%)发生了与药物相关的间质性肺病或肺炎事件(均为1级或2级),6-4毫克/千克组有5名患者(13%)发生了与药物相关的间质性肺病或肺炎事件(4例为1级或2级,1例为5级):曲妥珠单抗德鲁司坦5-4毫克/千克的抗肿瘤活性和良好的安全性支持将其作为HER2阳性转移性结直肠癌预处理患者的最佳单药剂量,包括RAS突变、既往接受过抗HER2治疗或两者兼有的患者:资金来源:第一三共公司和阿斯利康公司。
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引用次数: 0
Disappointment facing patients with breast cancer as trastuzumab deruxtecan too expensive for NHS. 由于曲妥珠单抗德鲁司坦对国民医疗服务体系而言过于昂贵,乳腺癌患者面临失望。
IF 41.6 1区 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY Pub Date : 2024-09-01 Epub Date: 2024-08-08 DOI: 10.1016/S1470-2045(24)00446-7
Elizabeth Gourd
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引用次数: 0
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 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY 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 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY 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 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY 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 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY 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 农林科学 Q1 AGRICULTURE, MULTIDISCIPLINARY 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
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Journal of Agricultural and Food Chemistry
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