JTO Clinical and Research Reports最新文献

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BRAF Fusion as Resistance Mechanism to Osimertinib in EGFR-Mutated NSCLC: A Case Report and Review of Literature BRAF融合作为egfr突变的非小细胞肺癌对奥西替尼的耐药机制:一例报告和文献综述
IF 3
JTO Clinical and Research Reports Pub Date : 2025-06-19 DOI: 10.1016/j.jtocrr.2025.100867
Marianna Peroni MD , Alessandro Leonetti MD, PhD , Roberta Minari MSc, PhD , Michela Verzè MSc , Letizia Gnetti MD , Lorena Bottarelli MSc, PhD , Cinzia Azzoni MSc, PhD , Marco Galaverni MD , Nicola Simoni MD , Gabriele Missale MD , Elisabetta Biasini MD , Marcello Tiseo MD, PhD
{"title":"BRAF Fusion as Resistance Mechanism to Osimertinib in EGFR-Mutated NSCLC: A Case Report and Review of Literature","authors":"Marianna Peroni MD ,&nbsp;Alessandro Leonetti MD, PhD ,&nbsp;Roberta Minari MSc, PhD ,&nbsp;Michela Verzè MSc ,&nbsp;Letizia Gnetti MD ,&nbsp;Lorena Bottarelli MSc, PhD ,&nbsp;Cinzia Azzoni MSc, PhD ,&nbsp;Marco Galaverni MD ,&nbsp;Nicola Simoni MD ,&nbsp;Gabriele Missale MD ,&nbsp;Elisabetta Biasini MD ,&nbsp;Marcello Tiseo MD, PhD","doi":"10.1016/j.jtocrr.2025.100867","DOIUrl":"10.1016/j.jtocrr.2025.100867","url":null,"abstract":"<div><div>Despite the efficacy of osimertinib in the first-line treatment of advanced <em>EGFR</em>-mutated NSCLC, the development of resistance is nearly inevitable. <em>BRAF</em> mutations and fusions are reported in 1% to 3% of patients with <em>EGFR</em>-mutated NSCLC receiving osimertinib and represent potential targetable alterations.</div><div>In this case report, we discuss the rationale for EGFR-MEK co-inhibition in a patient with <em>EGFR</em>-mutated NSCLC treated with osimertinib that developed a <em>CTNNA</em><em>1-BRAF</em> fusion at progression. In addition, we provide a brief overview of the current evidence of <em>BRAF</em> fusions as an acquired resistance mechanism to osimertinib and potential treatment strategies.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100867"},"PeriodicalIF":3.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144632070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CANOPY-N: A Phase 2 Study of Canakinumab or Pembrolizumab, Alone or in Combination, as Neoadjuvant Therapy in Patients With Resectable, Stage IB–IIIA NSCLC CANOPY-N: Canakinumab或Pembrolizumab单独或联合作为可切除的IB-IIIA期NSCLC患者的新辅助治疗的2期研究
IF 3
JTO Clinical and Research Reports Pub Date : 2025-06-13 DOI: 10.1016/j.jtocrr.2025.100859
Jay M. Lee MD , Jean-Louis Pujol MD, PhD , Jun Zhang MD, PhD , Oleg Leonov MD, PhD , Masahiro Tsuboi MD, PhD , Edward S. Kim MD, MBA , Calvin Ng MD , Nicolas Moreno-Mata MD, PhD , Amy Cummings MD, PhD , Ilhan Hacibekiroglu MD , Abidin Sehitogullari MD , Nirmal Veeramachaneni MD , Cathy Spillane PhD , Jiawei Duan PhD , Claudia Bossen PhD , Alexander Savchenko MD, PhD , Chiara Lobetti-Bodoni MD, PhD , Tony Mok MD , Pilar Garrido MD
{"title":"CANOPY-N: A Phase 2 Study of Canakinumab or Pembrolizumab, Alone or in Combination, as Neoadjuvant Therapy in Patients With Resectable, Stage IB–IIIA NSCLC","authors":"Jay M. Lee MD ,&nbsp;Jean-Louis Pujol MD, PhD ,&nbsp;Jun Zhang MD, PhD ,&nbsp;Oleg Leonov MD, PhD ,&nbsp;Masahiro Tsuboi MD, PhD ,&nbsp;Edward S. Kim MD, MBA ,&nbsp;Calvin Ng MD ,&nbsp;Nicolas Moreno-Mata MD, PhD ,&nbsp;Amy Cummings MD, PhD ,&nbsp;Ilhan Hacibekiroglu MD ,&nbsp;Abidin Sehitogullari MD ,&nbsp;Nirmal Veeramachaneni MD ,&nbsp;Cathy Spillane PhD ,&nbsp;Jiawei Duan PhD ,&nbsp;Claudia Bossen PhD ,&nbsp;Alexander Savchenko MD, PhD ,&nbsp;Chiara Lobetti-Bodoni MD, PhD ,&nbsp;Tony Mok MD ,&nbsp;Pilar Garrido MD","doi":"10.1016/j.jtocrr.2025.100859","DOIUrl":"10.1016/j.jtocrr.2025.100859","url":null,"abstract":"<div><h3>Introduction</h3><div>Canakinumab is a human monoclonal anti–interleukin-1β antibody with the potential to enhance the activity of programmed death-ligand 1 inhibitors by inhibiting protumor inflammation.</div></div><div><h3>Methods</h3><div>CANOPY-N was a randomized, phase 2 study to evaluate safety and efficacy of neoadjuvant canakinumab (200 mg subcutaneous once every three weeks) and pembrolizumab (200 mg intravenous once every three weeks), either in combination or alone, in patients with early-stage (stage Ib–IIIa) NSCLC. The primary end point was major pathologic response (MPR) rates (≤10% of residual tumor cells) by central pathology review in the arms containing canakinumab. Secondary end points included overall response rates, safety, pharmacokinetics, surgical feasibility rates, and MPR rate in the pembrolizumab arm. The impact of treatment on surgical outcomes was assessed as an exploratory outcome.</div></div><div><h3>Results</h3><div>In total, 88 patients were enrolled: 35 to the canakinumab arm, 35 to the canakinumab + pembrolizumab arm, and 18 to the pembrolizumab arm. One patient (2.9%) in the canakinumab arm (95% confidence interval [CI]: 0.07–14.92), six patients (17.1%) in the canakinumab + pembrolizumab arm (95% CI: 6.56–33.65), and three patients (16.7%) in the pembrolizumab arm (95% CI: 3.58–41.42) achieved MPR. No unexpected safety signals were observed. Of the 84 patients (95.5%) who underwent operation, the prespecified 6-week window was achieved for 72 patients (85.7%).</div></div><div><h3>Conclusions</h3><div>Neoadjuvant treatment with canakinumab alone or combined with pembrolizumab did not improve MPR rates compared with pembrolizumab alone. No unexpected safety signals were observed and canakinumab did not adversely affect surgical outcomes. Intraoperative perihilar or perilobular fibrosis after neoadjuvant immunotherapy was rare.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100859"},"PeriodicalIF":3.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144579962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Occult Node Detection With Lobectomy Versus Segmentectomy for Stage IA NSCLC IA期非小细胞肺癌肺叶切除术与节段切除术的隐匿淋巴结检测
IF 3
JTO Clinical and Research Reports Pub Date : 2025-06-13 DOI: 10.1016/j.jtocrr.2025.100861
Yota Suzuki MD , Rajeev Dhupar MD , Inderpal S. Sarkaria MD, MBA , Ian G. Christie MD , Summer N. Mazur BS , Arjun Pennathur MD , James D. Luketich MD , Ryan M. Levy MD , Rodney J. Landreneau MD , Matthew J. Schuchert MD
{"title":"Occult Node Detection With Lobectomy Versus Segmentectomy for Stage IA NSCLC","authors":"Yota Suzuki MD ,&nbsp;Rajeev Dhupar MD ,&nbsp;Inderpal S. Sarkaria MD, MBA ,&nbsp;Ian G. Christie MD ,&nbsp;Summer N. Mazur BS ,&nbsp;Arjun Pennathur MD ,&nbsp;James D. Luketich MD ,&nbsp;Ryan M. Levy MD ,&nbsp;Rodney J. Landreneau MD ,&nbsp;Matthew J. Schuchert MD","doi":"10.1016/j.jtocrr.2025.100861","DOIUrl":"10.1016/j.jtocrr.2025.100861","url":null,"abstract":"<div><h3>Objective</h3><div>Besides the discussion on parenchymal margin, data on the extent of lymph node (LN) dissection are scarce, especially in segmentectomy. This study aimed to investigate the extent of LN dissection and detection of occult disease in segmentectomy compared with lobar resection.</div></div><div><h3>Methods</h3><div>We performed a single-institution, retrospective analysis for patients who underwent segmentectomy or lobectomy for clinical T1N0M0 (≤3 cm) NSCLC from 2012 to 2022. The extent of LN dissection and the rate of detection of occult LN disease were compared. N1 nodes were further classified as collected as a specimen during the operation (N1 dissection) and the nodes retrieved from lung specimens by pathologists (N1 lung specimen).</div></div><div><h3>Results</h3><div>During the study period, 957 lobectomies and 402 segmentectomies were performed for clinical T1N0M0 NSCLC. The median number of sampled LNs was significantly higher in the lobectomy group (18 versus 12; <em>p</em> &lt; 0.001). This tendency was similar across all node groups, including N2 nodes (7 versus 5), N1 dissection nodes (6 versus 4), and most significantly N1 lung specimen nodes (4 versus 0; all <em>p</em> &lt; 0.001) There was a significant difference in N1 occult nodes (13.3% versus 3.7%; <em>p</em> &lt; 0.001), whereas the difference was not significant in N2 occult nodes (5.5% versus 3.2%; <em>p</em> = 0.074).</div></div><div><h3>Conclusions</h3><div>Segmentectomy was associated with less LN sampling, which translated into lower detection of occult nodal metastasis in N1 LNs. Although standardized pathologic dissection could potentially improve detection, there is likely an inevitable inferiority in LN sampling with segmentectomy.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100861"},"PeriodicalIF":3.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144588218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Midkine Expression as a Candidate Biomarker to Predict the Recurrence of Stage IA Lung Adenocarcinoma Midkine表达作为预测IA期肺腺癌复发的候选生物标志物
IF 3
JTO Clinical and Research Reports Pub Date : 2025-06-13 DOI: 10.1016/j.jtocrr.2025.100858
Xiao Yang PhD, Shuo Sun BSc, Xunjie Kuang BSc, Xianfeng Lu MM, He Xiao MM, Yi Duan BSc, Yanli Xiong MM, Di Zhang BSc, Yu Xu PhD, Jianwu Zhu PhD, Mengxia Li PhD
{"title":"Midkine Expression as a Candidate Biomarker to Predict the Recurrence of Stage IA Lung Adenocarcinoma","authors":"Xiao Yang PhD,&nbsp;Shuo Sun BSc,&nbsp;Xunjie Kuang BSc,&nbsp;Xianfeng Lu MM,&nbsp;He Xiao MM,&nbsp;Yi Duan BSc,&nbsp;Yanli Xiong MM,&nbsp;Di Zhang BSc,&nbsp;Yu Xu PhD,&nbsp;Jianwu Zhu PhD,&nbsp;Mengxia Li PhD","doi":"10.1016/j.jtocrr.2025.100858","DOIUrl":"10.1016/j.jtocrr.2025.100858","url":null,"abstract":"<div><h3>Background</h3><div>Early recurrence limits the long-term survival of postoperative patients with stage IA lung adenocarcinoma (LUAD). This study aims to risk-stratify postoperative stage IA LUAD by means of the expression of Midkine (MDK).</div></div><div><h3>Materials and Methods</h3><div>We collected surgical samples from 62 patients with stage IA LUAD, of which 30 patients had early recurrence and others without. Intratumoral and peritumoral MDK expression were measured by immunohistochemistry staining. We also analyzed the MDK expression of stage IA LUAD from The Cancer Genome Atlas (TCGA) and Gene Expression Omnibus repository.</div></div><div><h3>Results</h3><div>The intratumoral MDK was significantly overexpressed in patients with early recurrence (<em>p</em> &lt; 0.001). Kaplan-Meier survival analysis revealed that patients with higher intratumoral MDK expression had poor recurrence-free survival (<em>p</em> &lt; 0.001) and overall survival (<em>p</em> = 0.004). Univariate Cox regression analysis indicated that intratumoral MDK expression significantly increased the risk of recurrence (hazard ratio [HR] 1.408 (1.076–1.842), <em>p</em> = 0.013) and death (HR 1.888 [1.127–3.162], <em>p</em> = 0.016). Stepwise Cox regression analysis revealed that smoking (HR 2.944 [1.419–6.107], <em>p</em> = 0.004), intratumoral MDK expression (HR 1.316 [1.037–1.669], <em>p</em> = 0.024), and <em>EGFR</em> mutation (HR 2.407 [1.110–5.221], <em>p</em> = 0.026) were independent prognostic factors for early recurrence. In TCGA data set, the MDK expression significantly increased the risk of recurrence (HR 1.559 [1.035–2.349], <em>p</em> = 0.034), and patients with higher MDK expression had worse disease-free survival (<em>p</em> = 0.024). In GSE31210, the MDK expression significantly increased the risk of recurrence (HR 2.617 [1.791–3.824], <em>p</em> &lt; 0.001) and death (HR 2.495 [1.429–4.356], <em>p</em> = 0.001), whereas patients with higher MDK expression also had worse recurrence-free survival (<em>p</em> = 0.006) and overall survival (<em>p</em> &lt; 0.001).</div></div><div><h3>Conclusion</h3><div>MDK was considered a putative candidate for predicting early recurrence in patients with stage IA LUAD.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 9","pages":"Article 100858"},"PeriodicalIF":3.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Phase II Study of Cabozantinib in Patients With MET-Altered Lung Cancers 卡博赞替尼治疗met改变肺癌的II期研究
IF 3
JTO Clinical and Research Reports Pub Date : 2025-06-05 DOI: 10.1016/j.jtocrr.2025.100857
Guilherme Harada MD , Fernando C. Santini MD , Clare J. Wilhelm PhD , Rebecca W. Repetti NP , Jason C. Chang MD , Soo-Ryum Yang MD , Yun-Te Lin MSc , Khadeja A. Moses BA , Christina Falcon MPH, PMP , Michelle Goldstein MSW , Alex Makhnin MA , Michelle S. Ginsberg MD , Andrew J. Plodkowski MD , Mark G. Kris MD , Alexander Drilon MD
{"title":"A Phase II Study of Cabozantinib in Patients With MET-Altered Lung Cancers","authors":"Guilherme Harada MD ,&nbsp;Fernando C. Santini MD ,&nbsp;Clare J. Wilhelm PhD ,&nbsp;Rebecca W. Repetti NP ,&nbsp;Jason C. Chang MD ,&nbsp;Soo-Ryum Yang MD ,&nbsp;Yun-Te Lin MSc ,&nbsp;Khadeja A. Moses BA ,&nbsp;Christina Falcon MPH, PMP ,&nbsp;Michelle Goldstein MSW ,&nbsp;Alex Makhnin MA ,&nbsp;Michelle S. Ginsberg MD ,&nbsp;Andrew J. Plodkowski MD ,&nbsp;Mark G. Kris MD ,&nbsp;Alexander Drilon MD","doi":"10.1016/j.jtocrr.2025.100857","DOIUrl":"10.1016/j.jtocrr.2025.100857","url":null,"abstract":"<div><h3>Introduction</h3><div>Only type I MET tyrosine kinase inhibitors (TKIs) are approved for treating <em>MET</em>-altered NSCLCs. Preclinically, type II TKIs, such as cabozantinib, can rescue progression on type I TKIs. This phase 2 trial (NCT01639508) evaluated the activity of cabozantinib in patients with MET-dependent lung cancers, including TKI-pretreated cancers.</div></div><div><h3>Methods</h3><div>This phase 2 trial with a Simon two-stage minimax design treated patients with metastatic, <em>MET</em>-altered lung cancers with cabozantinib (60 mg daily) until progression or intolerable toxicity. The primary end point was objective response rate (ORR). We prespecified that cabozantinib would be considered a useful agent if at least a 20% ORR was observed. Secondary end points included progression-free survival, overall survival, and safety.</div></div><div><h3>Results</h3><div>We enrolled 28 patients, 23 patients (82%) with only a <em>MET</em> exon 14 alteration, two patients (7%) with <em>MET</em> amplification, and three patients (11%) with concurrent <em>MET</em> exon 14 alteration and amplification. There were 24 patients (86%) previously treated with a type I MET TKI. The ORR was 20% (5/25 assessable patients; 95% confidence interval [CI]: 8.9%–39.1%), with five partial responses (duration ranged from 4 to 39 mo). Four of five responders were type I MET TKI pretreated. The median progression-free survival and overall survival were 4.5 (95% CI: 3.3–5.7) months and 7.2 (95% CI: 2.9–11.5) months, respectively. Dose modification and discontinuation occurred in 64% (18/28) and 7% (2/28) of patients, respectively.</div></div><div><h3>Conclusion</h3><div>This trial met its primary end point. Importantly, we demonstrated that cabozantinib, a type II MET TKI, could benefit patients with MET-altered lung cancers previously treated with type I MET TKIs.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100857"},"PeriodicalIF":3.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Uneven Playing Field: Survival Gains in Stage IV NSCLC Across Sociodemographic Strata 一个不公平的竞争环境:跨社会人口阶层的IV期非小细胞肺癌的生存收益
IF 3
JTO Clinical and Research Reports Pub Date : 2025-05-27 DOI: 10.1016/j.jtocrr.2025.100854
Justin A. Olivera MD, Sara Sakowitz MD, MPH, Mara B. Antonoff MD, FACS
{"title":"An Uneven Playing Field: Survival Gains in Stage IV NSCLC Across Sociodemographic Strata","authors":"Justin A. Olivera MD,&nbsp;Sara Sakowitz MD, MPH,&nbsp;Mara B. Antonoff MD, FACS","doi":"10.1016/j.jtocrr.2025.100854","DOIUrl":"10.1016/j.jtocrr.2025.100854","url":null,"abstract":"","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100854"},"PeriodicalIF":3.0,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lung Cancer Screening Eligibility, Uptake, and Adherence in Puerto Rico, 2022 波多黎各肺癌筛查的资格、吸收和依从性,2022
IF 3
JTO Clinical and Research Reports Pub Date : 2025-05-26 DOI: 10.1016/j.jtocrr.2025.100852
Maira A. Castañeda-Avila PhD, MS , Eduardo J. Santiago-Rodríguez PhD, MPH , William Rodríguez-Cintrón MD, MPH , Coral Olazagasti MD , Efrén J. Flores MD , Estelamari Rodríguez MD, MPH , Ana I. Velázquez Mañana MD, MSc , Yomayra Otero-Domínguez MD, MS , Eduardo R. Núñez MD, MS
{"title":"Lung Cancer Screening Eligibility, Uptake, and Adherence in Puerto Rico, 2022","authors":"Maira A. Castañeda-Avila PhD, MS ,&nbsp;Eduardo J. Santiago-Rodríguez PhD, MPH ,&nbsp;William Rodríguez-Cintrón MD, MPH ,&nbsp;Coral Olazagasti MD ,&nbsp;Efrén J. Flores MD ,&nbsp;Estelamari Rodríguez MD, MPH ,&nbsp;Ana I. Velázquez Mañana MD, MSc ,&nbsp;Yomayra Otero-Domínguez MD, MS ,&nbsp;Eduardo R. Núñez MD, MS","doi":"10.1016/j.jtocrr.2025.100852","DOIUrl":"10.1016/j.jtocrr.2025.100852","url":null,"abstract":"<div><h3>Importance</h3><div>Lung cancer screening (LCS) with yearly low-dose computed tomography reduces lung cancer mortality, but uptake remains low. Puerto Rico, a U.S. territory, faces significant barriers to LCS implementation, but data on LCS eligibility and use are limited.</div></div><div><h3>Objective</h3><div>This study aimed to estimate the number of individuals eligible for LCS in Puerto Rico and assess the prevalence of LCS use and up-to-date status compared with U.S. Hispanic and non-Hispanic populations.</div></div><div><h3>Design, Setting, and Participants</h3><div>This cross-sectional study analyzed data from the 2022 Behavioral Risk Factor Surveillance System, a population-based telephone survey. Adults eligible for LCS per 2021 U.S. Preventive Services Task Force guidelines (aged 50–80 years, ≥20 pack-year smoking history, current or recent smokers) from Puerto Rico and the United States were included.</div></div><div><h3>Exposures</h3><div>Participants were categorized into three groups: Puerto Rico residents, U.S. Hispanic, and U.S. non-Hispanic populations.</div></div><div><h3>Primary Outcomes and Measures</h3><div>The primary outcomes and measures were self-reported receipt of initial LCS (ever had chest CT for screening) and being up to date with LCS (i.e., chest CT in the past year). Multivariable Poisson models estimated adjusted prevalence ratios for LCS outcomes.</div></div><div><h3>Results</h3><div>After population weighting, 94,955 individuals were eligible for LCS in Puerto Rico, compared with 12.8 million in the U.S., representing 7.9% and 11.9% of their respective populations. The prevalence of self-reported LCS use was 28.4% in Puerto Rico, 27.6% among U.S. Hispanics, and 31.5% among U.S. non-Hispanics. Being up to date with LCS was lower among Puerto Rico residents (9.8%) than among U.S. Hispanics (17.3%) and non-Hispanics (18.1%). Multivariable models found Puerto Rico residents were less likely to be up to date with LCS than were U.S. non-Hispanics (adjusted prevalence ratios, 0.54; 95% CI 0.29–0.99).</div></div><div><h3>Conclusions and Relevance</h3><div>Fewer than 10% of eligible individuals in Puerto Rico self-reported being up to date with LCS, indicating they are almost half as likely to self-report as eligible individuals in the United States, highlighting significant gaps in care. Implementing high-quality LCS in Puerto Rico is critical to reducing lung cancer mortality and providing equitable lung cancer care.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100852"},"PeriodicalIF":3.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Parallel Phase II Clinical Trials of Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma 塞利那索治疗晚期胸腺瘤和胸腺癌的平行II期临床试验
IF 3
JTO Clinical and Research Reports Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100848
Chul Kim MD , Vanya Aggarwal MD , Gedske Daugaard MD, DMSc , Tianzhi Tang MD , Jaeil Ahn PhD , Benjamin Besse MD, PhD , Nicolas Girard MD, PhD , Giuseppe Giaccone MD, PhD , Peter Meidahl Petersen MD, PhD
{"title":"Parallel Phase II Clinical Trials of Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma","authors":"Chul Kim MD ,&nbsp;Vanya Aggarwal MD ,&nbsp;Gedske Daugaard MD, DMSc ,&nbsp;Tianzhi Tang MD ,&nbsp;Jaeil Ahn PhD ,&nbsp;Benjamin Besse MD, PhD ,&nbsp;Nicolas Girard MD, PhD ,&nbsp;Giuseppe Giaccone MD, PhD ,&nbsp;Peter Meidahl Petersen MD, PhD","doi":"10.1016/j.jtocrr.2025.100848","DOIUrl":"10.1016/j.jtocrr.2025.100848","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Thymic epithelial tumors (TETs) are rare and include thymomas (T) and thymic carcinomas (TC). Effective treatment options are needed for patients with progressive disease after platinum-based chemotherapy. Preclinical studies demonstrated antitumor activity of selinexor, an inhibitor of the nuclear receptor exportin-1 (XPO1/CRM1), supporting the clinical development of XPO1-targeted therapy for the treatment of TETs. To further assess the safety and efficacy of selinexor in TETs, we conducted two coordinated parallel phase II clinical trials.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This report includes two nearly identical phase II trials, designed to run in parallel, conducted in the United States (NCT03193437) and Europe (Denmark and France; NCT03466827). Analysis was performed on data pooled from both trials. Both trials were nonrandomized, open-label, two-armed phase II trials (arm A: thymoma, arm B: thymic carcinoma) with the same study design. Patients with histologically confirmed, advanced, inoperable TETs who had progressive disease after treatment with at least one platinum-containing chemotherapy regimen were included. In each 4-week cycle, patients received selinexor 60 mg twice weekly for 3 weeks. To improve tolerability, the starting dose was reduced to 40 mg twice weekly during the study. The primary objective was overall response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors 1.1, with secondary objectives including progression free survival (PFS), overall survival (OS), and adverse events (AEs) assessed per Common Terminology Criteria for Adverse Event version 4.03.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;A total of 31 patients were enrolled between the two trials: 16 with T and 15 with TC. The median age was 57 (range: 41–81) years, with 17 men and 14 women. The median number of previous systemic therapies was 2 (range: 1–9). The starting dose was 60 mg twice weekly for 29 patients (93.5%) and 40 mg twice weekly for two patients (6.5%). There was one complete response in the TC group (ORR 6.7%; 95% confidence interval [CI]: 1.2%–29.8%) and two partial responses (ORR 12.5%; 95% CI: 3.5%–36.0%) in the T group. Stable disease as the best response was observed in 11 patients (68.6%) with T and 12 patients (80%) with TC. The median duration of selinexor therapy was 4.5 (range: 0.1–44.3) months. The most common treatment-related adverse events (TRAEs) were nausea (83.8%), vomiting (45.2%), anemia (41.9%), fatigue (38.7%), and asthenia (38.7%). The most common grade 3 or higher TRAEs were anemia (16.1%), thrombocytopenia (12.9%), and asthenia (12.9%). Furthermore, 20 patients (64.5%) required dose reductions due to AEs and 20 patients (64.5%) required dose interruptions. In the T group, the median PFS was 13.6 months (95% CI: 6.3–44.3), and the median OS was not reached. In the TC group, the median PFS was 7.8 months (95% CI: 4.3–15.5) and the median OS was 15.5 months (95% CI: 13.0–29.9). ","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 9","pages":"Article 100848"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144672261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Phase I Dose-Escalation Clinical Trial of Bronchoscopic Cryoimmunotherapy in Advanced-Stage NSCLC 支气管镜下低温免疫治疗晚期NSCLC的I期剂量递增临床试验
IF 3
JTO Clinical and Research Reports Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100849
Jun-Chieh J. Tsay MD, MS , Antonio Velez MD , Destiny Collazo BS , Isaac Laniado MD , Jamie Bessich MD , Vivek Murthy MD , Andrew DeMaio MD , Samaan Rafeq MD , Benjamin Kwok MD , Fares Darawshy MD , Ray Pillai MD , Kendrew Wong MD , Yonghua Li MD, PhD , Rosemary Schluger RN , Alena Lukovnikova BS , Sofia Roldan BS , Matt Blaisdell BS , Fernanda Paz , Kelsey Krolikowski BS , Katherine Gershner MD , Daniel H. Sterman MD
{"title":"A Phase I Dose-Escalation Clinical Trial of Bronchoscopic Cryoimmunotherapy in Advanced-Stage NSCLC","authors":"Jun-Chieh J. Tsay MD, MS ,&nbsp;Antonio Velez MD ,&nbsp;Destiny Collazo BS ,&nbsp;Isaac Laniado MD ,&nbsp;Jamie Bessich MD ,&nbsp;Vivek Murthy MD ,&nbsp;Andrew DeMaio MD ,&nbsp;Samaan Rafeq MD ,&nbsp;Benjamin Kwok MD ,&nbsp;Fares Darawshy MD ,&nbsp;Ray Pillai MD ,&nbsp;Kendrew Wong MD ,&nbsp;Yonghua Li MD, PhD ,&nbsp;Rosemary Schluger RN ,&nbsp;Alena Lukovnikova BS ,&nbsp;Sofia Roldan BS ,&nbsp;Matt Blaisdell BS ,&nbsp;Fernanda Paz ,&nbsp;Kelsey Krolikowski BS ,&nbsp;Katherine Gershner MD ,&nbsp;Daniel H. Sterman MD","doi":"10.1016/j.jtocrr.2025.100849","DOIUrl":"10.1016/j.jtocrr.2025.100849","url":null,"abstract":"<div><h3>Introduction</h3><div>Outcomes for NSCLC remain suboptimal. Recent data suggest that cryoablation can generate antitumor immune effects. In this first-in-human phase I clinical trial, we investigated the safety and feasibility of bronchoscopic cryoimmunotherapy (BCI) delivered during standard-of-care bronchoscopy and explored associated systemic immune responses.</div></div><div><h3>Methods</h3><div>Subjects with known or suspected advanced-stage NSCLC were recruited. BCI was delivered in dose-escalated freeze-thaw cycles to determine maximum dose tolerance. Feasibility assessment was determined with a pre-set goal of achieving successful BCI in more than or equal to 80% of subjects. Safety was assessed by review of BCI-related complications, including grades 2 to 3 bleeding, pneumothorax requiring intervention, and National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 to 5 adverse events. Pre- and post-BCI blood samples were collected to explore changes in the systemic immune profile.</div></div><div><h3>Results</h3><div>Subjects with predominantly clinical TNM stage 3 or 4 adenocarcinoma or squamous cell carcinoma were enrolled. We reached the maximum dose of 30 seconds with 100% feasibility and no BCI-related adverse events. In peripheral blood analysis, we observed a significant decrease in derived neutrophil-to-lymphocyte ratio in the high-dose BCI group in comparison to the low-dose BCI cohort. We also observed increases in inflammatory cytokines—GM-CSF, IFN-γ, IL-1β, IL-17A, and IL-2—and effector memory T cells post-BCI.</div></div><div><h3>Conclusion</h3><div>BCI is safe and feasible. In addition, we provide preliminary evidence that at higher dose levels there is a systemic immune response consistent with a cytotoxic profile. Further immune analyses will determine the potential of BCI as an adjunctive therapy in combination with immune checkpoint inhibition in NSCLC treatment.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100849"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144480623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Prospective Exploratory Study of Functional Immunity Assessed by Pretreatment Interferon Gamma Release Assay in Relation to Different Systemic Therapies in Patients With Advanced-Stage NSCLC 一项前瞻性探索性研究,通过预处理干扰素γ释放法评估晚期非小细胞肺癌患者不同全身治疗的功能免疫
IF 3
JTO Clinical and Research Reports Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100845
Hsu-Ching Huang MD , Han-Jhih Chang MS , Chi-Lu Chiang MD , Hsin-Yi Huang MS , Yung-Hung Luo MD , Yuh-Min Chen MD , Tsu-Hui Shiao MD , Chao-Hua Chiu MD
{"title":"A Prospective Exploratory Study of Functional Immunity Assessed by Pretreatment Interferon Gamma Release Assay in Relation to Different Systemic Therapies in Patients With Advanced-Stage NSCLC","authors":"Hsu-Ching Huang MD ,&nbsp;Han-Jhih Chang MS ,&nbsp;Chi-Lu Chiang MD ,&nbsp;Hsin-Yi Huang MS ,&nbsp;Yung-Hung Luo MD ,&nbsp;Yuh-Min Chen MD ,&nbsp;Tsu-Hui Shiao MD ,&nbsp;Chao-Hua Chiu MD","doi":"10.1016/j.jtocrr.2025.100845","DOIUrl":"10.1016/j.jtocrr.2025.100845","url":null,"abstract":"<div><h3>Introduction</h3><div>Predictive markers for chemotherapy and immunotherapy response in advanced NSCLC are limited, and no objective tool exists to assess immune function, which is critical for treatment outcomes. This study prospectively evaluated the interferon gamma (IFN-γ) release assay (IGRA) as a potential predictor of treatment response and a tool for assessing immune function.</div></div><div><h3>Methods</h3><div>We enrolled patients with stage IV NSCLC undergoing first-line chemotherapy, EGFR tyrosine kinase inhibitor (TKI) therapy, or any line of single-agent immunotherapy, alongside stage I controls. Peripheral blood samples were collected pre- and post-treatment for IGRA testing using the QuantiFERON-TB Gold In-Tube (QFT-GIT) kit. Phytohemagglutinin-stimulated IFN-γ (PSIG) responses were measured by both QFT-GIT and in-house enzyme-linked immunosorbent assay, with stage IV patients categorized into high- and low-PSIG response groups based on median pretreatment values.</div></div><div><h3>Results</h3><div>A total of 117 patients were analyzed (32 surgery, 30 EGFR TKI, 25 chemotherapy, 30 immunotherapy). The median PSIG response was significantly higher in stage I patients than stage IV (1420 pg/mL versus 960 pg/mL; <em>p</em> = 0.032). In stage IV, those with driver mutations had higher pretreatment PSIG responses (1278 pg/mL versus 288 pg/mL; <em>p =</em> 0.004). Kaplan–Meier analysis suggested a trend toward longer progression-free and overall survival in the EGFR TKI and immunotherapy groups with higher PSIG responses, though not statistically significant.</div></div><div><h3>Conclusions</h3><div>Patients with advanced-stage NSCLC exhibited reduced lymphocyte function, and patients with driver mutations correlated to less exhausted lymphocyte. IGRA demonstrates potential as a clinical tool for assessing immune function in these patients.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100845"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","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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