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":" ","pages":""},"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":"Inclusion of Surgery in Multimodality Treatment is Predictive of Better Survival in Stage IIIA Non-small Cell Lung Cancer: An Inverse Probability Treatment-Weighting Analysis.","authors":"Feitong Lei, Janeesh Sekkath-Veedu, Bin Huang, Quan Chen, Mansi Shah-Jadeja, Thomas E Stinchcombe, Zhonglin Hao","doi":"10.1016/j.cllc.2024.10.007","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.007","url":null,"abstract":"<p><strong>Introduction: </strong>Stage IIIA non-small cell lung cancers (NSCLC) are treated with surgery-based multimodality approach or definitive chemoradiation therapy plus durvalumab consolidation. It is not clear whether surgery-based multimodality therapy has any survival advantage over definitive chemoradiation plus immunotherapy consolidation.</p><p><strong>Method: </strong>National Cancer Database (NCDB) was used to identify NSCLC patients at stage IIIA (AJCC8, T3N1/T4N0-1 or T1N2/T2N2) who are treated with surgery-based multimodality approach or definitive chemoradiation plus durvalumab. Survival between groups were compared using inverse probability treatment weighting (IPTW)-adjusted Kaplan Meier curves and Cox proportional hazards regression analysis. Results were independently confirmed by Landmark Inverse and Clone Censor Weight analyses to address immortal time bias.</p><p><strong>Results: </strong>From 2017 to 2019, 24,170 patients are identified as potentially resectable stage IIIA (T3N1, T4N0-1, T1N2/T2N2). Among them, 2,615 (10.8%) received surgery-based multimodality therapy and 2,985 (12.4%) received definitive chemoradiation plus durvalumab. Surgery based multimodality approach had significant survival advantage over definitive chemoradiation plus durvalumab (HR 0.74; 95% CI 0.69-0.79, P < .001). The median overall survival (mOS) for the definitive chemoradiation plus durvalumab group was 48.59 m whereas mOS was not reached for surgery-based multimodality group. This trend persisted in both N2 negative and positive tumors. Neoadjuvant chemotherapy was just as effective as adjuvant chemotherapy and delay of immunotherapy consolidation to 12 weeks after initiation of chemoradiation did not negatively affect survival outcome.</p><p><strong>Conclusion: </strong>For stage IIIA NSCLC patients, surgery-based multimodality treatment outperformed chemoradiation plus durvalumab in survival.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643897","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":"Perioperative Outcomes of Neoadjuvant Therapy in Resectable Lung Cancer Patients With Endobronchial Disease in the Era of Personalized Medicine.","authors":"Joseph Seitlinger, Devangi Patel, Andrew Meng, Luciano Bulgarelli-Maqueda, Jonathan Cools-Lartigue, Christian Sirois, Lorenzo Ferri, Jonathan Spicer, Sara Najmeh","doi":"10.1016/j.cllc.2024.10.003","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.003","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Lung cancer remains the leading cause of cancer-related deaths worldwide. Recent studies have highlighted the benefit of neo-adjuvant therapies in the treatment of resectable stage IB to IIIA cases which will likely increase the use of neoadjuvant therapies (NAT) across multiple stages, both earlier and later. This includes the combination of chemotherapy and immunotherapy as well as the more widespread use of targeted therapies with or without the addition of radiation. This heterogenous group of resectable tumors includes proximal tumors with different levels of endobronchial involvement and secondary distal atelectasis and sometimes superimposed infections which adds a level of concern and complexity when using NAT. In this study, we evaluate the prevalence of endobronchial lesions in patients treated with NAT, as well as the rate of associated complications.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Patients and methods: &lt;/strong&gt;Data was obtained from a prospectively maintained thoracic surgery database, the Thoracic Oncology Clinical Database and Biobank. Patients with proven clinical stage II-III NSCLC that underwent resection within the Division of Thoracic Surgery at the McGill University Health Centre (Montreal, QC, Canada) from January 2015 to December 2020 were included. Chest computed tomography scans prior to neoadjuvant therapy were reviewed by 2 senior thoracic surgeons to establish the presence of an endobronchial tumor lesion. The presence of an endobronchial lesion was defined by a tumoral lesion obstructing a bronchus or several bronchi AND responsible for lung atelectasis distally (with at least 1 occluded segment). Treatment-related and postoperative complications were collected retrospectively by reviewing patient charts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Overall, 110 patients met the inclusion criteria, of which 37/110 patients had endobronchial lesions before starting neoadjuvant therapy (33.6%). These patients had a higher rate of global complications 23/37 (62.2%) during neoadjuvant treatment compared to patients without obstruction 30/73 (41.1%) (P = .04). There was no difference in terms of severity of complications between the 2 groups (P = .34). The group with endobronchial lesions was found to have an increased rate of pulmonary complications, of which there were none in the other group (5/37, 13.5% vs. 0/73, 0%, P = .004). There were 2 cases of patients requiring urgent surgeries before completing NAT due to pulmonary complications in the endobronchial lesion group (2/37, 5.4%) and none in the group without obstruction.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Patients who are treated with NAT for locally advanced resectable lung cancer usually have larger tumors, where it is not uncommon to encounter endobronchial lesions responsible for downstream obstruction. In this study, the prevalence of endobronchial lesions was found to be 1 third of the patients undergoing NAT. The presence of endobronchial disease was assoc","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643898","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":"Comparison of Long-Term Survival Between Robotic and Video-Assisted Lobectomy for Stage Ⅰ NSCLC With Radiologic Solid Tumors: A Propensity Score Matching Study.","authors":"Jianfeng Zhang, Zhongjie Wang, Yuming Wang, Xuewen Yu, Yanpen Liang, Changbo Sun, Qianjun Zhou","doi":"10.1016/j.cllc.2024.10.004","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.004","url":null,"abstract":"<p><strong>Background: </strong>To compare the long-term survival between robotic and video-assisted thoracic surgery (VATS) lobectomy for stage Ⅰ non-small-cell lung cancer (NSCLC) with radiologic solid tumors.</p><p><strong>Methods: </strong>Clinical stage Ⅰ NSCLC patients with radiologic solid tumors who underwent robotic-assisted thoracic surgery (RATS) or VATS lobectomy between 2015 and 2017 were retrospectively reviewed. A propensity score matching analysis was performed to balance the baseline characteristics. The primary end points were overall survival (OS) and recurrence-free survival (RFS).</p><p><strong>Results: </strong>A total of 518 patients (225 RATS and 293 VATS) were included. After propensity score matching, there were 170 cases in each group. Patients undergoing RATS had shorter operative time than VATS (98.12 min vs. 112.26 min; P < 0.001). The RATS approach resulted in a higher number of resected lymph nodes (LNs) (11.75 vs. 9.77; P < 0.001). The postoperative complication rates were comparable (7.6% vs. 10.0%, P = .566). The rates of 5-year OS and RFS for the RATS and VATS were 92% versus 89% (P = .62) and 82% vs. 86% (P = .70), respectively. Multivariate analysis revealed that the number of resected LNs was significantly associated with overall survival (OR = 1.94 [95% confidence interval [CI]: 1.07-3.51], P = .029).</p><p><strong>Conclusion: </strong>The long-term survival outcomes of RATS and VATS are similar for c-stage Ⅰ NSCLC with radiologic solid tumors. The use of robotics is associated with more lymph node dissection and shorter operative time. We suggested that the number of examined lymph nodes rather than surgical approaches was associated with overall survival.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614748","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":" ","pages":""},"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":"Augmenting Prognostication: Utilizing Activity Trackers to Enhance Survival Prediction in Metastatic Non-Small Cell Lung Cancer.","authors":"Yeonjung Jo, Sonam Puri, Benjamin Haaland, Adriana M Coletta, Jonathan J Chipman, Kelsey Embrey, Kathleen C Kerrigan, Shiven B Patel, Kelly Moynahan, Matthew Gumbleton, Wallace L Akerley","doi":"10.1016/j.cllc.2024.10.001","DOIUrl":"https://doi.org/10.1016/j.cllc.2024.10.001","url":null,"abstract":"<p><strong>Introduction/background: </strong>Prognostication by performance status (PS) assessment is a fundamental element of treatment decisions and clinical trial design in oncology, but it is limited by subjectivity and potential miscommunication between patient, physician, and family. Activity tracker offers the potential to collect a broad range of patient-generated data to supplement the assessment of PS.</p><p><strong>Patients and methods: </strong>Patients with metastatic NSCLC (mNSCLC) participated in a single institute, prospective, observational feasibility study conducted at Huntsman Cancer Institute. Patients were given a Fitbit® activity tracker, which collects their steps taken, distance moved, heart rate, and activity intensity. At baseline, PS was assessed by physicians and patients, and demographics and clinical data were collected. We defined novel indices of health: Heart rate Activity zone Mismatch (HAM) and excessive Sedentary Heart Rate (eSHR). We used multivariable Cox proportional hazards models adjusted for age, sex, and treatment line to estimate and test the prognostic ability of clinical and fitness metrics on overall survival (OS). Each prognostic model was evaluated using Harrell's concordance index (C-index).</p><p><strong>Results: </strong>Fifty-five patients with mNSCLC were enrolled. The median OS was 10.4 months (95% CI: 7.2, 15.2). PS-physician (HR = 2.0; P < .001) and Fitbit metrics were associated with OS, including daily total steps (1,000-steps) (HR = 0.8; P = .004), HAM (HR = 2; P = .02), eSHR (HR = 0.3; P = .001). The prognostic model that includes PS-physician was associated with the best concordance (C-index = 0.75), followed by daily total distance (C-index = 0.74) and steps (C-index = 0.73) CONCLUSIONS: Tracker-based measures were prognostic of survival in mNSCLC and may be useful as a supplement or alternative to PS in practice and clinical trials.</p>","PeriodicalId":10490,"journal":{"name":"Clinical lung cancer","volume":" ","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686026","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":" ","pages":""},"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":" ","pages":""},"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":"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":" ","pages":""},"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":" ","pages":""},"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}