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https://www.readbyqxmd.com/read/28345368/sponsors-and-investigative-staffs-perceptions-of-the-current-investigational-new-drug-safety-reporting-process-in-oncology-trials
#1
Raymond Perez, Patrick Archdeacon, Nancy Roach, Robert Goodwin, Jonathan Jarow, Nina Stuccio, Annemarie Forrest
BACKGROUND/AIMS: The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes...
March 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28344933/precision-medicine-the-golden-gate-for-detection-treatment-and-prevention-of-alzheimer-s-disease
#2
H Hampel, S E O'Bryant, J I Castrillo, C Ritchie, K Rojkova, K Broich, N Benda, R Nisticò, R A Frank, B Dubois, V Escott-Price, S Lista
During this decade, breakthrough conceptual shifts have commenced to emerge in the field of Alzheimer's disease (AD) recognizing risk factors and the non-linear dynamic continuum of complex pathophysiologies amongst a wide dimensional spectrum of multi-factorial brain proteinopathies/neurodegenerative diseases. As is the case in most fields of medicine, substantial advancements in detecting, treating and preventing AD will likely evolve from the generation and implementation of a systematic precision medicine strategy...
December 2016: Journal of Prevention of Alzheimer's Disease
https://www.readbyqxmd.com/read/28325248/bridging-innovation-and-outreach-to-overcome-global-gaps-in-radiation-oncology-through-information-and-communication-tools-trainee-advancement-engaging-industry-attention-to-ethical-challenges-and-political-advocacy
#3
REVIEW
Luqman Dad, Trevor J Royce, Zachary Morris, Meena Moran, Todd Pawlicki, Deepak Khuntia, Patricia Hardenbergh, Bernard Cummings, Nina Mayr, Kenneth Hu
An evolving paradigm in global outreach in radiation oncology has been the implementation of a more region-specific, needs-based approach to help close the gap in radiation services to low- and middle-income countries through the use of innovative tools in information and communication technology. This report highlights 4 information and communication technology tools in action today: (1) the NCCN Framework for Resource Stratification of NCCN guidelines, (2) ASTRO e-Contouring, (3) i.treatsafely.org, and (4) ChartRounds...
April 2017: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/28325246/challenges-and-prospects-for-providing-radiation-oncology-services-in-africa
#4
REVIEW
Onyinye Balogun, Danielle Rodin, Wilfred Ngwa, Surbhi Grover, John Longo
There are considerable challenges to meeting the demands of the impending cancer crisis in Africa. These include a rising incidence of cancer and cancer-related deaths, equipment and maintenance costs, and deficits in human resources and training. Addressing these issues would be crucial to tackling the increasing burden of cancer on the continent. Innovations in technology and collaborative efforts within the global oncology community have created promising solutions for establishing quality cancer care in Africa and eradicating the massive disparities that currently exist...
April 2017: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/28325244/perspectives-on-patient-access-to-radiation-oncology-services-in-south-america
#5
REVIEW
Beatriz Amendola, Aldo Quarneti, Arthur Accioly Rosa, Gustavo Sarria, Marco Amendola
Cancer represents a fast-growing challenge worldwide, and is being recognized as an emerging and critical issue in low- and middle-income countries, such most of South America. This subcontinent is unique for its geography, culture, and ethnical diversity. Most of its countries have large expanses of jungle and desert where underserved population groups including indigenous (native Indians), represent a challenge for cancer care. Many indigent patients have no access to preventive care nor early diagnosis. This results in late presentations with advanced disease and frequently incurable cancer...
April 2017: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/28325240/cancer-care-access-and-outcomes-for-american-indian-populations-in-the-united-states-challenges-and-models-for-progress
#6
REVIEW
B Ashleigh Guadagnolo, Daniel G Petereit, C Norman Coleman
Low socioeconomic and health care access realities of being American Indian/Alaskan Native (AI/AN) in the United States combined with decades of data documenting poor cancer outcomes for this population provide a population nested within the United States that is analogous to the cancer care landscape of low- and middle-income countries internationally. We reviewed the medical literature with respect to cancer prevention, access to cancer treatment, and access to effective supportive and palliative care for AI/AN populations in the United States...
April 2017: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/28325238/radiation-oncology-quality-and-safety-considerations-in-low-resource-settings-a-medical-physics-perspective
#7
REVIEW
Jacob Van Dyk, Ahmed Meghzifene
The past few years have seen a significant growth of interest in the global radiation therapy (RT) crisis. Various organizations have quantified the need and are providing aid in support of addressing the shortfalls existing in many low-to-middle income countries. With the tremendous demand for new facilities, equipment, and personnel, it is very important to recognize the quality and safety challenges and to address them directly. An examination of publications on quality and safety in RT indicates a consistency in a number of the recommendations; however, these authoritative reports were generally based on input from high-resourced contexts...
April 2017: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/28325237/global-health-in-radiation-oncology-the-emergence-of-a-new-career-pathway
#8
REVIEW
Danielle Rodin, Mei Ling Yap, Surbhi Grover, John M Longo, Onyinye Balogun, Sandra Turner, Jesper G Eriksen, C Norman Coleman, Meredith Giuliani
The massive global shortfall in radiotherapy equipment and human resources in developing countries is an enormous challenge for international efforts in cancer control. This lack of access to treatment has been long-standing, but there is now a growing consensus about the urgent need to prioritize solutions to this problem and that a global strategy is required for them to be successful. An essential element of making radiotherapy universally accessible is a coordinated approach to clinical training and practice...
April 2017: Seminars in Radiation Oncology
https://www.readbyqxmd.com/read/28304402/prospective-longitudinal-study-on-quality-of-life-in-relapsed-refractory-multiple-myeloma-patients-receiving-second-or-third-line-lenalidomide-or-bortezomib-treatment
#9
X Leleu, C Kyriakou, I Vande Broek, P Murphy, P Bacon, P Lewis, H Gilet, B Arnould, M T Petrucci
Treatment advances for multiple myeloma (MM) that have prolonged survival emphasise the importance of measuring patients' health-related quality of life (HRQoL) in clinical studies. HRQoL/functioning and symptoms of patients with relapsed/refractory MM (RRMM) receiving second- or third-line lenalidomide or bortezomib treatment were measured in a prospective European multicentre, observational study at different time points. At baseline, patients in the lenalidomide cohort were frailer than in the bortezomib cohort with more rapid disease progression at study entry (more patients with Eastern Cooperative Oncology Group performance status >2, shorter time from diagnosis, more chronic heart failure, higher serum creatinine levels, more patients with dialysis required)...
March 17, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/28303380/nutritional-and-functional-factors-as-prognostic-of-surgical-cancer-patients
#10
Jéssica Härter, Silvana Paiva Orlandi, Maria Cristina Gonzalez
PURPOSE: We evaluated phase angle, sarcopenia, and handgrip strength as prognostic factors of postoperative morbimortality in patients with cancer. METHODOLOGY: We conducted a prospective study with 60 oncology patients admitted for elective surgery between November 2015 and May 2016. We calculated the standardized phase angle (SPA) and the skeletal mass index of the subjects based on their bioelectrical impedance tests. Handgrip strength (HGS) was measured using a hydraulic dynamometer...
March 16, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28293794/do-all-patients-in-the-phase-i-oncology-trials-need-to-be-hospitalized-domestic-but-outstanding-issues-for-globalization-of-drug-development-in-japan
#11
Akihiko Shimomura, Shunsuke Kondo, Noriko Kobayashi, Satoru Iwasa, Shigehisa Kitano, Kenji Tamura, Yutaka Fujiwara, Noboru Yamamoto
INTRODUCTION: Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. PATIENTS AND METHODS: Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment...
March 14, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28286989/a-precision-medicine-initiative-for-alzheimer-s-disease-the-road-ahead-to-biomarker-guided-integrative-disease-modeling
#12
REVIEW
H Hampel, S E O'Bryant, S Durrleman, E Younesi, K Rojkova, V Escott-Price, J-C Corvol, K Broich, B Dubois, S Lista
After intense scientific exploration and more than a decade of failed trials, Alzheimer's disease (AD) remains a fatal global epidemic. A traditional research and drug development paradigm continues to target heterogeneous late-stage clinically phenotyped patients with single 'magic bullet' drugs. Here, we propose that it is time for a paradigm shift towards the implementation of precision medicine (PM) for enhanced risk screening, detection, treatment, and prevention of AD. The overarching structure of how PM for AD can be achieved will be provided through the convergence of breakthrough technological advances, including big data science, systems biology, genomic sequencing, blood-based biomarkers, integrated disease modeling and P4 medicine...
April 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28285980/activities-function-and-health-related-quality-of-life-hrqol-of-older-adults-with-cancer
#13
Mackenzi Pergolotti, Allison M Deal, Grant R Williams, Ashley L Bryant, Jeannette T Bensen, Hyman B Muss, Bryce B Reeve
OBJECTIVE: This study aims to (1) describe the activities, function, and health-related quality of life (HRQOL) of a large sample of older adults (age ≥65) with cancer, (2) identify the associations with demographics, cancer type, comorbid conditions, and ability to participate in activities and functional status. MATERIALS AND METHODS: The Health Registry/Cancer Survivorship Cohort is an institutional database designed to aid cancer survivorship research. The registry includes three measures of patient-reported HRQOL: FACT-G and PROMIS® Global measures for physical and mental health...
March 9, 2017: Journal of Geriatric Oncology
https://www.readbyqxmd.com/read/28279063/symposium-oncology-leadership-in-asia
#14
Dong-Young Noh, Jae Kyung Roh, Yeul Hong Kim, Kazuhiro Yoshida, Hideo Baba, Marie Cherry Lynn Samson-Fernando, Sanjeev Misra, Zeba Aziz, Rainy Umbas, Yogendra P Singh, Tony Shu Kam Mok, Han-Kwang Yang, Hideyuki Akaza
The Symposium on "Oncology Leadership in Asia" was held as part of the official program of the 42nd Annual Meeting of the Korean Cancer Association. Given the increasing incidence of cancer in all countries and regions of Asia, regardless of developmental stage, and also in light of the recognized need for Asian countries to enhance collaboration in cancer prevention, research, treatment and follow-up, the symposium was held with the aim of bringing together oncology specialists from eight countries and regions in Asia to present the status in their own national context and discuss the key challenges and requirements in order to establish a greater Asian presence in the area of cancer control and research...
March 9, 2017: Cancer Research and Treatment: Official Journal of Korean Cancer Association
https://www.readbyqxmd.com/read/28277261/building-a-palliative-radiation-oncology-program-from-bedside-to-b-e-d
#15
Mark J Stavas, Jonathan D Pagan, Sumeeta Varma, Benjamin Li, Lisa A Kachnic
A growing body of evidence supports the integration of palliative care with standard cancer treatments. In these situations, patients often experience a better quality of life, better quality of care, decreased cost, and, in some cases, improved survival with the addition of palliative care services to traditional treatment pathways. In this manuscript, we explore the integration of radiation oncology at palliative care. First, we discuss the impetus for change at Vanderbilt University and the inception of Vanderbilt's inpatient Palliative Radiation Oncology Service at Vanderbilt...
September 13, 2016: Practical Radiation Oncology
https://www.readbyqxmd.com/read/28270931/design-and-methods-of-the-pan-canadian-applying-biomarkers-to-minimize-long-term-effects-of-childhood-adolescent-cancer-treatment-able-nephrotoxicity-study-a-prospective-observational-cohort-study
#16
Kelly R McMahon, Shahrad Rod Rassekh, Kirk R Schultz, Maury Pinsk, Tom Blydt-Hansen, Cherry Mammen, Ross T Tsuyuki, Prasad Devarajan, Geoff D E Cuvelier, Lesley G Mitchell, Sylvain Baruchel, Ana Palijan, Bruce C Carleton, Colin J D Ross, Michael Zappitelli
BACKGROUND: Childhood cancer survivors experience adverse drug events leading to lifelong health issues. The Applying Biomarkers to Minimize Long-Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) team was established to validate and apply biomarkers of cancer treatment effects, with a goal of identifying children at high risk of developing cancer treatment complications associated with thrombosis, graft-versus-host disease, hearing loss, and kidney damage. Cisplatin is a chemotherapy well known to cause acute and chronic nephrotoxicity...
2017: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/28267243/overall-survival-of-1st-line-axitinib-in-metastatic-renal-cell-carcinoma-japanese-subgroup-analysis-from-phase-ii-study
#17
Mototsugu Oya, Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Tomonori Habuchi, Brian I Rini, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, Angel H Bair, Hirotsugu Uemura
Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and updated safety in 44 Japanese patients and compared with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored using a Cox proportional hazard model in all patients...
March 7, 2017: Cancer Science
https://www.readbyqxmd.com/read/28266259/-burden-and-rehabilitation-goals-of-families-in-pediatric-oncological-rehabilitation
#18
Laura Inhestern, Volker Beierlein, Konstantin A Krauth, Thomas Schulte, Dieter Berger, Uwe Koch, Corinna Bergelt
Burden and Rehabilitation Goals of Families in Pediatric-oncological Rehabilitation Survival rates of childhood cancer patients increased during the past years up to 80 %. Therefore, pediatric oncological rehabilitation is essential for reintegrating children with cancer into normal life. We performed an analysis of the current state in pediatric oncological rehabilitation with regards to the impairments of the participants and results in rehabilitation. Descriptive and content analyses of 422 medical discharge summaries were conducted...
March 2017: Praxis der Kinderpsychologie und Kinderpsychiatrie
https://www.readbyqxmd.com/read/28263047/mapping-the-connectome-in-awake-surgery-for-gliomas-an-update
#19
Hugues Duffau
The traditional principle underlying oncological neurosurgery is to remove a tumor mass displacing the brain in order to increase survival. Recently, advances in connectomics enabled an improved understanding of cerebral processing, and led to a paradigmatic shift in tumor surgery based upon interactions between neurooncology and cognitive neurosciences. First, glioma is not a focal tumor invaginated within the parenchyma but a diffuse neoplastic disease migrating in the brain. This concept resulted in a new surgical ideology, i...
March 6, 2017: Journal of Neurosurgical Sciences
https://www.readbyqxmd.com/read/28247266/rucaparib-first-global-approval
#20
Yahiya Y Syed
Rucaparib (Rubraca™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by Clovis Oncology, Inc. (Boulder, CO, USA) for the treatment of solid tumours. It has been approved in the USA as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. A marketing authorization application for rucaparib for the same indication has been submitted to the European Medicines Agency...
March 1, 2017: Drugs
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