{"title":"Am I a Survivor?","authors":"Cara E Texler","doi":"10.1001/jama.2024.23388","DOIUrl":"https://doi.org/10.1001/jama.2024.23388","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813404","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}
E Shelley Hwang, Terry Hyslop, Thomas Lynch, Marc D Ryser, Anna Weiss, Anna Wolf, Kelsey Norris, Meredith Witten, Lars Grimm, Stuart Schnitt, Sunil Badve, Rachel Factor, Elizabeth Frank, Deborah Collyar, Desiree Basila, Donna Pinto, Mark A Watson, Robert West, Louise Davies, Jenny L Donovan, Ayako Shimada, Yutong Li, Yan Li, Antonia V Bennett, Shoshana Rosenberg, Jeffrey Marks, Eric Winer, Marc Boisvert, Armando Giuliano, Kelsey E Larson, Kathleen Yost, Priscilla F McAuliffe, Amy Krie, Nina Tamirisa, Lisa A Carey, Alastair M Thompson, Ann H Partridge
{"title":"Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial.","authors":"E Shelley Hwang, Terry Hyslop, Thomas Lynch, Marc D Ryser, Anna Weiss, Anna Wolf, Kelsey Norris, Meredith Witten, Lars Grimm, Stuart Schnitt, Sunil Badve, Rachel Factor, Elizabeth Frank, Deborah Collyar, Desiree Basila, Donna Pinto, Mark A Watson, Robert West, Louise Davies, Jenny L Donovan, Ayako Shimada, Yutong Li, Yan Li, Antonia V Bennett, Shoshana Rosenberg, Jeffrey Marks, Eric Winer, Marc Boisvert, Armando Giuliano, Kelsey E Larson, Kathleen Yost, Priscilla F McAuliffe, Amy Krie, Nina Tamirisa, Lisa A Carey, Alastair M Thompson, Ann H Partridge","doi":"10.1001/jama.2024.26698","DOIUrl":"https://doi.org/10.1001/jama.2024.26698","url":null,"abstract":"<p><strong>Importance: </strong>Active monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown.</p><p><strong>Objective: </strong>To compare rates of invasive cancer in patients with low-risk DCIS receiving active monitoring vs guideline-concordant care.</p><p><strong>Design, setting, and participants: </strong>Prospective, randomized noninferiority trial enrolling 995 women aged 40 years or older with a new diagnosis of hormone receptor-positive grade 1 or grade 2 DCIS without invasive cancer at 100 US Alliance Cancer Cooperative Group clinical trial sites from 2017 to 2023.</p><p><strong>Interventions: </strong>Participants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical examination; n = 484) or guideline-concordant care (surgery with or without radiation therapy; n = 473).</p><p><strong>Main outcomes and measures: </strong>The primary outcome was 2-year cumulative risk of ipsilateral invasive cancer diagnosis, according to planned intention-to-treat and per-protocol analyses, with a noninferiority bound of 0.05%.</p><p><strong>Results: </strong>The median age of the 957 participants analyzed was 63.6 (95% CI, 55.5-70.5) years in the guideline-concordant care group and 63.7 (95% CI, 60.0-71.6) years in the active monitoring group. Overall, 15.7% of participants were Black and 75.0% were White. In this prespecified primary analysis, median follow-up was 36.9 months; 346 patients had surgery for DCIS, 264 in the guideline-concordant care group and 82 in the active monitoring group. Forty-six women were diagnosed with invasive cancer, 19 in the active monitoring group and 27 in the guideline-concordant care group. The 2-year Kaplan-Meier cumulative rate of ipsilateral invasive cancer was 4.2% in the active monitoring group vs 5.9% in the guideline-concordant care group, a difference of -1.7% (upper limit of the 95% CI, 0.95%), indicating that active monitoring is not inferior to guideline-concordant care. Invasive tumor characteristics did not differ significantly between groups.</p><p><strong>Conclusions and relevance: </strong>Women with low-risk DCIS randomized to active monitoring did not have a higher rate of invasive cancer in the same breast at 2 years compared with those randomized to guideline-concordant care.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02926911.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813402","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}
{"title":"Paying More for Primary Care-A New Approach by Medicare.","authors":"Soleil Shah, Suhas Gondi, Amol S Navathe","doi":"10.1001/jama.2024.23933","DOIUrl":"https://doi.org/10.1001/jama.2024.23933","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813417","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}
{"title":"Lister's New Antiseptic Dressing.","authors":"","doi":"10.1001/jama.2023.18480","DOIUrl":"10.1001/jama.2023.18480","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1950"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142623092","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}
{"title":"Why Evidence Generation Should Matter to Payers.","authors":"Joshua Hauser, Rita F Redberg","doi":"10.1001/jama.2024.20644","DOIUrl":"10.1001/jama.2024.20644","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1947"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142623115","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}
Jennifer N Brudno, Marcela V Maus, Christian S Hinrichs
{"title":"CAR T Cells and T-Cell Therapies for Cancer: A Translational Science Review.","authors":"Jennifer N Brudno, Marcela V Maus, Christian S Hinrichs","doi":"10.1001/jama.2024.19462","DOIUrl":"10.1001/jama.2024.19462","url":null,"abstract":"<p><strong>Importance: </strong>Chimeric antigen receptor (CAR) T cells are T lymphocytes that are genetically engineered to express a synthetic receptor that recognizes a tumor cell surface antigen and causes the T cell to kill the tumor cell. CAR T treatments improve overall survival for patients with large B-cell lymphoma and progression-free survival for patients with multiple myeloma.</p><p><strong>Observations: </strong>Six CAR T-cell products are approved by the US Food and Drug Administration (FDA) for 6 hematologic malignancies: B-cell acute lymphoblastic leukemia, large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, and multiple myeloma. Compared with standard chemotherapy followed by stem cell transplant, CAR T cells improved 4-year overall survival in patients with large B-cell lymphoma (54.6% vs 46.0%). Patients with pediatric acute lymphoblastic leukemia achieved durable remission after CAR T-cell therapy. At 3-year follow-up, 48% of patients were alive and relapse free. In people with multiple myeloma treated previously with 1 to 4 types of non-CAR T-cell therapy, CAR T-cell therapy prolonged treatment-free remissions compared with standard treatments (in 1 trial, CAR T-cell therapy was associated with progression-free survival of 13.3 months compared with 4.4 months with standard therapy). CAR T-cell therapy is associated with reversible acute toxicities, such as cytokine release syndrome in approximately 40% to 95% of patients, and neurologic disorders in approximately 15% to 65%. New CAR T-cell therapies in development aim to increase efficacy, decrease adverse effects, and treat other types of cancer. No CAR T-cell therapies are FDA approved for solid tumors, but recently, 2 other T lymphocyte-based treatments gained approvals: 1 for melanoma and 1 for synovial cell sarcoma. Additional cellular therapies have attained responses for certain solid tumors, including pediatric neuroblastoma, synovial cell sarcoma, melanoma, and human papillomavirus-associated cancers. A common adverse effect occurring with these T lymphocyte-based therapies is capillary leak syndrome, which is characterized by fluid retention, pulmonary edema, and kidney dysfunction.</p><p><strong>Conclusions and relevance: </strong>CAR T-cell therapy is an FDA-approved therapy that has improved progression-free survival for multiple myeloma, improved overall survival for large B-cell lymphoma, and attained high rates of cancer remission for other hematologic malignancies such as acute lymphoblastic leukemia, follicular lymphoma, and mantle cell lymphoma. Recently approved T lymphocyte-based therapies demonstrated the potential for improved outcomes in solid tumor malignancies.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1924-1935"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569016","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}
Marie Vibeke Vestergaard, Anne Krogh Nøhr, Kristine Højgaard Allin, Henrik Krarup, Lone Larsen, Aleksejs Sazonovs, Tine Jess
{"title":"HLA-DRB1*01:03 and Severe Ulcerative Colitis.","authors":"Marie Vibeke Vestergaard, Anne Krogh Nøhr, Kristine Højgaard Allin, Henrik Krarup, Lone Larsen, Aleksejs Sazonovs, Tine Jess","doi":"10.1001/jama.2024.20429","DOIUrl":"10.1001/jama.2024.20429","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1941-1943"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11480900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"piecing together after.","authors":"Katherine L Rosenblum","doi":"10.1001/jama.2024.15860","DOIUrl":"10.1001/jama.2024.15860","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1949"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142623098","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}
{"title":"FDA Approves New Class of Hemophilia Treatment.","authors":"Samantha Anderer","doi":"10.1001/jama.2024.23052","DOIUrl":"10.1001/jama.2024.23052","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1873"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638785","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}
{"title":"Study Offers Insights Into Male HPV Infection's Potential Role in Infertility.","authors":"Lori Youmshajekian","doi":"10.1001/jama.2024.22534","DOIUrl":"10.1001/jama.2024.22534","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"1870-1871"},"PeriodicalIF":0.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638807","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}