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https://www.readbyqxmd.com/read/29306512/erratum-to-checkmate-025-randomized-phase-3-study-outcomes-by-key-baseline-factors-and-prior-therapy-for-nivolumab-versus-everolimus-in-advanced-renal-cell-carcinoma-eur-urol-2017-72-962-71
#1
Bernard Escudier, Padmanee Sharma, David F McDermott, Saby George, Hans J Hammers, Sandhya Srinivas, Scott S Tykodi, Jeffrey A Sosman, Giuseppe Procopio, Elizabeth R Plimack, Daniel Castellano, Howard Gurney, Frede Donskov, Katriina Peltola, John Wagstaff, Thomas C Gauler, Takeshi Ueda, Huanyu Zhao, Ian M Waxman, Robert J Motzer
No abstract text is available yet for this article.
January 3, 2018: European Urology
https://www.readbyqxmd.com/read/29239191/-advances-in-immunotherapy-of-malignant-melanoma
#2
I Krajsová
Development of immunotherapy has dramatically changed poor prognosis of metastatic malignant melanoma (MM). Inhibition of immune checkpoints represents a new effective treatment. Monoclonal antibodies against CTLA-4 ipilimumab and against PD-1 (programme death 1) nivolumab and pembrolizumab prolong progression free survival and overall survival (OS) in patients with advanced metastatic MM. Both achieved significant improvement in relapse-free survival and OS also in adjuvant setting. It looks like the efficacy of the combined immunotherapy of ipilimumab with anti-PD-1 antibodies is superior to the monotherapy, but combined therapy is accompanied by higher toxicity...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29223605/updated-european-association-of-urology-guidelines-recommendations-for-the-treatment-of-first-line-metastatic-clear-cell-renal-cancer
#3
REVIEW
Thomas Powles, Laurence Albiges, Michael Staehler, Karim Bensalah, Saeed Dabestani, Rachel H Giles, Fabian Hofmann, Milan Hora, Markus A Kuczyk, Thomas B Lam, Lorenzo Marconi, Axel S Merseburger, Sergio Fernández-Pello, Rana Tahbaz, Alessandro Volpe, Börje Ljungberg, Axel Bex
The randomised phase III clinical trial Checkmate-214 showed a survival superiority for the combination of ipilimumab and nivolumab when compared with the previous standard of care in first-line metastatic/advanced clear cell renal cell carcinoma (RCC) (Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. LBA5, ESMO 2017, 2017)...
December 6, 2017: European Urology
https://www.readbyqxmd.com/read/29207684/recurrent-glioma-clinical-trial-checkmate-143-the-game-is-not-over-yet
#4
REVIEW
Anna C Filley, Mario Henriquez, Mahua Dey
Glioblastoma (GBM) is the most common, and aggressive, primary brain tumor in adults. With a median patient survival of less than two years, GBM represents one of the biggest therapeutic challenges of the modern era. Even with the best available treatment, recurrence rates are nearly 100% and therapeutic options at the time of relapse are extremely limited. Nivolumab, an anti-programmed cell death-1 (PD-1) monoclonal antibody, has provided significant clinical benefits in the treatment of various advanced cancers and represented a promising therapy for primary and recurrent GBM...
October 31, 2017: Oncotarget
https://www.readbyqxmd.com/read/29145036/liver-immunotolerance-and-hepatocellular-carcinoma-patho-physiological-mechanisms-and-therapeutic-perspectives
#5
REVIEW
Gaël S Roth, Thomas Decaens
At the moment of the diagnosis of hepatocellular carcinoma (HCC), 70% of patients have only access to palliative treatments, with very few therapeutic options. Liver immunology is very specific, and liver immunotolerance is particularly developed because of the constant and massive influx of antigens. Deregulation of hepatic immunotolerance is implicated in chronic liver diseases development and particularly in liver carcinogenesis. For these reasons, HCC may be an excellent candidate for anticancer immunotherapies such as immune checkpoint inhibitors targeting CTLA-4 and PD-L1/PD-1...
November 13, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29139554/immune-checkpoint-inhibitors-new-strategies-to-checkmate-cancer
#6
REVIEW
Ruairi A M Wilson, T R Jeffry Evans, Alasdair R Fraser, Robert J B Nibbs
Immune checkpoint inhibitors (ICIs) targeting Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) or Programmed cell Death protein 1 (PD-1) receptors have demonstrated remarkable efficacy in subsets of patients with malignant disease. This emerging treatment modality holds great promise for future cancer treatment and has engaged pharmaceutical research interests in tumour immunology. While ICIs can induce rapid and durable responses in some patients, identifying predictive factors for effective clinical responses has proven challenging...
November 15, 2017: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/29130342/nivolumab-in-recurrent-metastatic-head-and-neck-cancers
#7
Andy Karabajakian, Thibaut Reverdy, Max Gau, Jérôme Fayette
Head and neck cancer is an immunosuppressive disease, with a high proportion expressing PD-L1. Until recently, options were lacking in second line. Prognosis is poor especially for patients who progress during chemotherapy with survival often inferior to 6 months. Nivolumab is the only anti-PD1 agent to prolong survival in the second-line setting and is now the standard option since the CheckMate-141 trial. Treatment is generally well tolerated, patients seem to have a better quality of life when compared with chemotherapy...
November 13, 2017: Future Oncology
https://www.readbyqxmd.com/read/29129758/impact-of-nivolumab-versus-docetaxel-on-health-related-quality-of-life-and-symptoms-in-patients-with-advanced-squamous-non-small-cell-lung-cancer-results-from-the-checkmate-017-study
#8
Martin Reck, Fiona Taylor, John R Penrod, Michael DeRosa, Laura Morrissey, Homa Dastani, Lucinda Orsini, Richard J Gralla
INTRODUCTION: In the phase III CheckMate 017 study, nivolumab prolonged overall survival versus docetaxel in previously treated patients with advanced squamous non-small cell lung cancer (NSCLC). Study objectives included health-related quality of life (HRQoL) and symptom assessments. METHODS: Patients serially completed Lung Cancer Symptom Scale (LCSS) and European Quality of Life Five Dimensions (EQ-5D) questionnaires. The LCSS average symptom burden index (ASBI; mean score for six lung cancer-specific symptoms; range, 0-100), LCSS 3-item global index, EQ-5D utility index, and EQ-5D visual analog scale scores were analyzed...
November 9, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/29126314/cost-effectiveness-analysis-of-nivolumab-for-treatment-of-platinum-resistant-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck
#9
Kathryn R Tringale, Kate T Carroll, Kaveh Zakeri, Assuntina G Sacco, Linda Barnachea, James D Murphy
Background: The CheckMate 141 trial found that nivolumab improved survival for patients with recurrent or metastatic head and neck cancer (HNC). Despite the improved survival, nivolumab is much more expensive than standard therapies. This study assesses the cost-effectiveness of nivolumab for the treatment of HNC. Methods: We constructed a Markov model to simulate treatment with nivolumab or standard single-agent therapy for patients with recurrent or metastatic platinum-refractory HNC...
November 3, 2017: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/29106665/nivolumab-with-or-without-ipilimumab-in-patients-with-recurrent-glioblastoma-results-from-exploratory-phase-1-cohorts-of-checkmate-143
#10
Antonio Omuro, Gordana Vlahovic, Michael Lim, Solmaz Sahebjam, Joachim Baehring, Timothy Cloughesy, Alfredo Voloschin, Shakti H Ramkissoon, Keith L Ligon, Robert Latek, Ricardo Zwirtes, Lewis Strauss, Prashni Paliwal, Christopher T Harbison, David A Reardon, John H Sampsonc
Background: Immunotherapies have demonstrated efficacy across a diverse set of tumors supporting further evaluation in glioblastoma. The objective of this study was to evaluate the safety/tolerability and describe immune-mediated effects of nivolumab ± ipilimumab in patients with recurrent glioblastoma. Exploratory efficacy outcomes are also reported. Methods: Patients were randomized to receive nivolumab 3 mg/kg every 2 weeks (Q2W; NIVO3) or nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks (Q3W) for 4 doses, then nivolumab 3 mg/kg Q2W (NIVO1+IPI3)...
October 28, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/29103751/cost-effectiveness-of-nivolumab-for-recurrent-or-metastatic-head-and-neck-cancer%C3%A2
#11
Matthew C Ward, Chirag Shah, David J Adelstein, Jessica L Geiger, Jacob A Miller, Shlomo A Koyfman, Mendel E Singer
OBJECTIVE: Nivolumab is the first drug to demonstrate a survival benefit for platinum-refractory recurrent or metastatic head and neck cancer. We performed a cost-utility analysis to assess the economic value of nivolumab as compared to alternative standard agents in this context. MATERIALS AND METHODS: Using data from the CheckMate 141 trial, we constructed a Markov simulation model from the US payer's perspective to evaluate the cost-effectiveness of nivolumab compared to physician choice of either cetuximab, methotrexate or docetaxel...
November 2017: Oral Oncology
https://www.readbyqxmd.com/read/29023213/nivolumab-versus-docetaxel-in-previously-treated-patients-with-advanced-non-small-cell-lung-cancer-two-year-outcomes-from-two-randomized-open-label-phase-iii-trials-checkmate-017-and-checkmate-057
#12
RANDOMIZED CONTROLLED TRIAL
Leora Horn, David R Spigel, Everett E Vokes, Esther Holgado, Neal Ready, Martin Steins, Elena Poddubskaya, Hossein Borghaei, Enriqueta Felip, Luis Paz-Ares, Adam Pluzanski, Karen L Reckamp, Marco A Burgio, Martin Kohlhäeufl, David Waterhouse, Fabrice Barlesi, Scott Antonia, Oscar Arrieta, Jérôme Fayette, Lucio Crinò, Naiyer Rizvi, Martin Reck, Matthew D Hellmann, William J Geese, Ang Li, Anne Blackwood-Chirchir, Diane Healey, Julie Brahmer, Wilfried E E Eberhardt
Purpose Nivolumab, a programmed death-1 inhibitor, prolonged overall survival compared with docetaxel in two independent phase III studies in previously treated patients with advanced squamous (CheckMate 017; ClinicalTrials.gov identifier: NCT01642004) or nonsquamous (CheckMate 057; ClinicalTrials.gov identifier: NCT01673867) non-small-cell lung cancer (NSCLC). We report updated results, including a pooled analysis of the two studies. Methods Patients with stage IIIB/IV squamous (N = 272) or nonsquamous (N = 582) NSCLC and disease progression during or after prior platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks)...
December 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29021380/cost-effectiveness-of-nivolumab-in-recurrent-metastatic-head-and-neck-squamous-cell-carcinoma
#13
Mahdi Zargar, Thomas McFarlane, Kelvin K W Chan, William W L Wong
BACKGROUND: Treatment options for patients with platinum-refractory, recurrent, metastatic head and neck squamous cell carcinoma (r/m HNSCC) are limited and prognosis is poor. The recent CheckMate 141 clinical trial demonstrated that nivolumab, an anti-programmed cell death protein 1 monoclonal antibody, was efficacious in extending the median overall survival (OS) in this patient population compared with standard therapies. We conducted a cost-effectiveness analysis to determine whether nivolumab is a cost-effective treatment in this patient population and examined various subgroups to determine for which, if any, the treatment is more cost-effective...
October 11, 2017: Oncologist
https://www.readbyqxmd.com/read/28939066/a-randomized-open-label-phase-iii-clinical-trial-of-nivolumab-vs-therapy-of-investigator-s-choice-in-recurrent-squamous-cell-carcinoma-of-the-head-and-neck-a-subanalysis-of-asian-patients-versus-the-global-population-in-checkmate-141
#14
Naomi Kiyota, Yasuhisa Hasegawa, Shunji Takahashi, Tomoya Yokota, Chia-Jui Yen, Shigemichi Iwae, Yasushi Shimizu, Ruey-Long Hong, Masahiro Goto, Jin-Hyoung Kang, Wing Sum Kenneth Li, Robert L Ferris, Maura Gillison, Yoshinobu Namba, Manish Monga, Mark Lynch, Makoto Tahara
OBJECTIVES: To assess efficacy and safety of nivolumab versus investigator's choice of therapy (IC) in Asian patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). MATERIALS AND METHODS: Thirty-four patients from Japan, Taiwan, Hong Kong, and Korea received nivolumab 3mg/kg (n=23) every 2weeks or IC (n=11), as part of a global trial (n=361), until intolerable toxicity or disease progression. The primary endpoint was overall survival (OS)...
October 2017: Oral Oncology
https://www.readbyqxmd.com/read/28917031/the-effect-of-propensity-to-trust-and-perceptions-of-trustworthiness-on-trust-behaviors-in-dyads
#15
Gene M Alarcon, Joseph B Lyons, James C Christensen, Samantha L Klosterman, Margaret A Bowers, Tyler J Ryan, Sarah A Jessup, Kevin T Wynne
Research on trust has burgeoned in the last few decades. Despite the growing interest in trust, little is known about trusting behaviors in non-dichotomous trust games. The current study explored propensity to trust, trustworthiness, and trust behaviors in a new computer-mediated trust relevant task. We used multivariate multilevel survival analysis (MMSA) to analyze behaviors across time. Results indicated propensity to trust did not influence trust behaviors. However, trustworthiness perceptions influenced initial trust behaviors and trust behaviors influenced subsequent trustworthiness perceptions...
September 15, 2017: Behavior Research Methods
https://www.readbyqxmd.com/read/28894827/the-genetic-landscape-of-programmed-death-ligand-1-pd-l1-alterations-in-head-and-neck-cancer
#16
Thomas E Heineman, Adam Widman, Edward C Kuan, Maie St John
OBJECTIVES: Nivolumab has recently been shown in the phase III clinical trial CheckMate-141 to have superior survival rates compared to the current standard of care chemotherapy for recurrent or metastatic platinum-resistant head and neck squamous cell carcinoma (HNSCC). Nivolumab targets the immune inhibitory receptor programmed cell death 1 (PD-1). Programmed cell death ligand 1 (PD-L1) genomics have been poorly characterized in the context of HNSCC, including expression levels of PD-L1 in individual tumors as well as related up or down-regulated genes that might function as co-targets...
June 2017: Laryngoscope Investigative Otolaryngology
https://www.readbyqxmd.com/read/28891423/adjuvant-nivolumab-versus-ipilimumab-in-resected-stage-iii-or-iv-melanoma
#17
RANDOMIZED CONTROLLED TRIAL
Jeffrey Weber, Mario Mandala, Michele Del Vecchio, Helen J Gogas, Ana M Arance, C Lance Cowey, Stéphane Dalle, Michael Schenker, Vanna Chiarion-Sileni, Ivan Marquez-Rodas, Jean-Jacques Grob, Marcus O Butler, Mark R Middleton, Michele Maio, Victoria Atkinson, Paola Queirolo, Rene Gonzalez, Ragini R Kudchadkar, Michael Smylie, Nicolas Meyer, Laurent Mortier, Michael B Atkins, Georgina V Long, Shailender Bhatia, Celeste Lebbé, Piotr Rutkowski, Kenji Yokota, Naoya Yamazaki, Tae M Kim, Veerle de Pril, Javier Sabater, Anila Qureshi, James Larkin, Paolo A Ascierto
BACKGROUND: Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that were higher than those with placebo in a phase 3 trial. We wanted to determine the efficacy of nivolumab versus ipilimumab for adjuvant therapy in patients with resected advanced melanoma. METHODS: In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients (≥15 years of age) who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients)...
November 9, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28889792/overall-survival-with-combined-nivolumab-and-ipilimumab-in-advanced-melanoma
#18
RANDOMIZED CONTROLLED TRIAL
Jedd D Wolchok, Vanna Chiarion-Sileni, Rene Gonzalez, Piotr Rutkowski, Jean-Jacques Grob, C Lance Cowey, Christopher D Lao, John Wagstaff, Dirk Schadendorf, Pier F Ferrucci, Michael Smylie, Reinhard Dummer, Andrew Hill, David Hogg, John Haanen, Matteo S Carlino, Oliver Bechter, Michele Maio, Ivan Marquez-Rodas, Massimo Guidoboni, Grant McArthur, Celeste Lebbé, Paolo A Ascierto, Georgina V Long, Jonathan Cebon, Jeffrey Sosman, Michael A Postow, Margaret K Callahan, Dana Walker, Linda Rollin, Rafia Bhore, F Stephen Hodi, James Larkin
BACKGROUND: Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma. We now report 3-year overall survival outcomes in this trial. METHODS: We randomly assigned, in a 1:1:1 ratio, patients with previously untreated advanced melanoma to receive nivolumab at a dose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of 3 mg per kilogram every 2 weeks; nivolumab at a dose of 3 mg per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses plus placebo, until progression, the occurrence of unacceptable toxic effects, or withdrawal of consent...
October 5, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28866758/modelling-the-survival-outcomes-of-immuno-oncology-drugs-in-economic-evaluations-a-systematic-approach-to-data-analysis-and-extrapolation
#19
Eddie Gibson, Ian Koblbauer, Najida Begum, George Dranitsaris, Danny Liew, Phil McEwan, Amir Abbas Tahami Monfared, Yong Yuan, Ariadna Juarez-Garcia, David Tyas, Michael Lees
BACKGROUND: New immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival. OBJECTIVES: Using a systematic approach to data management and analysis, the study assessed the applicability of traditional and flexible approaches and, as a test case of flexible methods, investigated the suitability of restricted cubic splines (RCS) to model progression-free survival (PFS) in I-O therapy...
September 2, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28807351/cost-effectiveness-of-nivolumab-in-advanced-renal-cell-carcinoma
#20
Michal Sarfaty, Moshe Leshno, Noa Gordon, Assaf Moore, Victoria Neiman, Eli Rosenbaum, Daniel A Goldstein
BACKGROUND: In recent years, new drugs have been introduced for second-line treatment of advanced renal cell carcinoma (RCC). Nivolumab increases overall survival and is associated with less toxicity compared to everolimus in this setting according to the CheckMate 025 study. However, because of the high cost of nivolumab, there is a need to define its value by considering both efficacy and cost. OBJECTIVE: To estimate the cost effectiveness of nivolumab for second-line treatment of advanced RCC from the US payer perspective...
August 11, 2017: European Urology
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