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PSMA-PET research: addressing challenges and prospects – Authors' reply PSMA-PET 研究:应对挑战,展望未来 - 作者回复
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00582-5
Boris A Hadaschik, Madeleine J Karpinski, Johannes Hüsing, Wolfgang P Fendler
No Abstract
无摘要
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引用次数: 0
Concerns regarding the AtTEnd trial in advanced endometrial carcinoma 对晚期子宫内膜癌 AtTEnd 试验的担忧
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00486-8
Queran Lin, Wenyi Jin, Dan Shan
No Abstract
无摘要
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引用次数: 0
Ischaemic cardiotoxicity of aromatase inhibitors in postmenopausal patients with early breast cancer in Denmark: a cohort study of real-world data 丹麦绝经后早期乳腺癌患者服用芳香化酶抑制剂引起的缺血性心脏毒性:对真实世界数据的队列研究
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00491-1
Marie Lund, Giulia Corn, Maj-Britt Jensen, Tonny Petersen, Kim Dalhoff, Bent Ejlertsen, Lars Køber, Jan Wohlfahrt, Mads Melbye

Background

For aromatase inhibitor treatment (AIT) in breast cancer, there is an unresolved concern about ischaemic cardiotoxicity. We investigated the association between AIT and ischaemic cardiotoxicity in a prospective cohort of female patients with early breast cancer who received contemporary treatment in Denmark.

Methods

In this prospective cohort study in Denmark, we identified postmenopausal patients of any age diagnosed with breast cancer as recorded in the nationwide Danish Breast Cancer Cooperative Group (DBCG) clinical database between Jan 1, 2009, and Dec 31, 2020, and linked them to other nationwide registries. Exclusion criteria included having a history of other primary cancer, less than 2 years of residency in Denmark, and no inclusion in a treatment protocol according to the DBCG database, including for metastatic or locally advanced breast cancer. Information on demography, hospital diagnoses, filled prescriptions, laboratory testing, and socioeconomic status were recorded. We stratified the patient cohort according to history (yes vs no) of selected cardiovascular disease defined as ischaemic heart disease, ischaemic stroke, and heart failure, and defined the primary outcome as two-point major adverse cardiovascular events (MACE; acute myocardial infarction or ischaemic stroke). We estimated cause-specific hazard ratios (HRs) according to allocation to AIT versus not in an intention-to-treat analysis using a Cox proportional hazards regression model with age as the underlying time scale, adjusting for demographic characteristics, tumour characteristics, and other anti-cancer treatments.

Findings

43 440 postmenopausal patients diagnosed with breast cancer were identified, of whom 32 635 were followed up and included in analyses. Of 29 118 postmenopausal patients with no history of selected cardiovascular disease, we observed 510 two-point MACEs among 22 135 patients allocated to AIT (incidence rate 4·3/1000 person-years of follow-up) and 170 two-point MACEs among 6983 patients not allocated to AIT (4·1/1000 person-years). The adjusted HR was 0·91 (95% CI 0·73–1·14) for patients allocated to AIT versus patients not allocated to AIT. Among 3517 patients with a history of selected cardiovascular disease, we observed 158 two-point MACEs among 2661 patients allocated to AIT (incidence rate 12·4/1000 person-years) and 50 two-point MACEs (12·1/1000 person-years) among 856 patients not allocated to AIT (adjusted HR 0·81 [95% CI 0·58–1·15]).

Interpretation

Our findings do not support a clinically relevant ischaemic cardiotoxic potential of AIT in patients with early breast cancer and do not support avoiding AIT prescription in patients with early breast cancer.

Funding

Bispebjerg and Frederiksberg Hospital, Kræftens Bekæmpelse, Fonden til Lægevidenskabens Fremme, Aase og Ejnar Danielsens Fond, Helsefonden, and Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis’ Legat.
背景对于乳腺癌的芳香化酶抑制剂治疗(AIT),缺血性心脏毒性是一个尚未解决的问题。在丹麦进行的这项前瞻性队列研究中,我们确定了 2009 年 1 月 1 日至 2020 年 12 月 31 日期间在全国性丹麦乳腺癌合作组(DBCG)临床数据库中记录的任何年龄的绝经后乳腺癌患者,并将其与其他全国性登记资料进行了关联。排除标准包括:有其他原发性癌症病史、在丹麦居住时间不足两年、未被纳入 DBCG 数据库的治疗方案(包括转移性或局部晚期乳腺癌)。我们还记录了人口统计学、医院诊断、已开处方、实验室检测和社会经济状况等信息。我们根据缺血性心脏病、缺血性中风和心力衰竭等特定心血管疾病的病史(有与无)对患者队列进行了分层,并将主要结果定义为两点主要不良心血管事件(MACE;急性心肌梗死或缺血性中风)。在意向性治疗分析中,我们使用以年龄为基本时间尺度的 Cox 比例危险回归模型,并根据人口统计学特征、肿瘤特征和其他抗癌治疗进行调整,估算了分配 AIT 与未分配 AIT 的特异性病因危险比 (HRs)。在 29 118 名无特定心血管疾病史的绝经后患者中,我们观察到 22 135 名被分配接受 AIT 治疗的患者中发生了 510 例两点 MACE(发生率为 4-3/1000 随访年),而在 6983 名未被分配接受 AIT 治疗的患者中发生了 170 例两点 MACE(发生率为 4-1/1000 随访年)。分配使用 AIT 的患者与未分配使用 AIT 的患者相比,调整后 HR 为 0-91(95% CI 0-73-1-14)。在 3517 例有特定心血管疾病史的患者中,我们观察到 2661 例接受 AIT 治疗的患者中发生了 158 例两点 MACE(发生率为 12-4/1000 人-年),856 例未接受 AIT 治疗的患者中发生了 50 例两点 MACE(12-1/1000 人-年)(调整 HR 为 0-81 [95% CI 0-58-1-15])。释义我们的研究结果不支持AIT对早期乳腺癌患者具有临床相关的缺血性心脏毒性潜能,也不支持避免为早期乳腺癌患者开具AIT处方。
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引用次数: 0
The state of the science of oral selective oestrogen receptor degraders 口服选择性雌激素受体降解剂的科学现状
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00443-1
Kristina Fanucci, Erica L Mayer
No Abstract
无摘要
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引用次数: 0
Site-specific or empirical chemotherapy for cancer of unknown primary: the right answer? – Authors' reply 原发灶不明癌症的部位特异性化疗或经验性化疗:正确答案?- 作者回复
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00569-2
Xichun Hu, Shiyu Jiang, Xin Liu
No Abstract
无摘要
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引用次数: 0
Caring for carers of people with cancer 关爱癌症患者的照顾者
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00588-6
No Abstract
无摘要
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引用次数: 0
[18F]FDG-PET-guided radiotherapy for stage III non-small-cell lung cancer – Authors' reply [18F]FDG-PET引导的III期非小细胞肺癌放疗 - 作者回复
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00578-3
Sébastien Thureau, Philippe Giraud, Gérard Zalcman, Pierre Vera
No Abstract
无摘要
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引用次数: 0
Artificial Intelligence for Response Assessment in Neuro Oncology (AI-RANO), part 1: review of current advancements 神经肿瘤学响应评估人工智能(AI-RANO),第 1 部分:当前进展回顾
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00316-4
Javier E Villanueva-Meyer, Spyridon Bakas, Pallavi Tiwari, Janine M Lupo, Evan Calabrese, Christos Davatzikos, Wenya Linda Bi, Marwa Ismail, Hamed Akbari, Philipp Lohmann, Thomas C Booth, Benedikt Wiestler, Hugo J W L Aerts, Ghulam Rasool, Joerg C Tonn, Martha Nowosielski, Rajan Jain, Rivka R Colen, Sarthak Pati, Ujjwal Baid, Norbert Galldiks
The development, application, and benchmarking of artificial intelligence (AI) tools to improve diagnosis, prognostication, and therapy in neuro-oncology are increasing at a rapid pace. This Policy Review provides an overview and critical assessment of the work to date in this field, focusing on diagnostic AI models of key genomic markers, predictive AI models of response before and after therapy, and differentiation of true disease progression from treatment-related changes, which is a considerable challenge based on current clinical care in neuro-oncology. Furthermore, promising future directions, including the use of AI for automated response assessment in neuro-oncology, are discussed.
用于改善神经肿瘤学诊断、预后和治疗的人工智能(AI)工具的开发、应用和基准测试正在快速增长。本政策综述对该领域迄今为止的工作进行了概述和批判性评估,重点关注关键基因组标记物的诊断性人工智能模型、治疗前后反应的预测性人工智能模型,以及真正的疾病进展与治疗相关变化的区分,这在神经肿瘤学目前的临床治疗中是一个相当大的挑战。此外,还讨论了未来的发展方向,包括将人工智能用于神经肿瘤学的自动反应评估。
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引用次数: 0
Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial 在雌激素受体阳性、HER2 阴性晚期乳腺癌绝经后妇女中,新一代口服 SERD 卡米雌酯与氟维司群的对比(SERENA-2):一项多剂量、开放标签、随机 2 期试验
Pub Date : 2024-10-28 DOI: 10.1016/s1470-2045(24)00387-5
Mafalda Oliveira, Denys Pominchuk, Zbigniew Nowecki, Erika Hamilton, Yaroslav Kulyaba, Timur Andabekov, Yevhen Hotko, Tamar Melkadze, Gia Nemsadze, Patrick Neven, Vladimir Vladimirov, Claudio Zamagni, Hannelore Denys, Frédéric Forget, Zsolt Horvath, Alfiya Nesterova, Maxine Ajimi, Bistra Kirova, Teresa Klinowska, Justin P O Lindemann, Ekaterine Arkania
<h3>Background</h3>Resistance to endocrine therapies in hormone receptor-positive breast cancer is challenging. We aimed to assess the next-generation oral selective oestrogen receptor degrader (SERD) and complete oestrogen receptor antagonist, camizestrant, versus the first-approved SERD, fulvestrant, in post-menopausal women with oestrogen receptor-positive, HER2-negative, advanced breast cancer.<h3>Methods</h3>SERENA-2 is an open-label, randomised, phase 2 trial that is being conducted at 74 study centres across Asia, Europe, the Middle East, and North America. Female patients aged 18 years or older who were post-menopausal with histologically or cytologically confirmed metastastic or locoregional oestrogen receptor-positive, HER2-negative breast cancer, an Eastern Cooperative Oncology Group or WHO performance status of 0 or 1, and disease recurrence or progression on at least one line of endocrine therapy, and no more than one previous endocrine therapy in the advanced setting. Patients were initially randomly assigned (1:1:1:1) to receive oral camizestrant once daily at 75 mg, 150 mg, or 300 mg (until the 300 mg group was closed), or fulvestrant intramuscularly at 500 mg (per label). Randomisation was managed through an interactive web-based system and stratified by previous treatment with CDK4/6 inhibitors and presence of liver and/or lung metastases. The primary objective was to determine clinical efficacy of camizestrant versus fulvestrant at each dose level using the primary endpoint of investigator-assessed progression-free survival, per Response Evaluation Criteria in Solid Tumours (version 1.1), assessed by intention to treat in all randomly assigned patients (full analysis set). No formal statistical comparison for the efficacy analysis of the camizestrant 300 mg dose versus fulvestrant was to be performed. Safety analyses included all randomly assigned patients who received at least one dose of study treatment. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, <span><span>NCT04214288</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, and is ongoing.<h3>Findings</h3>Between May 11, 2020, and Aug 10, 2021, 240 patients were randomly assigned to receive camizestrant 75 mg (n=74), 150 mg (n=73), 300 mg (n=20), or fulvestrant (n=73), and were included in the full analysis set. All patients received at least one dose of study drug. Median follow-up was 16·6 months (IQR 12·9–19·4) for the camizestrant 75 mg group, 16·3 months (12·9–18·3) for the camizestrant 150 mg group, and 14·7 months (12·7–20·1) for the fulvestrant 500 mg group. Median progression-free surv
背景激素受体阳性乳腺癌患者对内分泌疗法的耐药性是一项挑战。我们旨在评估新一代口服选择性雌激素受体降解剂(SERD)和完全雌激素受体拮抗剂坎米司群与首个获批的SERD氟维司群在雌激素受体阳性、HER2阴性的绝经后晚期乳腺癌女性患者中的疗效。方法SERENA-2是一项开放标签、随机的2期试验,目前正在亚洲、欧洲、中东和北美的74个研究中心进行。研究对象为绝经后、组织学或细胞学确诊为转移性或局部性雌激素受体阳性、HER2阴性乳腺癌的18岁或18岁以上女性患者,东方合作肿瘤组织或世卫组织表现状态为0或1,接受过至少一种内分泌治疗后疾病复发或进展,且既往接受过的晚期内分泌治疗不超过一种。患者最初被随机分配(1:1:1:1:1)接受口服坎米司群,每天一次,剂量为75毫克、150毫克或300毫克(直到300毫克组结束),或肌肉注射氟维司群,剂量为500毫克(按标签)。随机分组通过交互式网络系统进行管理,并根据既往接受过CDK4/6抑制剂治疗以及是否存在肝脏和/或肺部转移进行分层。主要目的是确定坎米司群与氟维司群在各剂量水平上的临床疗效,主要终点是研究者评估的无进展生存期,根据《实体瘤反应评价标准》(1.1版),对所有随机分配的患者进行意向治疗评估(完整分析集)。坎米司群300毫克剂量与氟维司群的疗效分析不进行正式的统计比较。安全性分析包括所有接受了至少一个剂量研究治疗的随机分配患者。研究结果在2020年5月11日至2021年8月10日期间,240名患者被随机分配接受75毫克(约合74人)、150毫克(约合73人)、300毫克(约合20人)或氟维司群(约合73人)的治疗,并纳入完整的分析集。所有患者均接受了至少一剂研究药物。卡米雌酯 75 毫克组的中位随访时间为 16-6 个月(IQR 12-9-19-4),卡米雌酯 150 毫克组为 16-3 个月(12-9-18-3),氟维司群 500 毫克组为 14-7 个月(12-7-20-1)。中位无进展生存期为:坎米雌酯75毫克组7-2个月(90% CI 3-7-10-9),坎米雌酯150毫克组7-7个月(5-5-12-9),氟维司群组3-7个月(2-0-6-0)。Camizestrant 75 mg与氟维司群的危险比为0-59(90% CI 0-42-0-82;P=0-017),Camizestrant 150 mg与氟维司群的危险比为0-64(0-46-0-89;P=0-0090)。与治疗相关的不良事件发生率分别为:坎咪司群 75 毫克组 74 例患者中 39 例(53%),坎咪司群 150 毫克组 73 例患者中 49 例(67%),坎咪司群 300 毫克组 20 例患者中 14 例(70%),氟维司群组 73 例患者中 13 例(18%)。任何组别中都没有超过两名(3%)患者发生3级或更严重的治疗突发不良事件。坎维司群75毫克组有6名(8%)患者、坎维司群150毫克组有7名(10%)患者、坎维司群300毫克组有2名(10%)患者、氟维司群组有4名(5%)患者发生了严重的治疗突发不良事件。与氟维司群相比,75 毫克和 150 毫克的坎米司群在无进展生存期方面具有显著优势。这些结果支持进一步开发治疗雌激素受体阳性、HER2阴性乳腺癌的坎米司群。
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引用次数: 0
Correction to Lancet Oncol 2024; 25: 1176–87 Lancet Oncol 2024; 25: 1176-87 更正
Pub Date : 2024-10-25 DOI: 10.1016/s1470-2045(24)00626-0
Vera P, Thureau S, Le Tinier F, et al. Adaptive radiotherapy (up to 74 Gy) or standard radiotherapy (66 Gy) for patients with stage III non-small-cell lung cancer, according to [18F]FDG-PET tumour residual uptake at 42 Gy (RTEP7–IFCT-1402): a multicentre, randomised, controlled phase 2 trial. Lancet Oncol 2024; 25: 1176–87—In this Article, Pierre Boissellier should have been spelled Pierre Boisselier. This correction has been made to the online version as of Oct 25, 2024.
Vera P, Thureau S, Le Tinier F, et al. 根据42 Gy时[18F]FDG-PET肿瘤残留摄取量对III期非小细胞肺癌患者进行适应性放疗(最高74 Gy)或标准放疗(66 Gy)(RTEP7-IFCT-1402):一项多中心随机对照2期试验。Lancet Oncol 2024; 25: 1176-87-在本文中,Pierre Boissellier应拼写为Pierre Boisselier。在线版本已于2024年10月25日进行了更正。
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引用次数: 0
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The Lancet Oncology
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