Journal of Thoracic Oncology最新文献

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Neoadjuvant or Perioperative Chemoimmunotherapy Treatment in Patients with Resectable NSCLC: Still an Open Question. Comments on Marinelli et al. J Thorac Oncol. 2025;20:285-295. 可切除的非小细胞肺癌患者的新辅助或围手术期化学免疫治疗:仍然是一个悬而未决的问题。对Marinelli等人的评论。[J]中华胸外科杂志,2015;20:285-295。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-04 DOI: 10.1016/j.jtho.2025.05.007
Urania Dafni, Zoi Tsourti, Aikaterini Vervita, Panagiota Zygoura, Solange Peters
{"title":"Neoadjuvant or Perioperative Chemoimmunotherapy Treatment in Patients with Resectable NSCLC: Still an Open Question. Comments on Marinelli et al. J Thorac Oncol. 2025;20:285-295.","authors":"Urania Dafni, Zoi Tsourti, Aikaterini Vervita, Panagiota Zygoura, Solange Peters","doi":"10.1016/j.jtho.2025.05.007","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.05.007","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144216240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Updated Efficacy and Safety From the Phase 2 PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic NSCLC‒A Brief Report. enorafenib + Binimetinib治疗BRAF v600e突变转移性非小细胞肺癌的最新疗效和安全性-简要报告
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-04 DOI: 10.1016/j.jtho.2025.05.023
Gregory J Riely, Myung-Ju Ahn, Jeffrey M Clarke, Ibiayi Dagogo-Jack, Raymond Esper, Enriqueta Felip, Francesco Gelsomino, Jonathan W Goldman, Maen Hussein, Melissa Johnson, Kristen A Marrone, Daniel Morgensztern, Ernest Nadal, Marcelo V Negrao, Michael Offin, Mariano Provencio, Suresh S Ramalingam, Logan Roof, Rachel E Sanborn, Egbert F Smit, Anne Tsao, Tiziana Usari, Ann Alcasid, Keith Wilner, Svitlana Tonkovyd, Xiaosong Zhang, Bruce E Johnson
{"title":"Updated Efficacy and Safety From the Phase 2 PHAROS Study of Encorafenib Plus Binimetinib in Patients With BRAF V600E-Mutant Metastatic NSCLC‒A Brief Report.","authors":"Gregory J Riely, Myung-Ju Ahn, Jeffrey M Clarke, Ibiayi Dagogo-Jack, Raymond Esper, Enriqueta Felip, Francesco Gelsomino, Jonathan W Goldman, Maen Hussein, Melissa Johnson, Kristen A Marrone, Daniel Morgensztern, Ernest Nadal, Marcelo V Negrao, Michael Offin, Mariano Provencio, Suresh S Ramalingam, Logan Roof, Rachel E Sanborn, Egbert F Smit, Anne Tsao, Tiziana Usari, Ann Alcasid, Keith Wilner, Svitlana Tonkovyd, Xiaosong Zhang, Bruce E Johnson","doi":"10.1016/j.jtho.2025.05.023","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.05.023","url":null,"abstract":"<p><strong>Introduction: </strong>The PHAROS primary analysis showed robust antitumor activity and acceptable safety with encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC). We report results after 18 months of additional follow-up.</p><p><strong>Methods: </strong>In this ongoing open-label, single-arm, phase 2 study, patients with BRAF V600E-mutant mNSCLC (59 treatment-naïve and 39 previously treated) received encorafenib 450 mg once daily and binimetinib 45 mg twice daily. Primary endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.</p><p><strong>Results: </strong>At this data cutoff, median treatment duration with encorafenib plus binimetinib was 16.3 months in treatment-naïve and 5.5 months in previously treated patients; minimum follow-up was approximately 32 and 22 months, respectively. In treatment-naïve patients, the ORR was 75%, median DOR was 40.0 months, median PFS was 30.2 months, median OS was not estimable (NE; 95% CI: 31.3-NE), and the 3-year OS rate was 53%. In previously treated patients, the ORR was 46%, median DOR was 16.7 months, median PFS was 9.3 months, median OS was 22.7 months, and the 3-year OS rate was 29%. Overall, the most frequent treatment-related adverse events (TRAEs) were nausea (52%), diarrhea (44%), fatigue (33%), and vomiting (30%). TRAEs led to dose reductions and permanent treatment discontinuations in 25 (26%) and 16 (16%) patients, respectively.</p><p><strong>Conclusions: </strong>With longer follow-up, encorafenib plus binimetinib showed durable and clinically meaningful antitumor activity, especially in treatment-naïve patients, with a manageable safety profile in patients with BRAF V600E-mutant mNSCLC.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144248483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-PD-(L)1 Plus Platinum Chemotherapy. LEAP-008: Lenvatinib + Pembrolizumab用于抗pd -(L)1 +铂化疗后进展的转移性NSCLC。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-03 DOI: 10.1016/j.jtho.2025.05.020
Natasha B Leighl, Luis Paz-Ares, Delvys Rodriguez Abreu, Rina Hui, Sofia Baka, Frédéric Bigot, Makoto Nishio, Alexey Smolin, Samreen Ahmed, Adam J Schoenfeld, Sameh Daher, Diego L Cortinovis, Vincenzo Di Noia, Helena Linardou, Justin F Gainor, Corina Dutcus, Chinyere E Okpara, Xuan Deng, Debra Kush, Ashwini Arunachalam, Andrew Song, Byoung Chul Cho
{"title":"LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-PD-(L)1 Plus Platinum Chemotherapy.","authors":"Natasha B Leighl, Luis Paz-Ares, Delvys Rodriguez Abreu, Rina Hui, Sofia Baka, Frédéric Bigot, Makoto Nishio, Alexey Smolin, Samreen Ahmed, Adam J Schoenfeld, Sameh Daher, Diego L Cortinovis, Vincenzo Di Noia, Helena Linardou, Justin F Gainor, Corina Dutcus, Chinyere E Okpara, Xuan Deng, Debra Kush, Ashwini Arunachalam, Andrew Song, Byoung Chul Cho","doi":"10.1016/j.jtho.2025.05.020","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.05.020","url":null,"abstract":"<p><strong>Background: </strong>LEAP-008 (NCT03976375) was an open-label, randomized, phase 3 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic NSCLC that progressed on anti‒programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapy and platinum-containing chemotherapy.</p><p><strong>Methods: </strong>Participants were randomized 4:4:1 to once-daily lenvatinib 20 mg plus pembrolizumab 200 mg every 3 weeks (maximum 35 cycles), docetaxel 75 mg/m<sup>2</sup> every 3 weeks, or once-daily lenvatinib 24 mg. Primary endpoints were overall survival (OS) and progression-free survival (PFS) per RECIST version 1.1 by central review. Superiority of lenvatinib plus pembrolizumab versus docetaxel was assessed at interim analysis 2 for PFS and at final analysis for OS.</p><p><strong>Results: </strong>Participants (N=422) were randomized to lenvatinib plus pembrolizumab (n=185), docetaxel (n=189), or lenvatinib monotherapy (n=48). Median (95% CI) PFS was 5.6 (4.2‒6.5) months with lenvatinib plus pembrolizumab and 4.2 (3.2‒5.2) months with docetaxel (hazard ratio [HR], 0.89 [95% CI, 0.70‒1.12]; P=0.164). Median (95% CI) OS was 11.3 (9.4‒13.2) versus 12.0 (9.6‒13.7) months (HR, 0.98 [95% CI, 0.78‒1.23]; P=0.434). Rates of treatment-related adverse events (AEs) were 91.7%, 91.0%, and 89.4% with lenvatinib plus pembrolizumab, docetaxel, and lenvatinib, respectively; rates of grade 3 to 5 treatment-related AEs were 59.7%, 48.6%, and 57.4%. Health-related quality of life scores were similar between treatment arms.</p><p><strong>Conclusion: </strong>Lenvatinib plus pembrolizumab did not improve efficacy versus docetaxel in participants with stage IV NSCLC that progressed on anti‒PD-1/PD-L1 therapy and platinum-containing chemotherapy. There were no unexpected safety signals. More effective therapies are needed for this patient population.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Treatment-Free Survival Over 6 Years of Follow-up in Patients With Metastatic Non-small Cell Lung Cancer Treated With First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in CheckMate 227 Part 1. 在CheckMate 227第1部分中,接受一线Nivolumab + Ipilimumab治疗的转移性非小细胞肺癌患者的无治疗生存率超过6年的随访
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-03 DOI: 10.1016/j.jtho.2025.05.019
Solange Peters, Meredith M Regan, Luis G Paz-Ares, Martin Reck, Hossein Borghaei, Kenneth J O'Byrne, Julie R Brahmer, John R Penrod, Janice Li, LaRee Tracy, Yong Yuan, Judith Bushong, Adam Lee, Laura J Eccles, Saurabh Ray, Suresh S Ramalingam
{"title":"Treatment-Free Survival Over 6 Years of Follow-up in Patients With Metastatic Non-small Cell Lung Cancer Treated With First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in CheckMate 227 Part 1.","authors":"Solange Peters, Meredith M Regan, Luis G Paz-Ares, Martin Reck, Hossein Borghaei, Kenneth J O'Byrne, Julie R Brahmer, John R Penrod, Janice Li, LaRee Tracy, Yong Yuan, Judith Bushong, Adam Lee, Laura J Eccles, Saurabh Ray, Suresh S Ramalingam","doi":"10.1016/j.jtho.2025.05.019","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.05.019","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment-free survival (TFS) characterizes periods of disease control and durable clinical benefit following treatment discontinuation in patients treated with immunotherapy. In CheckMate 227 Part 1, nivolumab plus ipilimumab showed long-term durable overall survival (OS) benefit versus chemotherapy in patients with metastatic NSCLC. Here, we report updated long-term TFS results.</p><p><strong>Methods: </strong>This analysis included all randomized patients (tumor PD-L1 expression ≥1% and <1%). TFS was estimated as the restricted-mean survival time (between Kaplan-Meier curves for time to treatment discontinuation and time to subsequent systemic therapy/death) over 6-years post-randomization. TFS was further divided into periods with/without ongoing toxicity (grade ≥3 treatment-related adverse events [TRAEs]) and estimated over 2- and 6-years post-randomization.</p><p><strong>Results: </strong>At 6-years post-randomization (minimum follow-up: 73.5 months [∼6.1 years]), the estimated OS rate was 20% with nivolumab plus ipilimumab versus 11% with chemotherapy; 13% versus 2% of patients were treatment free. The 6-year mean TFS was 12.2 versus 5.0 (difference 7.2 [95% confidence interval (CI): 5.4-9.2]) months, with 17% versus 7% of the 6-year period spent in TFS. The 6-year mean TFS without grade ≥3 TRAEs was 11.6 versus 4.8 (difference, 6.9 [95% CI: 5.1-8.9]) months. The proportion of mean TFS time increased from 15% of 2-year to 17% of 6-year period with nivolumab plus ipilimumab but decreased from 14% to 7% with chemotherapy. Similar results were observed by tumor PD-L1 expression.</p><p><strong>Conclusions: </strong>Nivolumab plus ipilimumab improved TFS versus chemotherapy, regardless of tumor PD-L1 expression, supporting its use as an efficacious first-line treatment for metastatic NSCLC.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Quantitative and dynamic ctDNA as a biomarker of response and survival in lung squamous cancer patients receiving immunochemotherapy or chemotherapy alone. 定量和动态ctDNA作为肺鳞癌患者接受免疫化疗或单独化疗的反应和生存的生物标志物。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-03 DOI: 10.1016/j.jtho.2025.05.021
Fei Zhou, Jiao Zhang, Shengxiang Ren, Jianhua Chen, Feifei Li, Ting Ma, Yong Fang, Qiming Wang, Wenxiu Yao, Renhua Guo, Dongqing Lv, Shundong Cang, Xiaorong Dong, Huijuan Wang, Nong Yang, Yun Fan, Jiuwei Cui, Ziping Wang, Jianxing He, Yu S Huang, Weizhi Chen, Li-Di Xu, Caicun Zhou
{"title":"Quantitative and dynamic ctDNA as a biomarker of response and survival in lung squamous cancer patients receiving immunochemotherapy or chemotherapy alone.","authors":"Fei Zhou, Jiao Zhang, Shengxiang Ren, Jianhua Chen, Feifei Li, Ting Ma, Yong Fang, Qiming Wang, Wenxiu Yao, Renhua Guo, Dongqing Lv, Shundong Cang, Xiaorong Dong, Huijuan Wang, Nong Yang, Yun Fan, Jiuwei Cui, Ziping Wang, Jianxing He, Yu S Huang, Weizhi Chen, Li-Di Xu, Caicun Zhou","doi":"10.1016/j.jtho.2025.05.021","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.05.021","url":null,"abstract":"<p><strong>Introduction: </strong>Although circulating tumor DNA (ctDNA) dynamics have been widely explored for therapeutic response assessment, standardized methodologies remain elusive. Here, we developed MinerVa-Delta, a novel approach to quantify ctDNA dynamics by calculating weighted mutation changes in samples with multiple tracked variants.</p><p><strong>Methods: </strong>MinerVa-Delta was developed and analytically validated using serially diluted reference samples. The optimal cutoff was determined in a discovery cohort of 227 advanced lung squamous cell carcinoma (LUSC) patients receiving PD-1 blockade plus chemotherapy or chemotherapy alone, and further validated in an independent cohort of 97 LUSC patients treated with chemotherapy alone. Variants were de-novo called in pre-treatment samples using a 769-gene next-generation sequencing (NGS) panel, serving as a basis for personalized variant tracking in post-treatment plasma after two cycles of treatment. We applied MinerVa-Delta to evaluate prognosis and therapeutic response in advanced LUSC.</p><p><strong>Results: </strong>Patients classified as molecular responders (MinerVa-Delta < 30%) exhibited significantly improved outcomes compared to non-responder (MinerVa-Delta ≥ 30%), with superior progression-free survival (PFS) and overall survival (OS) (HR = 0.19, p < 0.001 for PFS; HR = 0.24, p < 0.001 for OS). MinerVa-Delta displayed consistent prediction performance in the validation cohort. Furthermore, MinerVa-Delta accurately identified radiologic stable disease (SD) patients, a clinically heterogeneous population, who could benefit from initial treatment.</p><p><strong>Conclusions: </strong>Our findings demonstrate MinerVa-Delta is feasible for evaluating treatment response in advanced LUSC patients. Integrating ctDNA profiling with conventional imaging could enhance response assessment, particularly in radiologic SD patients, enabling more precise therapeutic decision-making.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Advances in lung cancer basic and translational research in 2025 - Overview and perspectives focusing on non-small cell lung cancer. 2025年肺癌基础与转化研究进展——以非小细胞肺癌为重点的综述与展望
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-03 DOI: 10.1016/j.jtho.2025.05.024
Celine Mascaux, Triparna Sen, Montse Sanchez-Cespedes, Sandra Ortiz-Cuaran, Yohan Bossé, Floris Dammeijer, Milena Cavic, Martin P Barr, Surein Arulananda, Ricardo Armisen, Alice H Berger, Fabrizio Bianchi, David P Carbone, Ferdinando Cerciello, William W Lockwood, Tetsuya Mitsudomi, Shuta Ohara, Katerina Politi, Sida Qin, Laila C Roisman, Robert Samstein, Ferdinandos Skoulidis, Aaron C Tan, Anish Thomas, Jianjun Zhang, Murry W Wynes, Thomas John, Ming Sound Tsao
{"title":"Advances in lung cancer basic and translational research in 2025 - Overview and perspectives focusing on non-small cell lung cancer.","authors":"Celine Mascaux, Triparna Sen, Montse Sanchez-Cespedes, Sandra Ortiz-Cuaran, Yohan Bossé, Floris Dammeijer, Milena Cavic, Martin P Barr, Surein Arulananda, Ricardo Armisen, Alice H Berger, Fabrizio Bianchi, David P Carbone, Ferdinando Cerciello, William W Lockwood, Tetsuya Mitsudomi, Shuta Ohara, Katerina Politi, Sida Qin, Laila C Roisman, Robert Samstein, Ferdinandos Skoulidis, Aaron C Tan, Anish Thomas, Jianjun Zhang, Murry W Wynes, Thomas John, Ming Sound Tsao","doi":"10.1016/j.jtho.2025.05.024","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.05.024","url":null,"abstract":"<p><p>Basic and translational research in lung cancer is a rapidly evolving field with transformational impact in early detection, diagnosis, therapeutic development and personalization of care. Recent advances have greatly increased our understanding in the molecular genomics, proteomics, pathogenesis and cellular biology of this deadly malignancy. The International Association for the Study of Lung Cancer (IASLC) recently formed a Basic and Translational Science (BaTS) Committee to further enhance the scientific leadership of IASLC in thoracic cancer research. This review by members of the committee highlights the breadth of current research in NSCLC, with a focus on molecular risk factors and processes in tumorigenesis, heterogeneity, phenotypic plasticity, metabolic reprograming, immunobiology, the immune microenvironment and microbiome. This review also identifies future research areas that may lead to further improvement in survival outcomes and curative therapies especially for patients with advanced NSCLC.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Prophylaxis We Should Not SKIPP: Reducing Amivantamab-Related Infusion-Related Reactions With Dexamethasone 我们不应该跳过的预防措施:用地塞米松减少阿米伐他麦输注相关反应
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-01 DOI: 10.1016/j.jtho.2025.02.028
Stephanie P.L. Saw MBBS, MMed, MRCP, PhD , Paolo Bironzo MD, PhD
{"title":"Prophylaxis We Should Not SKIPP: Reducing Amivantamab-Related Infusion-Related Reactions With Dexamethasone","authors":"Stephanie P.L. Saw MBBS, MMed, MRCP, PhD ,&nbsp;Paolo Bironzo MD, PhD","doi":"10.1016/j.jtho.2025.02.028","DOIUrl":"10.1016/j.jtho.2025.02.028","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 6","pages":"Pages 695-698"},"PeriodicalIF":21.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144231376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Safety, Efficacy, and Biomarker Analysis of Deulorlatinib (TGRX-326) in Anaplastic Lymphoma Kinase-Positive NSCLC: A Multicenter, Open-Label, Phase 1/1b Trial ALK阳性非小细胞肺癌患者服用deulorlatinib(TGRX-326)的安全性、疗效和生物标志物分析:一项多中心、开放标签、1/1b期试验。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-01 DOI: 10.1016/j.jtho.2024.11.010
Shen Zhao MD , Huaqiang Zhou MD , Nong Yang MD , Zhehai Wang MD , Wenjian Jin MD , Yuxiang Ma MD , Jinhui Xue MD , Xingya Li MD , Yunpeng Liu MD , Rui Meng MD , Jianying Zhou MD , Ying Cheng MD , Yongsheng Wang MD , Zhuang Yu MD , Yu Cao MD , Yuanyuan Zhao MD , Yan Huang MD , Wenfeng Fang MD , Yang Zhang MD , Shaodong Hong MD , Hongyun Zhao MD
{"title":"Safety, Efficacy, and Biomarker Analysis of Deulorlatinib (TGRX-326) in Anaplastic Lymphoma Kinase-Positive NSCLC: A Multicenter, Open-Label, Phase 1/1b Trial","authors":"Shen Zhao MD ,&nbsp;Huaqiang Zhou MD ,&nbsp;Nong Yang MD ,&nbsp;Zhehai Wang MD ,&nbsp;Wenjian Jin MD ,&nbsp;Yuxiang Ma MD ,&nbsp;Jinhui Xue MD ,&nbsp;Xingya Li MD ,&nbsp;Yunpeng Liu MD ,&nbsp;Rui Meng MD ,&nbsp;Jianying Zhou MD ,&nbsp;Ying Cheng MD ,&nbsp;Yongsheng Wang MD ,&nbsp;Zhuang Yu MD ,&nbsp;Yu Cao MD ,&nbsp;Yuanyuan Zhao MD ,&nbsp;Yan Huang MD ,&nbsp;Wenfeng Fang MD ,&nbsp;Yang Zhang MD ,&nbsp;Shaodong Hong MD ,&nbsp;Hongyun Zhao MD","doi":"10.1016/j.jtho.2024.11.010","DOIUrl":"10.1016/j.jtho.2024.11.010","url":null,"abstract":"<div><h3>Introduction</h3><div>Patients with anaplastic lymphoma kinase (ALK)–positive NSCLC developing resistance to second-generation inhibitors have limited treatment options. Deulorlatinib is a highly brain-penetrant, new-generation ALK/ROS1 inhibitor. We evaluated the safety, efficacy, and pharmacokinetics of deulorlatinib in ALK-positive NSCLC.</div></div><div><h3>Methods</h3><div>This three-part (dose-escalation/dose-expansion/cohort-expansion), open-label, phase 1/1b trial was conducted at 22 sites in the People’s Republic of China (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT05441956</span><svg><path></path></svg></span>). Patients who were eligible had advanced ALK/ROS1-positive NSCLC. Patients enrolled in dose-escalation/dose-expansion parts were previously treated with one or more second-generation ALK inhibitors (ALK-positive) or crizotinib (ROS1-positive) and received deulorlatinib 5 to 125 mg once per day. Patients enrolled in cohort-expansion parts were either crizotinib-treated, second-generation tyrosine kinase inhibitor (TKI)–treated, or TKI-naïve; and received deulorlatinib at the recommended phase 2 dose (RP2D). The primary outcomes were safety and tolerability. Here, we report safety analysis in all patients and efficacy analysis in patients who were ALK-positive.</div></div><div><h3>Results</h3><div>Between April 2021 and March 2023, 198 patients were enrolled (ALK-positive = 171, ROS1-positive = 27). The most common treatment-related adverse events (TRAEs) were hypercholesterolemia (79.3%), hypertriglyceridemia (77.3%), and weight gain (53.0%). 40.4% of patients had grade 3 or higher TRAEs. Meanwhile, TRAE-associated dose interruptions, reduction, and discontinuation occurred in 11.1%, 3.0%, and 1.5% of patients, respectively. The RP2D was set at 60 mg once per day. A total of 144 patients who were ALK-positive were treated at RP2D. For crizotinib-treated (n = 14), second-generation TKI-treated (n = 97), and TKI-naïve (n = 33) patients, the objective response rate to deulorlatinib at RP2D was 71.4%, 38.1%, and 87.9%, respectively. Intracranial objective response rate was 50%, 70.4%, and 75%, respectively. The median duration of response was 18.0 months for second-generation TKI-treated patients, and not reached for patients who were crizotinib-treated and TKI-naïve. Biomarker analyses identified undetectable ALK alterations at baseline and ALK circulating tumor DNA clearance at week 6 as potential predictive biomarkers.</div></div><div><h3>Conclusions</h3><div>Deulorlatinib reported desirable tolerability and efficacy in ALK-positive NSCLC, demonstrating the potential to become a new treatment option in this population.</div></div>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 6","pages":"Pages 750-762"},"PeriodicalIF":21.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Overcoming Barriers to Lung Cancer Screening: The Incidental Pulmonary Nodule Strategy 克服肺癌筛查障碍:偶发肺结节策略
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-01 DOI: 10.1016/j.jtho.2025.03.001
Marie-Pierre Revel PhD
{"title":"Overcoming Barriers to Lung Cancer Screening: The Incidental Pulmonary Nodule Strategy","authors":"Marie-Pierre Revel PhD","doi":"10.1016/j.jtho.2025.03.001","DOIUrl":"10.1016/j.jtho.2025.03.001","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 6","pages":"Pages 705-707"},"PeriodicalIF":21.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144229750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Tobacco News Update — From the IASLC Tobacco Control Committee 烟草新闻更新-来自IASLC烟草控制委员会
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-06-01 DOI: 10.1016/j.jtho.2025.04.004
{"title":"Tobacco News Update — From the IASLC Tobacco Control Committee","authors":"","doi":"10.1016/j.jtho.2025.04.004","DOIUrl":"10.1016/j.jtho.2025.04.004","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 6","pages":"Pages 689-691"},"PeriodicalIF":21.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144231374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
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