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New England Journal of Medicine

Rachel R Hardeman, Eduardo M Medina, Katy B Kozhimannil
On July 7, 2016, in our Minneapolis community, Philando Castile was shot and killed by a police officer in the presence of his girlfriend and her 4-year-old daughter. Acknowledging the role of racism in Castile’s death, Minnesota Governor Mark Dayton asked rhetorically, "Would this have happened if..
October 12, 2016: New England Journal of Medicine
Leemore S Dafny, Christopher J Ody, Matthew A Schmitt
In 2015, the U.S. Department of Health and Human Services announced a goal of linking at least 50% of Medicare spending to value-based payment models such as accountable care organizations. Health care providers are now scrambling to reorganize in a way that delivers value while preserving or..
October 12, 2016: New England Journal of Medicine
Peter W Gething, Daniel C Casey, Daniel J Weiss, Donal Bisanzio, Samir Bhatt, Ewan Cameron, Katherine E Battle, Ursula Dalrymple, Jennifer Rozier, Puja C Rao, Michael J Kutz, Ryan M Barber, Chantal Huynh, Katya A Shackelford, Matthew M Coates, Grant Nguyen, Maya S Fraser, Rachel Kulikoff, Haidong Wang, Mohsen Naghavi, David L Smith, Christopher J L Murray, Simon I Hay, Stephen S Lim
Background Malaria control has not been routinely informed by the assessment of subnational variation in malaria deaths. We combined data from the Malaria Atlas Project and the Global Burden of Disease Study to estimate malaria mortality across sub-Saharan Africa on a grid of 5 km(2) from 1990 through 2015. Methods We estimated malaria mortality using a spatiotemporal modeling framework of geolocated data (i.e., with known latitude and longitude) on the clinical incidence of malaria, coverage of antimalarial drug treatment, case fatality rate, and population distribution according to age...
October 10, 2016: New England Journal of Medicine
Alain Ravaud, Robert J Motzer, Hardev S Pandha, Daniel J George, Allan J Pantuck, Anup Patel, Yen-Hwa Chang, Bernard Escudier, Frede Donskov, Ahmed Magheli, Giacomo Carteni, Brigitte Laguerre, Piotr Tomczak, Jan Breza, Paola Gerletti, Mariajose Lechuga, Xun Lin, Jean-Francois Martini, Krishnan Ramaswamy, Michelle Casey, Michael Staehler, Jean-Jacques Patard
Background Sunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic renal-cell carcinoma. We sought to determine the efficacy and safety of sunitinib in patients with locoregional renal-cell carcinoma at high risk for tumor recurrence after nephrectomy. Methods In this randomized, double-blind, phase 3 trial, we assigned 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib (50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal...
October 9, 2016: New England Journal of Medicine
Bruce E Johnson
No abstract text is available yet for this article.
October 8, 2016: New England Journal of Medicine
Martin Reck, Delvys Rodríguez-Abreu, Andrew G Robinson, Rina Hui, Tibor Csőszi, Andrea Fülöp, Maya Gottfried, Nir Peled, Ali Tafreshi, Sinead Cuffe, Mary O'Brien, Suman Rao, Katsuyuki Hotta, Melanie A Leiby, Gregory M Lubiniecki, Yue Shentu, Reshma Rangwala, Julie R Brahmer
Background Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1). Methods In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy...
October 8, 2016: New England Journal of Medicine
Robert L Ferris, George Blumenschein, Jerome Fayette, Joel Guigay, A Dimitrios Colevas, Lisa Licitra, Kevin Harrington, Stefan Kasper, Everett E Vokes, Caroline Even, Francis Worden, Nabil F Saba, Lara C Iglesias Docampo, Robert Haddad, Tamara Rordorf, Naomi Kiyota, Makoto Tahara, Manish Monga, Mark Lynch, William J Geese, Justin Kopit, James W Shaw, Maura L Gillison
Background Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition. Methods In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab)...
October 8, 2016: New England Journal of Medicine
Gabriel N Hortobagyi, Salomon M Stemmer, Howard A Burris, Yoon-Sim Yap, Gabe S Sonke, Shani Paluch-Shimon, Mario Campone, Kimberly L Blackwell, Fabrice André, Eric P Winer, Wolfgang Janni, Sunil Verma, Pierfranco Conte, Carlos L Arteaga, David A Cameron, Katarina Petrakova, Lowell L Hart, Cristian Villanueva, Arlene Chan, Erik Jakobsen, Arnd Nusch, Olga Burdaeva, Eva-Maria Grischke, Emilio Alba, Erik Wist, Norbert Marschner, Anne M Favret, Denise Yardley, Thomas Bachelot, Ling-Ming Tseng, Sibel Blau, Fengjuan Xuan, Farida Souami, Michelle Miller, Caroline Germa, Samit Hirawat, Joyce O'Shaughnessy
Background The inhibition of cyclin-dependent kinases 4 and 6 (CDK4/6) could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). Methods In this randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of the selective CDK4/6 inhibitor ribociclib combined with letrozole for first-line treatment in 668 postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer who had not received previous systemic therapy for advanced disease...
October 7, 2016: New England Journal of Medicine
Mansoor R Mirza, Bradley J Monk, Jørn Herrstedt, Amit M Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A Ledermann, Domenica Lorusso, Ignace Vergote, Noa E Ben-Baruch, Christian Marth, Radosław Mądry, René D Christensen, Jonathan S Berek, Anne Dørum, Anna V Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert, Bobbie J Rimel, Joseph Buscema, John P Balser, Shefali Agarwal, Ursula A Matulonis
Background Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. Methods In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2:1 ratio to receive niraparib (300 mg) or placebo once daily...
October 7, 2016: New England Journal of Medicine
Alexander M M Eggermont, Vanna Chiarion-Sileni, Jean-Jacques Grob, Reinhard Dummer, Jedd D Wolchok, Henrik Schmidt, Omid Hamid, Caroline Robert, Paolo A Ascierto, Jon M Richards, Céleste Lebbé, Virginia Ferraresi, Michael Smylie, Jeffrey S Weber, Michele Maio, Lars Bastholt, Laurent Mortier, Luc Thomas, Saad Tahir, Axel Hauschild, Jessica C Hassel, F Stephen Hodi, Corina Taitt, Veerle de Pril, Gaetan de Schaetzen, Stefan Suciu, Alessandro Testori
Background On the basis of data from a phase 2 trial that compared the checkpoint inhibitor ipilimumab at doses of 0.3 mg, 3 mg, and 10 mg per kilogram of body weight in patients with advanced melanoma, this phase 3 trial evaluated ipilimumab at a dose of 10 mg per kilogram in patients who had undergone complete resection of stage III melanoma. Methods After patients had undergone complete resection of stage III cutaneous melanoma, we randomly assigned them to receive ipilimumab at a dose of 10 mg per kilogram (475 patients) or placebo (476) every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred...
October 7, 2016: New England Journal of Medicine
Beatriz Parra, Jairo Lizarazo, Jorge A Jiménez-Arango, Andrés F Zea-Vera, Guillermo González-Manrique, José Vargas, Jorge A Angarita, Gonzalo Zuñiga, Reydmar Lopez-Gonzalez, Cindy L Beltran, Karen H Rizcala, Maria T Morales, Oscar Pacheco, Martha L Ospina, Anupama Kumar, David R Cornblath, Laura S Muñoz, Lyda Osorio, Paula Barreras, Carlos A Pardo
Background Zika virus (ZIKV) infection has been linked to the Guillain-Barré syndrome. From November 2015 through March 2016, clusters of cases of the Guillain-Barré syndrome were observed during the outbreak of ZIKV infection in Colombia. We characterized the clinical features of cases of Guillain-Barré syndrome in the context of this ZIKV infection outbreak and investigated their relationship with ZIKV infection. Methods A total of 68 patients with the Guillain-Barré syndrome at six Colombian hospitals were evaluated clinically, and virologic studies were completed for 42 of the patients...
October 5, 2016: New England Journal of Medicine
Anthony C Gordon, Gavin D Perkins, Mervyn Singer, Daniel F McAuley, Robert M L Orme, Shalini Santhakumaran, Alexina J Mason, Mary Cross, Farah Al-Beidh, Janis Best-Lane, David Brealey, Christopher L Nutt, James J McNamee, Henrik Reschreiter, Andrew Breen, Kathleen D Liu, Deborah Ashby
Background Levosimendan is a calcium-sensitizing drug with inotropic and other properties that may improve outcomes in patients with sepsis. Methods We conducted a double-blind, randomized clinical trial to investigate whether levosimendan reduces the severity of organ dysfunction in adults with sepsis. Patients were randomly assigned to receive a blinded infusion of levosimendan (at a dose of 0.05 to 0.2 μg per kilogram of body weight per minute) for 24 hours or placebo in addition to standard care. The primary outcome was the mean daily Sequential Organ Failure Assessment (SOFA) score in the intensive care unit up to day 28 (scores for each of five systems range from 0 to 4, with higher scores indicating more severe dysfunction; maximum score, 20)...
October 5, 2016: New England Journal of Medicine
Jennifer A Frontera, Ivan R F da Silva
No abstract text is available yet for this article.
October 5, 2016: New England Journal of Medicine
Eric L Simpson, Thomas Bieber, Emma Guttman-Yassky, Lisa A Beck, Andrew Blauvelt, Michael J Cork, Jonathan I Silverberg, Mette Deleuran, Yoko Kataoka, Jean-Philippe Lacour, Külli Kingo, Margitta Worm, Yves Poulin, Andreas Wollenberg, Yuhwen Soo, Neil M H Graham, Gianluca Pirozzi, Bolanle Akinlade, Heribert Staudinger, Vera Mastey, Laurent Eckert, Abhijit Gadkari, Neil Stahl, George D Yancopoulos, Marius Ardeleanu
Background Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. Methods In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo...
September 30, 2016: New England Journal of Medicine
Hillary Clinton
The editors invited the Democratic and Republican presidential nominees, Hillary Clinton and Donald Trump, to answer the following question for Journal readers: What specific changes in policy do you support to improve access to care, improve quality of care, and control health care costs for our..
September 28, 2016: New England Journal of Medicine
Sankar Swaminathan, Robert Schlaberg, Julia Lewis, Kimberly E Hanson, Marc R Couturier
To the Editor: Epidemic transmission of Zika virus (ZIKV) has rapidly occurred in the Americas, with most cases limited to mild or asymptomatic disease. To date, nine deaths from ZIKV infection that were unrelated to the Guillain–Barré syndrome have been confirmed in adults. Here, we report a..
September 28, 2016: New England Journal of Medicine
Molly Frean, Jonathan Gruber, Benjamin D Sommers
Since the passage of the Affordable Care Act (ACA), an estimated 20 million Americans have gained health insurance, and the country’s uninsured rate has dropped from 16% to 9% since 2010. In the upcoming presidential election, the ACA’s future is again at stake. Understanding how the law has..
September 21, 2016: New England Journal of Medicine
Clifford J Rosen, Julie R Ingelfinger
No abstract text is available yet for this article.
September 18, 2016: New England Journal of Medicine
Felicia Cosman, Daria B Crittenden, Jonathan D Adachi, Neil Binkley, Edward Czerwinski, Serge Ferrari, Lorenz C Hofbauer, Edith Lau, E Michael Lewiecki, Akimitsu Miyauchi, Cristiano A F Zerbini, Cassandra E Milmont, Li Chen, Judy Maddox, Paul D Meisner, Cesar Libanati, Andreas Grauer
Background Romosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. Methods We enrolled 7180 postmenopausal women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months...
September 18, 2016: New England Journal of Medicine
Deborah A Zarin, Tony Tse, Rebecca J Williams, Sarah Carr
Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) expanded the legal mandate for sponsors and others responsible for certain clinical trials of FDA-regulated drug, biologic, and device products to register their studies and report summary results information to..
September 16, 2016: New England Journal of Medicine
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