Clinical lung cancer最新文献

{"title":"Phrenic Nerve Palsy after Stereotactic Body Radiotherapy for Central Lung Cancer: A Case Report.","authors":"James C H Chow, Jeannie Y K Chik, Ka Man Cheung, Luke T Y Lee, Kam Hung Wong, Kwok Hung Au","doi":"10.1016/j.cllc.2024.10.006","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.006","url":null,"abstract":"","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142602166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multicentre Validation of the RESECT-90 Prediction Model for 90-Day Mortality After Lung Resection.","authors":"Marcus Taylor, Glen P Martin, Udo Abah, Michael Shackcloth, Felice Granato, Richard Booton, Aman Coonar, Stuart W Grant","doi":"10.1016/j.cllc.2024.10.005","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.005","url":null,"abstract":"<p><strong>Background: </strong>The RESECT-90 model was developed to predict 90-day mortality for patients undergoing lung resection but hasn't been externally validated. The aim of this study was to validate the RESECT-90 clinical prediction model using multicentre patient data from across the United Kingdom (UK).</p><p><strong>Materials and methods: </strong>Data from 12 UK thoracic surgery centers for patients undergoing lung resection between 2016 and 2020 with available 90-day mortality status were used to externally validate the RESECT-90 model. Measures of discrimination (area under the receiving operator characteristic curve [AUC]) and calibration (calibration slope, calibration intercept and flexible calibration plot) were assessed as measures of model performance. Model recalibration was also performed by updating the original model intercept and coefficients.</p><p><strong>Results: </strong>A total of 12,241 patients were included. Overall 90-day mortality was 2.9% (n = 360). Acceptable model discrimination was demonstrated (AUC 0.74 [0.73, 0.75]). Calibration varied between centers with some evidence of overall model miscalibration (calibration slope 0.80 [0.66, 0.95] and calibration intercept 0.40 [0.29, 0.52]) despite acceptable appearances of the flexible calibration plot. The model was subsequently recalibrated, after which all measures of calibration indicated excellent performance.</p><p><strong>Conclusions: </strong>After external validation and recalibration using a large contemporary cohort of patients undergoing surgery in multiple geographical locations across the UK, the RESECT-90 model demonstrated satisfactory statistical performance for the prediction of 90-day mortality after lung resection. Whilst the recalibrated model will require ongoing validation, the results of this study suggest that routine use of the RESECT-90 model in UK thoracic surgery practice should be considered.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Primary Care Providers in Lung Cancer Screening: A Cross-Sectional Survey.","authors":"Lye-Yeng Wong, Ntemena Kapula, Augustine Kang, Anuradha J Phadke, Andrew D Schechtman, Irmina A Elliott, Brandon A Guenthart, Douglas Z Liou, Leah M Backhus, Mark F Berry, Joseph B Shrager, Natalie S Lui","doi":"10.1016/j.cllc.2024.10.002","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.002","url":null,"abstract":"<p><strong>Background: </strong>Multidisciplinary lung cancer screening (LCS) programs that perform shared decision-making visits (SDMV) and follow up annual low dose computed tomography (LDCT) have been emerging. We hypothesize that primary care providers (PCPs) prefer to refer patients to LCS programs instead of facilitating the screening process themselves.</p><p><strong>Methods: </strong>This is a mixed-methods, cross-sectional study in which an online survey was administered to PCPs between April 2023 and June 2023.</p><p><strong>Results: </strong>58 PCPs in the same hospital network participated in the study with a median age of 43 (34-51), predominance of women (77.6%), and clinicians of white and Asian race (44.8% and 48.3%). Respondents estimated that 26.1% (SD 32.4%) of their eligible patients participate in LCS screening. PCPs thought that an LCS program was equally convenient to performing screening themselves for identifying eligible patients and ordering LDCT. However, 63.8% of participants preferred an LCS program for performing SDMVs, 62.1% for ensuring annual follow-up on negative LDCTs, 70.7% for deciding next steps on positive LDCTs, and 60.4% for performing smoking cessation counseling. PCPs agreed that an LCS program saves time (69%), allows patients to receive specialty care (65.6%), addresses patient concerns (70.7%), ensures annual follow-up (77.6%), and manages abnormal findings (79.3%). However, they also expressed concerns about an additional visit for the patient (48.2%) and patient cost (46.5%).</p><p><strong>Conclusion: </strong>Most PCPs believe that formal LCS programs have many benefits including providing specialized care and follow up, although there were concerns about patient time and cost.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Participation in Non-small Cell Lung Cancer Clinical Trials in the United States by Race/Ethnicity.","authors":"Meghann Wheeler, Shama Karanth, Joel Divaker, Hyung-Suk Yoon, Jae Jeong Yang, Maisey Ratcliffe, Marissa Blair, Hiren J Mehta, Mindaugas Rackauskas, Dejana Braithwaite","doi":"10.1016/j.cllc.2024.09.009","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.009","url":null,"abstract":"<p><strong>Introduction: </strong>Despite efforts by Cancer Centers and community organizations to increase diversity in clinical trials, significant racial/ethnic disparities remain. Given the high mortality rates in non-small cell lung cancer (NSCLC), it is important to increase diversity in NSCLC trials, ensuring all patients benefit from advances in new treatment modalities.</p><p><strong>Materials and methods: </strong>We evaluated the distribution of racial/ethnic minority enrollment in NSCLC clinical trials using data from ClinicalTrials.gov. We extracted trial characteristics, including start year, study phase, tumor stage, sample size, sponsor, geographic region, and masking. The number of participants by race/ethnicity was obtained from ClinicalTrials.gov or linked publications. Using annual NSCLC incidence data from SEER*Stat for each racial/ethnic group from 2010 to 2019, we applied a 2-sample test for equality of proportions with continuity correction to assess differences between incidence and trial participation.</p><p><strong>Results: </strong>A total of 147 unique studies were included in the final analysis. Of the 28,540 participants, 79.6% were White, with 3% Black, 10.4% Asian or Pacific Islander and 3.4% Hispanic/Latino. Most participants were enrolled in phase III trials (63.8%), industry-sponsored (93.9%), and open-label (67.7%). Black patients were more commonly enrolled in academic sponsored trials and less commonly enrolled in masked (i.e., blinded) studies. When comparing trial participation to annual incidence data, we observed underrepresentation among Black participants (Difference: -7.9%) and Hispanic/Latino participants (Difference: -3.2%).</p><p><strong>Conclusion: </strong>Persistent underrepresentation exists in NSCLC clinical trials among Black and Hispanic/Latino patients. We urge further investigation of these findings through well-designed clinical trials among diverse patient populations.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation and Retrospective Examination of a Lung Cancer Survivorship Clinic in a Comprehensive Cancer Center.","authors":"Sarah N Price, Alana R Willis, Amy Hensley, Jill Hyson, Stephanie J Sohl, Ralph B D'Agostino, Michael Farris, W Jeffrey Petty, Alberto de Hoyos, Kathryn E Weaver, Stacy Wentworth","doi":"10.1016/j.cllc.2024.09.008","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.008","url":null,"abstract":"<p><strong>Purpose: </strong>The number of early-stage lung cancer survivors (LCS) is increasing, yet few survivorship programs address their specific needs. We developed a workflow to transition early-stage LCS to dedicated lung survivorship care and comprehensively identify and address their needs using electronic patient-reported outcomes (ePROs).</p><p><strong>Methods: </strong>A lung cancer multidisciplinary team developed a workflow (eg, referrals, survivorship care plan delivery, documentation, orders, tracking, ePROs, and surveillance) for a survivorship clinic staffed by Advanced Practice Providers (APPs). ePROs included the NCCN Distress Thermometer, PROMIS-29, and investigator-developed patient satisfaction items. Patient characteristics, ePROs, and referrals are described; chi-square and t-tests examined ePRO completion by patient characteristics and compared PROMIS-29 domains by treatment modality and to a national sample.</p><p><strong>Results: </strong>From January 2020-March 2023, 315 early-stage LCS completed a survivorship orientation visit. Patient satisfaction was high; 75% completed ePROs. Females were overall less likely to complete ePROs than males; male, age 65+, Black or other race, and rural patients were more likely to complete ePROs in clinic versus online. Patients reported lower symptom burden compared to a general population of early-stage LCS in the United States; scores were similar regardless of treatment modality. Rates of moderate-severe symptoms ranged from 6% (depression) to 42% (poor physical function); ≤ 20% had a referral placed.</p><p><strong>Conclusions: </strong>A referral-based, APP-staffed survivorship clinic model for early-stage LCS which includes ePROs to identify specific needs is acceptable to patients. Future work should include outreach to female LCS and increasing supportive care referrals and acceptability to further address early-stage LCS reported needs.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized Phase II Trial of Amrubicin Plus Irinotecan Versus Cisplatin Plus Irinotecan in Chemo-naïve Patients With Extensive-Disease Small-Cell Lung Cancer: Results of the Japan Multinational Trial Organization (JMTO) LC 08-01.","authors":"Hiroshige Yoshioka, Tadashi Ishida, Shinji Atagi, Akihiro Tamiya, Takashi Nishimura, Yasuo Iwamoto, Masashi Kanehara, Young Hak Kim, Yohei Korogi, Keisuke Tomii, Nobuyuki Katakami, Kiyoshi Komuta, Masanori Nishikawa, Akihiko Gemma, Kenichi Yamaki, Masaaki Kawahara, Chisato Miyakoshi, Tadashi Mio","doi":"10.1016/j.cllc.2024.09.004","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.004","url":null,"abstract":"<p><strong>Background: </strong>We conducted a randomize phase II study to evaluate the efficacy and safety of topoisomerase II inhibitor amrubicin plus topoisomerase I inhibitor irinotecan (AI) compared with cisplatin plus irinotecan (PI) as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer (SCLC).</p><p><strong>Patients and methods: </strong>Chemo-naïve patients with pathologically proven ED-SCLC (including limited disease (LD) SCLC with malignant effusion) were enrolled. Patients were randomized 1:1 to receive either AI (amrubicin 90mg/m² on day 1 and irinotecan 50mg/m² on days 1 and 8 of a 21-day cycle) or PI (cisplatin 60mg/m² on day 1 and irinotecan 60mg/m² on days 1, 8 and 15 of a 28-day cycle). The primary endpoint was overall survival proportion at 1 year.</p><p><strong>Results: </strong>A total of 100 patients were randomly assigned to AI (n = 50) or to PI (n = 50). The 1-year overall survival proportions were 68.0% (95% confidence interval (CI): 56.2-82.2%) for AI and 59.2% (46.9-74.7%) for PI (1-sided P = .18). Median survival time was 14.8 months for AI and 13.5 months for PI with a hazard ratio (HR) of 0.618 (0.398-0.961, stratified log-rank test P = .031). Median progression-free survival time was 4.8 months for AI and 5.4 months for PI (stratified log-rank test, P = .54). Objective response rate was 70.0% (55.4-82.1%) for AI and 55.1% (40.2-69.3%) for PI (Fisher exact test, P = .15). There was no significant difference in hematological toxicity, whereas rates of vomiting, loss of appetite, diarrhea, and elevated serum creatinine are more frequent in PI. Interstitial lung disease (Grade 2 or 3) developed in 5 patients in AI and in 1 patient in PI. There was no treatment-related death.</p><p><strong>Conclusion: </strong>Although the study did not meet its primary endpoint, AI showed promising efficacy and good tolerability in chemo-naïve patients with ED-SCLC.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Medicaid Expansion on the Receipt of Adjuvant Chemotherapy in Patients With Lung Cancer.","authors":"Hamza Rshaidat, Shale J Mack, Scott H Koeneman, Jonathan Martin, Gregory L Whitehorn, Isheeta Madeka, Sarah W Gordon, T Olugbenga T Okusanya","doi":"10.1016/j.cllc.2024.09.007","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.007","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to utilize a nationally representative database to study the effect of Medicaid expansion on the receipt of adjuvant chemotherapy in eligible patients.</p><p><strong>Materials and methods: </strong>Retrospective review of the National Cancer Database (NCDB) was performed between 2006 and 2019. Patients with clinical T1-T3, N1, and M0 were included. Patients with nodal disease or tumors > 4 cm were eligible for adjuvant therapy. Demographic and clinical information were collected. A difference-in-difference analysis was performed to compare changes in the rate of adjuvant chemotherapy.</p><p><strong>Results: </strong>Total 9954 eligible patients were treated in states that expanded Medicaid coverage in January 2014 or later, with 4809 patients treated in the pre-expansion years (2012-2013) and 5145 patients treated in the postexpansion years (2017-2018). Following Medicaid expansion, eligible patients were more likely to receive adjuvant therapy (70.2% vs. 62.3%; P < .001). Compared with the pre-expansion period, patients who received adjuvant therapy were more likely to use Medicaid insurance postexpansion (7.8% vs. 5%, P < .001). Among patients using Medicaid coverage only, a greater percentage started adjuvant therapy within 8 weeks of resection following Medicaid expansion (46.6% vs. 38.3%, P = .048). The observed difference-in-difference in the change in adjuvant therapy rate from the pre-expansion period to the postexpansion period between expansion and nonexpansion states was 1.25% (95% Bootstrap CI -0.36% to -3.18%). There was a modest survival benefit in expansion states postexpansion.</p><p><strong>Conclusion: </strong>Medicaid expansion appears to be associated with increased access to care, as shown by the increased receipt of adjuvant systemic therapy in eligible patients.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Patterns and Clinical Outcomes in Patients With EGFR-Mutated Non-Small-Cell Lung Cancer After Progression on Osimertinib.","authors":"Nathaniel D Robinson, Maureen E Canavan, Peter L Zhan, Brooks V Udelsman, Ranjan Pathak, Daniel J Boffa, Sarah B Goldberg","doi":"10.1016/j.cllc.2024.09.006","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.006","url":null,"abstract":"<p><strong>Introduction: </strong>For patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) who progress on first-line osimertinib, the optimal second-line treatment regimen after progression is not known. We sought to assess practice patterns and evaluate the association between different therapies and survival in patients with EGFR-mutated NSCLC following progression on first-line osimertinib.</p><p><strong>Methods: </strong>Retrospective cohort study of patients who received first-line treatment with osimertinib using a population-based, multicenter nationwide electronic health record-derived deidentified database.</p><p><strong>Results: </strong>We identified 2373 patients who received first-line osimertinib. The majority (n = 2279) received osimertinib monotherapy. A total of 538 patients received first-line osimertinib and had second-line treatment data available. Second-line treatment regimens were varied: 65% (n = 348) included chemotherapy, 37% (n = 197) included an immune checkpoint inhibitor (ICI), and 44% (n = 234) included an EGFR tyrosine kinase inhibitor (TKI). We then analyzed the 333 patients with performance status 0-2 who received chemotherapy with osimertinib (n = 107, 32%) versus chemotherapy without osimertinib (n = 226, 68%). The continuation of osimertinib with chemotherapy was associated with superior progression-free survival (PFS; median: 10.1 versus 5.9 months, Hazard Ratio [HR]: 0.48, 95% Confidence Interval [CI]: [0.34, 0.68], P < .001) and overall survival (OS; median: 17.0 versus 12.8 months, HR: 0.64, 95% CI: [0.44, 0.93], P = .018) compared to other chemotherapy approaches without osimertinib. This effect was most pronounced in patients with an EGFR exon 19 deletion.</p><p><strong>Conclusions: </strong>Following progression on osimertinib, a wide variety of treatment regimens were used. The continuation of osimertinib with chemotherapy in the second line was associated with increased PFS and OS.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of First-Line Nivolumab Plus Ipilimumab in Unresectable Pleural Mesothelioma: A Multicenter Real-World Study (ImmunoMeso LATAM).","authors":"Diego Enrico, Juan Elias Gomez, Danilo Aguirre, Natalia Soledad Tissera, Florencia Tsou, Carmen Pupareli, Delfina Peralta Tanco, Federico Waisberg, Andrés Rodríguez, Manglio Rizzo, Nicolás Minatta, Picon Rafael, Luis Basbus, Lorena Lupinacci, Diego Kaen, Mauro Ramos, Virginia Bluthgen, Nicolas Castagneris, María Pía Coppola, Alejandra Scocimarro, María Florencia Guerra, Aldo Perfetti, Patricio Levit, Marco Galvez-Nino, Luis Mas, Leonardo Rojas, Jairo Zuluaga, Matías Chacón, Luis Corrales, Suraj Samtani, Oscar Arrieta, Andrés Cardona, Jordi Remon, Claudio Martín","doi":"10.1016/j.cllc.2024.09.005","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.005","url":null,"abstract":"<p><strong>Background: </strong>The phase 3 CheckMate-743 trial demonstrated a prolonged overall survival (OS) benefit with nivolumab plus ipilimumab over chemotherapy as first-line treatment in patients with unresectable pleural mesothelioma (PM). However, given that Latin American (LATAM) patients were notably underrepresented in this trial, we retrospectively assessed the effectiveness and safety of this regimen in this population.</p><p><strong>Methods: </strong>This retrospective study included patients from 15 centers in LATAM with unresectable or metastatic PM treated with first-line nivolumab plus ipilimumab in a real-world data (RWD) scenario. Demographic, clinicopathological characteristics, and safety data were collected from medical charts. Progression-free survival (PFS), and OS were calculated using the Kaplan-Meier method.</p><p><strong>Results: </strong>From June 2017, and January 2024 96 patients were included: epithelioid 78% (n = 75), 81% were ECOG 0-1 (n = 78). With a median follow-up of 24.1 months, median PFS and OS were 8 months (95% CI, 6.6-9.4), and 22 months (95% CI, 18.9-25), respectively. No statistical difference in OS was observed between epithelioid versus nonepithelioid histology (median 23 months vs. 19 months, respectively; P = .29). Treatment efficacy was also consistent among different clinical subgroups. Any and grade 3-4 adverse events were found in 43.1% (n = 28), and 18.5% (n = 12) of patients, respectively. Remarkably, no OS impact was observed in patients who had dose delay or treatment discontinuation due to immune-related adverse events, and those who experienced any adverse event.</p><p><strong>Conclusions: </strong>This multicenter RWD study demonstrated the clinically meaningful benefit of first-line ipilimumab and nivolumab in LATAM patients with unresectable or metastatic PM, and data is consistent with previous trial findings.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FLAIR: A Phase II, Open Label, Randomized Study of Osimertinib Plus Bevacizumab Versus Osimertinib in Recurrent or Metastatic Treatment-Naïve NSCLC Patients Harboring EGFR 21L858R Mutation.","authors":"Qing Zhou, Jie Li, Shun-Dong Cang, Jia-Xin Lin, Hai-Yan Tu, Yingying Du, Jian-Wen Qin, Xiao-Hua Liang, Yan Yu, Hai-Tao Lan, Hua-Qiu Shi, Dong Hua, Si-Yang Maggie Liu, Yi-Long Wu","doi":"10.1016/j.cllc.2024.09.002","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.09.002","url":null,"abstract":"<p><strong>Introduction: </strong>Osimertinib, the 3rd generation EGFR-TKI, has emerged as standard first-line treatment for patients with advanced EGFR mutated nonsmall cell lung cancer (NSCLC). Patients with exon 21 L858R mutation showed lower efficacy with EGFR-TKIs than those with 19Del mutation, even with osimertinib, it remains an unmet medical need to further improve the efficacy in L858R population. We present the rationale and design for FLAIR (NCT04988607), which will investigate the efficacy and safety of osimertinib plus bevacizumab versus osimertinib monotherapy in treatment-naïve recurrent or metastatic NSCLC patients harboring EGFR exon 21 L858R mutation.</p><p><strong>Materials and methods: </strong>FLAIR is a prospective, multicenter, randomized, open label study, which is initiated by Chinese Thoracic Oncology Group (CTONG2002). Patients age ≥18 years with primary recurrent or metastatic nonsquamous NSCLC who are treatment-naïve with documented EGFR exon 21 L858R mutation is eligible. Patients will be randomized 1:1 to receive osimertinib 80 mg once daily plus bevacizumab 15mg/kg every 3 weeks or osimertinib monotherapy 80 mg once daily until progression or another discontinuation criterion is met. The primary endpoint is investigator-assessed progression free survival (PFS). Secondary endpoints include: overall survival rate at 24 months, time to treatment failure (TTF), overall response rate (ORR), disease control rate (DCR), duration of response (DoR), central nervous system (CNS) PFS, CNS ORR and safety.</p><p><strong>Results: </strong>FLAIR has completed the enrollment, and results are expected in the fourth quarter of 2025 (depending on the actual event rate).</p><p><strong>Conclusions: </strong>This study will offer better perspectives on the efficacy and safety of osimertinib plus bevacizumab combination therapy in treatment-naïve recurrent or metastatic NSCLC patients harboring EGFR exon 21 L858R mutation, providing valuable guidance for clinical practice.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}