Lung Cancer最新文献

{"title":"Validity and responsiveness of patient-reported outcomes common terminology criteria for adverse events (PRO-CTCAE) among Italian lung cancer patients","authors":"Maria Lucia Iacovino ,&nbsp;Laura Arenare ,&nbsp;Alessandro Morabito ,&nbsp;Marcello Tiseo ,&nbsp;Andrea Antonuzzo ,&nbsp;Salvatore Pisconti ,&nbsp;Silvia Della Torre ,&nbsp;Elisa Anselmi ,&nbsp;Maura Rossi ,&nbsp;Filippo Giovanardi ,&nbsp;Roberto Bollina ,&nbsp;Francesca Zanelli ,&nbsp;Domenico Galetta ,&nbsp;Silvana Leo ,&nbsp;Domenico Bilancia ,&nbsp;Elisa Biscaldi ,&nbsp;Anna Manzo ,&nbsp;Roberta Camisa ,&nbsp;Agnese Montanino ,&nbsp;Vincenzo Sforza ,&nbsp;Francesco Perrone","doi":"10.1016/j.lungcan.2026.109312","DOIUrl":"10.1016/j.lungcan.2026.109312","url":null,"abstract":"<div><h3>Background</h3><div>Patient-reported symptom monitoring may improve the outcomes of cancer treatment. Knowledge of psychometric properties may drive the selection of optimal tools. Here we report the analysis of PRO-CTCAE in Italian lung cancer patients.</div></div><div><h3>Methods</h3><div>A PRO-CTCAE list (74 items, 44 symptoms) was administered to on-treatment patients at registration (visit 1) and after 2–6 weeks (visit 2). Convergent validity with EORTC LC-13 and Hospital Anxiety and Depression Scale (HADS) was assessed by Pearson correlation. Known-group validity and responsiveness were tested with ECOG performance status (PS 0 vs 1) and Patients’ Global Impression of Change (PGIC) scale as anchors, respectively.</div></div><div><h3>Results</h3><div>From September 2019 to November 2022, 186 patients filled PRO-CTCAE at visit 1 and 164 at visit 2. Median age (IQR) was 66.4 (60.9 – 73.1) years; 58.6% were male; 68.0% had PS 0. Convergent validity showed high correlation (r ≥ 0.50) of PRO-CTCAE hair loss (r = 0.78), dyspnoea (0.63), limb numbness (0.63), cough (0.58) and pain (0.51) with selected LC-13 anchors. PRO-CTCAE anxiety, depression and sadness highly correlated with HADS. For known-group validity, small to medium correlations were found for oral, cutaneous and respiratory toxicity, fatigue, appetite loss, insomnia and depression, that were worse for PS 1; limb swelling and pain were worse in PS 0. Responsiveness analysis at visit 2 found some PRO-CTCAE score changes consistently and directly correlated with impression of change measured with PGIC.</div></div><div><h3>Conclusions</h3><div>These results support the use of selected PRO-CTCAE items for lung cancer patients as a reliable tool for detection of treatment related toxicities.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109312"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Participation in lung cancer biospecimen studies: an analysis of the ECOG-ACRIN phase 3 E1505 and E5508 clinical trials","authors":"Yating Wang ,&nbsp;Zhuoxin Sun ,&nbsp;Arthi Sridhar ,&nbsp;Suresh S. Ramalingam ,&nbsp;Heather A. Wakelee ,&nbsp;David E. Gerber","doi":"10.1016/j.lungcan.2026.109304","DOIUrl":"10.1016/j.lungcan.2026.109304","url":null,"abstract":"<div><h3>Background</h3><div>Biospecimen analyses may provide important insights into patient selection and pharmacodynamic effects. To provide generalizable findings, such studies must enroll adequate and diverse populations.</div></div><div><h3>Methods</h3><div>We analyzed patient and institutional characteristics according to agreement to participate in optional, embedded biospecimen studies among patients enrolled in the E1505 and E5508 phase 3 lung cancer therapeutic trials. Differences were compared using Wilcoxon rank sum test, Pearson’s Chi-squared test, and logistic regression.</div></div><div><h3>Results</h3><div>Overall, 3,017 patients were enrolled in the two trials. Mean age was 63 years, 49% were female, and 83% were non-Hispanic white. Among these individuals, 2,692 (89%) agreed to participate in at least one biospecimen study, and 2,577 (85%) agreed to studies requiring future biospecimen collection. In multivariable logistic regression, compared to non-Hispanic white patients, other patients were less likely to agree to participate: OR 0.59 (95% CI, 0.45–0.79; <em>P</em> &lt; 0.001) for any biospecimen study; OR 0.62 (95% CI, 0.48–0.80; <em>P</em> &lt; 0.001) for studies requiring future biospecimen collection. Women and patients treated outside main academic institutions (e.g., affiliates, community sites) were also less likely to participate.</div></div><div><h3>Conclusions</h3><div>Among patients enrolled in lung cancer clinical trials, women, racial and ethnic minorities, and patients treated outside major academic centers are less likely to participate in optional biospecimen studies. Because some of these populations may already be under-represented in trial populations, this pattern may exacerbate disparities in translational and clinical research.</div><div><strong>Trial registration:</strong> NCT00324805, NCT01107626.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109304"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep exploration of sotorasib-related hepatobiliary AEs: Based on FDA Adverse Event reporting system","authors":"Xinmei Pan ,&nbsp;Lin Zhang ,&nbsp;Linli Xie,&nbsp;Xiaohong Li,&nbsp;Ying Li,&nbsp;Qian Wang,&nbsp;Jing Hu","doi":"10.1016/j.lungcan.2026.109311","DOIUrl":"10.1016/j.lungcan.2026.109311","url":null,"abstract":"<div><h3>Objectives</h3><div>This study focused on the exploration of sotorasib-related hepatobiliary adverse events (AEs) through the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, to provide reference for safe clinical use.</div></div><div><h3>Materials and methods</h3><div>We extracted sotorasib AEs report data from FAERS database from May 28, 2021 to September 30, 2024. Four algorithms were used for disproportionality analysis to comprehensively identify AEs signals related to sotorasib, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi item gamma Poisson shrinker (MGPS). We focused on analyzing and evaluating the signals of hepatobiliary AEs and described their characteristics and risk factors.</div></div><div><h3>Results</h3><div>We collected 2383 AEs with sotorasib as the main suspected drug. Among them, 291 cases were related to hepatobiliary AEs, involving 36 PTs, of which 15 PTs had positive signals. Eleven PTs in the positive signals were identified not listed in the drug instructions, among which hepatic function abnormal, cholestasis, and cholestatic liver injury had strong signals. There was still a correlation between sotorasib and hepatobiliary AEs after analyzed by gender, age, reporter type, and serious reports, but the atlas was different in the hierarchical scheme. Hepatotoxicity and drug-induced liver injury were classified as moderate clinical priority and should be given priority in clinical practice.</div></div><div><h3>Conclusion</h3><div>This study obtained the real hepatobiliary toxicity spectrum, characteristics, and influencing factors of sotorasib through FAERS data mining, which provides valuable insights for healthcare professionals to effectively manage the risk of sotorasib-related hepatobiliary AEs in clinical practice.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109311"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HDAC1-modified lamin A/C drives nuclear deformation in RB1-deficient lung adenocarcinoma","authors":"Hongxia Li ,&nbsp;Yu Chen ,&nbsp;Lihong Wei ,&nbsp;Peng Wu ,&nbsp;Fei Fang ,&nbsp;Fengru Li ,&nbsp;Bixia Liu ,&nbsp;Shuhua Li ,&nbsp;Qiong He ,&nbsp;Jianwen Zhou ,&nbsp;Kejing Tang ,&nbsp;Zunfu Ke","doi":"10.1016/j.lungcan.2026.109301","DOIUrl":"10.1016/j.lungcan.2026.109301","url":null,"abstract":"<div><h3>Background</h3><div>Lineage transformation from lung adenocarcinoma (LUAD) to small cell lung cancer (SCLC) represents a rare yet well-documented off-target mechanism associated with acquired resistance to tyrosine kinase inhibitors (TKIs). However, the relationship between this transformation and morphological changes remains inadequately understood. This study seeks to elucidate the molecular mechanisms by which RB1 depletion facilitates lineage transformation, with a particular emphasis on its role in morphological alterations.</div></div><div><h3>Methods</h3><div>Integrated molecular, morphological, and structural analyses were conducted in RB1-deficient LUAD models in vitro and in vivo. Functional perturbation and pharmacological inhibition of RB1-associated regulators were further performed to delineate the mechanism of the RB1/E2F1/HDAC1 axis.</div></div><div><h3>Results</h3><div>Patients with LUAD exhibiting low expression levels of TP53 and RB1 exhibited enhanced tumor invasion characteristics and a poor clinical prognosis. Our findings demonstrated that RB1 depletion induced epithelial-mesenchymal transition (EMT) characteristics in LUAD cells, as evidenced by spindle-shaped morphology, increased vimentin expression, and decreased E-cadherin expression. Furthermore, RB1 loss is responsible for nuclear abnormalities, including irregular distribution of nuclear hallmarks such as lamin A/C and emerin, which contribute to tumor aggressiveness. Through the downregulation of individual components of the RB1/E2F1/HDAC1 complex, we identified HDAC1 as a key regulatory factor influencing lamin A/C modification and nuclear deformation. Pharmacological inhibition of HDAC1 derivatives ameliorates the nuclear abnormalities observed in RB1-depleted lung cancer cells, suggesting a potential therapeutic strategy. Mechanistically, the loss of acetylated lamin A/C leads to its degradation and granular distribution, resulting in compromised nuclear mechanostability and defective cytoskeletal dynamics, which may elucidate the observed EMT.</div></div><div><h3>Conclusions</h3><div>Collectively, our findings suggested that the downregulation of RB1 significantly influences the morphology of LUAD by facilitating EMT and nuclear abnormalities through HDAC1-mediated deacetylation of lamin A/C. Future research should prioritize the development of targeted therapies aimed at restoring RB1 function or inhibiting HDAC1 to mitigate cancer progression, thereby enhancing patient stratification and treatment strategies in TKI-resistant LUAD.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109301"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to Letter to the Editor entitled “Methodological considerations in assessing the clinical impact of TP53 classifications in advanced NSCLC”","authors":"Deborah Di-Xin Zhou,&nbsp;Chee Khoon Lee","doi":"10.1016/j.lungcan.2026.109303","DOIUrl":"10.1016/j.lungcan.2026.109303","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109303"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility and safety of nintedanib in combination with nivolumab in pretreated patients with advanced or metastatic adenocarcinoma of the lung – An AIO phase Ib/II trial","authors":"Martin Reck ,&nbsp;Cornelius Waller ,&nbsp;Parvis Sadjadian ,&nbsp;Kato Kambartel ,&nbsp;Christian Grohé ,&nbsp;Andrea Sendler ,&nbsp;Niels Reinmuth ,&nbsp;Achim Rittmeyer ,&nbsp;Marcos Marin-Galiano ,&nbsp;Ralph Wirtz ,&nbsp;Markus Eckstein ,&nbsp;Ralph Keller ,&nbsp;Hanna von Suchodoletz ,&nbsp;Martin Sebastian","doi":"10.1016/j.lungcan.2026.109318","DOIUrl":"10.1016/j.lungcan.2026.109318","url":null,"abstract":"<div><h3>Objectives</h3><div>Nivolumab and nintedanib are both established agents for pre-treated NSCLC of adenocarcinoma histology. Hypothesizing that the combination of immune checkpoint inhibition (nivolumab) and anti-angiogenesis (nintedanib) increases efficacy, we intended to determine a safe and efficacious dose for the combination.</div></div><div><h3>Materials and Methods</h3><div>Our multi-center, open-label, single arm, phase Ib/II study enrolled patients with histologically confirmed stage IIIB/IV adenocarcinoma NSCLC and one or two previous lines of systemic treatment with platinum-based chemotherapy +/− checkpoint inhibitors (CPI). A traditional 3 + 3 design was used to determine a recommended phase II dose (RP2D) for nintedanib combined with nivolumab. Primary endpoints were safety and tolerability together with 6- and 9-month rates of progression-free survival (PFS).</div></div><div><h3>Results</h3><div>The RP2D was determined as 200 mg nintedanib twice daily (bid) with 240 mg nivolumab biweekly (Q2W). No new safety signals were detected. PFS milestone rates at 6 and 9 months for the 52 patients who received this dose were 25% [95% CI 14.3–37.3%] and 11.5% [4.7–21.8%], respectively. Median overall survival (mOS) was 12.2 months [95% CI: 8.13–18.37]. Central biomarker analysis based on combined positive score (CPS) revealed that high PD-L1 and low PD-L1/low FGFR1 identified patients with prolonged OS at 36 months (70% and 40%, respectively), while low PD-L1/high FGFR1 was associated with shorter OS (p = 0.0195). CPI-rechallenged patients had better OS outcomes than those who were CPI-naïve (mOS 8.13 months [95% CI 2.03–15.2] vs. 14.7 months [95% CI 8.2-NR]; logrank p = 0.0493).</div></div><div><h3>Conclusion</h3><div>Combination of nivolumab and nintedanib was shown to be safe and feasible. Despite missing synergistic effects on efficacy for the overall population, promising OS was observed for patients with high PD-L1 expression and for patients with previous immunotherapy. Therefore, CPI responsiveness may have been restored in some cases. Inhibition of FGFR-mediated tumor progression seems relevant in tumors with lower levels of both PD-L1 and FGFR1 expression and might be effectively inhibited by nintedanib. The combination nivolumab/nintedanib might warrant further exploration in selected patients.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109318"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Altered bacteriome and mycobiome in small cell lung cancer: insights from microbial profiling","authors":"Ines Rolim ,&nbsp;Antonio Lopez-Beltran ,&nbsp;Marcos Pantarotto ,&nbsp;Eric de Sousa ,&nbsp;Joao Sobral ,&nbsp;Nuno Gil ,&nbsp;Carlos Penha-Gonçalves ,&nbsp;Carol Farver","doi":"10.1016/j.lungcan.2026.109315","DOIUrl":"10.1016/j.lungcan.2026.109315","url":null,"abstract":"<div><h3>Background</h3><div>The tumor-associated microbiome influences cancer development and progression, yet the microbial landscape of small cell lung cancer (SCLC) remains unexplored. Given the absence of SCLC–specific microbiome studies, we conducted an exploratory analysis to describe the bacterial and fungal communities present in SCLC tissue.</div></div><div><h3>Results</h3><div>Using 16S rRNA sequencing, we profiled the bacteriome of lung specimens from SCLC and control cases and observed increased bacterial signal and reduced bacterial diversity in SCLC, accompanied by relative enrichment of Firmicutes and Bacteroidota. Actinobacteria were comparatively underrepresented, resulting in a higher Proteobacteria–to–Actinobacteria ratio, although this difference did not reach statistical significance. At the genus level, SCLC samples were dominated by <em>Pseudomonas</em>, <em>Streptococcus</em>, <em>Haemophilus</em>, and <em>Granulicatella</em>, which together accounted for approximately half of the bacterial community. As a secondary, hypothesis–generating analysis, we examined the mycobiome using ITS sequencing and detected the unexpected presence of the biotrophic plant–pathogenic genus <em>Taphrina</em> in a subset (25%) of SCLC samples. Given the methodological constraints and contamination risks inherent to low–biomass FFPE tissues, this fungal signal is interpreted cautiously and framed strictly as preliminary.</div></div><div><h3>Conclusions</h3><div>This study provides the first descriptive characterization of the lung bacteriome and mycobiome in SCLC using FFPE tissue. The observed alterations in microbial composition, including an unexpected fungal signal, offer hypothesis–generating insights that require validation in larger, prospectively collected cohorts incorporating more comprehensive contamination–control strategies.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109315"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Overall survival for amivantamab plus lazertinib versus osimertinib as first-line treatment in Asian participants with EGFR-mutant advanced NSCLC: A MARIPOSA subset analysis","authors":"Hidetoshi Hayashi ,&nbsp;Byoung Chul Cho ,&nbsp;Yu Jung Kim ,&nbsp;Se-Hoon Lee ,&nbsp;Pongwut Danchaivijitr ,&nbsp;Adlinda Alip ,&nbsp;Hailin Xiong ,&nbsp;Soon-Hin How ,&nbsp;Gee-Chen Chang ,&nbsp;James Chih-Hsin Yang ,&nbsp;Yuta Yamanaka ,&nbsp;Mehmet Ali Nahit Şendur ,&nbsp;Kumar Prabhash ,&nbsp;Koichi Azuma ,&nbsp;Alianu Akawung ,&nbsp;Elizabeth Fennema ,&nbsp;Xiaodan Tang ,&nbsp;Sujay Shah ,&nbsp;Seema Sethi ,&nbsp;Shun Lu","doi":"10.1016/j.lungcan.2026.109305","DOIUrl":"10.1016/j.lungcan.2026.109305","url":null,"abstract":"<div><h3>Background</h3><div>Approximately 60 % of lung cancer cases occur in Asia, indicating an epidemiological disparity and need for effective therapies. Amivantamab-lazertinib is approved for first-line <em>EGFR</em>-mutated advanced non-small cell lung cancer (NSCLC) in many countries. In the protocol-specified final overall survival (OS) analysis of MARIPOSA (NCT04487080), amivantamab-lazertinib showed a statistically significant and clinically meaningful improvement in OS versus osimertinib (HR, 0.75; <em>P</em> = 0.005) among all participants. We evaluated OS for amivantamab-lazertinib versus osimertinib in Asian participants.</div></div><div><h3>Patients and methods</h3><div>Participants with previously untreated <em>EGFR</em>-mutated, locally advanced/metastatic NSCLC were randomized 2:2:1 to receive amivantamab-lazertinib, osimertinib, or lazertinib (for evaluating contribution of components). Self-identified Asian race was a stratification factor. OS was a key secondary endpoint.</div></div><div><h3>Results</h3><div>Of 1074 randomized participants, 629 self-identified as Asian (amivantamab-lazertinib:250; osimertinib:251; lazertinib:128). At a median follow-up of 38.7 months, amivantamab-lazertinib significantly prolonged OS versus osimertinib among Asian participants. Median OS was not reached (NR; 95 % CI, NR–NR) for amivantamab-lazertinib versus 38.4 months (95 % CI, 35.1–NR) for osimertinib (HR, 0.74; 95 % CI, 0.56–0.97; nominal <em>P</em> = 0.026). Assuming exponential distribution of OS in both arms, amivantamab-lazertinib is projected to prolong median OS among Asian participants by &gt; 12 months versus osimertinib. At 36 months, 61 % and 53 % were alive in the amivantamab-lazertinib and osimertinib arms. Safety profile was consistent with the overall population.</div></div><div><h3>Conclusions</h3><div>Consistent with the overall population, amivantamab-lazertinib significantly improved OS versus osimertinib among Asian participants with previously untreated <em>EGFR</em>-mutated advanced NSCLC, making it the first regimen to improve survival among Asian patients.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109305"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety evaluation of tarlatamab: A pharmacovigilance study based on the FAERS database","authors":"Jiesong Wang ,&nbsp;Xue Wang ,&nbsp;Yaxin Li ,&nbsp;Chunxia Huang ,&nbsp;Xiaopeng Xu ,&nbsp;Mei Zhang","doi":"10.1016/j.lungcan.2025.108801","DOIUrl":"10.1016/j.lungcan.2025.108801","url":null,"abstract":"<div><h3>Objectives</h3><div>Tarlatamab (Imdelltra, AMG757) has been approved for extensive-stage small cell lung cancer (ES-SCLC) treatment, yet post-marketing data remain limited. Existing studies lack conclusive evidence on its real-world safety profile.</div></div><div><h3>Materials and methods</h3><div>Leveraging the FDA Adverse Event Reporting System (FAERS), this study evaluated adverse events (AEs) attributed to Tarlatamab between Q2 2024 and Q1 2025. Disproportionality analysis using reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) quantified associations between Tarlatamab and AEs.</div></div><div><h3>Results</h3><div>Among 448 analyzed AE reports, the median time to AE onset was 5.0 days. Tarlatamab-associated AEs reports showed elevated hospitalization (21.7 %) and fatality rates (16.7 %). Significant signals emerged across 5 System Organ Classes (SOCs) and 31 Preferred Terms (PTs), including unlabeled events: atrial fibrillation (IC025: 0.77), ageusia (IC025: 3.79), mental status changes (IC025: 2.45), and unresponsiveness to stimuli (IC025: 2.22). Notable discrepancies with labeled information included dual hypertension (IC025: 0.18) and hypotension (IC025: 1.61) signals, suggesting complex blood pressure effects, and a higher mortality risk in male patients. Mild AEs correlated with reduced severe outcome risks.</div></div><div><h3>Conclusion</h3><div>These findings offer critical insights for clinicians to identify and manage Tarlatamab-related AEs, highlighting underestimated risks and informing tailored practice.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 108801"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Broadening clinical trial inclusivity of patients with lung cancer and brain metastases utilizing the Graded Prognostic Assessment (GPA): A call to action","authors":"Laura Alder ,&nbsp;Trey C. Mullikin ,&nbsp;Chris Lascola ,&nbsp;Paul W. Sperduto","doi":"10.1016/j.lungcan.2026.109317","DOIUrl":"10.1016/j.lungcan.2026.109317","url":null,"abstract":"<div><div>Brain metastases (BM) occur in 30–50% of non-small cell lung cancer (NSCLC) and up to 80% of small cell lung cancer (SCLC) patients, yet historically over 80% of clinical trials excluded this population. Current eligibility requirements often mandate completion of radiation therapy with prolonged washout periods, delaying systemic therapy initiation and limiting trial generalizability. Despite recommendations from ASCO-Friends of Cancer Research and FDA guidance, only 11.4% of lung cancer trials include patients with active, untreated BM.</div><div>We propose incorporating the Graded Prognostic Assessment (GPA) to standardize and broaden clinical trial enrollment. The 2022 Lung GPA, validated in 4,183 patients, incorporates age, Karnofsky Performance Status, extracranial metastases, number of BM, and molecular markers (EGFR, ALK, PD-L1 for NSCLC).</div><div>The GPA-based Eligibility Quotient (EQ) uses conditional probability to determine trial eligibility for patients with previously treated BM. We recommend including patients with GPA-predicted median survival ≥ 12 months or EQ ≥ 0.50. For asymptomatic, untreated BM, enrollment should be permitted with protocol-specified CNS imaging at 4–6-week intervals, reserving radiation for progression or inadequate response. Trials should stratify by GPA category, specify RANO-BM or modified RECIST criteria prospectively, and report both full analysis sets and evaluable CNS disease subsets. This evidence-based framework ensures patients with BM gain timely access to potentially life-extending therapies while maintaining trial integrity.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"214 ","pages":"Article 109317"},"PeriodicalIF":4.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146193072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}