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Considerations of Lay Health Worker Intervention Among Patients With Advanced Cancer. 对晚期癌症患者进行非专业卫生工作者干预的考虑因素。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-17 DOI: 10.1001/jamaoncol.2024.4575
Kai Kang,Yijun Wu
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引用次数: 0
Lenvatinib Plus Ifosfamide and Etoposide in Children and Young Adults With Relapsed Osteosarcoma: A Phase 2 Randomized Clinical Trial. 在复发性骨肉瘤儿童和青少年患者中使用乐伐替尼+伊夫法胺和依托泊苷:2期随机临床试验。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-17 DOI: 10.1001/jamaoncol.2024.4381
Nathalie Gaspar,Giun-Yi Hung,Sandra J Strauss,Quentin Campbell-Hewson,Filemon S Dela Cruz,Julia L Glade Bender,Kyung-Nam Koh,Sarah B Whittle,Godfrey Chi-Fung Chan,Nicolas U Gerber,Sauli Palmu,Daniel A Morgenstern,Alessandra Longhi,Fredrik Baecklund,Jun Ah Lee,Franco Locatelli,Catalina Márquez Vega,Katherine A Janeway,Geoffrey McCowage,Martin G McCabe,Behzad Bidadi,Jie Huang,Jodi McKenzie,Chinyere E Okpara,Francisco Bautista,
ImportanceThe combination of ifosfamide and etoposide (IE) is commonly used to treat relapsed or refractory osteosarcoma; however, second-line treatment recommendations vary across guidelines.ObjectiveTo evaluate whether the addition of lenvatinib to IE (LEN-IE) improves outcomes in children and young adults with relapsed or refractory osteosarcoma.Design, Setting, and ParticipantsThe OLIE phase II, open-label, randomized clinical trial was conducted globally across Europe, Asia and the Pacific, and North America. From March 22, 2020, through November 11, 2021, the trial enrolled patients aged 2 to 25 years with high-grade osteosarcoma, measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), and 1 to 2 prior lines of systemic treatment. The data analyses were performed between March 22, 2020 (first patient in) and June 22, 2022 (data cutoff for the primary analysis), and September 29, 2023 (end of study final database lock).InterventionsThe OLIE trial assessed the efficacy and safety of lenvatinib (14 mg/m2 taken orally once daily) combined with up to 5 cycles of ifosfamide (3000 mg/m2 intravenously) and etoposide (100 mg/m2 intravenously) on days 1 to 3 of each cycle vs IE alone at the same doses. Patients randomized to IE could cross over to receive lenvatinib upon disease progression by independent imaging review.Main Outcomes and MeasuresThe primary end point was progression-free survival (PFS) per RECIST 1.1 by independent imaging review. The Kaplan-Meier method was used to estimate the PFS distribution, with a prespecified 1-sided significance threshold of .025 by stratified log-rank test. Secondary end points included PFS rate at 4 months and overall survival. Adverse events were summarized using descriptive statistics.ResultsA total of 81 patients were enrolled (median [IQR] age, 15.0 [12.0-18.0] years; 46 males [56.8%]), with 40 in the LEN-IE arm and 41 in the IE arm. Median PFS was 6.5 months (95% CI, 5.7-8.2 months) for the LEN-IE arm and 5.5 months (95% CI, 2.9-6.5 months) for the IE arm (hazard ratio [HR], 0.54; 95% CI, 0.27-1.08; 1-sided P = .04). The rate of PFS at 4 months was 76.3% (95% CI, 59.3%-86.9%) in the LEN-IE arm and 66.0% (95% CI, 47.7%-79.2%) in the IE arm. Median overall survival was 11.9 months (95% CI, 10.1 months to not estimable) with LEN-IE and 17.4 months (95% CI, 14.2 months to not estimable) with IE (HR, 1.28; 95% CI, 0.60-2.70; 1-sided nominal P = .75). Grade 3 or higher treatment-related adverse events occurred in 35 of 39 patients (89.7%) in the LEN-IE arm and 31 of 39 patients (79.5%) in the IE arm.Conclusions and RelevanceAlthough LEN-IE did not meet prespecified statistical significance for improved PFS vs IE, this study demonstrates the importance of international collaboration and randomized clinical trials in patients with relapsed or refractory osteosarcoma and may inform future trial design.Trial RegistrationClinicalTrials.gov Identifier: NCT0415418
重要性伊佛酰胺和依托泊苷(IE)联合疗法常用于治疗复发或难治性骨肉瘤;然而,不同指南对二线治疗的建议各不相同。目的评估在IE(LEN-IE)中添加来伐替尼是否能改善复发或难治性骨肉瘤儿童和年轻成人患者的预后。从2020年3月22日到2021年11月11日,该试验招募了2至25岁的高级别骨肉瘤患者,根据《实体瘤反应评价标准1.1版》(RECIST 1.1),这些患者的疾病可测量或可评价,且之前接受过1至2种系统治疗。干预措施OLIE试验评估了来伐替尼(14毫克/平方米,每天口服一次)与伊福法胺(3000毫克/平方米,静脉注射)和依托泊苷(100毫克/平方米,静脉注射)最多5个周期(每个周期的第1至3天)的疗效和安全性。经独立影像学审查,随机接受IE治疗的患者在疾病进展时可交叉接受来伐替尼治疗。主要结果和测量指标主要终点是经独立影像学审查,根据RECIST 1.1标准得出的无进展生存期(PFS)。采用Kaplan-Meier法估计PFS分布,通过分层对数秩检验,预设的单侧显著性阈值为0.025。次要终点包括4个月的PFS率和总生存率。结果 共有81名患者入组(中位数[IQR]年龄为15.0[12.0-18.0]岁;46名男性[56.8%]),其中LEN-IE组40人,IE组41人。LEN-IE 治疗组的中位 PFS 为 6.5 个月(95% CI,5.7-8.2 个月),IE 治疗组为 5.5 个月(95% CI,2.9-6.5 个月)(危险比 [HR],0.54;95% CI,0.27-1.08;单侧 P = .04)。LEN-IE治疗组4个月的PFS率为76.3%(95% CI,59.3%-86.9%),IE治疗组为66.0%(95% CI,47.7%-79.2%)。LEN-IE的中位总生存期为11.9个月(95% CI,10.1个月至无法估计),IE为17.4个月(95% CI,14.2个月至无法估计)(HR,1.28;95% CI,0.60-2.70;单侧名义P = .75)。LEN-IE治疗组39例患者中有35例(89.7%)发生了3级或3级以上治疗相关不良事件,IE治疗组39例患者中有31例(79.5%)发生了3级或3级以上治疗相关不良事件。结论与相关性虽然LEN-IE与IE相比在改善PFS方面未达到预设的统计学显著性,但这项研究表明了国际合作和随机临床试验在复发或难治性骨肉瘤患者中的重要性,并可为未来的试验设计提供参考:NCT04154189。
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引用次数: 0
Endometrial Cancer Classification and Management in the Molecular Subtyping Era 分子亚型时代的子宫内膜癌分类与管理
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4376
Anjelica Hodgson, Kathy Han
A 65-year-old woman presented with a 6-month history of postmenopausal vaginal bleeding, and endometrial biopsy showed grade 2 endometrioid adenocarcinoma. What would you do next?
一名 65 岁的妇女绝经后阴道出血 6 个月,子宫内膜活检显示为 2 级子宫内膜样腺癌。接下来您会怎么做?
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引用次数: 0
Differences in Sentinel Node Biopsy and Targeted Axillary Dissection Following Neoadjuvant Chemotherapy-Reply. 新辅助化疗后前哨节点活检和腋窝靶向切除术的差异--回复。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4572
Giacomo Montagna,Monica Morrow,Walter P Weber
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引用次数: 0
Differences in Sentinel Node Biopsy and Targeted Axillary Dissection Following Neoadjuvant Chemotherapy. 新辅助化疗后前哨节点活检和靶向腋窝切除术的差异。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4569
Mangesh A Thorat
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引用次数: 0
Natural Language Processing–Assessed Unmet Medical and Social Needs in Cancer Crowdfunding Stories 通过自然语言处理评估癌症众筹故事中未满足的医疗和社会需求
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4412
Zhiyuan Zheng, Shaojun Yu, Farhad Islami, Matthew P. Banegas, Jingxuan Zhao, Jing Zhang, Fumiko Chino, K. Robin Yabroff
This cross-sectional study uses a large natural language processing model to examine unmet medical and social needs based on cancer-related fundraising stories in the US.
这项横断面研究使用大型自然语言处理模型,根据美国癌症相关筹款故事,研究未得到满足的医疗和社会需求。
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引用次数: 0
Ninth Version of the AJCC and UICC Nasopharyngeal Cancer TNM Staging Classification 第九版 AJCC 和 UICC 鼻咽癌 TNM 分期分类法
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4354
Jian-Ji Pan, Hai-Qiang Mai, Wai Tong Ng, Chao-Su Hu, Jin-Gao Li, Xiao-Zhong Chen, James C. H. Chow, Edwin Wong, Victor Lee, Ling-Yu Ma, Qiao-Juan Guo, Qin Liu, Li-Zhi Liu, Ting-Ting Xu, Xiao-Chang Gong, Meng-Yun Qiang, Kwok-Hung Au, Tsz-Chim Liu, Chi Leung Chiang, You-Ping Xiao, Shao-Jun Lin, Yun-Bin Chen, Shan-Shan Guo, Charlene H. L. Wong, Lin-Quan Tang, Zhi-Yuan Xu, Yi-Zhen Jia, Wen-Sa Peng, Li-Ping Hu, Tian-Zhu Lu, Feng Jiang, Cai-Neng Cao, Wei Xu, Jun Ma, Pierre Blanchard, Michelle Williams, Christine M. Glastonbury, Ann D. King, Snehal G. Patel, Raja R. Seethala, A. Dimitrios Colevas, Dai-Ming Fan, Melvin L. K. Chua, Shao Hui Huang, Brian O’Sullivan, William Lydiatt, Anne W. M. Lee
ImportanceAccurate staging is a fundamental step in treating patients with nasopharyngeal carcinoma (NPC) worldwide; this is crucial not only for prognostication, but also for guiding treatment decisions. The American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) tumor-node-metastasis (TNM) system is the global language for clinicians, researchers, and cancer registries. Continual improvement that aligns with contemporary pattern of care is essential.ObjectiveTo improve the prognostic accuracy and clinical applicability of the eighth edition (TNM-8) for NPC.Design, Setting, and ParticipantsThis multicenter study analyzed patients with NPC with detailed tumor features during January 2014 and December 2015 and was reviewed by experienced radiologists. The data analysis was completed in December 2023. The findings were further confirmed with internal and external validation. Statistical analyses and clinical considerations were reviewed by the AJCC/UICC multidisciplinary head and neck panels and attained consensus. The recommendations were evaluated by the AJCC Evidence-Based Medicine Committee before final endorsement as the ninth version (TNM-9).Main Outcomes and MeasuresThe primary end point was overall survival. Adjusted hazard ratios of different subgroups were then assessed for confirmation of optimal stage grouping.ResultsOf the 4914 patients analyzed, 1264 (25.7%) were female and 3650 (74.3%) were male; the median (SD) age was 48.1 (12.0) years. Advanced radiological extranodal extension (with involvement of adjacent muscles, skin, and/or neurovascular bundles) was identified as an independent adverse factor for all end points: this was added as a criterion for N3. Patients with nonmetastatic disease were regrouped into stages I to III instead of TNM-8 stages I to IVA. Significant hazard discrimination was achieved by grouping T1-2N0-1 as stage I, T3/N2 as stage II, and T4/N3 as stage III. Although the T1-2N0-1 subgroups had comparable 5-year overall survival, subdivisions into IA (T1-T2N0) and IB (T1-T2N1) were recommended due to the distinction in adjusted hazard ratios following adjustment for chemotherapy use. Metastatic disease was exclusively classified as stage IV, and prognostication was further refined by subdivision into IVA (M1a, ≤3 lesions) and IVB (M1b, >3 lesions). TNM-9 demonstrated superiority compared with TNM-8 in major statistical aspects.Conclusion and RelevanceThe results of this diagnostic study suggest that the ninth version of TNM staging for NPC, based on robust analyses and a comprehensive review by the AJCC/UICC staging committees, provides an improved staging system for global application and a framework for future incorporation of nonanatomical factors. This will be launched for global application in January 2025.
重要性准确分期是全球鼻咽癌(NPC)患者治疗的基本步骤;这不仅对预后至关重要,而且对指导治疗决策也至关重要。美国癌症联合委员会(AJCC)/国际癌症控制联盟(UICC)的肿瘤-结节-转移(TNM)系统是临床医生、研究人员和癌症登记处的全球语言。这项多中心研究分析了 2014 年 1 月至 2015 年 12 月间具有详细肿瘤特征的鼻咽癌患者,并由经验丰富的放射科医生进行了审查。数据分析于 2023 年 12 月完成。研究结果经内部和外部验证进一步确认。AJCC/UICC头颈部多学科小组对统计分析和临床考虑进行了审查,并达成了共识。AJCC循证医学委员会对这些建议进行了评估,最终将其批准为第九版(TNM-9)。然后评估不同亚组的调整后危险比,以确认最佳分期分组。结果在分析的4914例患者中,女性1264例(25.7%),男性3650例(74.3%);中位(标清)年龄为48.1(12.0)岁。晚期放射学结节外扩展(累及邻近肌肉、皮肤和/或神经血管束)被认为是影响所有终点的一个独立不利因素:这也是N3的一个新增标准。非转移性疾病患者被重新分组为 I 至 III 期,而不是 TNM-8 I 至 IVA 期。将T1-2N0-1分为I期,将T3/N2分为II期,将T4/N3分为III期,可以显著区分危险。虽然T1-2N0-1亚组的5年总生存率相当,但由于化疗调整后的调整危险比存在差异,建议将其细分为IA(T1-T2N0)和IB(T1-T2N1)。转移性疾病完全被划分为IV期,并通过细分为IVA(M1a,≤3个病灶)和IVB(M1b,>3个病灶)进一步细化预后。这项诊断研究的结果表明,基于AJCC/UICC分期委员会的可靠分析和全面审查,第九版鼻咽癌TNM分期为全球应用提供了一个改进的分期系统,并为未来纳入非解剖学因素提供了一个框架。该系统将于 2025 年 1 月在全球推出。
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引用次数: 0
Staging and Prognosis of Nasopharyngeal Cancer: The Time for Change Is Now. 鼻咽癌的分期与预后:现在是改变的时候了。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4201
Sweet Ping Ng,Darrion Mitchell
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引用次数: 0
Implementing Resource-Stratified Guidelines in LMICs—More Issues Than Solutions 在低收入与中等收入国家实施资源分层指南--问题多于解决方案
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-10 DOI: 10.1001/jamaoncol.2024.4351
Shweta Baral
This Viewpoint discusses the importance of formulating more stable local treatment guidelines because international guidelines and even resource-stratified guidelines may not be as applicable in low- to middle-income countries.
本视点讨论了制定更加稳定的本地治疗指南的重要性,因为国际指南甚至是资源分级指南可能并不适用于中低收入国家。
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引用次数: 0
Error in Abstract and Methods. 摘要和方法中的错误。
IF 22.5 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-01 DOI: 10.1001/jamaoncol.2022.0062
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引用次数: 0
期刊
JAMA Oncology
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