Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
Robert J. Motzer,Bernard Escudier,David F. McDermott,Saby George,Hans J. Hammers,Sandhya Srinivas,Scott S. Tykodi,Jeffrey A. Sosman,Giuseppe Procopio,Elizabeth R. Plimack,Daniel Castellano,Toni K. Choueiri,Howard Gurney,Frede Donskov,Petri Bono,John Wagstaff,Thomas Gauler,Takeshi Ueda,Yoshihiko Tomita,Fabio A.B. Schutz,Christian Kollmannsberger,James Larkin,Alain Ravaud,Jason S. Simon,Li-an Xu,Ian M. Waxman,Padmanee Sharma +26 more
TLDR
Overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus among patients with previously treated advanced renal-cell carcinoma.Abstract:
BackgroundNivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment. MethodsA total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily. The primary end point was overall survival. The secondary end points included the objective response rate and safety. ResultsThe median overall survival was 25.0 months (95% confidence interval [CI], 21.8 to not estimable) with nivolumab and 19.6 months (95% CI, 17.6 to 23.1) with everolimus. The haz...read more
Citations
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Inflammatory CNS disease caused by immune checkpoint inhibitors: status and perspectives
TL;DR: The mechanisms of action of ICIs are introduced and their adverse effects on the CNS are reviewed, highlighting the importance of early detection of these neurotoxic effects, which should be distinguished from brain metastasis.
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FDG-PET response and outcome from anti-PD-1 therapy in metastatic melanoma.
Aaron C. Tan,Aaron C. Tan,Louise Emmett,Louise Emmett,Louise Emmett,Serigne Lo,Victor Liu,Rony Kapoor,Rony Kapoor,Matteo S. Carlino,Matteo S. Carlino,Alexander Guminski,Alexander Guminski,Alexander Guminski,Georgina V. Long,Georgina V. Long,Georgina V. Long,Alexander M. Menzies,Alexander M. Menzies,Alexander M. Menzies +19 more
TL;DR: PET may have utility in predicting long-term benefit and help guide discontinuation of therapy after anti-PD-1 treatment, and almost all patients with CMR at 1 year have ongoing response to therapy thereafter.
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Anti-angiogenic agents - overcoming tumour endothelial cell anergy and improving immunotherapy outcomes.
Zowi R. Huinen,Elisabeth J. M. Huijbers,Judy R. van Beijnum,Patrycja Nowak-Sliwinska,Arjan W. Griffioen +4 more
TL;DR: In this article, the authors describe how angiogenesis-induced endothelial immune cell barrier hampers antitumour immunity and the role of endothelial cell anergy as the vascular counterpart of immune checkpoints, and provide an update on the current clinical successes achieved when these agents are combined with immune checkpoint inhibitors.
Journal ArticleDOI
Infections associated with immunotherapeutic and molecular targeted agents in hematology and oncology. A position paper by the European Conference on Infections in Leukemia (ECIL).
Georg Maschmeyer,Julien De Greef,Sibylle C. Mellinghoff,Annamaria Nosari,Anne Thiebaut-Bertrand,Anne Bergeron,Tomás Franquet,Nicole M. A. Blijlevens,Johan Maertens +8 more
TL;DR: Hematologists, infectious disease specialists, stem cell transplant experts, pulmonologists and radiologists have met to provide a critical state-of-the-art on infectious complications associated with immunotherapeutic and molecular targeted agents used in clinical routine.
Journal ArticleDOI
Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study.
Ronan Flippot,C. Dalban,Brigitte Laguerre,Delphine Borchiellini,Gwenaelle Gravis,Sylvie Negrier,Christine Chevreau,Florence Joly,Lionnel Geoffrois,Sylvain Ladoire,Hakim Mahammedi,Frederic Rolland,Marine Gross-Goupil,Elise Deluche,Frank Priou,Mathieu Laramas,Philippe Barthélémy,Bérengère Narciso,Nadine Houede,Stéphane Culine,Stéphane Oudard,Marina Chenot,Florence Tantot,Sylvie Chabaud,Bernard Escudier,Laurence Albiges +25 more
TL;DR: Nivolumab activity is limited in patients with untreated brain metastases from ccRCC, and brain imaging and focal therapy should be considered before immune checkpoint inhibitors in patients who failed vascular endothelial growth factor-directed therapies.
References
More filters
Journal ArticleDOI
Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012.
Jacques Ferlay,Isabelle Soerjomataram,Rajesh Dikshit,Sultan Eser,Colin Mathers,Marise Souto Rebelo,Donald Maxwell Parkin,David Forman,Freddie Bray +8 more
TL;DR: The GLOBOCAN series of the International Agency for Research on Cancer (IARC) as mentioned in this paper provides estimates of the worldwide incidence and mortality from 27 major cancers and for all cancers combined for 2012.
Journal ArticleDOI
New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
Elizabeth Eisenhauer,P. Therasse,Jan Bogaerts,Lawrence H. Schwartz,Daniel J. Sargent,Robert Ford,Janet Dancey,S. Arbuck,S. Gwyther,Margaret M. Mooney,Larry Rubinstein,Lalitha K. Shankar,Lori E. Dodd,Robert M. Kaplan,Denis Lacombe,Jaap Verweij +15 more
TL;DR: The revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions, and a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included.
Journal ArticleDOI
Categorical Data Analysis
TL;DR: In this article, categorical data analysis was used for categorical classification of categorical categorical datasets.Categorical Data Analysis, categorical Data analysis, CDA, CPDA, CDSA
Journal ArticleDOI
Safety, activity, and immune correlates of anti-PD-1 antibody in cancer.
Suzanne L. Topalian,F. Stephen Hodi,Julie R. Brahmer,Scott N. Gettinger,David Smith,David F. McDermott,John D. Powderly,Richard D. Carvajal,Jeffrey A. Sosman,Michael B. Atkins,Philip D. Leming,David R. Spigel,Scott J. Antonia,Leora Horn,Charles G. Drake,Drew M. Pardoll,Lieping Chen,William H. Sharfman,Robert A. Anders,Janis M. Taube,Tracee L. McMiller,Haiying Xu,Alan J. Korman,Maria Jure-Kunkel,Shruti Agrawal,Dan McDonald,Georgia Kollia,Ashok Kumar Gupta,Jon M. Wigginton,Mario Sznol +29 more
TL;DR: Anti-PD-1 antibody produced objective responses in approximately one in four to one in five patients with non-small-cell lung cancer, melanoma, or renal-cell cancer; the adverse-event profile does not appear to preclude its use.
Journal ArticleDOI
Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer
Julie R. Brahmer,Karen L. Reckamp,Paul Baas,Lucio Crinò,Wilfried Eberhardt,Elena Poddubskaya,Scott J. Antonia,Adam Pluzanski,Everett E. Vokes,Esther Holgado,David M. Waterhouse,Neal Ready,Justin F. Gainor,Osvaldo Arén Frontera,Libor Havel,Martin Steins,Marina Chiara Garassino,Joachim G.J.V. Aerts,Manuel Domine,Luis Paz-Ares,Martin Reck,Christine Baudelet,Christopher T. Harbison,Brian Lestini,David R. Spigel +24 more
TL;DR: Among patients with advanced, previously treated squamous-cell NSCLC, overall survival, response rate, and progression-free survival were significantly better with nivolumab than with docetaxel, regardless of PD-L1 expression level.
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