Ziwei Zeng, Shuangling Luo, Hong Zhang, Miao Wu, Dan Ma, Quan Wang, Ming Xie, Qing Xu, Jun Ouyang, Yi Xiao, Yongchun Song, Bo Feng, Qingwen Xu, Yanan Wang, Yi Zhang, Lishuo Shi, Li Ling, Xingwei Zhang, Liang Huang, Zuli Yang, Junsheng Peng, Xiaojian Wu, Donglin Ren, Meijin Huang, Ping Lan, Jianping Wang, Weidong Tong, Mingyang Ren, Huashan Liu, Liang Kang
Importance: Previous studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME.
Objective: To evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer.
Design, setting, and participants: This randomized, open-label, noninferiority, phase 3 clinical trial was performed in 16 different centers in China. Between April 2016 and June 2021, a total of 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled. The last date of participant follow-up was in June 2024.
Interventions: Participants were randomly assigned in a 1:1 ratio before their surgical procedure to undergo either transanal TME (n = 558) or laparoscopic TME (n = 557).
Main outcomes and measures: The primary end point was 3-year disease-free survival, with a noninferiority margin of -10% for the comparison between transanal TME and laparoscopic TME. Secondary outcomes included 3-year overall survival and 3-year local recurrence.
Results: In the primary analysis set, the median patient age was 60 years. A total of 692 male and 397 female patients were included in the analysis. Three-year disease-free survival was 82.1% (97.5% CI, 78.4%-85.8%) for the transanal TME group and 79.4% (97.5% CI, 75.6%-83.4%) for the laparoscopic TME group, with a difference of 2.7% (97.5% CI, -3.0% to 8.1%). The lower tail of a 2-tailed 97.5% CI for the group difference in 3-year disease-free survival was above the noninferiority margin of -10 percentage points. Furthermore, the 3-year local recurrence was 3.6% (95% CI, 2.0%-5.1%) for transanal TME and 4.4% (95% CI, 2.6%-6.1%) for laparoscopic TME. Three-year overall survival was 92.6% (95% CI, 90.4%-94.8%) for transanal TME and 90.7% (95% CI, 88.3%-93.2%) for laparoscopic TME.
Conclusions and relevance: In patients with mid-low rectal cancer, 3-year disease-free survival for transanal TME was noninferior to that of laparoscopic TME.
{"title":"Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial.","authors":"Ziwei Zeng, Shuangling Luo, Hong Zhang, Miao Wu, Dan Ma, Quan Wang, Ming Xie, Qing Xu, Jun Ouyang, Yi Xiao, Yongchun Song, Bo Feng, Qingwen Xu, Yanan Wang, Yi Zhang, Lishuo Shi, Li Ling, Xingwei Zhang, Liang Huang, Zuli Yang, Junsheng Peng, Xiaojian Wu, Donglin Ren, Meijin Huang, Ping Lan, Jianping Wang, Weidong Tong, Mingyang Ren, Huashan Liu, Liang Kang","doi":"10.1001/jama.2024.24276","DOIUrl":"10.1001/jama.2024.24276","url":null,"abstract":"<p><strong>Importance: </strong>Previous studies have demonstrated the advantages of short-term histopathological outcomes and complications associated with transanal total mesorectal excision (TME) compared with laparoscopic TME. However, the long-term oncological outcomes of transanal TME remain ambiguous. This study aims to compare 3-year disease-free survival of transanal TME with laparoscopic TME.</p><p><strong>Objective: </strong>To evaluate 3-year disease-free survival between transanal TME and laparoscopic TME in patients with rectal cancer.</p><p><strong>Design, setting, and participants: </strong>This randomized, open-label, noninferiority, phase 3 clinical trial was performed in 16 different centers in China. Between April 2016 and June 2021, a total of 1115 patients with clinical stage I to III mid-low rectal cancer were enrolled. The last date of participant follow-up was in June 2024.</p><p><strong>Interventions: </strong>Participants were randomly assigned in a 1:1 ratio before their surgical procedure to undergo either transanal TME (n = 558) or laparoscopic TME (n = 557).</p><p><strong>Main outcomes and measures: </strong>The primary end point was 3-year disease-free survival, with a noninferiority margin of -10% for the comparison between transanal TME and laparoscopic TME. Secondary outcomes included 3-year overall survival and 3-year local recurrence.</p><p><strong>Results: </strong>In the primary analysis set, the median patient age was 60 years. A total of 692 male and 397 female patients were included in the analysis. Three-year disease-free survival was 82.1% (97.5% CI, 78.4%-85.8%) for the transanal TME group and 79.4% (97.5% CI, 75.6%-83.4%) for the laparoscopic TME group, with a difference of 2.7% (97.5% CI, -3.0% to 8.1%). The lower tail of a 2-tailed 97.5% CI for the group difference in 3-year disease-free survival was above the noninferiority margin of -10 percentage points. Furthermore, the 3-year local recurrence was 3.6% (95% CI, 2.0%-5.1%) for transanal TME and 4.4% (95% CI, 2.6%-6.1%) for laparoscopic TME. Three-year overall survival was 92.6% (95% CI, 90.4%-94.8%) for transanal TME and 90.7% (95% CI, 88.3%-93.2%) for laparoscopic TME.</p><p><strong>Conclusions and relevance: </strong>In patients with mid-low rectal cancer, 3-year disease-free survival for transanal TME was noninferior to that of laparoscopic TME.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02966483.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"774-783"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880948/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023923","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":"CDC Advises Expedited Influenza Subtyping in Hospitalized Patients to Help Identify Bird Flu Cases Sooner.","authors":"Anna Bock","doi":"10.1001/jama.2025.0679","DOIUrl":"10.1001/jama.2025.0679","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"741-742"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143066592","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":"Sweetened Beverages Linked to Millions of Global Diabetes and Heart Disease Cases.","authors":"Samantha Anderer","doi":"10.1001/jama.2024.28816","DOIUrl":"10.1001/jama.2024.28816","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"747"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143066619","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":"Minor Comments.","authors":"","doi":"10.1001/jama.2024.18753","DOIUrl":"10.1001/jama.2024.18753","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"818"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256112","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":"Patient Messaging Declines After E-Billing, but Clinician Workload Persists.","authors":"Samantha Anderer","doi":"10.1001/jama.2024.28815","DOIUrl":"10.1001/jama.2024.28815","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"746-747"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143066607","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":"DoxyPEP Shows Promise for Reducing STIs in 2 Studies.","authors":"Samantha Anderer","doi":"10.1001/jama.2024.28812","DOIUrl":"10.1001/jama.2024.28812","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"746"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143066593","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":"Screening for Helicobacter pylori to Prevent Gastric Cancer.","authors":"Shria Kumar, Michael Bretthauer","doi":"10.1001/jama.2024.26377","DOIUrl":"10.1001/jama.2024.26377","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"812-813"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189787","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":"Screening for Helicobacter pylori to Prevent Gastric Cancer.","authors":"Yasutoshi Shiratori, Naoki Ishii, Anthony Kalloo","doi":"10.1001/jama.2024.26386","DOIUrl":"10.1001/jama.2024.26386","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"812"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189790","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":"Screening for Helicobacter pylori to Prevent Gastric Cancer.","authors":"Chin-Yuan Yii, Su-Boon Yong, Chia-Jung Li","doi":"10.1001/jama.2024.26383","DOIUrl":"10.1001/jama.2024.26383","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"813-814"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189789","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":"What Is Pericarditis?","authors":"Rebecca Voelker","doi":"10.1001/jama.2024.26822","DOIUrl":"10.1001/jama.2024.26822","url":null,"abstract":"","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":" ","pages":"822"},"PeriodicalIF":0.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256114","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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