<h3>Background</h3>Treatment guidelines recommend neoadjuvant or adjuvant chemotherapy, with or without immune checkpoint inhibitors, for resectable non-small-cell lung cancer (NSCLC). We report the interim results for the phase 3 RATIONALE-315 study, which aimed to investigate perioperative tislelizumab for the treatment of resectable NSCLC.<h3>Methods</h3>RATIONALE-315 is a randomised, double-blind, placebo-controlled phase 3 trial conducted at 50 sites (hospitals or academic research centres) in China. Patients (aged ≥18 years) with untreated stage II–IIIA squamous or non-squamous NSCLC were randomly assigned (1:1) to neoadjuvant tislelizumab 200 mg or placebo intravenously every 3 weeks, plus platinum-based doublet chemotherapy followed by surgery and adjuvant tislelizumab 400 mg or placebo every 6 weeks. Dual primary endpoints were major pathological response rate and event-free survival, analysed by intention to treat. Safety was also assessed in all patients who received at least one dose of study treatment. RATIONALE-315 is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, <span><span>NCT04379635</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, and is active but not recruiting.<h3>Findings</h3>Between June 8, 2020, and Aug 31, 2022, 453 patients were assigned to tislelizumab (n=226) or placebo (n=227). The median age of patients was 62·0 years (IQR 56·0–67·0). 410 (91%) of 453 patients were male and 43 (9%) were female. As of Aug 21, 2023 (data cutoff for the interim analysis of event-free survival), median duration of follow-up was 22·0 months (IQR 15·5–28·0). Tislelizumab significantly improved event-free survival versus placebo (stratified hazard ratio 0·56 [95% CI 0·40–0·79]; one-sided p=0·0003). The major pathological response rate was significantly higher in the tislelizumab group (56% [95% CI 50–63]) than in the placebo group (15% [11–20]; difference 41% [33–49]; one-sided p<0·0001). Grade 3 or worse adverse events and serious treatment-related adverse events occurred in 163 (72%) of 226 patients and 35 (15%) of 226 patients, respectively, in the tislelizumab group, and in 150 (66%) and 18 (8%) patients, respectively, in the placebo group. The most common grade 3 or worse treatment-related adverse event was decreased neutrophil count (138 [61%] of 226 in the tislelizumab group <em>vs</em> 134 [59%] of 226 in the placebo group). 31 (14%) of 226 patients in the tislelizumab group and 45 (20%) of 227 patients in the placebo group died during the study.<h3>Interpretation</h3>Perioperative tislelizumab plus neoadjuvant chemotherapy showed a clinically meaningful and
{"title":"Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial","authors":"Dongsheng Yue, Wenxiang Wang, Hongxu Liu, Qixun Chen, Chun Chen, Lunxu Liu, Peng Zhang, Guofang Zhao, Fan Yang, Guang Han, Ying Cheng, Bentong Yu, Yue Yang, Haiquan Chen, Jie Jiang, Lijie Tan, Shidong Xu, Naiquan Mao, Jian Hu, Lanjun Zhang, Xibin Zhuang","doi":"10.1016/s2213-2600(24)00269-8","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00269-8","url":null,"abstract":"<h3>Background</h3>Treatment guidelines recommend neoadjuvant or adjuvant chemotherapy, with or without immune checkpoint inhibitors, for resectable non-small-cell lung cancer (NSCLC). We report the interim results for the phase 3 RATIONALE-315 study, which aimed to investigate perioperative tislelizumab for the treatment of resectable NSCLC.<h3>Methods</h3>RATIONALE-315 is a randomised, double-blind, placebo-controlled phase 3 trial conducted at 50 sites (hospitals or academic research centres) in China. Patients (aged ≥18 years) with untreated stage II–IIIA squamous or non-squamous NSCLC were randomly assigned (1:1) to neoadjuvant tislelizumab 200 mg or placebo intravenously every 3 weeks, plus platinum-based doublet chemotherapy followed by surgery and adjuvant tislelizumab 400 mg or placebo every 6 weeks. Dual primary endpoints were major pathological response rate and event-free survival, analysed by intention to treat. Safety was also assessed in all patients who received at least one dose of study treatment. RATIONALE-315 is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT04379635</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and is active but not recruiting.<h3>Findings</h3>Between June 8, 2020, and Aug 31, 2022, 453 patients were assigned to tislelizumab (n=226) or placebo (n=227). The median age of patients was 62·0 years (IQR 56·0–67·0). 410 (91%) of 453 patients were male and 43 (9%) were female. As of Aug 21, 2023 (data cutoff for the interim analysis of event-free survival), median duration of follow-up was 22·0 months (IQR 15·5–28·0). Tislelizumab significantly improved event-free survival versus placebo (stratified hazard ratio 0·56 [95% CI 0·40–0·79]; one-sided p=0·0003). The major pathological response rate was significantly higher in the tislelizumab group (56% [95% CI 50–63]) than in the placebo group (15% [11–20]; difference 41% [33–49]; one-sided p<0·0001). Grade 3 or worse adverse events and serious treatment-related adverse events occurred in 163 (72%) of 226 patients and 35 (15%) of 226 patients, respectively, in the tislelizumab group, and in 150 (66%) and 18 (8%) patients, respectively, in the placebo group. The most common grade 3 or worse treatment-related adverse event was decreased neutrophil count (138 [61%] of 226 in the tislelizumab group <em>vs</em> 134 [59%] of 226 in the placebo group). 31 (14%) of 226 patients in the tislelizumab group and 45 (20%) of 227 patients in the placebo group died during the study.<h3>Interpretation</h3>Perioperative tislelizumab plus neoadjuvant chemotherapy showed a clinically meaningful and ","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"23 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142684542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-20DOI: 10.1016/s2213-2600(24)00375-8
No Abstract
无摘要
{"title":"One health, one flu: the re-emergence of avian influenza","authors":"","doi":"10.1016/s2213-2600(24)00375-8","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00375-8","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"6 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-15DOI: 10.1016/s2213-2600(24)00377-1
Talha Burki
No Abstract
无摘要
{"title":"Health care in Ukraine: If everybody leaves, who will stay?","authors":"Talha Burki","doi":"10.1016/s2213-2600(24)00377-1","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00377-1","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"35 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142642705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1016/s2213-2600(24)00293-5
Amy Shackleford, Liam G Heaney, Charlene Redmond, P Jane McDowell, John Busby
<h3>Background</h3>Clinical remission has emerged as an important treatment goal in severe asthma; however, studies have reported variable attainment due to differences in study populations, definitions, and methods. We aimed to perform a systematic review and meta-analysis of clinical remission attainment, definitions, and correlates among patients with severe asthma who have been treated with biologics.<h3>Methods</h3>In this systematic review and meta-analysis, we searched Web of Science, Embase, and MEDLINE, using the keywords “asthma” and “remission”, for studies published between database inception and June 13, 2024, that reported clinical remission among patients with severe asthma treated with biologics. Studies were eligible for inclusion in both the systematic review and meta-analysis if they were published in English language peer-reviewed journals and reported rates of clinical remission for patients treated with biologics for severe asthma. There were no limitations by study design. Two reviewers independently screened identified papers (AS and CR), with disagreements resolved through consensus or referral to a third reviewer (JB). Study-level data on study characteristics, clinical remission definitions, clinical remission attainment, and the potential correlates of clinical remission were extracted independently by two reviewers (AS and CR) using Covidence. We defined a three-component definition of clinical remission, which included use of maintenance oral corticosteroids, exacerbations, and asthma symptom burden, and a four-component definition, which additionally included lung function. We meta-analysed the rate of attainment of clinical remission and assessed the correlates of clinical remission using DerSimonian-Laird random-effects models. Statistical heterogeneity was assessed using the <em>I</em><sup>2</sup> statistic. This study was registered with PROSPERO, CRD42024507233.<h3>Findings</h3>Our search identified 3014 potentially eligible studies, of which 1812 were screened. 25 studies were included, which reported 28 analyses of clinical remission attainment. 68 definitions of clinical remission were identified, of which 48 were unique. Little consensus was found between studies in terms of the clinical remission definition, particularly for symptoms and lung function. Eight analyses used the three-component definition of clinical remission and 25 used the four-component definition. The pooled proportion of patients who attained clinical remission was 38% (95% CI 29–47; <em>I</em><sup>2</sup>=93%) for the three-component definition and 30% (27–34; <em>I</em><sup>2</sup>=83%) for the four-component definition. Several pulmonary factors were associated with lower clinical remission rates, including worse FEV<sub>1</sub> (odds ratio 0·09 [95% CI 0·01–0·92]; <em>I</em><sup>2</sup>=87%), worse asthma symptoms (0·23 [0·17–0·33]; <em>I</em><sup>2</sup>=0%), longer asthma duration (0·49 [0·32–0·76]; <em>I</em><sup>2</sup>=22%), an
{"title":"Clinical remission attainment, definitions, and correlates among patients with severe asthma treated with biologics: a systematic review and meta-analysis","authors":"Amy Shackleford, Liam G Heaney, Charlene Redmond, P Jane McDowell, John Busby","doi":"10.1016/s2213-2600(24)00293-5","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00293-5","url":null,"abstract":"<h3>Background</h3>Clinical remission has emerged as an important treatment goal in severe asthma; however, studies have reported variable attainment due to differences in study populations, definitions, and methods. We aimed to perform a systematic review and meta-analysis of clinical remission attainment, definitions, and correlates among patients with severe asthma who have been treated with biologics.<h3>Methods</h3>In this systematic review and meta-analysis, we searched Web of Science, Embase, and MEDLINE, using the keywords “asthma” and “remission”, for studies published between database inception and June 13, 2024, that reported clinical remission among patients with severe asthma treated with biologics. Studies were eligible for inclusion in both the systematic review and meta-analysis if they were published in English language peer-reviewed journals and reported rates of clinical remission for patients treated with biologics for severe asthma. There were no limitations by study design. Two reviewers independently screened identified papers (AS and CR), with disagreements resolved through consensus or referral to a third reviewer (JB). Study-level data on study characteristics, clinical remission definitions, clinical remission attainment, and the potential correlates of clinical remission were extracted independently by two reviewers (AS and CR) using Covidence. We defined a three-component definition of clinical remission, which included use of maintenance oral corticosteroids, exacerbations, and asthma symptom burden, and a four-component definition, which additionally included lung function. We meta-analysed the rate of attainment of clinical remission and assessed the correlates of clinical remission using DerSimonian-Laird random-effects models. Statistical heterogeneity was assessed using the <em>I</em><sup>2</sup> statistic. This study was registered with PROSPERO, CRD42024507233.<h3>Findings</h3>Our search identified 3014 potentially eligible studies, of which 1812 were screened. 25 studies were included, which reported 28 analyses of clinical remission attainment. 68 definitions of clinical remission were identified, of which 48 were unique. Little consensus was found between studies in terms of the clinical remission definition, particularly for symptoms and lung function. Eight analyses used the three-component definition of clinical remission and 25 used the four-component definition. The pooled proportion of patients who attained clinical remission was 38% (95% CI 29–47; <em>I</em><sup>2</sup>=93%) for the three-component definition and 30% (27–34; <em>I</em><sup>2</sup>=83%) for the four-component definition. Several pulmonary factors were associated with lower clinical remission rates, including worse FEV<sub>1</sub> (odds ratio 0·09 [95% CI 0·01–0·92]; <em>I</em><sup>2</sup>=87%), worse asthma symptoms (0·23 [0·17–0·33]; <em>I</em><sup>2</sup>=0%), longer asthma duration (0·49 [0·32–0·76]; <em>I</em><sup>2</sup>=22%), an","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"95 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142609771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1016/s2213-2600(24)00342-4
Emmanuel Drouin, Eric Wiel, Edouard Lansiaux, Jacalyn Duffin, Arnaud Chambellan
Section snippets
Two late 18th century manuscripts
Both of the manuscripts we feature here were written by students hearing the lectures of famous authors, but whose advice on thoracentesis is previously unknown. They are fascinating not only for expanding our understanding of these two important figures but because they provide precise descriptions of the site and technique of thoracic drainage just before auscultation, which would provide the means for locating the pathological change. Student lecture notes could have served as a sort of
Discussion
This Spotlight suggests that until the 18th century, doctors carried out thoracentesis largely in accordance with Hippocrates' recommendations to make the incision low in the chest. The question arose as to whether the approach should be anterior or posterior. We can see that at least two reputed doctors with considerable anatomical knowledge, Astruc and Bichat, raised the question of the drainage technique, with particular reference to the surgical approach. Astruc went further in describing
{"title":"Thoracentesis: an old story and some new sources","authors":"Emmanuel Drouin, Eric Wiel, Edouard Lansiaux, Jacalyn Duffin, Arnaud Chambellan","doi":"10.1016/s2213-2600(24)00342-4","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00342-4","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Two late 18th century manuscripts</h2>Both of the manuscripts we feature here were written by students hearing the lectures of famous authors, but whose advice on thoracentesis is previously unknown. They are fascinating not only for expanding our understanding of these two important figures but because they provide precise descriptions of the site and technique of thoracic drainage just before auscultation, which would provide the means for locating the pathological change. Student lecture notes could have served as a sort of</section></section><section><section><h2>Discussion</h2>This Spotlight suggests that until the 18th century, doctors carried out thoracentesis largely in accordance with Hippocrates' recommendations to make the incision low in the chest. The question arose as to whether the approach should be anterior or posterior. We can see that at least two reputed doctors with considerable anatomical knowledge, Astruc and Bichat, raised the question of the drainage technique, with particular reference to the surgical approach. Astruc went further in describing</section></section>","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"72 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142609770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1016/s2213-2600(24)00304-7
Marek Lommatzsch, J Christian Virchow
No Abstract
无摘要
{"title":"Asthma remission: a call for a globally standardised definition","authors":"Marek Lommatzsch, J Christian Virchow","doi":"10.1016/s2213-2600(24)00304-7","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00304-7","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"158 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142609802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-09-12DOI: 10.1016/S2213-2600(24)00298-4
Joanne McPeake, Mark Oakes, Colin Graham, Nahid Ahmad, Nazir Lone, Bronwen Connolly
{"title":"Top ten research priorities for sepsis research: UK James Lind Alliance priority setting partnership.","authors":"Joanne McPeake, Mark Oakes, Colin Graham, Nahid Ahmad, Nazir Lone, Bronwen Connolly","doi":"10.1016/S2213-2600(24)00298-4","DOIUrl":"10.1016/S2213-2600(24)00298-4","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"e68-e69"},"PeriodicalIF":38.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01Epub Date: 2024-08-13DOI: 10.1016/S2213-2600(24)00243-1
Katherine Odem-Davis, Jennifer L Taylor-Cousar
{"title":"Compassionate use trials and equitable access to variant-specific treatment for cystic fibrosis.","authors":"Katherine Odem-Davis, Jennifer L Taylor-Cousar","doi":"10.1016/S2213-2600(24)00243-1","DOIUrl":"10.1016/S2213-2600(24)00243-1","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"842-844"},"PeriodicalIF":38.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141996916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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