Sukruth A Shashikumar, Andrew M Ryan, Karen E Joynt Maddox
{"title":"Medicare's New Mandatory Bundled-Payment Program - Are We Ready for TEAM?","authors":"Sukruth A Shashikumar, Andrew M Ryan, Karen E Joynt Maddox","doi":"10.1056/NEJMp2410850","DOIUrl":"https://doi.org/10.1056/NEJMp2410850","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774770","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}
Valsan P Verghese, Yogesh Jain, Vasundhara Rangaswamy
{"title":"Azithromycin to Reduce Mortality.","authors":"Valsan P Verghese, Yogesh Jain, Vasundhara Rangaswamy","doi":"10.1056/NEJMc2412661","DOIUrl":"https://doi.org/10.1056/NEJMc2412661","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2059-2060"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741414","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}
Brian J Carney, Maureen O Achebe, Richard L Haspel
{"title":"Sickle Cell Trait, Inequity, and the Need for Change.","authors":"Brian J Carney, Maureen O Achebe, Richard L Haspel","doi":"10.1056/NEJMp2408196","DOIUrl":"10.1056/NEJMp2408196","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1972-1974"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717229","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}
Thierry Andre, Elena Elez, Eric Van Cutsem, Lars Henrik Jensen, Jaafar Bennouna, Guillermo Mendez, Michael Schenker, Christelle de la Fouchardiere, Maria Luisa Limon, Takayuki Yoshino, Jin Li, Heinz-Josef Lenz, Jose Luis Manzano Mozo, Giampaolo Tortora, Rocio Garcia-Carbonero, Laetitia Dahan, Myriam Chalabi, Rohit Joshi, Eray Goekkurt, Maria Ignez Braghiroli, Timucin Cil, Elvis Cela, Tian Chen, Ming Lei, Matthew Dixon, Sandzhar Abdullaev, Sara Lonardi
{"title":"Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer.","authors":"Thierry Andre, Elena Elez, Eric Van Cutsem, Lars Henrik Jensen, Jaafar Bennouna, Guillermo Mendez, Michael Schenker, Christelle de la Fouchardiere, Maria Luisa Limon, Takayuki Yoshino, Jin Li, Heinz-Josef Lenz, Jose Luis Manzano Mozo, Giampaolo Tortora, Rocio Garcia-Carbonero, Laetitia Dahan, Myriam Chalabi, Rohit Joshi, Eray Goekkurt, Maria Ignez Braghiroli, Timucin Cil, Elvis Cela, Tian Chen, Ming Lei, Matthew Dixon, Sandzhar Abdullaev, Sara Lonardi","doi":"10.1056/NEJMoa2402141","DOIUrl":"10.1056/NEJMoa2402141","url":null,"abstract":"<p><strong>Background: </strong>Patients with microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) metastatic colorectal cancer have poor outcomes with standard chemotherapy with or without targeted therapies. Nivolumab plus ipilimumab has shown clinical benefit in nonrandomized studies of MSI-H or dMMR metastatic colorectal cancer.</p><p><strong>Methods: </strong>In this phase 3 open-label trial, we randomly assigned patients with unresectable or metastatic colorectal cancer and MSI-H or dMMR status according to local testing to receive, in a 2:2:1 ratio, nivolumab plus ipilimumab, nivolumab alone, or chemotherapy with or without targeted therapies. The dual primary end points, assessed in patients with centrally confirmed MSI-H or dMMR status, were progression-free survival with nivolumab plus ipilimumab as compared with chemotherapy as first-line therapy and progression-free survival with nivolumab plus ipilimumab as compared with nivolumab alone in patients regardless of previous systemic treatment for metastatic disease. At this prespecified interim analysis, the first primary end point (involving nivolumab plus ipilimumab vs. chemotherapy) was assessed.</p><p><strong>Results: </strong>A total of 303 patients who had not previously received systemic treatment for metastatic disease were randomly assigned to receive nivolumab plus ipilimumab or chemotherapy; 255 patients had centrally confirmed MSI-H or dMMR tumors. At a median follow-up of 31.5 months (range, 6.1 to 48.4), progression-free survival outcomes (the primary analysis) were significantly better with nivolumab plus ipilimumab than with chemotherapy (P<0.001 for the between-group difference in progression-free survival, calculated with the use of a two-sided stratified log-rank test); 24-month progression-free survival was 72% (95% confidence interval [CI], 64 to 79) with nivolumab plus ipilimumab as compared with 14% (95% CI, 6 to 25) with chemotherapy. At 24 months, the restricted mean survival time was 10.6 months (95% CI, 8.4 to 12.9) longer with nivolumab plus ipilimumab than with chemotherapy, a finding consistent with the primary analysis of progression-free survival. Grade 3 or 4 treatment-related adverse events occurred in 23% of the patients in the nivolumab-plus-ipilimumab group and in 48% of the patients in the chemotherapy group.</p><p><strong>Conclusions: </strong>Progression-free survival was longer with nivolumab plus ipilimumab than with chemotherapy among patients who had not previously received systemic treatment for MSI-H or dMMR metastatic colorectal cancer. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 8HW ClinicalTrials.gov number, NCT04008030.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2014-2026"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741430","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}
{"title":"Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma.","authors":"Hussam Alkaissi, Karel Pacak, Jared Rosenblum","doi":"10.1056/NEJMc2411843","DOIUrl":"https://doi.org/10.1056/NEJMc2411843","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2061-2062"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741416","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}
{"title":"Azithromycin to Reduce Mortality.","authors":"Maple Goh, Aaron S Kesselheim, Kevin Outterson","doi":"10.1056/NEJMc2412661","DOIUrl":"10.1056/NEJMc2412661","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2060"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741413","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}
Christian Rosas-Salazar, Leonard B Bacharier, Tina V Hartert
{"title":"Azithromycin to Reduce Mortality.","authors":"Christian Rosas-Salazar, Leonard B Bacharier, Tina V Hartert","doi":"10.1056/NEJMc2412661","DOIUrl":"https://doi.org/10.1056/NEJMc2412661","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2058-2059"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741412","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}
{"title":"Doxorubicin-Trabectedin in Leiomyosarcoma. Reply.","authors":"Patricia Pautier, Jean-Yves Blay, Florence Duffaud","doi":"10.1056/NEJMc2412479","DOIUrl":"https://doi.org/10.1056/NEJMc2412479","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2058"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741427","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}
{"title":"Immunotherapy for Early-Stage Triple-Negative Breast Cancer.","authors":"Harold J Burstein","doi":"10.1056/NEJMe2411606","DOIUrl":"https://doi.org/10.1056/NEJMe2411606","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 21","pages":"2048-2049"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741429","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}
Peter Schmid, Javier Cortes, Rebecca Dent, Heather McArthur, Lajos Pusztai, Sherko Kümmel, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck, Masato Takahashi, Seock-Ah Im, Michael Untch, Peter A Fasching, Marie-Ange Mouret-Reynier, Theodoros Foukakis, Marta Ferreira, Fatima Cardoso, Xuan Zhou, Vassiliki Karantza, Konstantinos Tryfonidis, Gursel Aktan, Joyce O'Shaughnessy
{"title":"Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer.","authors":"Peter Schmid, Javier Cortes, Rebecca Dent, Heather McArthur, Lajos Pusztai, Sherko Kümmel, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck, Masato Takahashi, Seock-Ah Im, Michael Untch, Peter A Fasching, Marie-Ange Mouret-Reynier, Theodoros Foukakis, Marta Ferreira, Fatima Cardoso, Xuan Zhou, Vassiliki Karantza, Konstantinos Tryfonidis, Gursel Aktan, Joyce O'Shaughnessy","doi":"10.1056/NEJMoa2409932","DOIUrl":"10.1056/NEJMoa2409932","url":null,"abstract":"<p><strong>Background: </strong>In patients with early-stage triple-negative breast cancer, the phase 3 KEYNOTE-522 trial showed significant improvements in pathological complete response and event-free survival with the addition of pembrolizumab to platinum-containing chemotherapy. Here we report the final results for overall survival.</p><p><strong>Methods: </strong>We randomly assigned, in a 2:1 ratio, patients with previously untreated stage II or III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks plus paclitaxel and carboplatin, followed by four cycles of pembrolizumab or placebo plus doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, patients received adjuvant pembrolizumab (pembrolizumab-chemotherapy group) or placebo (placebo-chemotherapy group) every 3 weeks for up to nine cycles. The primary end points were pathological complete response and event-free survival. Overall survival was a secondary end point.</p><p><strong>Results: </strong>Of the 1174 patients who underwent randomization, 784 were assigned to the pembrolizumab-chemotherapy group and 390 to the placebo-chemotherapy group. At the data-cutoff date (March 22, 2024), the median follow-up was 75.1 months (range, 65.9 to 84.0). The estimated overall survival at 60 months was 86.6% (95% confidence interval [CI], 84.0 to 88.8) in the pembrolizumab-chemotherapy group, as compared with 81.7% (95% CI, 77.5 to 85.2) in the placebo-chemotherapy group (P = 0.002). Adverse events were consistent with the established safety profiles of pembrolizumab and chemotherapy.</p><p><strong>Conclusions: </strong>Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab resulted in a significant improvement, as compared with neoadjuvant chemotherapy alone, in overall survival among patients with early-stage triple-negative breast cancer. (Funded by Merck Sharp and Dohme, a subsidiary of Merck [Rahway, NJ]; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1981-1991"},"PeriodicalIF":96.2,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142301190","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}