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Precision palliative care in advanced/recurrent esophageal cancer patients treated with anti-PD-1/PD-L1 immunotherapy (ESO-Shanghai 25): a randomized, phase III Trial. 精确姑息治疗晚期/复发食管癌患者接受抗pd -1/PD-L1免疫治疗(ESO-Shanghai 25):一项随机III期试验
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-03-04 DOI: 10.1080/14796694.2026.2637738
Shengnan Hao, Xiaomin Wang, Huiping Ding, Yun Chen, Qi Liu, Junhua Zhang, Xingwen Fan, Zhenhua Wu, Ying Lin, Xiaofang Xu, Guangmin Mao, Dashan Ai, Jiaying Deng, Hongcheng Zhu, Jinjun Ye, Miao Mo, Zhihuang Hu, Huijie Wang, Wenwu Cheng, Wei Feng, Yiqun Ling, Yufen Xu, Shisuo Du, Jialei Wang, Kuaile Zhao

Over half of patients with advanced or recurrent esophageal cancer experience malnutrition, psychological distress, and cancer-related pain, which impair immune function, diminish quality of life, and attenuate responses to immunotherapy. Whether a precision palliative care (PC) model that integrates nutritional, psychological, and symptomatic support can improve survival and quality of life in these patients undergoing anti-PD-1/PD-L1 immunotherapy remains unknown. We are conducting a multicenter randomized trial to evaluate the superiority of a precision PC model compared with standard oncology care in improving patients' overall survival (OS). All patients will be randomly assigned to either the Standard Arm (standard oncology care)or the Precision Arm (standard oncology care + precision PC). Patients in the Standard Arm receive anti-PD-1/PD-L1 immunotherapy-based standard oncology care. Patients assigned to the Precision Arm receive anti-PD-1/PD-L1 immunotherapy-based standard oncologic care and precision PC, in which patients meeting any of the following criteria are stepped up to meet with the precision PC clinicians every 4 weeks: (1) malnutrition (NRS2002 ≥ 3 or meeting GLIM criteria), (2) psychological distress (GAD-7 ≥ 5 or PHQ-9 ≥ 5), or (3) moderate-to-severe symptoms (any MDASI symptom score ≥4). The primary endpoint is overall survival (OS). The secondary endpoints are quality of life and progression-free survival (PFS).Clinical trial registration: NCT06787313 (clinicaltrials.gov).

超过一半的晚期或复发食管癌患者经历营养不良、心理困扰和与癌症相关的疼痛,这损害了免疫功能,降低了生活质量,减弱了对免疫治疗的反应。在这些接受抗pd -1/PD-L1免疫治疗的患者中,一种整合营养、心理和症状支持的精确姑息治疗(PC)模式是否能提高生存率和生活质量尚不清楚。我们正在进行一项多中心随机试验,以评估精确PC模型与标准肿瘤治疗相比在提高患者总生存期(OS)方面的优势。所有患者将被随机分配到标准组(标准肿瘤治疗)或精确组(标准肿瘤治疗+精确PC)。标准组患者接受基于抗pd -1/PD-L1免疫治疗的标准肿瘤治疗。分配到精确组的患者接受基于抗pd -1/PD-L1免疫治疗的标准肿瘤护理和精确PC,其中符合以下任何标准的患者每4周升级一次与精确PC临床医生见一次:(1)营养不良(NRS2002≥3或符合GLIM标准),(2)心理困扰(GAD-7≥5或PHQ-9≥5),或(3)中度至重度症状(任何MDASI症状评分≥4)。主要终点是总生存期(OS)。次要终点是生活质量和无进展生存期(PFS)。临床试验注册:NCT06787313 (clinicaltrials.gov)。
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引用次数: 0
Trastuzumab deruxtecan in HER2-mutant metastatic non-small-cell lung cancer: a plain language summary of the DESTINY-Lung02 study. 曲妥珠单抗deruxtecan治疗her2突变的转移性非小细胞肺癌:DESTINY-Lung02研究的简明语言总结
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-14 DOI: 10.1080/14796694.2025.2598216
Pasi A Jänne
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引用次数: 0
Correction. 修正。
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2025-07-31 DOI: 10.1080/14796694.2025.2541136
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引用次数: 0
Time to achieve response and depth of maximal tumor response as potential surrogates for overall survival in advanced non-small cell lung cancer. 在晚期非小细胞肺癌中,达到反应的时间和最大肿瘤反应的深度作为总生存期的潜在替代指标。
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-17 DOI: 10.1080/14796694.2026.2630984
Rachel Woodford, Sally Lord, Tom John, James Chih-Hsin Yang, John Simes, Ian Marschner, Chee Khoon Lee

Introduction: Objective response rate (ORR) is a common early endpoint in NSCLC trials, but its ability to predict overall survival (OS) is limited, especially for immunotherapy and targeted treatments. Alternative metrics like time to and depth of response are under evaluation as surrogate endpoints.

Methods: We analyzed pooled data from two randomized trials (OAK, POPLAR) comparing atezolizumab to docetaxel. Tumor response metrics, including RECIST response, time to response, response nadir, time to nadir, and duration of response (DOR), were correlated with OS using landmark survival analyses at 6, 12, and 18 weeks.

Results: Of 1137 patients, 31.2% achieved best RECIST response by week 6, with 17.5% and 12.7% by weeks 12 and 18. Patients with CR/PR had a 61% reduced risk of death versus those with PD. Longer DOR correlated with improved 12-month OS: 54.6% (6 weeks), 67.5% (12 weeks), and 82.1% (18 weeks). Mean target lesion reduction was -33.9%. Greater tumor reduction improved survival, but timing of nadir did not significantly affect OS or differ by treatment arm.

Conclusion: Depth and duration of response are predictive of OS in NSCLC and may aid patient management, however are not adequate surrogate endpoints for OS in clinical trials.

客观缓解率(ORR)是NSCLC试验中常见的早期终点,但其预测总生存期(OS)的能力有限,特别是对于免疫治疗和靶向治疗。响应时间和响应深度等替代指标作为替代端点进行评估。方法:我们分析了两项比较阿特唑单抗和多西他赛的随机试验(OAK, POPLAR)的汇总数据。肿瘤反应指标,包括RECIST反应、反应时间、反应最低点、反应最低点时间和反应持续时间(DOR),在6周、12周和18周时使用里程碑生存分析与OS相关。结果:在1137例患者中,31.2%在第6周达到最佳RECIST反应,在第12周和第18周分别为17.5%和12.7%。与PD患者相比,CR/PR患者的死亡风险降低了61%。较长的DOR与改善的12个月OS相关:54.6%(6周),67.5%(12周)和82.1%(18周)。靶病灶平均缩小率为-33.9%。更大的肿瘤缩小提高了生存率,但最低点的时间对OS没有显著影响,治疗组之间也没有差异。结论:缓解的深度和持续时间可以预测非小细胞肺癌的生存期,并可能有助于患者的管理,但在临床试验中并不是生存期的足够替代终点。
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引用次数: 0
The first United Arab Emirates expert consensus recommendations for the diagnosis and management of early and advanced non-small cell lung cancer. 第一个阿拉伯联合酋长国专家共识建议诊断和管理早期和晚期非小细胞肺癌。
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2025-12-30 DOI: 10.1080/14796694.2025.2610171
Humaid Al Shamsi, Nadia Abdelwahed, Hassan Jaafar, Hassan Ghazal, Hampig Raphael Kourie, Nabih Naim, Sonia Otsman, Nouri Bennini, Emad Dawoud, Diaeddine Trad, Deborah Mukherjee, Saeed Rafii, Dorai Ramanathan, Syed Hamad Tirmazy, Dalia M Elshourbagy, Dina Hamza, Fathi Azribi, Maroun El Khoury, David Planchard, Solange Peters

Lung cancer is the first cause of mortality and the third most common cancer worldwide. In the United Arab Emirates (UAE), lung cancer ranks third in terms of cancer-related mortality and sixth in terms of incidence. In order to strengthen and to improve the management of this cancer in the UAE, a panel of 15 oncologist and pathologist experts in the field of lung cancer developed the first UAE consensus recommendations for the diagnosis and management of early and advanced lung cancer. A total of thirty-three, statements were drafted, discussed, and voted on, using a modified Delphi process. This consensus meeting acts as a cornerstone for the management of cancers in the UAE and highlights the importance of optimized, evidence-based, and patient-centered practices.

肺癌是导致死亡的第一大原因,也是世界上第三大常见癌症。在阿拉伯联合酋长国(阿联酋),肺癌在癌症相关死亡率方面排名第三,在发病率方面排名第六。为了加强和改善阿联酋对这种癌症的管理,一个由肺癌领域的15名肿瘤学家和病理学家专家组成的小组制定了第一个阿联酋关于早期和晚期肺癌诊断和管理的共识建议。总共有33份声明被起草、讨论和投票,使用了一个改进的德尔菲过程。这次共识会议是阿联酋癌症管理的基石,并强调了优化、循证和以患者为中心的实践的重要性。
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引用次数: 0
Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs. 类固醇生成抑制剂opevesostat (MK-5684)用于转移性去势抵抗性前列腺癌:OMAHA-003和OMAHA-004试验设计
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-23 DOI: 10.1080/14796694.2025.2595914
Evan Y Yu, Christian Gratzke, Mauricio Burotto, Alison Y Zhang, Eric Lévesque, Francisco Ortega, Avivit Peer, Donald Vile, Zheng Hong Chen, Yue Song, Charles Schloss, Jelena Todoric, Chris Garratt, Christian Poehlein, Emmanuel S Antonarakis, Karim Fizazi

Treatment options for metastatic castration-resistant prostate cancer (mCRPC) include androgen receptor pathway inhibitors (ARPIs), taxanes, radium-223, Lu-PSMA, poly (ADP-ribose) polymerase inhibitors, and immunotherapy in select patients. Resistance to ARPIs and hormone-based therapies has been associated with AR-ligand-binding domain mutations that can lead to promiscuous stimulation by other steroid hormones. There is a need to explore alternative targets and develop next-generation ARPIs or combination therapies that overcome this resistance. We describe the rationale and design of the randomized phase III trials OMAHA-003 (NCT06136624) and OMAHA-004 (NCT06136650), which will evaluate the efficacy and safety of opevesostat, a steroidogenesis inhibitor, versus ARPI switch in previously treated mCRPC. Results may support opevesostat as a potential new treatment option for mCRPC.Clinical trial registration: www.clinicaltrials.gov identifiers are NCT06136624 and NCT06136650.

转移性去势抵抗性前列腺癌(mCRPC)的治疗选择包括雄激素受体途径抑制剂(arpi)、紫taxanes、镭-223、Lu-PSMA、聚(adp -核糖)聚合酶抑制剂和特定患者的免疫治疗。对arpi和激素治疗的耐药性与ar配体结合结构域突变有关,这种突变可导致其他类固醇激素的混杂刺激。有必要探索替代靶点并开发下一代arpi或联合疗法来克服这种耐药性。我们描述了随机III期试验OMAHA-003 (NCT06136624)和OMAHA-004 (NCT06136650)的基本原理和设计,该试验将评估甾体生成抑制剂opevesostat与ARPI开关在先前治疗的mCRPC中的有效性和安全性。结果可能支持opevesostat作为mCRPC的潜在新治疗选择。临床试验注册:www.clinicaltrials.gov标识符为NCT06136624和NCT06136650。
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引用次数: 0
Associations of systemic inflammatory markers with cancer survival outcomes: a systematic umbrella review. 系统性炎症标志物与癌症生存结局的关联:一项系统的总括性综述。
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-18 DOI: 10.1080/14796694.2026.2630979
Sheng Li, Yan-Yu Zhu, Harry Asena Musonye, Qian-Qian Shi, Jia-Jun Deng, Hai-Feng Pan, Peng Wang

Background: The systemic immune-inflammation index (SII) and systemic inflammation response index (SIRI) have been associated with poor cancer outcomes; however, no comprehensive evaluation across various cancer types has been conducted.

Objectives: To assess the impact of SII/SIRI on survival outcomes in cancer patients.

Methods: Meta-analyses up to May 10, 2025 were retrieved. Pooled hazard ratios were calculated using random-effects models, and evidence quality was evaluated with AMSTAR 2 and Ioannidis criteria.

Results: Seventy-four meta-analyses were included. Elevated SIRI was significantly associated with worse overall survival (HR=1.98), supported by Class I evidence. High SII was also linked to poor prognosis across multiple cancers, with consistent subgroup results.

Conclusions: SII and SIRI are reliable prognostic biomarkers across cancers and may aid clinical decision-making.

背景:全身免疫炎症指数(SII)和全身炎症反应指数(SIRI)与癌症预后不良相关;然而,目前还没有对各种癌症类型进行全面的评估。目的:评估SII/SIRI对癌症患者生存结局的影响。方法:检索截至2025年5月10日的meta分析。使用随机效应模型计算合并风险比,并使用AMSTAR 2和Ioannidis标准评估证据质量。结果:纳入74项荟萃分析。I级证据支持,SIRI升高与较差的总生存期显著相关(HR=1.98)。高SII也与多种癌症的不良预后有关,亚组结果一致。结论:SII和SIRI是可靠的癌症预后生物标志物,可能有助于临床决策。
{"title":"Associations of systemic inflammatory markers with cancer survival outcomes: a systematic umbrella review.","authors":"Sheng Li, Yan-Yu Zhu, Harry Asena Musonye, Qian-Qian Shi, Jia-Jun Deng, Hai-Feng Pan, Peng Wang","doi":"10.1080/14796694.2026.2630979","DOIUrl":"10.1080/14796694.2026.2630979","url":null,"abstract":"<p><strong>Background: </strong>The systemic immune-inflammation index (SII) and systemic inflammation response index (SIRI) have been associated with poor cancer outcomes; however, no comprehensive evaluation across various cancer types has been conducted.</p><p><strong>Objectives: </strong>To assess the impact of SII/SIRI on survival outcomes in cancer patients.</p><p><strong>Methods: </strong>Meta-analyses up to May 10, 2025 were retrieved. Pooled hazard ratios were calculated using random-effects models, and evidence quality was evaluated with AMSTAR 2 and Ioannidis criteria.</p><p><strong>Results: </strong>Seventy-four meta-analyses were included. Elevated SIRI was significantly associated with worse overall survival (HR=1.98), supported by Class I evidence. High SII was also linked to poor prognosis across multiple cancers, with consistent subgroup results.</p><p><strong>Conclusions: </strong>SII and SIRI are reliable prognostic biomarkers across cancers and may aid clinical decision-making.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"729-739"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146219438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Operational efficiencies of using one vs multiple bispecific antibodies for diffuse large B-cell lymphoma and follicular lymphoma in the US. 在美国使用一种与多种双特异性抗体治疗弥漫性大b细胞淋巴瘤和滤泡性淋巴瘤的操作效率
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-27 DOI: 10.1080/14796694.2026.2636559
Tara Graff, Savreet Bains Chawla, Monika Jun, Nicole Heaps, Abualbishr Alshreef, David Tybor, Donald C Moore, Nadine Zawadzki, Kathryn Spurrier, Jason Shafrin

Aim: To quantify the time- and cost-savings to US oncology practices from using a single bispecific antibody (bsAb) for both relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) compared with using two separate single-indication therapies.

Materials & methods: The study conducted a national survey of clinicians (oncologists, pharmacists, nurses/physician assistants) treating non-Hodgkin lymphoma (NHL) patients in the US to quantify the impact of operational efficiencies identified through formative qualitative interviews with oncology staff. Quantitative analysis estimated time-savings based on survey data, assuming one new prescription per patient per year and 12 (DLBCL) and 15 (FL) administration visits per patient per year. Time-savings were combined with staff wage rates to estimate cost-savings.

Results: Among n = 105 respondents, drivers of operational efficiencies included onboarding, coordinating insurance and financial aid, and medication preparation. For a hypothetical community practice treating 100 bsAb-eligible patients (61% DLBCL, 39% FL), total time-savings were 3110 h in the first year of adoption, resulting in total monetized time-savings of $278,013. For a hypothetical academic practice, monetized time-savings were $963,074 in the first year of adoption.

Conclusions: Using a single bsAb to treat R/R DLBCL and FL is predicted to lead to considerable time- and cost-savings for oncology practices.

目的:量化使用单一双特异性抗体(bsAb)治疗复发/难治性(R/R)弥漫性大b细胞淋巴瘤(DLBCL)和滤泡性淋巴瘤(FL)与使用两种单独的单指适应症治疗相比节省的时间和成本。材料与方法:本研究对美国治疗非霍奇金淋巴瘤(NHL)患者的临床医生(肿瘤学家、药剂师、护士/医师助理)进行了一项全国性调查,通过对肿瘤学工作人员的形成性定性访谈,量化了操作效率的影响。定量分析根据调查数据估计节省的时间,假设每位患者每年开一次新处方,每位患者每年12次(DLBCL)和15次(FL)给药。节省的时间与工作人员工资率相结合,以估计节省的费用。结果:在105名受访者中,运营效率的驱动因素包括入职、协调保险和经济援助以及药物准备。假设社区实践治疗100名bsab符合条件的患者(61%为DLBCL, 39%为FL),采用该方法的第一年总节省时间为3110小时,总节省时间为278,013美元。对于一个假设的学术实践,在采用的第一年,货币化的时间节省为963,074美元。结论:使用单一bsAb治疗R/R DLBCL和FL预计可为肿瘤学实践节省大量时间和成本。
{"title":"Operational efficiencies of using one vs multiple bispecific antibodies for diffuse large B-cell lymphoma and follicular lymphoma in the US.","authors":"Tara Graff, Savreet Bains Chawla, Monika Jun, Nicole Heaps, Abualbishr Alshreef, David Tybor, Donald C Moore, Nadine Zawadzki, Kathryn Spurrier, Jason Shafrin","doi":"10.1080/14796694.2026.2636559","DOIUrl":"10.1080/14796694.2026.2636559","url":null,"abstract":"<p><strong>Aim: </strong>To quantify the time- and cost-savings to US oncology practices from using a single bispecific antibody (bsAb) for both relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) compared with using two separate single-indication therapies.</p><p><strong>Materials & methods: </strong>The study conducted a national survey of clinicians (oncologists, pharmacists, nurses/physician assistants) treating non-Hodgkin lymphoma (NHL) patients in the US to quantify the impact of operational efficiencies identified through formative qualitative interviews with oncology staff. Quantitative analysis estimated time-savings based on survey data, assuming one new prescription per patient per year and 12 (DLBCL) and 15 (FL) administration visits per patient per year. Time-savings were combined with staff wage rates to estimate cost-savings.</p><p><strong>Results: </strong>Among n = 105 respondents, drivers of operational efficiencies included onboarding, coordinating insurance and financial aid, and medication preparation. For a hypothetical community practice treating 100 bsAb-eligible patients (61% DLBCL, 39% FL), total time-savings were 3110 h in the first year of adoption, resulting in total monetized time-savings of $278,013. For a hypothetical academic practice, monetized time-savings were $963,074 in the first year of adoption.</p><p><strong>Conclusions: </strong>Using a single bsAb to treat R/R DLBCL and FL is predicted to lead to considerable time- and cost-savings for oncology practices.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"719-727"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147304816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validation of a blood-based autoantibody test to assess lung cancer risk in 4-30 mm pulmonary nodules: a retrospective pooled analysis of four cohort studies. 基于血液的自身抗体检测评估4- 30mm肺结节肺癌风险的有效性:四项队列研究的回顾性汇总分析
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-02-17 DOI: 10.1080/14796694.2026.2626339
Trevor J Pitcher, Kathryn J Long, Michael N Kammer, Sandra Schuldheisz, Bharat Bajantri, Tammy Gleeson, Dragos Zanchi, Sandeep Bansal, Luke Yuhico, Laura J Peek, James R Jett, Viswam S Nair, Gerard A Silvestri

Aim: To validate a blood-based autoantibody test (AAT) as a high specificity, rule-in biomarker for 4-30 mm indeterminate pulmonary nodules (IPN) across malignancy risk.

Methods: Retrospective pooled analysis of four cohorts including adults with a 4-30 mm IPN, AAT result, and benign or malignant diagnosis. AAT results were classified as Moderate Level (all patients with elevated autoantibodies), High Level (stricter subset within Moderate Level), or No Significant Level of Autoantibodies Detected (NSLAD). Post-test probability of cancer (pCA) was calculated by applying AAT likelihood ratios to pretest pCA. Performance was assessed overall, by nodule size, and risk strata.

Results: Among 1164 patients (35% cancer prevalence), Moderate Level results showed sensitivity 16%, specificity 91%, and PPV 50%. A stricter subset of positives at the High Level, specificity 96%, and PPV 57%, with sensitivity 9%. When post-test pCA exceeded 65%, specificity was 97% and PPV 69%, while sensitivity was 12%. Performance was consistent across cohorts, nodule sizes, and risk strata, indicating size- and risk-independent discrimination. ~10% of intermediate-risk cancers (pretest 5-65%) were reclassified above the 65% threshold, creating a group with enriched malignancy risk.

Conclusions: AAT provides size- and risk-independent, high-specificity rule-in performance, identifying subsets of patients whose malignancy risk may justify expedited evaluation.

目的:验证基于血液的自身抗体测试(AAT)作为4- 30mm不确定肺结节(IPN)恶性肿瘤风险的高特异性、常规生物标志物。方法:回顾性汇总分析4个队列,包括4-30 mm IPN, AAT结果和良性或恶性诊断的成年人。AAT结果分为中度水平(所有自身抗体升高的患者)、高水平(中度水平内更严格的子集)或无显著水平自身抗体检测(NSLAD)。检测后癌症概率(pCA)通过应用AAT似然比来计算。通过结节大小和风险等级对绩效进行总体评估。结果:在1164例患者(35%的癌症患病率)中,Moderate Level结果的敏感性为16%,特异性为91%,PPV为50%。高水平阳性的严格子集,特异性为96%,PPV为57%,敏感性为9%。当检测后pCA超过65%时,特异性为97%,PPV为69%,敏感性为12%。结果在队列、结节大小和风险层之间是一致的,表明大小和风险无关的歧视。~10%的中危癌(前测5-65%)被重新分类到65%以上的阈值,形成恶性肿瘤风险高的一组。结论:AAT提供了大小和风险无关,高特异性的规则性能,确定了恶性肿瘤风险可能证明加速评估的患者亚群。
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引用次数: 0
Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. Beamion PANTUMOR-1:宗厄替尼治疗her2过表达/扩增或her2突变实体瘤的II期试验的基本原理和设计。
IF 2.6 4区 医学 Q2 ONCOLOGY Pub Date : 2026-03-01 Epub Date: 2026-03-04 DOI: 10.1080/14796694.2026.2637740
Alison M Schram, John J Park, Antoine Italiano, Shigehisa Kitano, Ye Guo, Jin Li, Philippe L Bedard, Cedric van Marcke, Ryo Ko, Lukas Lunger, Daniel M Klotz, Jo Hussain, Daniela Maier, Damijan Erzen, David Planchard, Hans Prenen, Timothy D Clay, Joon O Park, Hyung-Don Kim, Alberto Hernando-Calvo, Yuta Maruki, Mariano Ponz-Sarvise, Ecaterina Dumbrava

Human epidermal growth factor receptor 2 (HER2, encoded by ERBB2) alterations are known oncogenic drivers in many solid tumors. Zongertinib is a novel, oral, irreversible, HER2-selective tyrosine kinase inhibitor that spares wild-type epidermal growth factor receptor, thereby limiting associated toxicities. In a Phase Ia/Ib trial (NCT04886804), zongertinib demonstrated encouraging activity with a manageable safety profile in HER2-altered tumors (HER2 overexpression, amplification, or mutations).The Phase II, open-label, Beamion PANTUMOR-1 basket trial (NCT06581432) is evaluating the efficacy and safety of zongertinib monotherapy in previously treated patients with HER2-positive (HER2-overexpressed/amplified) or HER2-mutant solid tumors. Patients with HER2-positive tumors will be enrolled to one of eight cohorts: urothelial, biliary tract, uterine, cervical, non-squamous lung, salivary gland, colorectal or tumor agnostic. Patients with HER2-mutant tumors will be enrolled to one of five cohorts: urothelial, breast, gastroesophageal, biliary tract or tumor agnostic. Patients will receive zongertinib 120 mg orally once daily until disease progression (RECIST v1.1), unacceptable toxicity, death, or withdrawal of patient consent, whichever occurs first. The primary endpoint is objective response (central independent review, RECIST v1.1). Secondary endpoints include duration of response, progression-free survival, disease control, occurrence of treatment-emergent adverse events, and health-related quality of life. Recruitment is ongoing in 13 countries globally.Clinical trial registration http://www.clinicaltrials.gov identifier is NCT06581432.

人类表皮生长因子受体2 (HER2,由ERBB2编码)的改变是许多实体瘤中已知的致癌驱动因素。Zongertinib是一种新型的口服、不可逆、her2选择性酪氨酸激酶抑制剂,可避免野生型表皮生长因子受体,从而限制相关毒性。在一项Ia/Ib期试验(NCT04886804)中,zongertinib在HER2改变的肿瘤(HER2过表达、扩增或突变)中表现出令人鼓舞的活性和可管理的安全性。II期开放标签Beamion PANTUMOR-1一揽子试验(NCT06581432)正在评估宗厄替尼单药治疗先前治疗过的her2阳性(her2过表达/扩增)或her2突变实体瘤患者的疗效和安全性。her2阳性肿瘤患者将被纳入8个队列中的一个:尿路上皮、胆道、子宫、宫颈、非鳞状肺、唾液腺、结直肠或肿瘤不可测者。her2突变肿瘤患者将被纳入五个队列中的一个:尿路上皮、乳腺、胃食管、胆道或肿瘤不可知性队列。患者将每日口服一次宗尔替尼120mg,直至疾病进展(RECIST v1.1)、不可接受的毒性、死亡或患者撤回同意,以先发生者为准。主要终点是客观反应(中央独立审查,RECIST v1.1)。次要终点包括反应持续时间、无进展生存期、疾病控制、治疗后出现的不良事件的发生以及与健康相关的生活质量。目前正在全球13个国家进行招聘。临床试验注册http://www.clinicaltrials.gov标识符为NCT06581432。
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引用次数: 0
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Future oncology
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