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).
{"title":"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.","authors":"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","doi":"10.1080/14796694.2026.2637738","DOIUrl":"10.1080/14796694.2026.2637738","url":null,"abstract":"<p><p>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).</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"773-780"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12977270/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147354863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-02-14DOI: 10.1080/14796694.2025.2598216
Pasi A Jänne
{"title":"Trastuzumab deruxtecan in HER2-mutant metastatic non-small-cell lung cancer: a plain language summary of the DESTINY-Lung02 study.","authors":"Pasi A Jänne","doi":"10.1080/14796694.2025.2598216","DOIUrl":"10.1080/14796694.2025.2598216","url":null,"abstract":"","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"659-670"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146194432","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}
Pub Date : 2026-03-01Epub Date: 2026-02-17DOI: 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.
{"title":"Time to achieve response and depth of maximal tumor response as potential surrogates for overall survival in advanced non-small cell lung cancer.","authors":"Rachel Woodford, Sally Lord, Tom John, James Chih-Hsin Yang, John Simes, Ian Marschner, Chee Khoon Lee","doi":"10.1080/14796694.2026.2630984","DOIUrl":"10.1080/14796694.2026.2630984","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"699-707"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12962690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146212470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2025-12-30DOI: 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.
{"title":"The first United Arab Emirates expert consensus recommendations for the diagnosis and management of early and advanced non-small cell lung cancer.","authors":"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","doi":"10.1080/14796694.2025.2610171","DOIUrl":"10.1080/14796694.2025.2610171","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"757-763"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12977246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145855431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-02-23DOI: 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.
{"title":"Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs.","authors":"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","doi":"10.1080/14796694.2025.2595914","DOIUrl":"10.1080/14796694.2025.2595914","url":null,"abstract":"<p><p>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.<b>Clinical trial registration:</b> www.clinicaltrials.gov identifiers are NCT06136624 and NCT06136650.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"765-772"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12977254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147276050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-02-18DOI: 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.
{"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}
Pub Date : 2026-03-01Epub Date: 2026-02-27DOI: 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.
{"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}
Pub Date : 2026-03-01Epub Date: 2026-02-17DOI: 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。
{"title":"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.","authors":"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","doi":"10.1080/14796694.2026.2626339","DOIUrl":"10.1080/14796694.2026.2626339","url":null,"abstract":"<p><strong>Aim: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>AAT provides size- and risk-independent, high-specificity rule-in performance, identifying subsets of patients whose malignancy risk may justify expedited evaluation.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"831-842"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12977245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146212456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-03-04DOI: 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.
{"title":"Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or <i>HER2</i>-mutant solid tumors.","authors":"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","doi":"10.1080/14796694.2026.2637740","DOIUrl":"10.1080/14796694.2026.2637740","url":null,"abstract":"<p><p>Human epidermal growth factor receptor 2 (HER2, encoded by <i>ERBB2</i>) 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 <i>HER2</i>-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 <i>HER2</i>-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.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"795-803"},"PeriodicalIF":2.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12977268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147348224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}