Pub Date : 2025-01-13DOI: 10.1016/s1470-2045(24)00667-3
Jon Emery
No Abstract
没有抽象的
{"title":"The psychological impact of screening with a multicancer early detection test","authors":"Jon Emery","doi":"10.1016/s1470-2045(24)00667-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00667-3","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142974770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-13DOI: 10.1016/s1470-2045(24)00645-4
Lincoln Nadauld, Charles H McDonnell, Christina A Dilaveri, Eric A Klein, Robert Reid, Catherine R Marinac, Karen C Chung, Margarita Lopatin, Eric T Fung, Deborah Schrag, Donald L Patrick
<h3>Background</h3>PATHFINDER was a prospective cohort study of multicancer early detection (MCED) testing in an outpatient ambulatory population. The aim of this study is to report the patient-reported outcomes (PROs) collected as secondary and exploratory measures in the PATHFINDER study.<h3>Methods</h3>PATHFINDER is a prospective, multicentre, cohort study that enrolled existing healthy ambulatory outpatients at seven health networks in the USA, including hospitals, academic medical centres, and integrated health systems. Enrolled adults were aged 50 years or older without clinical suspicion of cancer, with or without additional cancer risk factors (smoking history, genetic predisposition, or previous cancer diagnosis). The primary objective was time to diagnostic resolution after an MCED cancer signal detected (CSD) result and extent of testing pursued. The objectives of the 12-month PATHFINDER study reported here were assessment of patient-reported outcomes and perceptions with MCED testing (the effect of the MCED test result disclosure, general anxiety symptoms, health-related quality of life, and satisfaction with the MCED test). PRO instruments used included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty, and positive experience at MCED test result disclosure; PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms; and Short Form 12-Item Health Survey (SF-12v2) for health-related quality of life. Intentions towards adherence to guideline recommended screening was also assessed as an exploratory objective. This study is registered at <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>NCT04241796</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 complete.<h3>Findings</h3>Between Dec 12, 2019, and Dec 4, 2020, 6662 participants were recruited and 6621 eligible participants had analysable MCED test results (n=92 CSD and n=6529 no CSD [NCSD]). The majority of participants were women (4204 [63·5%] of 6621) and White (6071 [91·7%] of 6621). For participants who completed the MICRA at results disclosure, the mean total MICRA score was 28·4 (SD 14·9) for the 50 patients with a CSD result and 8·8 (7·2) for those with an NCSD result (n=5864 completed the full questionnaire). Mean general anxiety scores increased in true-positive and false-positive groups at results disclosure. The PROMIS anxiety true-positive group baseline score of 46·2 (SD 6·5; n=35) increased to 48·4 (7·3; n=19) and the scores in the false-positive group increased from 47·3 (7·3; n=52) to 49·7 (7·7; n=30). Mean scores in both groups ret
{"title":"Psychosocial impact associated with a multicancer early detection test (PATHFINDER): a prospective, multicentre, cohort study","authors":"Lincoln Nadauld, Charles H McDonnell, Christina A Dilaveri, Eric A Klein, Robert Reid, Catherine R Marinac, Karen C Chung, Margarita Lopatin, Eric T Fung, Deborah Schrag, Donald L Patrick","doi":"10.1016/s1470-2045(24)00645-4","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00645-4","url":null,"abstract":"<h3>Background</h3>PATHFINDER was a prospective cohort study of multicancer early detection (MCED) testing in an outpatient ambulatory population. The aim of this study is to report the patient-reported outcomes (PROs) collected as secondary and exploratory measures in the PATHFINDER study.<h3>Methods</h3>PATHFINDER is a prospective, multicentre, cohort study that enrolled existing healthy ambulatory outpatients at seven health networks in the USA, including hospitals, academic medical centres, and integrated health systems. Enrolled adults were aged 50 years or older without clinical suspicion of cancer, with or without additional cancer risk factors (smoking history, genetic predisposition, or previous cancer diagnosis). The primary objective was time to diagnostic resolution after an MCED cancer signal detected (CSD) result and extent of testing pursued. The objectives of the 12-month PATHFINDER study reported here were assessment of patient-reported outcomes and perceptions with MCED testing (the effect of the MCED test result disclosure, general anxiety symptoms, health-related quality of life, and satisfaction with the MCED test). PRO instruments used included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty, and positive experience at MCED test result disclosure; PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms; and Short Form 12-Item Health Survey (SF-12v2) for health-related quality of life. Intentions towards adherence to guideline recommended screening was also assessed as an exploratory objective. This study is registered at <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>NCT04241796</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 complete.<h3>Findings</h3>Between Dec 12, 2019, and Dec 4, 2020, 6662 participants were recruited and 6621 eligible participants had analysable MCED test results (n=92 CSD and n=6529 no CSD [NCSD]). The majority of participants were women (4204 [63·5%] of 6621) and White (6071 [91·7%] of 6621). For participants who completed the MICRA at results disclosure, the mean total MICRA score was 28·4 (SD 14·9) for the 50 patients with a CSD result and 8·8 (7·2) for those with an NCSD result (n=5864 completed the full questionnaire). Mean general anxiety scores increased in true-positive and false-positive groups at results disclosure. The PROMIS anxiety true-positive group baseline score of 46·2 (SD 6·5; n=35) increased to 48·4 (7·3; n=19) and the scores in the false-positive group increased from 47·3 (7·3; n=52) to 49·7 (7·7; n=30). Mean scores in both groups ret","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142974714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-09DOI: 10.1016/s1470-2045(25)00002-6
Tony Kirby
No Abstract
没有抽象的
{"title":"US Surgeon General calls for cancer warning labels on alcohol","authors":"Tony Kirby","doi":"10.1016/s1470-2045(25)00002-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00002-6","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142939504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-06DOI: 10.1016/s1470-2045(24)00710-1
Katharine Herbert, Elizabeth C Smyth
Therapeutic options for patients with advanced gastric or gastro-oesophageal junction adenocarcinomas are rapidly evolving.1 Although chemotherapy alone results in a median survival of less than a year, the majority (approximately 75%) of gastric and gastro-oesophageal junction adenocarcinoma tumours express molecular targets that are amenable to personalised antibody-based therapies.2 These targeted treatments, if combined with cytotoxic chemotherapy, extend overall survival. Established monoclonal antibody targets include HER2 (also known as ERBB2) and PD-L1, with claudin-18.2 (CLD18.2) emerging as an addition within the past year. Zolbetuximab, a first-in-class monoclonal antibody targeting CLD18.2, improved overall survival when added to platinum-fluoropyrimidine chemotherapy in patients with CLD18.2-positive, advanced, untreated gastric or gastro-oesophageal junction adenocarcinoma.3 The positive results of SPOTLIGHT and GLOW validate CLD18.2 as a therapeutic target and established a basis for an expansive pipeline of next-generation CLD18.2-directed therapies.4, 5
{"title":"Expanding therapeutic options targeting claudin-18.2","authors":"Katharine Herbert, Elizabeth C Smyth","doi":"10.1016/s1470-2045(24)00710-1","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00710-1","url":null,"abstract":"Therapeutic options for patients with advanced gastric or gastro-oesophageal junction adenocarcinomas are rapidly evolving.<span><span><sup>1</sup></span></span> Although chemotherapy alone results in a median survival of less than a year, the majority (approximately 75%) of gastric and gastro-oesophageal junction adenocarcinoma tumours express molecular targets that are amenable to personalised antibody-based therapies.<span><span><sup>2</sup></span></span> These targeted treatments, if combined with cytotoxic chemotherapy, extend overall survival. Established monoclonal antibody targets include HER2 (also known as ERBB2) and PD-L1, with claudin-18.2 (CLD18.2) emerging as an addition within the past year. Zolbetuximab, a first-in-class monoclonal antibody targeting CLD18.2, improved overall survival when added to platinum-fluoropyrimidine chemotherapy in patients with CLD18.2-positive, advanced, untreated gastric or gastro-oesophageal junction adenocarcinoma.<span><span><sup>3</sup></span></span> The positive results of SPOTLIGHT and GLOW validate CLD18.2 as a therapeutic target and established a basis for an expansive pipeline of next-generation CLD18.2-directed therapies.<span><span>4</span></span>, <span><span>5</span></span>","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142934624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<h3>Background</h3>CMG901 is a novel first-in-class antibody–drug conjugate with a humanised anticlaudin 18.2 antibody linked to microtubule-disrupting agent monomethyl auristatin E. We aimed to assess the antitumour activity and safety of CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer and other solid tumours.<h3>Methods</h3>KYM901 is a multicentre, open-label, single-arm, phase 1 trial consisting of dose-escalation and dose-expansion stages. Patients with advanced solid tumours, including gastric or gastro-oesophageal junction and pancreatic cancers, were recruited from 31 hospital sites in China. Eligible patients were aged 18 years or older, were refractory to standard therapy or had no available standard-of-care regimen, and had an Eastern Cooperative Oncology Group performance status score of 0–1, a life expectancy of at least 3 months, and at least one measurable lesion. Patients received intravenous CMG901 every 3 weeks (0·3–3·4 mg/kg in dose escalation and 2·2–3·0 mg/kg in dose expansion) until disease progression, unacceptable toxic effects, initiation of new antitumour therapy, study withdrawal, or death. Primary endpoints were adverse events and dose-limiting toxic effects in the dose-escalation phase, and objective response rate and recommended phase 2 dose in the dose-expansion phase. Confirmed objective response was defined as a partial or complete response that was verified by follow-up imaging at least 4 weeks after the initial assessment. Safety was assessed in all patients who received at least one dose of CMG901 with at least one post-dose safety evaluation. Antitumour activity was assessed in all patients who received at least one dose of CMG901 (full analysis set) and in all CMG901-treated patients with at least one post-dose imaging evaluation and no major protocol deviations (efficacy analysis set). Dose-expansion data for patients with pancreatic cancer will be published separately. Due to small sample sizes, results in patients with other solid tumours (n=2) are not planned for publication. This ongoing trial 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>NCT04805307</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>.<h3>Findings</h3>Between Dec 24, 2020, and Feb 23, 2023, 27 patients were enrolled in the dose-escalation phase (median age 57·0 years [IQR 48·0–63·0]; 14 [52%] male, 13 [48%] female) and 107 patients with gastric or gastro-oesophageal junction cancer in the dose-expansion phase (median age 56·0 years [44·0–64·0]; 57 [53%] male, 50 [47%] female). As of Feb 24, 2024, one dose-limiting toxic effect
{"title":"Claudin 18.2-targeting antibody–drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial","authors":"Dan-Yun Ruan, Fu-Rong Liu, Xiao-Li Wei, Su-Xia Luo, Zhi-Xiang Zhuang, Zhen-Ning Wang, Fu-Nan Liu, Yan-Qiao Zhang, Jian-Wei Yang, Zhen-Dong Chen, Yong-Sheng Wang, Jun-Ye Wang, Xiao-Hua Liang, Xiao-Jie Wu, Yu-Long Zheng, Jian Liu, Xi Shi, Rakesh Kumar, Wei Liu, Bo Chen, Rui-Hua Xu","doi":"10.1016/s1470-2045(24)00636-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00636-3","url":null,"abstract":"<h3>Background</h3>CMG901 is a novel first-in-class antibody–drug conjugate with a humanised anticlaudin 18.2 antibody linked to microtubule-disrupting agent monomethyl auristatin E. We aimed to assess the antitumour activity and safety of CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer and other solid tumours.<h3>Methods</h3>KYM901 is a multicentre, open-label, single-arm, phase 1 trial consisting of dose-escalation and dose-expansion stages. Patients with advanced solid tumours, including gastric or gastro-oesophageal junction and pancreatic cancers, were recruited from 31 hospital sites in China. Eligible patients were aged 18 years or older, were refractory to standard therapy or had no available standard-of-care regimen, and had an Eastern Cooperative Oncology Group performance status score of 0–1, a life expectancy of at least 3 months, and at least one measurable lesion. Patients received intravenous CMG901 every 3 weeks (0·3–3·4 mg/kg in dose escalation and 2·2–3·0 mg/kg in dose expansion) until disease progression, unacceptable toxic effects, initiation of new antitumour therapy, study withdrawal, or death. Primary endpoints were adverse events and dose-limiting toxic effects in the dose-escalation phase, and objective response rate and recommended phase 2 dose in the dose-expansion phase. Confirmed objective response was defined as a partial or complete response that was verified by follow-up imaging at least 4 weeks after the initial assessment. Safety was assessed in all patients who received at least one dose of CMG901 with at least one post-dose safety evaluation. Antitumour activity was assessed in all patients who received at least one dose of CMG901 (full analysis set) and in all CMG901-treated patients with at least one post-dose imaging evaluation and no major protocol deviations (efficacy analysis set). Dose-expansion data for patients with pancreatic cancer will be published separately. Due to small sample sizes, results in patients with other solid tumours (n=2) are not planned for publication. This ongoing trial 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>NCT04805307</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>.<h3>Findings</h3>Between Dec 24, 2020, and Feb 23, 2023, 27 patients were enrolled in the dose-escalation phase (median age 57·0 years [IQR 48·0–63·0]; 14 [52%] male, 13 [48%] female) and 107 patients with gastric or gastro-oesophageal junction cancer in the dose-expansion phase (median age 56·0 years [44·0–64·0]; 57 [53%] male, 50 [47%] female). As of Feb 24, 2024, one dose-limiting toxic effect","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142934625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-02DOI: 10.1016/s1470-2045(24)00627-2
Axel Hauschild, Claus Garbe, Paolo Antonio Ascierto, Lev Demidov, Brigitte Dreno, Reinhard Dummer, Alexander Eggermont, Ana-Maria Forsea, Christoffer Gebhardt, Jeffrey E Gershenwald, Omid Hamid, Christoph Hoeller, Lidija Kandolf, Roland Kaufmann, John M Kirkwood, Celeste Lebbé, Georgina V Long, Josep Malvehy, Salvador Martin-Algarra, Grant McArthur, Paolo Nuti
No Abstract
没有抽象的
{"title":"Neoadjuvant or perioperative therapy for melanoma metastasis in clinical practice: an international survey","authors":"Axel Hauschild, Claus Garbe, Paolo Antonio Ascierto, Lev Demidov, Brigitte Dreno, Reinhard Dummer, Alexander Eggermont, Ana-Maria Forsea, Christoffer Gebhardt, Jeffrey E Gershenwald, Omid Hamid, Christoph Hoeller, Lidija Kandolf, Roland Kaufmann, John M Kirkwood, Celeste Lebbé, Georgina V Long, Josep Malvehy, Salvador Martin-Algarra, Grant McArthur, Paolo Nuti","doi":"10.1016/s1470-2045(24)00627-2","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00627-2","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"363 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142917335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-02DOI: 10.1016/s1470-2045(24)00629-6
Boris Freidlin, Edward L Korn
No Abstract
没有抽象的
{"title":"Non-inferiority trials: tyranny or good governance?","authors":"Boris Freidlin, Edward L Korn","doi":"10.1016/s1470-2045(24)00629-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00629-6","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142917422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-02DOI: 10.1016/s1470-2045(24)00374-7
Triparna Sen, Yosuke Dotsu, Virginia Corbett, Sonam Puri, Utsav Sen, Theresa A Boyle, Phil Mack, Fred Hirsch, Raid Aljumaily, Abdul Rafeh Naqash, Vineeth Sukrithan, Nagla Abdel Karim
Lung neuroendocrine neoplasms are a group of diverse, heterogeneous tumours that range from well-differentiated, low-grade neuroendocrine tumours—such as typical and atypical carcinoids—to high-grade, poorly differentiated aggressive malignancies, such as large-cell neuroendocrine carcinoma (LCNEC) and small-cell lung cancer (SCLC). While the incidence of SCLC has decreased, the worldwide incidence of other pulmonary neuroendocrine neoplasms has been increasing over the past decades. In addition to the standard histopathological classification of lung neuroendocrine neoplasms, the introduction of molecular and sequencing techniques has led to new advances in understanding the biology of these diseases and might influence future classifications and staging that can subsequently improve management guidelines in the adjuvant or metastatic settings. Due to the rarity of neuroendocrine neoplasms, there is a paucity of prospective studies that focus on the lungs, especially in rare, well-differentiated carcinoids and LCNECs. In contrast with the success of targeted therapies in non-small-cell lung cancer (NSCLC), high-grade neuroendocrine carcinomas of the lung often only have a few specific targetable gene alterations. Optimal therapy for LCNECs is not well defined and treatment recommendations are based on extrapolating guidelines for the management of patients with SCLC and NSCLC. This Review explores the epidemiology, diagnosis, and staging of lung neuroendocrine neoplasms to date. In addition, we focus on the evolving molecular landscape and biomarkers, ranging from tumour phenotypes to functional imaging studies and novel molecular biomarkers. We outline the various clinical outcomes, challenges, the treatment landscape, ongoing clinical trials, and future directions.
{"title":"Pulmonary neuroendocrine neoplasms: the molecular landscape, therapeutic challenges, and diagnosis and management strategies","authors":"Triparna Sen, Yosuke Dotsu, Virginia Corbett, Sonam Puri, Utsav Sen, Theresa A Boyle, Phil Mack, Fred Hirsch, Raid Aljumaily, Abdul Rafeh Naqash, Vineeth Sukrithan, Nagla Abdel Karim","doi":"10.1016/s1470-2045(24)00374-7","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00374-7","url":null,"abstract":"Lung neuroendocrine neoplasms are a group of diverse, heterogeneous tumours that range from well-differentiated, low-grade neuroendocrine tumours—such as typical and atypical carcinoids—to high-grade, poorly differentiated aggressive malignancies, such as large-cell neuroendocrine carcinoma (LCNEC) and small-cell lung cancer (SCLC). While the incidence of SCLC has decreased, the worldwide incidence of other pulmonary neuroendocrine neoplasms has been increasing over the past decades. In addition to the standard histopathological classification of lung neuroendocrine neoplasms, the introduction of molecular and sequencing techniques has led to new advances in understanding the biology of these diseases and might influence future classifications and staging that can subsequently improve management guidelines in the adjuvant or metastatic settings. Due to the rarity of neuroendocrine neoplasms, there is a paucity of prospective studies that focus on the lungs, especially in rare, well-differentiated carcinoids and LCNECs. In contrast with the success of targeted therapies in non-small-cell lung cancer (NSCLC), high-grade neuroendocrine carcinomas of the lung often only have a few specific targetable gene alterations. Optimal therapy for LCNECs is not well defined and treatment recommendations are based on extrapolating guidelines for the management of patients with SCLC and NSCLC. This Review explores the epidemiology, diagnosis, and staging of lung neuroendocrine neoplasms to date. In addition, we focus on the evolving molecular landscape and biomarkers, ranging from tumour phenotypes to functional imaging studies and novel molecular biomarkers. We outline the various clinical outcomes, challenges, the treatment landscape, ongoing clinical trials, and future directions.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"115 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142917415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-02DOI: 10.1016/s1470-2045(24)00721-6
Dianna L Ng, Katherine Van Loon, Jodi Weidler, Michael Bates, Elia J Mmbaga, Edda Vuhahula
No Abstract
没有抽象的
{"title":"FNAB samples with the STRAT4 assay for breast cancer diagnosis – Authors' reply","authors":"Dianna L Ng, Katherine Van Loon, Jodi Weidler, Michael Bates, Elia J Mmbaga, Edda Vuhahula","doi":"10.1016/s1470-2045(24)00721-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00721-6","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142917410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-02DOI: 10.1016/s1470-2045(24)00643-0
Yanjun Xu, Kaiyan Chen, Yujin Xu, Hui Li, Zhiyu Huang, Hongyang Lu, Dingzhi Huang, Sizhe Yu, Na Han, Lei Gong, Jing Qin, Jun Chen, Fajun Xie, Wei Hong, Xiao Lin, Fengzhuo Cheng, Xiaojie Luo, Yun Fan
<h3>Background</h3>Brain metastases are a common complication in patients with non-small-cell lung cancer (NSCLC) lacking actionable driver mutations, with limited treatment options and poor prognosis. We aimed to investigate the efficacy and safety of brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy in patients with newly diagnosed advanced NSCLC and brain metastases.<h3>Methods</h3>This multicentre, single-arm, phase 2 trial was done across nine tertiary hospitals in China. Eligible patients were aged 18 years or older, had newly diagnosed brain metastases from NSCLC with no actionable driver mutations (<em>EGFR</em>, <em>ALK</em>, or <em>ROS1</em>), and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Eligible patients were treated with stereotactic radiosurgery or whole-brain radiotherapy combined with camrelizumab (200 mg intravenously once every 3 weeks) and investigator-selected platinum-doublet chemotherapy (pemetrexed 500 mg/m<sup>2</sup> plus platinum [carboplatin, area under curve (AUC) of 5, or cis-platinum 75 mg/m<sup>2</sup>] for non-squamous NSCLC, and nab-paclitaxel 260 mg/m<sup>2</sup> plus platinum [carboplatin AUC 5, or cis-platinum 75 mg/m<sup>2</sup>] for squamous NSCLC) for four to six cycles. Patients with controlled disease then received maintenance treatment with camrelizumab alone (200 mg intravenously once every 3 weeks; for squamous NSCLC) or camrelizumab plus pemetrexed (500 mg/m<sup>2</sup> every 3 weeks; for non-squamous NSCLC). The primary endpoint was 6-month progression-free survival rate in the full analysis set, which included all patients who received at least one dose of study treatment regardless of whether they had measurable brain lesions per RECIST 1.1. The trial was 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>NCT04291092</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 ongoing.<h3>Findings</h3>Between May 6, 2020, and Jan 30, 2023, 67 patients were assessed for eligibility. Two patients were excluded (brain lesions less than 5 mm) and 65 patients were enrolled and treated. Median age was 66 years (IQR 62–70). 60 (92%) of 65 patients were male and five (8%) were female. All 65 patients were Han Chinese. 50 (77%) of 65 patients had non-squamous NSCLC and 46 (71%) were symptomatic. The 6-month progression-free survival rate was 71·7% (95% CI 58·9–81·1) during the median follow-up of 14·1 months (IQR 9·0–20·3; data cutoff Dec 13, 2023). The most common grade 3–4 treatment-related adverse events were decreased neutrophil count (14 [22%] of 65 patients), decreased w
{"title":"Brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy for previously untreated advanced non-small-cell lung cancer with brain metastases (C-Brain): a multicentre, single-arm, phase 2 trial","authors":"Yanjun Xu, Kaiyan Chen, Yujin Xu, Hui Li, Zhiyu Huang, Hongyang Lu, Dingzhi Huang, Sizhe Yu, Na Han, Lei Gong, Jing Qin, Jun Chen, Fajun Xie, Wei Hong, Xiao Lin, Fengzhuo Cheng, Xiaojie Luo, Yun Fan","doi":"10.1016/s1470-2045(24)00643-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00643-0","url":null,"abstract":"<h3>Background</h3>Brain metastases are a common complication in patients with non-small-cell lung cancer (NSCLC) lacking actionable driver mutations, with limited treatment options and poor prognosis. We aimed to investigate the efficacy and safety of brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy in patients with newly diagnosed advanced NSCLC and brain metastases.<h3>Methods</h3>This multicentre, single-arm, phase 2 trial was done across nine tertiary hospitals in China. Eligible patients were aged 18 years or older, had newly diagnosed brain metastases from NSCLC with no actionable driver mutations (<em>EGFR</em>, <em>ALK</em>, or <em>ROS1</em>), and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Eligible patients were treated with stereotactic radiosurgery or whole-brain radiotherapy combined with camrelizumab (200 mg intravenously once every 3 weeks) and investigator-selected platinum-doublet chemotherapy (pemetrexed 500 mg/m<sup>2</sup> plus platinum [carboplatin, area under curve (AUC) of 5, or cis-platinum 75 mg/m<sup>2</sup>] for non-squamous NSCLC, and nab-paclitaxel 260 mg/m<sup>2</sup> plus platinum [carboplatin AUC 5, or cis-platinum 75 mg/m<sup>2</sup>] for squamous NSCLC) for four to six cycles. Patients with controlled disease then received maintenance treatment with camrelizumab alone (200 mg intravenously once every 3 weeks; for squamous NSCLC) or camrelizumab plus pemetrexed (500 mg/m<sup>2</sup> every 3 weeks; for non-squamous NSCLC). The primary endpoint was 6-month progression-free survival rate in the full analysis set, which included all patients who received at least one dose of study treatment regardless of whether they had measurable brain lesions per RECIST 1.1. The trial was 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>NCT04291092</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 ongoing.<h3>Findings</h3>Between May 6, 2020, and Jan 30, 2023, 67 patients were assessed for eligibility. Two patients were excluded (brain lesions less than 5 mm) and 65 patients were enrolled and treated. Median age was 66 years (IQR 62–70). 60 (92%) of 65 patients were male and five (8%) were female. All 65 patients were Han Chinese. 50 (77%) of 65 patients had non-squamous NSCLC and 46 (71%) were symptomatic. The 6-month progression-free survival rate was 71·7% (95% CI 58·9–81·1) during the median follow-up of 14·1 months (IQR 9·0–20·3; data cutoff Dec 13, 2023). The most common grade 3–4 treatment-related adverse events were decreased neutrophil count (14 [22%] of 65 patients), decreased w","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"48 3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142917875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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