Hans Hoffmann, Andrew G Nicholson, Frank C Detterbeck, Ming S Tsao, Marcin Ostrowski, Ramón Rami-Porta, Alain Borczuk, Mirella Marino, William D Travis, Paul E Van Schil, John Edwards
{"title":"The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Application and Interpretation of the Residual Tumor Classification for Lung Cancer-Results from an International Survey Among Pathologists and Thoracic Surgeons.","authors":"Hans Hoffmann, Andrew G Nicholson, Frank C Detterbeck, Ming S Tsao, Marcin Ostrowski, Ramón Rami-Porta, Alain Borczuk, Mirella Marino, William D Travis, Paul E Van Schil, John Edwards","doi":"10.1016/j.jtho.2024.12.007","DOIUrl":"10.1016/j.jtho.2024.12.007","url":null,"abstract":"<p><strong>Objectives: </strong>The study aimed to assess the opinion of pathologists and thoracic surgeons of the International Association for the Study of Lung Cancer regarding the application and interpretation of the residual tumor (R) classification for lung cancer.</p><p><strong>Methods: </strong>On the basis of their membership profiles, a total of 623 pathologists and thoracic surgeons were identified and contacted by email with a cover letter and a link to an online survey. The questionnaire consisted of 12 questions about various aspects of the application and interpretation of the R classification for lung cancer. The response rate (to at least one question) was 72% (144 pathologists and 303 surgeons).</p><p><strong>Results: </strong>The frequency of use of the R classification varies by geographic region. Although R status is regularly reported in Europe and Asia, 70% of pathologists in the United States and Canada never include R status in reports. Similar variations exist about who assigns the R category for the resection-in Europe and the United Kingdom, it is mainly the pathologist, whereas in China, Japan and the United States, it is the surgeon. There are some good agreements about margins examined and how to manage staple lines. The category \"uncertain resection\" has not been practically implemented in most of the world, except at some centers in Japan and the United Kingdom.</p><p><strong>Conclusion: </strong>This survey shows that surgical resection margins are part of routine reporting in most institutions; but the assignment of an R category is not always part of the pathology report, with considerable variation between countries. Despite the International Association for the Study of Lung Cancer proposals, the application of the uncertain resection category has not been taken up by most institutions, and further evidence is needed.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828810","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}
So Yeon Kim, Gerard A Silvestri, Yeon Wook Kim, Roger Y Kim, Sang-Won Um, Yunjoo Im, Jung Hye Hwang, Seung Ho Choi, Jung Seop Eom, Kang Mo Gu, Yong-Soo Kwon, Shin Yup Lee, Hyun Woo Lee, Dong Won Park, Yeonjeong Heo, Seung Hun Jang, Kwang Yong Choi, Yeol Kim, Young Sik Park
{"title":"Screening for Lung Cancer, Overdiagnosis, and Healthcare Utilization: A Nationwide Population-Based Study.","authors":"So Yeon Kim, Gerard A Silvestri, Yeon Wook Kim, Roger Y Kim, Sang-Won Um, Yunjoo Im, Jung Hye Hwang, Seung Ho Choi, Jung Seop Eom, Kang Mo Gu, Yong-Soo Kwon, Shin Yup Lee, Hyun Woo Lee, Dong Won Park, Yeonjeong Heo, Seung Hun Jang, Kwang Yong Choi, Yeol Kim, Young Sik Park","doi":"10.1016/j.jtho.2024.12.006","DOIUrl":"10.1016/j.jtho.2024.12.006","url":null,"abstract":"<p><strong>Introduction: </strong>Guideline-discordant low-dose computed tomography (LDCT) screening may cause lung cancer (LC) overdiagnosis, but its extent and consequences are unclear. This study aimed to investigate the prevalence of self-initiated, non-reimbursed LDCT screening in a predominantly non-smoking population and its impact on LC epidemiology and healthcare utilization.</p><p><strong>Methods: </strong>This nationwide cohort study analyzed data from Korea's National Health Information Database and 11 academic hospital screening centers (1999-2022). The overall analysis encompassed the entire Korean population. For non-reimbursed LDCT screening prevalence, which the National Health Information Database does not capture, a separate analysis was conducted on a cohort of 1.7 million adults to extrapolate nationwide rates. Outcomes included trends in self-initiated, non-reimbursed LDCT screening, LC incidence, mortality, stage and age at diagnosis, 5-year survival, and LC-related healthcare utilization, including surgeries and biopsies. Joinpoint regression assessed trend changes.</p><p><strong>Results: </strong>Self-initiated, non-reimbursed LDCT screening during health check-ups increased from 29% to 60% in men and 7% to 46% in women, despite only 2.4% of men and 0.04% of women qualifying for risk-based screening. In women, localized-stage LC incidence nearly doubled (age-standardized incidence rate: from 7.6 to 13.7 per 100,000), whereas distant-stage incidence decreased (age-standardized incidence rate: from 16.1 to 15.0 per 100,000). LC mortality declined (age-standardized mortality rate: from 23.3 to 19.8 per 100,000), whereas 5-year survival rates improved substantially. LC diagnoses in women shifted towards earlier stages and younger ages. Lung surgeries for both malignant and benign lesions, frequently lacking nonsurgical biopsies, increased sharply in women.</p><p><strong>Conclusions: </strong>Widespread guideline-discordant LDCT screening correlates with LC overdiagnosis and increased healthcare utilization, particularly in women. Randomized controlled trials are needed to assess the risks and benefits of screening in low-risk populations to determine its efficacy and consequences.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813665","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}
William J Phillips, Alexander S Watson, D Ross Camidge
{"title":"The Use of Investigator-Assigned Subjective or Judgmental Efficacy and Toxicity Reporting in Early Phase Clinical Trials of Lung Cancer Treatments.","authors":"William J Phillips, Alexander S Watson, D Ross Camidge","doi":"10.1016/j.jtho.2024.12.003","DOIUrl":"10.1016/j.jtho.2024.12.003","url":null,"abstract":"<p><strong>Introduction: </strong>Investigator-assigned Subjective or Judgmental Efficacy and Toxicity (ISJET) reporting represents language used to contextualize efficacy or toxicity data in clinical trials that may be inappropriate or misleading. In addition, pooling of grade 1 and 2 adverse events (AEs) may reflect a practice based on acute chemotherapy treatments rather than the expansion of chronic treatments that are now commonplace for many patients with lung cancer. In this study, we set out to evaluate the use of ISJETs and combined grade 1 and 2 reporting in early phase clinical trials of lung treatments at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.</p><p><strong>Methods: </strong>Phase I and II clinical trials of systemic treatments in adults with at least one patient with lung cancer presented at the 2024 ASCO Annual Meeting were reviewed. Baseline information and toxicity/efficacy reporting were collected. ISJETs were captured based on predefined phrases such as \"tolerable,\" \"manageable,\" \"acceptable,\" or \"favorable.\"</p><p><strong>Results: </strong>A total of 100 eligible studies were identified. The median sample size was 43 (interquartile range 29-73), and 61 studies (61%) were phase I trials. Most studies reported any-grade (99%) and grade 3 (96%) AEs. Only 12% of the studies distinguished between grade 1 and 2 AEs. ISJETs were used to report toxicity in 88% and efficacy in 41% of the studies, respectively.</p><p><strong>Conclusion: </strong>Most early phase lung cancer clinical trials presented at the 2024 ASCO Annual Meeting included ISJETs and did not distinguish between grade 1 and 2 AEs. Initiatives to increase objective efficacy and toxicity reporting language and more fit-for-purpose toxicity reporting are warranted.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791957","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}
{"title":"Efficacy and Safety of KRASG12C Inhibitor IBI351 Monotherapy in Patients With Advanced NSCLC: Results From a Phase 2 Pivotal Study.","authors":"Qing Zhou, Xiangjiao Meng, Longhua Sun, Dingzhi Huang, Nong Yang, Yan Yu, Mingfang Zhao, Wu Zhuang, Renhua Guo, Yi Hu, Yueyin Pan, Jinlu Shan, Meili Sun, Ying Yuan, Yun Fan, Jianan Huang, Lian Liu, Qian Chu, Xiuwen Wang, Chongrui Xu, Jiaxin Lin, Jingjing Huang, Mengna Huang, Jiya Sun, Sujie Zhang, Hui Zhou, Yi-Long Wu","doi":"10.1016/j.jtho.2024.08.005","DOIUrl":"10.1016/j.jtho.2024.08.005","url":null,"abstract":"<p><strong>Introduction: </strong>KRAS glycine-to-cysteine substitution at codon 12 (G12C) mutation is a well-recognized and increasingly promising therapeutic target with huge unmet clinical needs in NSCLC patients. IBI351 is a potent covalent and irreversible inhibitor of KRAS G12C. Here, we present the efficacy and safety of IBI351 from an open-label, single-arm, phase 2 pivotal study.</p><p><strong>Methods: </strong>Eligible patients with NSCLC with KRAS G12C who failed standard therapy were enrolled. IBI351 was orally administered at a dose of 600 mg twice daily. The primary endpoint was confirmed objective response rate assessed by an independent radiological review committee (IRRC) as per Response Evaluation Criteria in Solid Tumors v1.1. Other endpoints were safety, IRRC-confirmed disease control rate, duration of response, progression-free survival (PFS), and overall survival.</p><p><strong>Results: </strong>As of December 13, 2023, 116 patients were enrolled (Eastern Cooperative Oncology Group Performance Status 1: 91.4%; brain metastasis: 30.2%; prior treatments with both anti-PD-1 or anti-PD-L1 inhibitors and platinum-based chemotherapy: 84.5%). As per the IRRC assessment, the confirmed objective response rate was 49.1% (95% confidence interval [CI]: 39.7-58.6), and the disease control rate was 90.5% (95% CI: 83.7-95.2). The median duration of response was not reached whereas disease progression or death events occurred in 22 patients (38.6%), and the median PFS was 9.7 months (95% CI: 5.6-11.0). overall survival data was immature. Treatment-related adverse events (TRAEs) occurred in 107 patients (92.2%) whereas 48 patients (41.4%) had equal to or higher than grade three TRAEs. Common TRAEs were anemia (44.8%), increased alanine aminotransferase (28.4%), increased aspartate aminotransferase (27.6%), asthenia (26.7%) and presence of protein in urine (25.0%). TRAEs leading to treatment discontinuation occurred in nine patients (7.8%). In biomarker evaluable patients (n = 95), all patients had positive KRAS G12C in tissue whereas 72 patients were blood-positive and 23 were blood-negative for KRAS G12C. Patients with KRAS G12C in both blood and tissue had higher tumor burden at baseline (p < 0.05) and worse PFS (p < 0.05). Tumor mutation profiling identified tumor protein p53 (45.3%), serine/threonine kinase 11 (STK11) (30.5%), and kelch-like ECH-associated protein 1 (21.1%) as the most common genes co-mutated with KRAS G12C. Among 13 genes with mutation frequency equal to or higher than 5%, mutations of six genes (STK11, kelch-like ECH-associated protein 1, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit gamma, DNA polymerase epsilon, SMAD family member 4, and BMP/retinoic acid-inducible neural-specific protein 3) were significantly associated with worse PFS (p < 0.05). Mutation in STK11 was also found to have a significant association with higher tumor burden at baseline and lower response rate (p < 0.05).</p><p><strong","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":"1630-1639"},"PeriodicalIF":21.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913108","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}
Sergi Call, Nina Reig-Oussedik, Bruno García-Cabo, José Sanz-Santos, Ramón Rami-Porta
{"title":"In the Era of Precision Medicine, Is Invasive Mediastinal Restaging Really Not Required Before Lung Resection?","authors":"Sergi Call, Nina Reig-Oussedik, Bruno García-Cabo, José Sanz-Santos, Ramón Rami-Porta","doi":"10.1016/j.jtho.2024.08.037","DOIUrl":"https://doi.org/10.1016/j.jtho.2024.08.037","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 12","pages":"e96-e97"},"PeriodicalIF":21.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791989","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}
Jonathan D Spicer, Tina Cascone, Murry W Wynes, Karen L Kelly
{"title":"Why and When Do We Invasively Restage After Neoadjuvant Chemoimmunotherapy?","authors":"Jonathan D Spicer, Tina Cascone, Murry W Wynes, Karen L Kelly","doi":"10.1016/j.jtho.2024.09.1436","DOIUrl":"https://doi.org/10.1016/j.jtho.2024.09.1436","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 12","pages":"e98-e99"},"PeriodicalIF":21.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142792060","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}
{"title":"Defining the Pathway to Precision Therapies for Squamous Lung Cancers.","authors":"Malinda Itchins, Aaron C Tan","doi":"10.1016/j.jtho.2024.09.1423","DOIUrl":"https://doi.org/10.1016/j.jtho.2024.09.1423","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 12","pages":"1591-1593"},"PeriodicalIF":21.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791986","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}
Henry S Park, Andreas Rimner, Arya Amini, Joe Y Chang, Stephen G Chun, Jessica Donington, Martin J Edelman, Matthew A Gubens, Kristin A Higgins, Puneeth Iyengar, Aditya Juloori, Benjamin Movsas, Zsuzsanna Nemeth, Matthew S Ning, George Rodrigues, Andrea Wolf, Charles B Simone
{"title":"Appropriate Use Criteria (AUC) for the Management of Non-Small Cell Lung Cancer in a Central/Ultra-Central Location: Guidelines from the American Radium Society.","authors":"Henry S Park, Andreas Rimner, Arya Amini, Joe Y Chang, Stephen G Chun, Jessica Donington, Martin J Edelman, Matthew A Gubens, Kristin A Higgins, Puneeth Iyengar, Aditya Juloori, Benjamin Movsas, Zsuzsanna Nemeth, Matthew S Ning, George Rodrigues, Andrea Wolf, Charles B Simone","doi":"10.1016/j.jtho.2024.09.1386","DOIUrl":"10.1016/j.jtho.2024.09.1386","url":null,"abstract":"<p><strong>Introduction: </strong>Definitive radiation therapy is considered standard therapy for medically inoperable early-stage NSCLC. Nevertheless, for patients with tumors located near structures such as the proximal tracheobronchial tree, esophagus, heart, spinal cord, and brachial plexus, the optimal management regimen is controversial. The objective was to develop expert multidisciplinary consensus guidelines on managing medically inoperable NSCLC located in a central or ultracentral location relative to critical organs at risk.</p><p><strong>Methods: </strong>Case variants regarding centrally and ultracentrally located lung tumors were developed by the 15-member multidisciplinary American Radium Society (ARS) Thoracic Appropriate Use Criteria (AUC) expert panel. A comprehensive review of the English medical literature was performed from January 1 1946 to December 31 2023 to inform consensus guidelines. Modified Delphi methods were used by the panel to evaluate the variants and procedures, with at least three rating points from median defining agreement/consensus. The guideline was then approved by the ARS Executive Committee and released for public comment per established ARS procedures.</p><p><strong>Results: </strong>The Thoracic ARS AUC Panel identified 90 relevant references and obtained consensus in all variants. Radiotherapy alone was considered appropriate, with additional immunotherapy to be considered primarily in the clinical trial setting. Hypofractionated radiotherapy in eight to 18 fractions was considered appropriate for ultracentral lesions near the proximal tracheobronchial tree, upper trachea, and esophagus. For other ultracentral lesions near the heart, great vessels, brachial plexus, and spine, or for non-ultracentral but still central lesions, five-fraction stereotactic body radiation therapy was also considered an appropriate option. Intensity-modulated radiotherapy was considered appropriate and three-dimensional-conformal radiotherapy inappropriate for all variants. Other treatment planning techniques to decrease the risk of overdosing critical organs at risk were also considered.</p><p><strong>Conclusions: </strong>The ARS Thoracic AUC panel has developed multidisciplinary consensus guidelines for various presentations of stage I NSCLC in a central or ultracentral location.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":"1640-1653"},"PeriodicalIF":21.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11670059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}