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Padmanee Sharma, Margaret K Callahan, Petri Bono, Joseph Kim, Pavlina Spiliopoulou, Emiliano Calvo, Rathi N Pillai, Patrick A Ott, Filippo de Braud, Michael Morse, Dung T Le, Dirk Jaeger, Emily Chan, Chris Harbison, Chen-Sheng Lin, Marina Tschaika, Alex Azrilevich, Jonathan E Rosenberg
BACKGROUND: Few effective treatments exist for patients with advanced urothelial carcinoma that has progressed after platinum-based chemotherapy. We assessed the activity and safety of nivolumab in patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after previous platinum-based chemotherapy. METHODS: In this phase 1/2, multicentre, open-label study, we enrolled patients (age ≥18 years) with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra at 16 sites in Finland, Germany, Spain, the UK, and the USA...
October 7, 2016: Lancet Oncology
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
Richard J Gralla, David Spigel, Bryan Bennett, Fiona Taylor, John R Penrod, Michael Derosa, Homa Dastani, Lucinda Orsini, Clarissa Mathias, Martin Reck
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
Hossein Borghaei, Julie Brahmer, Leora Horn, Neal Ready, Martin Steins, Enriqueta Felip, Luis Paz-Ares, Xx Xx, Fabrice Barlesi, Scott Antonia, Jérome Fayette, Naiyer Rizvi, Lucio Crino, Martin Reck, Wilfried Ernst Erich Eberhardt, Matthew Hellmann, Kaushal Desai, Ang Li, Diane Healey, David Spigel, Clarissa Mathias
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
David Waterhouse, Leora Horn, Craig Reynolds, David Spigel, Jason Chandler, Tarek Mekhail, Mohamed Mohamed, Ben Creelan, Kenneth B Blankstein, Petros Nikolinakos, Michael J Mccleod, Ang Li, Ian M Waxman, Nivedita Aanur, Shruti Agrawal, Eduardo Richardet
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
Richard J Gralla, David Spigel, Bryan Bennett, Fiona Taylor, John R Penrod, Michael Derosa, Homa Dastani, Lucinda Orsini, Clarissa Mathias, Martin Reck
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
Artin Assadi, Vahideh Sharifi Najafabadi, Seyed Ataollah Sadat Shandiz, Azadah Shayeq Boroujeni, Sepehr Ashrafi, Ali Zaman Vaziri, Seyedeh Masoumeh Ghoreishi, Mohammad Reza Aghasadeghi, Seyed Esmaeil Sadat Ebrahimi, Morteza Pirali-Hamedani, Mehdi Shafiee Ardestani
Evaluating the efficacy of anticancer drugs is an evolving and research-oriented issue. The objective of this study was to reduce the insolubility of chlorambucil (CBL) in water and improve the anticancer activity of CBL in vitro and in vivo through the conjugation of CBL with anionic linear-globular dendrimer (second generation, G2). In the current study, the anticancer activity among three groups that include CBL, CBL-G2 dendrimer, and control was measured in vitro and in vivo. In vitro studies showed that G2 anionic linear-globular polyethylene-glycol-based dendrimer, which conjugated to the CBL exterior through an ester linkage, was able to significantly improve the treatment efficacy over clinical CBL alone with respect to proliferation assay, 2,3-bis-(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide; half maximal inhibitory concentration (IC50) was calculated to be 141 µg/mL for CBL alone and 27...
2016: OncoTargets and Therapy
Raffaella Mormile
No abstract text is available yet for this article.
2016: Iranian Journal of Pharmaceutical Research: IJPR
F Stephen Hodi, Jason Chesney, Anna C Pavlick, Caroline Robert, Kenneth F Grossmann, David F McDermott, Gerald P Linette, Nicolas Meyer, Jeffrey K Giguere, Sanjiv S Agarwala, Montaser Shaheen, Marc S Ernstoff, David R Minor, April K Salama, Matthew H Taylor, Patrick A Ott, Christine Horak, Paul Gagnier, Joel Jiang, Jedd D Wolchok, Michael A Postow
BACKGROUND: Results from phase 2 and 3 trials in patients with advanced melanoma have shown significant improvements in the proportion of patients achieving an objective response and prolonged progression-free survival with the combination of nivolumab (an anti-PD-1 antibody) plus ipilimumab (an anti-CTLA-4 antibody) compared with ipilimumab alone. We report 2-year overall survival data from a randomised controlled trial assessing this treatment in previously untreated advanced melanoma...
September 9, 2016: Lancet Oncology
Sebastiano Buti, Alessandro Leonetti, Alice Dallatomasina, Melissa Bersanelli
INTRODUCTION: Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, and its pathogenesis is strictly related to altered cellular response to hypoxia, in which mTOR signaling pathway is implicated. Everolimus, an mTOR serine/threonine kinase inhibitor, represents a therapeutic option for the treatment of advanced RCC. AIM: The objective of this article is to review the evidence for the treatment of metastatic RCC with everolimus. EVIDENCE REVIEW: Everolimus was approved for second- and third-line therapy in patients with advanced RCC according to the results of a Phase III pivotal trial that demonstrated a benefit in median progression-free survival of ~2 months compared to placebo after failure of previous lines of therapy, of which at least one was an anti-VEGFR tyrosine kinase inhibitor (TKI)...
2016: Core Evidence
Mark J Selby, John J Engelhardt, Robert J Johnston, Li-Sheng Lu, Minhua Han, Kent Thudium, Dapeng Yao, Michael Quigley, Jose Valle, Changyu Wang, Bing Chen, Pina M Cardarelli, Diann Blanset, Alan J Korman
The monoclonal antibodies ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) have shown remarkable antitumor activity in an increasing number of cancers. When combined, ipilimumab and nivolumab have demonstrated superior activity in patients with metastatic melanoma (CHECKMATE-067). Here we describe the preclinical development strategy that predicted these clinical results. Synergistic antitumor activity in mouse MC38 and CT26 colorectal tumor models was observed with concurrent, but not sequential CTLA-4 and PD-1 blockade...
2016: PloS One
Paolo A Ascierto, Vito Vanella, Antonio Maria Grimaldi, Festino Lucia, Marco Palla, Ester Simeone, Nicola Mozzillo
The anti-PD-1 agent, nivolumab, has been approved both as monotherapy and in combination with ipilimumab for the treatment of unresectable or metastatic melanoma in the USA and European Union. Here we present the case of a patient with treatment-naive, metastatic mucosal melanoma and baseline LDH approximately seven times the upper limit of normal. The patient was enrolled in a clinical trial (CheckMate 066) and achieved a partial response, followed by a durable complete response with nivolumab treatment. The patient's LDH levels were documented in each cycle and dropped markedly within 2 months, when partial response to treatment was already evident...
September 7, 2016: Cancer Immunology, Immunotherapy: CII
Guillermo de Velasco, Diana Miao, Martin H Voss, A Ari Hakimi, James J Hsieh, Nizar M Tannir, Pheroze Tamboli, Leonard J Appleman, W Kimryn Rathmell, Eliezer M Van Allen, Toni K Choueiri
Patients with metastatic renal cell carcinoma (mRCC) have better overall survival when treated with nivolumab, a cancer immunotherapy that targets the immune checkpoint inhibitor programmed cell death 1 (PD-1), rather than everolimus (a chemical inhibitor of mTOR and immunosuppressant). Poor-risk mRCC patients treated with nivolumab seemed to experience the greatest overall survival benefit, compared with patients with favorable or intermediate risk, in an analysis of the CheckMate-025 trial subgroup of the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk groups...
October 2016: Cancer Immunology Research
Giulia Zago, Mirte Muller, Michel van den Heuvel, Paul Baas
Non-small-cell lung cancer (NSCLC) is often diagnosed at an advanced stage of disease, where it is no longer amenable to curative treatment. During the last decades, the survival has only improved significantly for lung cancer patients who have tumors harboring a driver mutation. Therefore, there is a clear unmet need for effective therapies for patients with no mutation. Immunotherapy has emerged as an effective treatment for different cancer types. Nivolumab, a monoclonal inhibitory antibody against PD-1 receptor, can prolong survival of NSCLC patients, with a manageable toxicity profile...
2016: Biologics: Targets & Therapy
Mark A Perazella
Immune checkpoint inhibitors are a class of drugs that utilizes immunotherapy to target various cancers. Included are the anti-CTLA-4 and anti-PD-1 receptor antibodies. By reprogramming the immune system, these agents provide a therapy that destroys cancer cells. However, this approach runs the risk of allowing pathologic autoimmunity and organ injury to develop. Unsurprisingly, immune-related adverse effects are described including pneumonitis, colitis, and various endocrinopathies. Now added to this list is AKI, primarily due to ATIN...
September 2016: Kidney International
Sara I Pai, Dan P Zandberg, Scott E Strome
We review the current clinical knowledge surrounding one of the most promising immune checkpoint pathways currently investigated in head and neck squamous cell carcinoma patients, programmed cell death-1 (PD-1) and its ligands (PD-L1 and PD-L2). We review ongoing clinical trials and associated clinical responses observed with targeting the receptor, PD-1, and its ligand, PD-L1. A recent phase III clinical trial (Checkmate 141) demonstrated an improved overall survival in head and neck cancer patients treated with anti-PD-1 monotherapy as compared to standard of care for recurrent and/or metastatic disease, which raises questions on how best to incorporate immunotherapy in the context of standard of care...
October 2016: Oral Oncology
G V Long, V Atkinson, P A Ascierto, C Robert, J C Hassel, P Rutkowski, K J Savage, F Taylor, C Coon, I Gilloteau, H B Dastani, I M Waxman, A P Abernethy
BACKGROUND: Nivolumab has shown significant survival benefit and a favorable safety profile compared with dacarbazine chemotherapy among treatment-naïve patients with metastatic melanoma in the CheckMate 066 phase III study. Results from the health-related quality of life (HRQoL) analyses from CheckMate 066 are presented. PATIENTS AND METHODS: HRQoL was evaluated at baseline and every 6 weeks while on treatment using the European Organisation for Research and Treatment of Care (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire (EQ-5D)...
October 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Scott Gettinger, Naiyer A Rizvi, Laura Q Chow, Hossein Borghaei, Julie Brahmer, Neal Ready, David E Gerber, Frances A Shepherd, Scott Antonia, Jonathan W Goldman, Rosalyn A Juergens, Scott A Laurie, Faith E Nathan, Yun Shen, Christopher T Harbison, Matthew D Hellmann
PURPOSE: Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, has demonstrated improved survival over docetaxel in previously treated advanced non-small-cell lung cancer (NSCLC). First-line monotherapy with nivolumab for advanced NSCLC was evaluated in the phase I, multicohort, Checkmate 012 trial. METHODS: Fifty-two patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity; postprogression treatment was permitted per protocol...
September 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Naiyer A Rizvi, Matthew D Hellmann, Julie R Brahmer, Rosalyn A Juergens, Hossein Borghaei, Scott Gettinger, Laura Q Chow, David E Gerber, Scott A Laurie, Jonathan W Goldman, Frances A Shepherd, Allen C Chen, Yun Shen, Faith E Nathan, Christopher T Harbison, Scott Antonia
PURPOSE: Nivolumab, a fully human immunoglobulin G4 programmed death-1 immune checkpoint inhibitor antibody, has demonstrated improved survival in previously treated patients with advanced non-small-cell lung cancer (NSCLC). CheckMate 012, a phase I, multicohort study, was conducted to explore the safety and efficacy of nivolumab as monotherapy or combined with current standard therapies in first-line advanced NSCLC. Here, we report results for nivolumab plus platinum-based doublet chemotherapy (PT-DC)...
September 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Christoph-A J VON Klot, Axel S Merseburger, Markus A Kuczyk
Metastatic renal cell carcinoma (mRCC) has gained a variety of therapeutic options since the introduction of targeted therapy, starting in 2007. The basic molecular mechanisms included predominantly the targeting of vascular endothelial growth factor or the inhibition of the mammalian target of rapamycin. Recently, results from two randomized controlled trials, the CheckMate-25 and the METEOR trial, regarding therapy for RCC in the second-line setting have been published. In the present review, the current status of second-line therapy in mRCC is discussed, together with results from the two newly introduced substances, nivolumab and cabozantinib...
June 2016: Molecular and Clinical Oncology
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