Pub Date : 2025-01-22DOI: 10.1016/s2213-2600(25)00012-8
Talha Burki
No Abstract
没有抽象的
{"title":"Population-based cancer registries: an essential partner in monitoring and establishing critical action points","authors":"Talha Burki","doi":"10.1016/s2213-2600(25)00012-8","DOIUrl":"https://doi.org/10.1016/s2213-2600(25)00012-8","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"12 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143020362","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 : 2025-01-21DOI: 10.1016/s2213-2600(24)00368-0
Scott M Norberg, Janet Valdez, Scott Napier, Meg Kenyon, Erin Ferraro, Melissa Wheatley, Laura Parsons-Wandell, Stacey L Doran, Amy Lankford, Helen Sabzevari, Douglas E Brough, Jeffrey Schlom, James L Gulley, Clint T Allen
Background
Recurrent respiratory papillomatosis (RRP) is a rare debilitating condition caused by chronic infection with human papillomavirus (HPV) type 6 or 11. Papillomas develop in the aerodigestive tract, leading to significant voice disturbance and airway obstruction. No systemic treatment currently exists. We aimed to assess the safety and clinical activity of PRGN-2012 in adult patients with RRP treated at the recommended phase 2 dose.
Methods
This was a single-centre, single-arm, phase 1/2 trial. Adult patients aged 18 years or older with RRP who required three or more interventions in the 1 year before treatment received adjuvant PRGN-2012 on day 1 following surgical debulking of disease, and on days 15, 43, and 85. Primary outcome measure was complete response rate, defined as the percentage of patients who did not require an intervention to control RRP in the 12 months after treatment. Safety outcomes included treatment-related adverse events. This study is registered ClinicalTrials.gov (NCT04724980).
Findings
From March 16, 2021, to June 1, 2023, 38 patients were enrolled and received the 12-week treatment course. Among the 35 patients treated at the recommended phase 2 dose of 5×1011 particle units, 18 (51%) of 35 patients had a complete response (95% CI 34–69) with the median duration of complete response yet to be reached. Adverse events were mild and included grades 1–2 injection site reaction (34 [97%] of 35), fatigue (28 [80%] of 35), chills (25 [71%] of 35), and fever (24 [69%] of 35).
Interpretation
PRGN-2012 treatment resulted in complete response in 51% of the patients treated and was safe. Based on these positive pivotal study results, a biologics license application to the US Food and Drug Administration (FDA) is planned, positioning PRGN-2012 to be an FDA-approved medical treatment for adult patients with RRP.
Funding
National Institutes of Health.
背景：复发性呼吸道乳头状瘤病（RRP）是由慢性感染6型或11型人乳头状瘤病毒（HPV）引起的一种罕见的衰弱疾病。乳突状瘤在空气消化道中发展，导致明显的声音障碍和气道阻塞。目前还没有系统性的治疗方法。我们的目的是评估PRGN-2012在推荐的2期剂量治疗的成年RRP患者中的安全性和临床活性。方法这是一项单中心、单臂、1/2期试验。年龄在18岁及以上的RRP成年患者在治疗前1年内需要3次或更多的干预，在手术切除疾病后第1天、第15天、第43天和第85天接受PRGN-2012辅助治疗。主要结局指标是完全缓解率，定义为治疗后12个月内不需要干预以控制RRP的患者百分比。安全性结果包括治疗相关的不良事件。该研究已在ClinicalTrials.gov注册（NCT04724980）。从2021年3月16日至2023年6月1日，38名患者入组并接受了为期12周的治疗。在35名接受推荐的5×1011颗粒单位2期剂量治疗的患者中，35名患者中有18名（51%）患者完全缓解（95% CI 34-69），中位完全缓解持续时间尚未达到。不良事件为轻度，包括1-2级注射部位反应（35例中34例[97%]）、疲劳（35例中28例[80%]）、发冷（35例中25例[71%]）和发热（35例中24例[69%]）。prgn -2012治疗导致51%的患者完全缓解，并且是安全的。基于这些积极的关键研究结果，计划向美国食品和药物管理局（FDA）申请生物制剂许可，将PRGN-2012定位为FDA批准的成人RRP患者的药物治疗。资助国家卫生研究院。
{"title":"PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial","authors":"Scott M Norberg, Janet Valdez, Scott Napier, Meg Kenyon, Erin Ferraro, Melissa Wheatley, Laura Parsons-Wandell, Stacey L Doran, Amy Lankford, Helen Sabzevari, Douglas E Brough, Jeffrey Schlom, James L Gulley, Clint T Allen","doi":"10.1016/s2213-2600(24)00368-0","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00368-0","url":null,"abstract":"<h3>Background</h3>Recurrent respiratory papillomatosis (RRP) is a rare debilitating condition caused by chronic infection with human papillomavirus (HPV) type 6 or 11. Papillomas develop in the aerodigestive tract, leading to significant voice disturbance and airway obstruction. No systemic treatment currently exists. We aimed to assess the safety and clinical activity of PRGN-2012 in adult patients with RRP treated at the recommended phase 2 dose.<h3>Methods</h3>This was a single-centre, single-arm, phase 1/2 trial. Adult patients aged 18 years or older with RRP who required three or more interventions in the 1 year before treatment received adjuvant PRGN-2012 on day 1 following surgical debulking of disease, and on days 15, 43, and 85. Primary outcome measure was complete response rate, defined as the percentage of patients who did not require an intervention to control RRP in the 12 months after treatment. Safety outcomes included treatment-related adverse events. This study is registered <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>NCT04724980</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>From March 16, 2021, to June 1, 2023, 38 patients were enrolled and received the 12-week treatment course. Among the 35 patients treated at the recommended phase 2 dose of 5×10<sup>11</sup> particle units, 18 (51%) of 35 patients had a complete response (95% CI 34–69) with the median duration of complete response yet to be reached. Adverse events were mild and included grades 1–2 injection site reaction (34 [97%] of 35), fatigue (28 [80%] of 35), chills (25 [71%] of 35), and fever (24 [69%] of 35).<h3>Interpretation</h3>PRGN-2012 treatment resulted in complete response in 51% of the patients treated and was safe. Based on these positive pivotal study results, a biologics license application to the US Food and Drug Administration (FDA) is planned, positioning PRGN-2012 to be an FDA-approved medical treatment for adult patients with RRP.<h3>Funding</h3>National Institutes of Health.","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"10 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142992103","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 : 2025-01-21DOI: 10.1016/s2213-2600(24)00424-7
Craig S Derkay
No Abstract
无摘要
{"title":"A high-impact study and landmark achievement in the treatment of recurrent respiratory papillomatosis","authors":"Craig S Derkay","doi":"10.1016/s2213-2600(24)00424-7","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00424-7","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"74 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142992101","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 : 2025-01-21DOI: 10.1016/s2213-2600(24)00374-6
Saleh Alsulami, Wanda Phipatanakul
No Abstract
无摘要
{"title":"Social and environmental determinants of health inequities in childhood asthma","authors":"Saleh Alsulami, Wanda Phipatanakul","doi":"10.1016/s2213-2600(24)00374-6","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00374-6","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"11 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142992102","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 : 2025-01-20DOI: 10.1016/s2213-2600(24)00422-3
Kian Fan Chung, Stuart B Mazzone, Lorcan McGarvey, Woo-Jung Song
No Abstract
没有抽象的
{"title":"Chronic cough as a disease: implications for practice, research, and health care","authors":"Kian Fan Chung, Stuart B Mazzone, Lorcan McGarvey, Woo-Jung Song","doi":"10.1016/s2213-2600(24)00422-3","DOIUrl":"https://doi.org/10.1016/s2213-2600(24)00422-3","url":null,"abstract":"No Abstract","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"31 1","pages":""},"PeriodicalIF":76.2,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142990891","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：