Jama OncologyPub Date : 2025-03-01DOI: 10.1001/jamaoncol.2024.6154
Bahadir Köylü, Deniz Can Güven
{"title":"Uncertain Prognostic Impact of Visceral Pleural Invasion.","authors":"Bahadir Köylü, Deniz Can Güven","doi":"10.1001/jamaoncol.2024.6154","DOIUrl":"10.1001/jamaoncol.2024.6154","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"351"},"PeriodicalIF":28.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957067","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}
Jama OncologyPub Date : 2025-02-27DOI: 10.1001/jamaoncol.2024.6649
Ross McCauley, Eunice S Wang
{"title":"A Partnership to Advance Care of Patients With Acute Promyelocytic Leukemia.","authors":"Ross McCauley, Eunice S Wang","doi":"10.1001/jamaoncol.2024.6649","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.6649","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516981","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}
Jama OncologyPub Date : 2025-02-27DOI: 10.1001/jamaoncol.2024.7033
Anand P Jillella, Sandra J Lee, Jessica K Altman, Selina M Luger, Martin S Tallman, James M Foran, Danielle Bradshaw, Lisa Y Law, Locke J Bryan, Abdallah Abou Zahr, Kebede H Begna, Alexander E Perl, Joseph J L Vadakara, Rubina Qamar, Raymond C Bergan, Michael J Fisch, Ruth C Carlos, Lynne I Wagner, Vamsi K Kota, Mark R Litzow
{"title":"Academic Community Partnership in Acute Promyelocytic Leukemia and Early Mortality: The ECOG-ACRIN EA9131 Trial.","authors":"Anand P Jillella, Sandra J Lee, Jessica K Altman, Selina M Luger, Martin S Tallman, James M Foran, Danielle Bradshaw, Lisa Y Law, Locke J Bryan, Abdallah Abou Zahr, Kebede H Begna, Alexander E Perl, Joseph J L Vadakara, Rubina Qamar, Raymond C Bergan, Michael J Fisch, Ruth C Carlos, Lynne I Wagner, Vamsi K Kota, Mark R Litzow","doi":"10.1001/jamaoncol.2024.7033","DOIUrl":"10.1001/jamaoncol.2024.7033","url":null,"abstract":"<p><strong>Importance: </strong>Acute promyelocytic leukemia (APL) is an acute illness that presents with cytopenia, infections, and disseminated intravascular coagulation. Achieving remission has been shown to make a major difference in patient outcomes; however, early death rates in the first month have been as high as 30% due to acute presentation, comorbidities, the rarity of APL, and clinician inexperience.</p><p><strong>Objective: </strong>To develop treatment strategies that would decrease estimated 1-month mortality from 30% to below 15%.</p><p><strong>Design, setting, and participants: </strong>In this nonrandomized clinical trial, a treatment algorithm that focused on supportive care was used to prevent early death in patients with APL treated at academic and community health centers between August 2017 and July 2021. Because of the rarity of the disease, expert support was available 24/7 from 7 designated APL experts at 6 participating academic lead centers, and included an additional 293 community centers. When a patient presented with APL, an expert was contacted and a consensus treatment plan was developed using the algorithm and expert suggestions. There were no exclusion criteria and all patients with a confirmed diagnosis of APL regardless of age or comorbid conditions were enrolled. Expert support was provided throughout induction. Initial data analysis was conducted May 2023.</p><p><strong>Main outcomes and measures: </strong>One-month mortality; additional objectives were to compare outcomes in academic and community centers and assess 1-year and overall survival.</p><p><strong>Results: </strong>A total of 201 patients were enrolled from 43 centers; 62 at lead centers and 139 from 37 community centers. The median age was 53 years (range, 18-91 years), with 72 patients (35.8%) who were aged 60 years or older; 105 patients (52.2%) were male. Fifty-two patients (26.4%) were diagnosed with high-risk APL. The 1-month mortality rate was 6 deaths of 201 patients (3.0%; 95% CI, 1.1%-6.4%) after adjusting for 1 interim analysis. In a secondary analysis using the Kaplan-Meier method, the 1-month overall survival (OS) rate was 97.0% (95% CI, 93.5%-98.6%) and the 1-year OS rate was 94.5% (95% CI, 90.3%-96.9%).</p><p><strong>Conclusions and relevance: </strong>In this nonrandomized clinical trial, use of an algorithm combined with expert support resulted in a dramatic decrease in early death in academic and community centers. Population-wide survival improved in this highly curable disease, which suggests that implementing an accessible support system with APL experts for comanagement is the most logical next step.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03253848.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2025-02-27DOI: 10.1001/jamaoncol.2024.7018
S Gail Eckhardt, Leonidas C Platanias
{"title":"The Oncology Industrial Complex-Community Oncology Must Be Given a Seat at the Table-Reply.","authors":"S Gail Eckhardt, Leonidas C Platanias","doi":"10.1001/jamaoncol.2024.7018","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.7018","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517047","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}
Jama OncologyPub Date : 2025-02-27DOI: 10.1001/jamaoncol.2024.7015
Russell Gollard
{"title":"The Oncology Industrial Complex-Community Oncology Must Be Given a Seat at the Table.","authors":"Russell Gollard","doi":"10.1001/jamaoncol.2024.7015","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.7015","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517067","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}
Jama OncologyPub Date : 2025-02-27DOI: 10.1001/jamaoncol.2024.7051
Gianmarco Leone, Francesco Orlando, Peter Dutey-Magni, Osvaldas Vainauskas, Emily Grist, Yari Ciani, Sharanpreet Lall, Suparna Thakali, Anna Wingate, Daniel Wetterskog, Ashwin Sachdeva, Matthew R Sydes, Neil McPhail, Thiagarajan Sreenivasan, Joe M O'Sullivan, Noel W Clarke, Mahesh K B Parmar, Louise C Brown, Nicholas D James, Francesca Demichelis, Gerhardt Attard
{"title":"Plasma AR Alterations and Timing of Intensified Hormone Treatment for Prostate Cancer: the STAMPEDE Phase 3 Randomized Clinical Trial.","authors":"Gianmarco Leone, Francesco Orlando, Peter Dutey-Magni, Osvaldas Vainauskas, Emily Grist, Yari Ciani, Sharanpreet Lall, Suparna Thakali, Anna Wingate, Daniel Wetterskog, Ashwin Sachdeva, Matthew R Sydes, Neil McPhail, Thiagarajan Sreenivasan, Joe M O'Sullivan, Noel W Clarke, Mahesh K B Parmar, Louise C Brown, Nicholas D James, Francesca Demichelis, Gerhardt Attard","doi":"10.1001/jamaoncol.2024.7051","DOIUrl":"10.1001/jamaoncol.2024.7051","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jama OncologyPub Date : 2025-02-20DOI: 10.1001/jamaoncol.2024.6998
Charalampos S Floudas, Meghali Goswami, Renee N Donahue, Danielle M Pastor, Jason M Redman, Isaac Brownell, Evrim B Turkbey, Lisa M Cordes, Seth M Steinberg, Michell Manu, Deneise C Francis, Elizabeth Lamping, Jennifer L Marté, Mary Kackley, Elizabeth Krauss, Manuk Manukyan, Caroline Jochems, Jeffrey Schlom, James L Gulley, Julius Strauss
{"title":"Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial.","authors":"Charalampos S Floudas, Meghali Goswami, Renee N Donahue, Danielle M Pastor, Jason M Redman, Isaac Brownell, Evrim B Turkbey, Lisa M Cordes, Seth M Steinberg, Michell Manu, Deneise C Francis, Elizabeth Lamping, Jennifer L Marté, Mary Kackley, Elizabeth Krauss, Manuk Manukyan, Caroline Jochems, Jeffrey Schlom, James L Gulley, Julius Strauss","doi":"10.1001/jamaoncol.2024.6998","DOIUrl":"10.1001/jamaoncol.2024.6998","url":null,"abstract":"<p><strong>Importance: </strong>Patients who experience progression of advanced human papillomavirus (HPV)-associated cancers and who have previously received first-line systemic treatment have a poor prognosis and limited therapeutic options.</p><p><strong>Objective: </strong>To assess the clinical activity of the combination of the HPV type 16 therapeutic vaccine PDS0101, the tumor-targeting interleukin 12 antibody-drug conjugate PDS01ADC, and the bifunctional anti-programmed cell death ligand 1 (PD-L1)/transforming growth factor β (TGF-β) bintrafusp alfa in advanced HPV-associated cancers.</p><p><strong>Design, setting, and participants: </strong>This nonrandomized clinical trial was phase 1/2 and investigator initiated, and was conducted at a single US cancer research center between June 2020 and July 2022. Patients with advanced or metastatic HPV-associated cancers were eligible, including patients who were both immune checkpoint blockade (ICB) naive and ICB resistant. The cutoff date for data analysis was May 13, 2024.</p><p><strong>Intervention: </strong>Patients received 1 mL of PDS0101 subcutaneously every 4 weeks for 6 doses then every 12 weeks for 2 additional doses, PDS01ADC, 16.8 µg/kg, subcutaneously every 4 weeks or PDS01ADC, 8 µg/kg, subcutaneously every 2 weeks, and bintrafusp alfa, 1200 mg, intravenously every 2 weeks.</p><p><strong>Main outcomes and measures: </strong>Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 in ICB-naive patients.</p><p><strong>Results: </strong>Of the 50 eligible patients, 26 (52%) were men and the median age was 56 years (range, 28-80 years). The median (IQR) follow-up was 37.7 (30.6-42.0) months. Fourteen patients (28%) were ICB naive, with an ORR of 35.7% (95% CI, 12.8%-64.9%), and median overall survival (OS) 42.4 months (95% CI, 8.3 months-not estimable); in ICB-resistant patients, the ORR was 16.7% (6 of 36 patients; 95% CI, 6.4%-32.8%) and median OS was 15.8 months (95% CI, 9.0-21.3 months). Among patients with HPV-16-positive tumors (37 patients [74%]), in the ICB-naive group (8 patients [21.6%]) the ORR was 62.5% (95% CI, 24.5%-91.5%) and a median OS measure was not reached. Grade 3 and 4 treatment-related adverse events occurred in 26 of 50 patients (52%). There were no treatment-related deaths.</p><p><strong>Conclusions and relevance: </strong>In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16-positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04287868.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}