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Michele Maio, Arnaud Scherpereel, Luana Calabrò, Joachim Aerts, Susana Cedres Perez, Alessandra Bearz, Kristiaan Nackaerts, Dean A Fennell, Dariusz Kowalski, Anne S Tsao, Paul Taylor, Federica Grosso, Scott J Antonia, Anna K Nowak, Maria Taboada, Martina Puglisi, Paul K Stockman, Hedy L Kindler
BACKGROUND: New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma. METHODS: DETERMINE was a double-blind, placebo-controlled, phase 2b trial done at 105 study centres across 19 countries in patients with unresectable pleural or peritoneal malignant mesothelioma who had progressed after one or two previous systemic treatments for advanced disease...
July 17, 2017: Lancet Oncology
#2
Georgina V Long, Victoria Atkinson, Jonathan S Cebon, Michael B Jameson, Bernie M Fitzharris, Catriona M McNeil, Andrew G Hill, Antoni Ribas, Michael B Atkins, John A Thompson, Wen-Jen Hwu, F Stephen Hodi, Alexander M Menzies, Alexander D Guminski, Richard Kefford, Benjamin Y Kong, Babak Tamjid, Archana Srivastava, Anna J Lomax, Mohammed Islam, Xinxin Shu, Scot Ebbinghaus, Nageatte Ibrahim, Matteo S Carlino
BACKGROUND: Reduced-dose nivolumab in combination with standard-dose ipilimumab improves objective response and progression-free survival compared with standard-dose ipilimumab alone, but increases toxicity. We assessed the safety and anti-tumour activity of standard-dose pembrolizumab in combination with reduced-dose ipilimumab. METHODS: In this open-label, phase 1b trial, we recruited patients from 12 medical centres in Australia, New Zealand, and the USA. Eligible patients were aged at least 18 years, had advanced melanoma, had an Eastern Coooperative Oncology Group performance status of 0 or 1, had measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1...
July 17, 2017: Lancet Oncology
#3
John K Chan, Wei Deng, Robert V Higgins, Krishnansu S Tewari, Albert J Bonebrake, Michael Hicks, Stephanie Gaillard, Pedro T Ramirez, Weldon Chafe, Bradley J Monk, Carol Aghajanian
BACKGROUND: Brivanib is an oral, tyrosine kinase inhibitor against vascular endothelial growth factor (VEGF) and fibroblast growth factor receptor (FGFR). We studied its efficacy and tolerability in persistent or recurrent cervical cancer patients. METHODS: Eligible patients had at least one prior cytotoxic regimen for recurrence and with measurable disease. Brivanib 800mg was administered orally every day (1cycle=28days) until disease progression or prohibitive toxicity...
July 17, 2017: Gynecologic Oncology
#4
Rodolfo Passalacqua, Silvia Lazzarelli, Maddalena Donini, Rodolfo Montironi, Rosa Tambaro, Ugo De Giorgi, Sandro Pignata, Raffaella Palumbo, Giovanni Luca Ceresoli, Gianluca Del Conte, Giuseppe Tonini, Franco Morelli, Franco Nolè, Stefano Panni, Ermanno Rondini, Annalisa Guida, Paolo Andrea Zucali, Laura Doni, Elisa Iezzi, Caterina Caminiti
BACKGROUND: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice...
July 19, 2017: BMC Cancer
#5
REVIEW
Giovanni B Frisoni, Marina Boccardi, Frederik Barkhof, Kaj Blennow, Stefano Cappa, Konstantinos Chiotis, Jean-Francois Démonet, Valentina Garibotto, Panteleimon Giannakopoulos, Anton Gietl, Oskar Hansson, Karl Herholz, Clifford R Jack, Flavio Nobili, Agneta Nordberg, Heather M Snyder, Mara Ten Kate, Andrea Varrone, Emiliano Albanese, Stefanie Becker, Patrick Bossuyt, Maria C Carrillo, Chiara Cerami, Bruno Dubois, Valentina Gallo, Ezio Giacobini, Gabriel Gold, Samia Hurst, Anders Lönneborg, Karl-Olof Lovblad, Niklas Mattsson, José-Luis Molinuevo, Andreas U Monsch, Urs Mosimann, Alessandro Padovani, Agnese Picco, Corinna Porteri, Osman Ratib, Laure Saint-Aubert, Charles Scerri, Philip Scheltens, Jonathan M Schott, Ida Sonni, Stefan Teipel, Paolo Vineis, Pieter Jelle Visser, Yutaka Yasui, Bengt Winblad
The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care...
August 2017: Lancet Neurology
#6
REVIEW
Kelly Y Kim, Quynh-Thu Le, Sue S Yom, Raymond H W Ng, K C Allen Chan, Scott V Bratman, John J Welch, Rao L Divi, Raymond A Petryshyn, Barbara A Conley
Epstein-Barr virus (EBV) DNA analysis has been shown to be useful for early detection, prognostication, and monitoring of treatment response of nasopharyngeal carcinoma (NPC), and the recent literature provides growing evidence of the clinical utility of EBV DNA testing, particularly to inform treatment decisions for NPC patients. Despite the fact that NPC is a rare disease, the NRG Oncology cooperative group has successfully activated a phase 2/3 randomized clinical trial for NPC with international partners and in that process has discovered that the development of a harmonized EBV DNA test is absolutely critical for integration into clinical trials and for future deployment in clinical and central laboratories...
August 1, 2017: International Journal of Radiation Oncology, Biology, Physics
#7
Douglas W Arthur, Kathryn A Winter, Henry M Kuerer, Bruce G Haffty, Laurie W Cuttino, Dorin A Todor, Nicole L Simone, Shelly B Hayes, Wendy A Woodward, Beryl McCormick, Randi J Cohen, Walter M Sahijdak, Daniel J Canaday, Doris R Brown, Adam D Currey, Christine M Fisher, Reshma Jagsi, Julia White
PURPOSE: To determine the associated toxicity, tolerance, and safety of partial-breast reirradiation. METHODS AND MATERIALS: Eligibility criteria included in-breast recurrence occurring >1 year after whole-breast irradiation, <3 cm, unifocal, and resected with negative margins. Partial-breast reirradiation was targeted to the surgical cavity plus 1.5 cm; a prescription dose of 45 Gy in 1.5 Gy twice daily for 30 treatments was used. The primary objective was to evaluate the rate of grade ≥3 treatment-related skin, fibrosis, and/or breast pain adverse events (AEs), occurring ≤1 year from re-treatment completion...
August 1, 2017: International Journal of Radiation Oncology, Biology, Physics
#8
Sumanta K Pal, Anh Pham, Winston Vuong, Xueli Liu, Yulan Lin, Nora Ruel, Bertram E Yuh, Kevin Chan, Timothy Wilson, Seth P Lerner, David McConkey, Richard Jove, Wei Liang
BACKGROUND: Preclinical studies suggest that signal transducer and activator of transcription 3 (STAT3)-mediated recruitment of neutrophils to premetastatic tissue occurs prior to metastatic progression. OBJECTIVE: We sought to determine if neutrophilic infiltration in benign nodal tissue is associated with poor clinical outcome in patients with muscle-invasive bladder cancer. DESIGN, SETTING, AND PARTICIPANTS: Formalin-fixed, paraffin-embedded tissue was secured from 55 patients with muscle-invasive bladder cancer who had undergone cystectomy at our institution...
February 2017: European Urology Focus
#9
Bärbel Rudolph, Alexander Wünsch, Peter Herschbach, Andreas Dinkel
Fear of progression (FoP) is an appropriate, rational response to the real threat of cancer and its treatments. However, patients experiencing elevated, dysfunctional levels of FoP often feel severely distressed and are in need of treatment. We previously conducted a (partly-)randomized controlled study with cancer patients undergoing in-patient rehabilitation and showed that a brief, four-session cognitive-behavioral group therapy significantly reduced dysfunctional FoP. In this report, we describe the adaption of the cognitive-behavioral group therapy program for use with cancer out-patients...
June 29, 2017: Psychotherapie, Psychosomatik, Medizinische Psychologie
#10
Darius N Lakdawalla, Jason Shafrin, Ningqi Hou, Desi Peneva, Seanna Vine, Jinhee Park, Jie Zhang, Ron Brookmeyer, Robert A Figlin
OBJECTIVES: To measure the relationship between randomized controlled trial (RCT) efficacy and real-world effectiveness for oncology treatments as well as how this relationship varies depending on an RCT's use of surrogate versus overall survival (OS) endpoints. METHODS: We abstracted treatment efficacy measures from 21 phase III RCTs reporting OS and either progression-free survival or time to progression endpoints in breast, colorectal, lung, ovarian, and pancreatic cancers...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
#11
Shaimaa Lasheen, Kyrillus S Shohdy, Loay Kassem, Omar Abdel-Rahman
BACKGROUND: Cyclin-dependent kinase (CDK) inhibitors emerge as efficacious agents in hormone positive metastatic breast cancer with more acceptable toxicity profiles than cytotoxic chemotherapy. However, some adverse effects such as fatigue, alopecia and stomatitis, vastly concern patients. METHODS: The search was conducted in PubMed, American Society of Clinical Oncology meeting library, European Society for Medical Oncology meeting abstract, and the San Antonio meeting abstract databases...
July 12, 2017: Expert Review of Anticancer Therapy
#12
Edvina Galiè, Veronica Villani, Irene Terrenato, Andrea Pace
Many chemotherapy treatments induce peripheral neuropathy (CIPN). These patients often experience neuropathic pain (NP) that reduces the quality of life. The aim of this prospective, open label study was to evaluate the efficacy and tolerability of tapentadol (TP) in patients affected by CIPN. CIPN were consecutively enrolled in a prospective open label study at the Neuro-Oncology Unit of the Regina Elena National Cancer Institute in Rome. During the titration phase, each patient initially received doses of TP 50 mg twice a day...
July 11, 2017: Neurological Sciences
#13
Ian Krop, Nofisat Ismaila, Fabrice Andre, Robert C Bast, William Barlow, Deborah E Collyar, M Elizabeth Hammond, Nicole M Kuderer, Minetta C Liu, Robert G Mennel, Catherine Van Poznak, Antonio C Wolff, Vered Stearns
Purpose This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. Methods ASCO uses a signals approach to facilitate guideline updates. For this focused update, the publication of the phase III randomized MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) study to evaluate the MammaPrint assay in 6,693 women with early-stage breast cancer provided a signal. An expert panel reviewed the results of the MINDACT study along with other published literature on the MammaPrint assay to assess for evidence of clinical utility...
July 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
#14
Mohan Suntharalingam, Kathryn Winter, David Ilson, Adam P Dicker, Lisa Kachnic, André Konski, A Bapsi Chakravarthy, Christopher J Anker, Harish Thakrar, Naomi Horiba, Ajay Dubey, Joel S Greenberger, Adam Raben, Jeffrey Giguere, Kevin Roof, Gregory Videtic, Jondavid Pollock, Howard Safran, Christopher H Crane
Importance: The role of epidermal growth factor receptor (EGFR) inhibition in chemoradation strategies in the nonoperative treatment of patients with esophageal cancer remains uncertain. Objective: To evaluate the benefit of cetuximab added to concurrent chemoradiation therapy for patients undergoing nonoperative treatment of esophageal carcinoma. Design, Setting, and Participants: A National Cancer Institute (NCI) sponsored, multicenter, phase 3, randomized clinical trial open to patients with biopsy-proven carcinoma of the esophagus...
July 6, 2017: JAMA Oncology
#15
Sina Jasim, Vera J Suman, Camilo Jimenez, Pamela Harris, Kostandinos Sideras, Jill K Burton, Francis Paul Worden, Richard J Auchus, Keith C Bible
INTRODUCTION: Pheochromocytomas and paragangliomas (Pheo/PGL) are rare, vascular, sometimes malignant endocrine tumors. Case reports indicate the activity of vascular endothelium growth factor receptor-targeted kinase inhibitors in these cancers. OBJECTIVES: To assess the antitumor activity and tolerability of pazopanib in progressive malignant Pheo/PGL. PATIENTS AND METHODS: This multicenter Phase II trial (MC107C) enrolled individuals ≥18 years old with disease progression ≤ 6 months prior to registration, Eastern Cooperative Oncology Group PS 0-2, and measurable disease (response evaluation criteria in solid tumors 1...
August 2017: Endocrine
#16
Charles S Fuchs, Kei Muro, Jiri Tomasek, Eric Van Cutsem, Jae Yong Cho, Sang-Cheul Oh, Howard Safran, György Bodoky, Ian Chau, Yasuhiro Shimada, Salah-Eddin Al-Batran, Rodolfo Passalacqua, Atsushi Ohtsu, Michael Emig, David Ferry, Kumari Chandrawansa, Yanzhi Hsu, Andreas Sashegyi, Astra M Liepa, Hansjochen Wilke
PURPOSE: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. MATERIALS AND METHODS: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW)...
June 2017: Journal of Gastric Cancer
#17
F Gwadry-Sridhar, S Nikan, A Hamou, S J Seung, T Petrella, A M Joshua, S Ernst, N Mittmann
BACKGROUND: The use and detailed costs of services provided for people with advanced melanoma (amel) are not well known. We conducted an analysis to determine the use of health care services and the associated costs delineated by relevant attributable costs, which we defined for subjects in the province of Ontario. METHODS: Through the Ontario Cancer Data Linkage Project, a cohort of amel patients with diagnoses between 31 August 2005 and 2012 (follow-up to 2013) and with valid International Classification of Diseases (9th revision, Clinical Modification) 172 codes and histology codes was identified...
June 2017: Current Oncology
#18
Jonas Doerner, Myriam Hauger, Tilman Hickethier, Jonathan Byrtus, Christian Wybranski, Nils Große Hokamp, David Maintz, Stefan Haneder
OBJECTIVES: To evaluate image quality parameters of virtual mono-energetic (MonoE) and conventional (CR) imaging derived from a dual-layer spectral detector CT (DLCT) in oncological follow-up venous phase imaging of the chest and comparison with conventional multi-detector CT (CRMDCT) imaging. MATERIALS AND METHODS: A total of 55 patients who had oncologic staging with conventional CT and DLCT of the chest in venous phase were included in this study. Established image quality parameters were derived from all datasets in defined thoracic landmarks...
August 2017: European Journal of Radiology
#19
Susanne Singer, Helge Danker, Julia Roick, Jens Einenkel, Susanne Briest, Henning Spieker, Andreas Dietz, Isabell Hoffmann, Kirsten Papsdorf, Jürgen Meixensberger, Joachim Mössner, Franziska Schiefke, Anja Dietel, Hubert Wirtz, Dietger Niederwieser, Thomas Berg, Anette Kersting
BACKGROUND: Emotional distress in cancer patients often goes unnoticed in daily routine; therefore distress screening is now recommended in many national guidelines. However, screening alone does not necessarily translate into better well-being. We examined whether stepped psycho-oncological care improves referral to consultation-liaison (CL) services and improves well-being. METHODS: In a cluster-randomised trial, wards were randomly allocated to stepped vs. standard care...
June 30, 2017: Psycho-oncology
#20
David C Norris
Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent 'confirmatory' Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational drug. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of 'the' maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived of, not as 'dose-finding', but as dosing algorithm-finding...
2017: F1000Research
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