{"title":"Phase III study of ramucirumab plus docetaxel versus atezolizumab for previously treated PD-L1 low or negative advanced non-small-cell lung cancer: WJOG10317L study","authors":"Yoshitaka Zenke , Seiji Niho , Yukihiro Toi , Masafumi Yamaguchi , Satoshi Hara , Yuki Akazawa , Yukio Hosomi , Kimio Yonesaka , Hiroaki Akamatsu , Toshihide Yokoyama , Junko Tanizaki , Kiyonobu Ueno , Hiroshi Gyotoku , Toshihiro Misumi , Kazuhiko Nakagawa , Nobuyuki Yamamoto , Masahiro Tsuboi","doi":"10.1016/j.lungcan.2025.108633","DOIUrl":"10.1016/j.lungcan.2025.108633","url":null,"abstract":"<div><h3>Purpose</h3><div>We aimed to compare the efficacy and safety of docetaxel plus ramucirumab and atezolizumab as second-line treatment for programmed death-ligand 1 (PD-L1)-negative or low advanced non-small-cell-lung cancer (NSCLC) after platinum-based chemotherapy.</div></div><div><h3>Patients and methods</h3><div>This multicenter randomized phase III study enrolled patients with advanced NSCLC who had progressed during or after first-line platinum-based chemotherapy. Patients were allocated randomly (1:1) to receive atezolizumab (arm A) or docetaxel plus ramucirumab (arm B) every 3 weeks. The primary endpoint was overall survival (OS).</div></div><div><h3>Results</h3><div>This study was activated in April 2018 and closed in March 2020 due to slow accrual. Seventy eligible patients were enrolled from 26 institutions, including 36 patients in arm A and 34 in arm B. The median OS (median follow-up, 24.2 months) were 17.1 and 15.8 months (HR = 1.508, 95 % confidence interval (CI), 0.86–2.65; P = 0.23), respectively. The 2-year OS rates were 42.8 % (95 % CI, 26.2 %–58.4 %) and 19.4 % (95 %CI, 7.5–35.3), the objective response rates (ORRs) were 5.6 % and 35.3 % (P = 0.002), and the median progression-free survival (PFS) were 1.5 and 5.5 months (P = 0.005), respectively. The crossover rates were 55.6 % and 64.7 %, and the median times from randomization to progression or death post-crossover were 12.9 and 9.1 months. Grade ≥ 3 toxicities included neutropenia (2.8 %/17.6 %), thrombocytopenia (2.8 %/8.8 %), anorexia (2.8 %/5.9 %), febrile neutropenia (0 %/5.9 %), and hypertension (2.8 %/8.8 %).</div></div><div><h3>Conclusions</h3><div>OS was similar in both arms, but docetaxel plus ramucirumab resulted in favorable ORR and PFS. The 2-year OS rates suggested that atezolizumab might enhance the efficacy of post-study cytotoxic chemotherapy; however, interpretation of the data was limited by the small sample size.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108633"},"PeriodicalIF":4.5,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144519029","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}
Lung CancerPub Date : 2025-06-20DOI: 10.1016/j.lungcan.2025.108628
Drew Moghanaki, Emily A Cameron, Edward B Garon
{"title":"Unbridled Enthusiasm for Neoadjuvant Chemoimmunotherapy followed by Surgery for Locally Advanced Non-Small Cell Lung Cancer.","authors":"Drew Moghanaki, Emily A Cameron, Edward B Garon","doi":"10.1016/j.lungcan.2025.108628","DOIUrl":"https://doi.org/10.1016/j.lungcan.2025.108628","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":" ","pages":"108628"},"PeriodicalIF":4.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144497429","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}
Lung CancerPub Date : 2025-06-20DOI: 10.1016/j.lungcan.2025.108630
Minna Zhang , Yi Tang , Jiafeng Liang , Lucheng Zhu , Bing Wang , Kaicheng Pan , Xiao Xu , Xueqin Chen , Bing Xia
{"title":"Combination of anlotinib and irinotecan as second-line therapy in extensive-stage small-cell lung cancer relapsed within six months: a single-arm phase Ⅱ study","authors":"Minna Zhang , Yi Tang , Jiafeng Liang , Lucheng Zhu , Bing Wang , Kaicheng Pan , Xiao Xu , Xueqin Chen , Bing Xia","doi":"10.1016/j.lungcan.2025.108630","DOIUrl":"10.1016/j.lungcan.2025.108630","url":null,"abstract":"<div><h3>Purpose</h3><div>There is still no satisfactory treatment strategy for patients with extensive-stage small-cell lung cancer (ES-SCLC) relapsed within 6 months after first-line treatment.</div></div><div><h3>Patients and Methods</h3><div>Subjects received 12 mg oral anlotinib on days 1–14 and irinotecan (65 mg/m<sup>2</sup>) on day 1 and 8 every 3 weeks (up to 4 cycles), followed by anlotinib maintainance therapy with anlotinib alone. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and safety.</div></div><div><h3>Results</h3><div>Thirty-seven patients were evaluable for efficacy and safety profile. ORR was 62.2 % (23/37) and DCR was 91.9 % (34/37). Median PFS and OS for all the patients were 4.5 and 7.2 months. PFS and OS of patients with a 3 < chemothrerapy-free survival (CTFI) ≤ 6 months were better than those of patients with a CTFI ≤ 3 months (PFS 6.5 vs 3.9 months, <em>P</em> = 0.0073; OS 18.5 vs 5.9 months, <em>P</em> < 0.001). Patients who previously received chemotherapy alone or chemotherapy combined with immunotherapy as first-line treatment had similar median PFS and OS (mPFS 4.4 vs 4.9 months, <em>P</em> = 0.38; mOS 7.2 vs 8.3 months, <em>P</em> = 0.79). Only three patients (8.5 %) suffered from Grade 3 adverse effects, which were thrombocytopenia, leukopenia, and anemia.</div></div><div><h3>Conclusion</h3><div>The combination of anlotinib and irinotecan as second-line treatment for ES-SCLC patients who relapsed within 6 months demonstrated promising efficacy and had manageable toxicities. Patients with 3 < CTFI ≤ 6 months had longer PFS and OS than those with CTFI ≤ 3 months. Previous immunotherapy did not affect the efficacy of subsequent anlotinib and irinotecan. It may become a novel therapeutic strategy for this population. The trial was registered with <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> (No. NCT04757779).</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108630"},"PeriodicalIF":4.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144338348","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}
Lung CancerPub Date : 2025-06-19DOI: 10.1016/j.lungcan.2025.108631
Hirokazu Iso , Ryo Ariyasu , Syunsuke Fujishima , Masahiro Ito , Kyujiro Nibuya , Mayu Sugai , Ryosuke Tsugitomi , Yoshiaki Amino , Ken Uchibori , Noriko Yanagitani , Hironori Ninomiya , Masahiro Seike , Makoto Nishio
{"title":"Prognostic impact of HNF4α expression in TTF-1-negative non-squamous NSCLC treated with immune checkpoint inhibitor","authors":"Hirokazu Iso , Ryo Ariyasu , Syunsuke Fujishima , Masahiro Ito , Kyujiro Nibuya , Mayu Sugai , Ryosuke Tsugitomi , Yoshiaki Amino , Ken Uchibori , Noriko Yanagitani , Hironori Ninomiya , Masahiro Seike , Makoto Nishio","doi":"10.1016/j.lungcan.2025.108631","DOIUrl":"10.1016/j.lungcan.2025.108631","url":null,"abstract":"<div><h3>Introduction</h3><div>Thyroid transcription factor-1 (TTF-1)-negative status is associated with poor response to immune checkpoint inhibitor (ICI); however, the underlying reasons remain unclear. Hepatocyte nuclear factor 4 alpha (HNF4α) is a nuclear receptor mutually exclusive with TTF-1 and is associated with cancer cell proliferation and metastasis. This study evaluated the impact of HNF4α expression on survival outcomes in patients with TTF-1-negative non-squamous non-small cell lung cancer (non-Sq NSCLC) treated with ICI.</div></div><div><h3>Methods</h3><div>We conducted this single-center retrospective study that analyzed patients with advanced or recurrent non-Sq NSCLC who received ICI therapy. Based on immunohistochemical analysis, the patients were classified into three groups: (1) TTF-1 negative and HNF4α positive, (2) TTF-1 negative and HNF4α negative, and (3) TTF-1 positive. Kaplan–Meier analysis was used to estimate overall survival (OS), and the log-rank test was used to compare intergroup differences.</div></div><div><h3>Results</h3><div>388 patients treated with ICI were included: 54 TTF-1 negative HNF4α positive, 48 TTF-1 negative HNF4α negative, and 286 TTF-1 positive. The median OS was significantly worse in the TTF-1-negative HNF4α-positive group than in the TTF-1-positive group (12.0 vs. 32.3 months; Hazard ratio (HR): 2.14 [95 % confidence interval (CI): 1.54–2.99], p < 0.001). Meanwhile, the median OS of the TTF-1-negative HNF4α-positive group was equivalent to that of the TTF-1-positive group (32.2 vs. 32.3 months; HR: 1.03 [95 % CI: 0.68–1.54], p = 0.90). Multivariate analysis identified HNF4α as an independent poor prognostic factor. Subgroup analyses restricted to patients with adenocarcinoma and those receiving first-line chemo-immunotherapy demonstrated similar trends.</div></div><div><h3>Conclusion</h3><div>HNF4α expression in TTF-1-negative non-Sq NSCLC was associated with worse prognosis in patients treated with ICI.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108631"},"PeriodicalIF":4.5,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144480086","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}
Lung CancerPub Date : 2025-06-19DOI: 10.1016/j.lungcan.2025.108629
Chandrakant S. Gawli , Bhatu R. Patil , Narendra R. Nagpure , Chandrgaouda R. Patil , Anoop Kumar , Harun M. Patel
{"title":"Prevalence of osimertinib-induced cardiotoxicity in non-small cell lung cancer patients: a systematic review and meta-analysis","authors":"Chandrakant S. Gawli , Bhatu R. Patil , Narendra R. Nagpure , Chandrgaouda R. Patil , Anoop Kumar , Harun M. Patel","doi":"10.1016/j.lungcan.2025.108629","DOIUrl":"10.1016/j.lungcan.2025.108629","url":null,"abstract":"<div><h3>Objective</h3><div>Osimertinib, a third-generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI), is the standard of care for patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC). While clinically effective, concerns have emerged regarding its potential cardiotoxicity. This study aims to systematically evaluate the prevalence and types of cardiotoxicity associated with Osimertinib.</div></div><div><h3>Methods</h3><div>A systematic review and <em>meta</em>-analysis were performed in accordance with PRISMA guidelines. Literature searches of PubMed and <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> were conducted for studies published between October 2014 and October 2024. Data from 68 studies encompassing 14,050 patients were analyzed using the <em>metafor</em> package in R Studio (version 4.4.1). A generalized linear mixed model with logit transformation was used to estimate pooled prevalence. Heterogeneity was assessed via I<sup>2</sup> statistics, and publication bias was evaluated using Egger’s and Begg’s tests.</div></div><div><h3>Results</h3><div>The overall pooled prevalence of Osimertinib-induced cardiotoxicity was 4.00 % (95 % CI: 2.9–5.48; I2 = 76.9 %). QT prolongation was the most commonly reported event (6.03 %), followed by atrial fibrillation (1.50 %) and cardiac failure (1.21 %). Subgroup analysis showed higher prevalence in randomized controlled trials (4.98 %) versus observational studies (0.78 %), and in combination therapies (4.89 %) versus monotherapy (3.64 %). Regional variation was noted, with the highest prevalence in North America (5.56 %). Egger’s test indicated significant publication bias (p < 0.0001) for several cardiotoxic outcomes.</div></div><div><h3>Conclusion</h3><div>Osimertinib is associated with a modest but clinically significant risk of cardiotoxicity, particularly QT prolongation. These findings support the need for routine cardiac monitoring in high-risk patients and emphasize the importance of standardized cardiotoxicity reporting in future trials to enhance the safety profile of Osimertinib in NSCLC treatment.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108629"},"PeriodicalIF":4.5,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144338347","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}
Lung CancerPub Date : 2025-06-18DOI: 10.1016/j.lungcan.2025.108627
Bo Yan , Bo Zhang , Tianqing Chu , Wei Zhang , Chunlei Shi , Huimin Wang , Xueyan Zhang , Baohui Han , Hua Zhong
{"title":"Osimertinib combined with anlotinib as first-line treatment in advanced or metastatic NSCLC patients with EGFR mutation: a prospective, single arm, exploratory study","authors":"Bo Yan , Bo Zhang , Tianqing Chu , Wei Zhang , Chunlei Shi , Huimin Wang , Xueyan Zhang , Baohui Han , Hua Zhong","doi":"10.1016/j.lungcan.2025.108627","DOIUrl":"10.1016/j.lungcan.2025.108627","url":null,"abstract":"<div><h3>Introduction</h3><div>Osimertinib plus chemotherapy significantly improved PFS as first-line (1L) treatment in EFGR mutated (EGFRm) advanced NSCLC (FLAURA2). To mitigate the cytotoxicity and inconvenience of chemotherapy, we explored a chemo-free oral combination therapy with osimertinib (osi) plus anlotinib (anlo, a multi-targeted TKI inhibit both tumor angiogenesis and growth) in 1L setting.</div></div><div><h3>Methods</h3><div>This is a prospective, single arm, exploratory study. Treatment-naïve patients (pts) with EGFRm advanced NSCLC were enrolled. The part A assessed the recommended dose of the combination of osimertinib plus anlotinib for further clinical evaluation based upon assessment of the safety and tolerability data (Part A: osi, 80mg daily; anlo, 8mg/10mg/12mg daily, D1-14, 21d/cycle). Part B was an expansion cohort. Primary endpoint was recommended phase 2 dose (RP2D) (Part A) and objective response rate (ORR) (Part B).</div></div><div><h3>Results</h3><div>25 eligible patients were enrolled. The RP2D is osimertinib 80mg, once daily and anlotinib (12 mg/day orally, 14 days on and 7 days off). Adverse events of any cause (TEAE) and any grade was observed in 24 (96.0%) patients. 8 (32.0%) patients experienced grade 3 TEAE. Serious adverse events were reported in 4 (16.0%) patients. In FAS population (defined as patients who received at least one dose of study drugs), ORR and DCR was 60.0% (15/25 patients, 95% CI, 38.7%-78.9%) and 88.0% (22/25 patients, 95% CI, 68.8%-97.5%), respectively. Median PFS and OS were 31.5 months (95%CI, 17.9 months-NE) and not reached, respectively, with 36 months PFS and OS rate were 31.9% (95%CI, 17.3%-58.8%) and 74.3% (95% CI, 58.5%-94.4%), respectively.</div></div><div><h3>Conclusions</h3><div>Osimertinib combined with full dose anlotinib showed manageable safety profile and encouraging efficacy, deserving further investigation.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108627"},"PeriodicalIF":4.5,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144366827","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":"Global trends in lung cancer incidence and mortality by age, gender and morphology and forecast: A bootstrap-based analysis","authors":"Jinto Edakkalathoor George, Preethi Sara George, Jagathnath K.M. Krishna, Aleyamma Mathew","doi":"10.1016/j.lungcan.2025.108626","DOIUrl":"10.1016/j.lungcan.2025.108626","url":null,"abstract":"<div><h3>Introduction</h3><div>Lung cancer (LC) is the most commonly diagnosed cancer and the leading cause of cancer-related deaths. Understanding temporal-trends and predicting future burden are essential for effective planning. This study aims to analyse time-trends in LC incidence and mortality and to forecast rates worldwide.</div></div><div><h3>Methods</h3><div>We included LC incidence and mortality rates (1970–2020) across 36 populations in 35 countries spanning America, Europe, Oceania and Asia. Datasets were extracted from Cancer Over Time and CI5plus, stratified by gender, age (<60 and ≥ 60 years), and morphology. Time-trends were assessed using joinpoint regression to calculate average annual percent change (AAPC). Future rates through 2030 were estimated using time-series bootstrap methods, and prediction accuracy was evaluated using normalized root mean squared error from ARIMA model.</div></div><div><h3>Results</h3><div>LC incidence and mortality rates declined among men in most countries, except for increasing incidence in Norway, Japan, and Israel, and rising mortality in Norway, Spain, Japan, and Republic of Korea. Among women, both rates increased across regions, with the highest AAPC in incidence in France (5.8 %) and in mortality in Norway (3.6 %). Adenocarcinoma incidence increased in both genders, notably in Chile (men: 7.4 %; women: 9.5 %). Squamous-cell and small-cell carcinomas also increased among women in several European countries. By 2030, the highest projected LC rates were in Croatia (men: incidence 54.5, mortality 40.3), Netherlands (women: incidence 43.0) and Northern Ireland (women: mortality 25.0).</div></div><div><h3>Conclusion</h3><div>Continued tobacco cessation initiatives are essential to reduce LC burden. Additionally, further investigation is warranted to identify the potential association between air-pollution and adenocarcinoma.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108626"},"PeriodicalIF":4.5,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144331333","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}
Lung CancerPub Date : 2025-06-18DOI: 10.1016/j.lungcan.2025.108625
Hyuna Sung, Chenxi Jiang, Elizabeth J. Schafer, Priti Bandi, Farhad Islami, Ahmedin Jemal
{"title":"Burden and trends in subsequent primary lung cancer incidence by sex in the United States","authors":"Hyuna Sung, Chenxi Jiang, Elizabeth J. Schafer, Priti Bandi, Farhad Islami, Ahmedin Jemal","doi":"10.1016/j.lungcan.2025.108625","DOIUrl":"10.1016/j.lungcan.2025.108625","url":null,"abstract":"<div><h3>Introduction</h3><div>Despite well-documented sex and age differences in lung cancer incidence and trends, it remains unclear whether the patterns differ by tumor sequence. This study compares sex- and age-specific incidence patterns of first primary lung cancers (FPLCs) and subsequent primary lung cancers (SPLCs) in the US.</div></div><div><h3>Methods</h3><div>Lung and bronchus (hereafter, lung) cancers diagnosed from 2001 to 2021 (ages, 20+ years) were identified from the U.S Cancer Statistics Public Use Database. Age-standardized incidence rates and female-to-male incidence rate ratios (RRs) were calculated for FPLC and SPLC, separately, overall and stratified by age groups (20–49, 50–59, 60–69, 70–79, 80+ years) and diagnosis years (2001–2006, 2007–2011, 2012–2016, 2017–2021).</div></div><div><h3>Results</h3><div>From 2001 to 2021, there were 3,494,840 FPLC and 1,017,025 SPLC diagnoses. Overall, the incidence rate was 27% lower in women than in men (57.51 versus 78.56 per 100,000) for FPLCs and 32% lower for SPLCs (16.65 versus 24.54 per 100,000). However, the sex gap narrowed at younger ages, with female predominance more pronounced for SPLCs than for FPLCs. Specifically, among ages 20–49, SPLC incidence was 88% higher in women (0.81 vs. 0.43 per 100,000; RR = 1.88, 95% confidence interval [CI] = 1.82–1.94) and, among ages 50–59, it was 26% higher (10.89 vs. 8.63 per 100,000; RR = 1.26, 95% CI = 1.25–1.28), in contrast to comparable or higher rates in males for FPLCs. The female predominance was consistent throughout 2001–2021 for SPLCs (ages, 20–59), whereas it emerged only since 2012–2016 for FPLCs (ages, 20–49).</div></div><div><h3>Conclusion</h3><div>Sex-specific lung cancer incidence considerably differs by tumor sequence. The female predominance of SPLC among young adults highlights the need for analytical studies to identify risk factors and has important implications for young adult cancer survivorship.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108625"},"PeriodicalIF":4.5,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144480097","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}
Lung CancerPub Date : 2025-06-16DOI: 10.1016/j.lungcan.2025.108623
Manuel Pérez-Pérez , Carmen García de Sola-Llamas , Laura Macías-García
{"title":"Diagnostic accuracy of the Idylla™ mutation test for detecting EGFR mutations in non-small cell lung cancer: a meta-analysis","authors":"Manuel Pérez-Pérez , Carmen García de Sola-Llamas , Laura Macías-García","doi":"10.1016/j.lungcan.2025.108623","DOIUrl":"10.1016/j.lungcan.2025.108623","url":null,"abstract":"<div><h3>Introduction</h3><div>The epidermal growth factor receptor (EGFR) plays a key role in non-small cell lung cancer (NSCLC) and is fundamental in therapeutic decision-making. The Idylla™ EGFR Mutation Test (Idylla™ MT) is an automated platform designed to detect mutations in EGFR. This <em>meta</em>-analysis evaluates its diagnostic test accuracy (DTA) in comparison with reference methods such as next-generation sequencing (NGS) and real-time PCR (qPCR).</div></div><div><h3>Material and Methods</h3><div>A systematic review was carried out of 27 studies including 10,585 samples from patients with NSCLC. Sensitivity, specificity and other DTA parameters were analyzed using a random effects model. The performance of Idylla™ MT was compared to NGS and other conventional methods, and heterogeneity between studies was evaluated.</div></div><div><h3>Results</h3><div>The combined sensitivity and specificity of Idylla™ MT were 0.92 (95 % CI: 0.88–0.95) and 1.00 (95 % CI: 0.99–1.00), respectively, with an area under the SROC curve (AUC-SROC) of 0.99, indicating excellent diagnostic performance. Compared to NGS, sensitivity and specificity were similar (0.92 and 1.00, respectively). The prevalence of EGFR mutations detected by Idylla™ MT was 43.1 %, with significant heterogeneity between studies. Its rapid response time allows for more agile clinical decision making.</div></div><div><h3>Conclusion</h3><div>Idylla™ MT is a precise and cost-effective alternative for the detection of EGFR mutations, especially in resource-limited settings. Its main limitations include restricted mutation detection and possible false negatives in samples with low tumor DNA. Its complementary use with broader molecular techniques is recommended to optimize the detection and management of NSCLC.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108623"},"PeriodicalIF":4.5,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144306343","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}
Lung CancerPub Date : 2025-06-10DOI: 10.1016/j.lungcan.2025.108621
Maria Gemelli , Diego Cortinovis , Giorgia Carola , Laura Moretti , Francesca Piazza , Stefano Calza , Riccardo Ricotta , Salvatore Grisanti , Matteo Rota
{"title":"Efficacy of immune checkpoint inhibitors (ICIs) in PD-L1 negative Non-Small Cell Lung Cancer (NSCLC) – A meta-analysis based on reconstructed individual participant data","authors":"Maria Gemelli , Diego Cortinovis , Giorgia Carola , Laura Moretti , Francesca Piazza , Stefano Calza , Riccardo Ricotta , Salvatore Grisanti , Matteo Rota","doi":"10.1016/j.lungcan.2025.108621","DOIUrl":"10.1016/j.lungcan.2025.108621","url":null,"abstract":"<div><h3>Background</h3><div>despite advancements in NSCLC treatment, PD-L1 negative patients remain a therapeutic challenge. This <em>meta</em>-analysis evaluates the efficacy of immune checkpoint inhibitors (ICIs) and their combinations in PD-L1 negative NSCLC.</div></div><div><h3>Materials and Methods</h3><div>Major databases (PubMed, Embase, Cochrane Library) were searched using terms such as “PD-L1 negative,” “NSCLC,” “chemotherapy,” and “immunotherapy.” Phase I-III clinical trials comparing ICIs-based treatments in PD-L1 negative NSCLC were included, excluding non-peer-reviewed studies. Data extraction followed PRISMA guidelines, with independent review by two researchers. Random-effects models were used to pool data, assessing overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).</div></div><div><h3>Results</h3><div>This analysis included 43 trials with 7039 patients. Immunotherapy alone yielded an ORR of 11 %, while immunotherapy combined with chemotherapy achieved the highest ORR (48 %). Combination immunotherapy alone and chemotherapy alone showed comparable ORRs (23 % vs. 22 %). Median PFS was 2.3 months for immunotherapy alone, 6.8 months for immunotherapy plus chemotherapy, and 5.7 months for combo immunotherapy. OS was 10.1 months for immunotherapy alone, 15.6 months for immunotherapy plus chemotherapy, and 17.6 months for combo immunotherapy. Network <em>meta</em>-analysis highlighted pembrolizumab with platinum-based chemotherapy as the most effective, achieving the highest ORR and a 45 % PFS improvement compared to chemotherapy alone.</div></div><div><h3>Conclusions</h3><div>Combination therapies, particularly ICIs with chemotherapy, significantly improve ORR, PFS, and OS in PD-L1 negative NSCLC, underscoring their potential as optimal strategies for this population.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"205 ","pages":"Article 108621"},"PeriodicalIF":4.5,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144297778","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}