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https://www.readbyqxmd.com/read/29031035/-controversy-in-the-postoperative-treatment-of-low-grade-gliomas
#1
T Kazda, R Lakomý, A Poprach, P Pospíšil, R Jančálek, P Šlampa
BACKGROUND: The optimal treatment for low-grade gliomas remains controversial. Neurosurgery, radiotherapy, and chemotherapy are the main treatment options. Despite advances in oncology, there are still a lot of uncertainties, and the optimal sequences, combinations, and timings of these procedures have not yet been optimized. It is still unclear whether temozolomide can replace effective, but toxic PCV chemotherapy (procarbazine, lomustine, vincristine) and whether temozolomide can be used upfront alone instead of radiotherapy alone...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29024738/new-hybrid-mini-laparoendoscopic-single-site-mi-less-partial-nephrectomy-with-early-unclamped-technique-for-renal-tumors-with-intermediate-padua-score-ideal-phase-2a
#2
Christopher Springer, Felix Kawan, Roberto La Rocca, Nasreldin Mohammed, Paolo Fornara, Vincenzo Mirone, Francesco Greco
OBJECTIVE: To evaluate a new hybrid technique which we defined mini-laparoendoscopic single-site partial nephrectomy (MILESS-PN) for renal masses presenting an intermediate PADUA score. MATERIAL AND METHODS: Forty consecutive cases of MILESS-PN performed between April 2013 and November 2015 were included in this study. MILESS consisted in the simultaneous use of two 3 mm pararectal trocars and an umbilical SILS trocar; the sequence of steps of MILESS-PN was comparable to standard laparoscopic partial nephrectomy...
October 9, 2017: Urology
https://www.readbyqxmd.com/read/29020279/cost-drivers-of-a-hospital-acquired-bacterial-pneumonia-and-ventilator-associated-bacterial-pneumonia-habp-vabp-phase-three-clinical-trial
#3
Stella Stergiopoulos, Sara B Calvert, Carrie A Brown, Josephine Awatin, Pamela Tenaerts, Thomas L Holland, Joseph A DiMasi, Kenneth A Getz
Background: Studies indicate that the prevalence of multi-drug resistant infections, including hospital acquired and ventilator associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their complex protocol designs and the difficulty in recruiting and retaining patients. Methodology: With input from clinicians, representatives from industry, and the Food and Drug Administriation (FDA), we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs, (2) to identify opportunities to lower these costs, and (3) to compare (1) and (2) to endocrine and oncology clinical trials...
August 17, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29016887/phase-i-ii-trial-of-vorinostat-combined-with-temozolomide-and-radiation-therapy-for-newly-diagnosed-glioblastoma-final-results-of-alliance-n0874-abtc-02
#4
Evanthia Galanis, S Keith Anderson, C Ryan Miller, Jann N Sarkaria, Kurt Jaeckle, Jan C Buckner, Keith L Ligon, Karla V Ballman, Dennis F Moore, Michael Nebozhyn, Andrey Loboda, David Schiff, Manmeet Singh Ahluwalia, Eudocia Q Lee, Elizabeth R Gerstner, Glenn J Lesser, Michael Prados, Stuart A Grossman, Jane Cerhan, Caterina Giannini, Patrick Y Wen
Background: Vorinostat, a histone deacetylase inhibitor, has shown radiosensitizing properties in preclinical studies. This open-label, single-arm trial evaluated the maximum tolerated dose (MTD; phase I) and efficacy (phase II) of vorinostat combined with standard chemoradiation in newly diagnosed glioblastoma. Methods: Patients received oral vorinostat (300 or 400 mg/day) on days 1-5 weekly during temozolomide chemoradiation. Following a 4- to 6-week rest, patients received up to 12 cycles of standard adjuvant temozolomide and vorinostat (400 mg/day) on days 1-7 and 15-21 of each 28-day cycle...
August 22, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/29016837/multicenter-pilot-study-of-radio-chemotherapy-as-first-line-treatment-for-adults-with-medulloblastoma-noa-07
#5
Dagmar Dagmar, Martin Proescholdt, Christiane Reinert, Torsten Pietsch, David T W Jones, Stefan M Pfister, Elke Hattingen, Clemens Seidel, Linda Dirven, Ralf Luerding, Jaap Reijneveld, Monika Warmuth-Metz, Matteo Bonsanto, Michael Bremer, Stephanie Combs, Stefan Rieken, Ulrich Herrlinger, Holger Kuntze, Regine Mayer-Steinacker, Dag Moskopp, Thomas Schneider, Andreas Beringer, Uwe Schlegel, Walter Stummer, Helmut Welker, Astrid Weyerbrock, Frank Paulsen, Stefan Rutkowski, Michael Weller, Wolfgang Wick, Rolf-Dieter Kortmann, Ulrich Bogdahn, Peter Hau
Background: Medulloblastoma in adult patients is rare, with 0.6 cases per million. Prognosis depends on clinical factors and medulloblastoma entity. No prospective data on the feasibility of radio-chemotherapy exist. The German Neuro-Oncology Working Group (NOA) performed a prospective descriptive multicenter single-arm Phase II trial to evaluate feasibility and toxicity of radio-polychemotherapy. Methods: The NOA-07 trial combined cranio-spinal irradiation with vincristine, followed by eight cycles of cisplatin, lomustine and vincristine...
August 21, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/29016225/asco-value-framework-highlights-the-relative-value-of-treatment-options-in-ovarian-cancer
#6
Jonathan Foote, Angeles Alvarez Secord, Margaret Liang, David E Cohn, Elizabeth Jewell, Laura J Havrilesky
PURPOSE: The ASCO value framework allows physicians and patients to compare the relative value of novel treatments. Our aim was to assess the value of three frontline ovarian cancer therapies by using this framework. METHODS: From phase III, randomized controlled clinical trial (RCT) data, the net health benefits (NHBs) for three frontline ovarian cancer treatment options-dose-dense paclitaxel (Japanese Gynecologic Oncology Group study JGOG 3016), intraperitoneal (IP)/intravenous (IV) chemotherapy (Gynecologic Oncology Group [GOG] study GOG 172), and concurrent plus maintenance bevacizumab (GOG 218 and the Seventh International Collaborative Ovarian Neoplasm study [ICON7])-were calculated...
October 10, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28994108/value-of-a-molecular-screening-program-to-support-clinical-trial-enrollment-in-asian-cancer-patients-the-integrated-molecular-analysis-of-cancer-imac-study
#7
Valerie Heong, Nicholas L Syn, Xiao Wen Lee, Nur Sabrina Sapari, Xue Qing Koh, Zul Fazreen Adam Isa, Joey Sy Lim, Diana Lim, Brendan Pang, Yee Liang Thian, Lai Kuan Ng, Andrea L Wong, Ross Andrew Soo, Wei Peng Yong, Cheng Ean Chee, Soo-Chin Lee, Boon-Cher Goh, Richie Soong, David S P Tan
The value of precision oncology initiatives in Asian contexts remains unresolved. Here we review the institutional implementation of prospective molecular screening to facilitate accrual of patients into biomarker-driven clinical trials, and to explore the mutational landscape of advanced tumors occurring in a prospective cohort of Asian patients (n = 396) with diverse cancer types. Next-generation sequencing (NGS) and routine clinicopathological assays such as immunohistochemistry, copy number analysis, and in situ hybridization tests were performed on tumor samples...
October 9, 2017: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/28993052/nivolumab-in-patients-with-advanced-gastric-or-gastro-oesophageal-junction-cancer-refractory-to-or-intolerant-of-at-least-two-previous-chemotherapy-regimens-ono-4538-12-attraction-2-a-randomised-double-blind-placebo-controlled-phase-3-trial
#8
Yoon-Koo Kang, Narikazu Boku, Taroh Satoh, Min-Hee Ryu, Yee Chao, Ken Kato, Hyun Cheol Chung, Jen-Shi Chen, Kei Muro, Won Ki Kang, Kun-Huei Yeh, Takaki Yoshikawa, Sang Cheul Oh, Li-Yuan Bai, Takao Tamura, Keun-Wook Lee, Yasuo Hamamoto, Jong Gwang Kim, Keisho Chin, Do-Youn Oh, Keiko Minashi, Jae Yong Cho, Masahiro Tsuda, Li-Tzong Chen
BACKGROUND: Patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, two or more previous regimens of chemotherapy have a poor prognosis, and current guidelines do not recommend any specific treatments for these patients. We assessed the efficacy and safety of nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 (PD-1), in patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens...
October 5, 2017: Lancet
https://www.readbyqxmd.com/read/28988170/effectiveness-of-the-hucare-quality-improvement-strategy-on-health-related-quality-of-life-in-patients-with-cancer-study-protocol-of-a-stepped-wedge-cluster-randomised-controlled-trial-hucare2-study
#9
Caterina Caminiti, Elisa Iezzi, Rodolfo Passalacqua
INTRODUCTION: Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient's health-related quality of life (HRQoL). METHODS AND ANALYSIS: Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters of five centres each, in three equally spaced time epochs...
October 6, 2017: BMJ Open
https://www.readbyqxmd.com/read/28984517/intermediate-risk-meningioma-initial-outcomes-from-nrg-oncology-rtog-0539
#10
Leland Rogers, Peixin Zhang, Michael A Vogelbaum, Arie Perry, Lynn S Ashby, Jignesh M Modi, Anthony M Alleman, James Galvin, David Brachman, Joseph M Jenrette, John De Groot, Joseph A Bovi, Maria Werner-Wasik, Jonathan P S Knisely, Minesh P Mehta
OBJECTIVE This is the first clinical outcomes report of NRG Oncology RTOG 0539, detailing the primary endpoint, 3-year progression-free survival (PFS), compared with a predefined historical control for intermediate-risk meningioma, and secondarily evaluating overall survival (OS), local failure, and prospectively scored adverse events (AEs). METHODS NRG Oncology RTOG 0539 was a Phase II clinical trial allocating meningioma patients to 1 of 3 prognostic groups and management strategies according to WHO grade, recurrence status, and resection extent...
October 6, 2017: Journal of Neurosurgery
https://www.readbyqxmd.com/read/28983557/role-of-deficient-dna-mismatch-repair-status-in-patients-with-stage-iii-colon-cancer-treated-with-folfox-adjuvant-chemotherapy-a-pooled-analysis-from-2-randomized-clinical-trials
#11
Aziz Zaanan, Qian Shi, Julien Taieb, Steven R Alberts, Jeffrey P Meyers, Thomas C Smyrk, Catherine Julie, Ayman Zawadi, Josep Tabernero, Enrico Mini, Richard M Goldberg, Gunnar Folprecht, Jean Luc Van Laethem, Karine Le Malicot, Daniel J Sargent, Pierre Laurent-Puig, Frank A Sinicrope
Importance: The prognostic impact of DNA mismatch repair (MMR) status in stage III colon cancer patients receiving FOLFOX (folinic acid, fluorouracil, and oxaliplatin) adjuvant chemotherapy remains controversial. Objective: To determine the association of MMR status with disease-free survival (DFS) in patients with stage III colon cancer treated with FOLFOX. Design, Setting, and Participants: The evaluated biomarkers for MMR status were determined from prospectively collected tumor blocks from patients treated with FOLFOX in 2 open-label, phase 3 randomized clinical trials: NCCTG N0147 and PETACC8...
October 5, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28976610/anxiety-during-cancer-diagnosis-examining-the-influence-of-monitoring-coping-style-and-treatment-plan
#12
Madelon B Bronner, Minh Hao Nguyen, Ellen M A Smets, Anthony W H van de Ven, Julia C M van Weert
OBJECTIVE: Studies on anxiety within oncology show a high prevalence of anxiety both during and after the course of the disease. However, little is known about factors that influence the level of anxiety in the diagnostic phase. This study examines the presence of anxiety during diagnosis and treatment planning and explores how a monitoring (i.e., information-seeking) coping style and the suggested treatment plan (i.e., with or without chemotherapy) interact with anxiety. METHODS: Anxiety scores (STAI-6) were collected from 81 colorectal cancer patients before and after their visit to the outpatient Gastro-Intestinal Oncological Center Amsterdam (GIOCA)...
October 4, 2017: Psycho-oncology
https://www.readbyqxmd.com/read/28976446/the-pharmacological-costs-of-second-line-treatments-for-recurrent-ovarian-cancer
#13
Jacopo Giuliani, Andrea Bonetti
INTRODUCTION: In ovarian cancer, it is uncertain which chemotherapy regimen is more clinically effective and cost-effective for the treatment of recurrence; therefore, it might be interesting to make a balance between the cost of the drugs administered and the difference in progression-free survival (PFS) and overall survival (OS). METHODS: The present evaluation was restricted to pivotal phase 3 randomized controlled trials. We calculated the pharmacological costs necessary to get the benefit in PFS and OS...
October 3, 2017: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/28966137/a-2-in-1-adaptive-phase-2-3-design-for-expedited-oncology-drug-development
#14
Cong Chen, Keaven Anderson, Devan V Mehrotra, Eric H Rubin, Archie Tse
We propose an adaptive design that allows us to expand an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program with fewer patients. Rather than the usual practice of increasing sample size with a less positive interim outcome, here we propose maintaining sample size with such a result and wait for fully mature data. The final Phase 2 data may be negative, may warrant a larger Phase 3 trial, or, in the extreme, could provide a definitively positive outcome. If the interim outcome is more positive, the trial continues to an originally planned larger sample size for a definitive Phase 3 evaluation...
September 28, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28958504/rilotumumab-plus-epirubicin-cisplatin-and-capecitabine-as-first-line-therapy-in-advanced-met-positive-gastric-or-gastro-oesophageal-junction-cancer-rilomet-1-a-randomised-double-blind-placebo-controlled-phase-3-trial
#15
Daniel V T Catenacci, Niall C Tebbutt, Irina Davidenko, André M Murad, Salah-Eddin Al-Batran, David H Ilson, Sergei Tjulandin, Evengy Gotovkin, Boguslawa Karaszewska, Igor Bondarenko, Mohamedtaki A Tejani, Anghel A Udrea, Mustapha Tehfe, Ferdinando De Vita, Cheryl Turkington, Rui Tang, Agnes Ang, Yilong Zhang, Tien Hoang, Roger Sidhu, David Cunningham
BACKGROUND: Rilotumumab is a fully human monoclonal antibody that selectively targets the ligand of the MET receptor, hepatocyte growth factor (HGF). We aimed to assess the efficacy, safety, and pharmacokinetics of rilotumumab combined with epirubicin, cisplatin, and capecitabine, and to assess potential biomarkers, in patients with advanced MET-positive gastric or gastro-oesophageal junction adenocarcinoma. METHODS: This multicentre, randomised, double-blind, placebo-controlled, phase 3 study was done at 152 centres in 27 countries...
September 25, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28958469/lenalidomide-maintenance-therapy-in-previously-treated-chronic-lymphocytic-leukaemia-continuum-a-randomised-double-blind-placebo-controlled-phase-3-trial
#16
Asher A Chanan-Khan, Andrey Zaritskey, Miklos Egyed, Samuel Vokurka, Sergey Semochkin, Anna Schuh, Jeannine Kassis, David Simpson, Jennie Zhang, Brendan Purse, Robin Foà
BACKGROUND: The efficacy and safety of lenalidomide as maintenance therapy after chemotherapy-based second-line therapy in patients with chronic lymphocytic leukaemia is unknown. Although kinase inhibitors can improve outcomes for some patients with relapsed and refractory disease, not all patients have access to these novel drugs. In this study, we aimed to assess the efficacy and safety of lenalidomide as maintenance therapy in patients with previously treated chronic lymphocytic leukaemia...
September 25, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28939574/publication-of-interventional-phase-3-and-4-clinical-trials-in-radiation-oncology-an-observational-study
#17
Jaime Pérez-Alija, Pedro Gallego, Isabel Linares, Eva Ambroa, Agustí Pedro
OBJECTIVES: Clinical trials produce the best data available for decision-making in modern evidence-based medicine. We aimed to determine the rate of non-publication of interventional phase 3 and 4 clinical trials involving patients with cancer undergoing radiotherapy. SETTING: The ClinicalTrials.gov database was searched for interventional phase 3 and 4 trials in radiotherapy with a primary completion date before 1 January 2013. We determined how many of these registry entries have not published the compulsory deposition of their results in the database and performed a systematic search for published studies in peer-reviewed journals...
September 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28939224/phase-1-2-dose-escalation-study-of-the-use-of-intensity-modulated-radiation-therapy-to-treat-the-prostate-and-pelvic-nodes-in-patients-with-prostate-cancer
#18
Miguel Reis Ferreira, Atia Khan, Karen Thomas, Lesley Truelove, Helen McNair, Annie Gao, Chris C Parker, Robert Huddart, Margaret Bidmead, Ros Eeles, Vincent Khoo, Nicholas J van As, Vibeke N Hansen, David P Dearnaley
PURPOSE: To investigate the feasibility of dose escalation and hypofractionation of pelvic lymph node intensity modulated radiation therapy (PLN-IMRT) in prostate cancer (PCa). METHODS AND MATERIALS: In a phase 1/2 study, patients with advanced localized PCa were sequentially treated with 70 to 74 Gy to the prostate and dose-escalating PLN-IMRT at doses of 50 Gy (cohort 1), 55 Gy (cohort 2), and 60 Gy (cohort 3) in 35 to 37 fractions. Two hypofractionated cohorts received 60 Gy to the prostate and 47 Gy to PLN in 20 fractions over 4 weeks (cohort 4) and 5 weeks (cohort 5)...
August 2, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28934023/biomarker-enrichment-considerations-in-oncology-early-development-single-arm-studies
#19
Hong Tian, Kevin Liu
Oncology drug development has been increasingly shaped by molecularly targeted agents (MTAs), which often demonstrate differential effectiveness driven by the biomarker expression levels on tumors. Innovative statistical designs have been proposed to tackle this challenge, e.g., Freidlin et al (2005), Jiang et al (2007) and Freidlin et al (2010). All of these are essentially adaptive confirmatory Phase 3 designs that combine the testing of treatment effectiveness in the overall population with an alternative pathway for a more restrictive efficacy claim in a sensitive subpopulation...
September 21, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28919740/low-toxic-maghemite-nanoparticles-for-theranostic-applications
#20
Elena A Kuchma, Peter V Zolotukhin, Anna A Belanova, Mikhail A Soldatov, Tatiana A Lastovina, Stanislav P Kubrin, Anatoliy V Nikolsky, Lidia I Mirmikova, Alexander V Soldatov
BACKGROUND: Iron oxide nanoparticles have numerous and versatile biological properties, ranging from direct and immediate biochemical effects to prolonged influences on tissues. Most applications have strict requirements with respect to the chemical and physical properties of such agents. Therefore, developing rational design methods of synthesis of iron oxide nanoparticles remains of vital importance in nanobiomedicine. METHODS: Low toxic superparamagnetic iron oxide nanoparticles (SPIONs) for theranostic applications in oncology having spherical shape and maghemite structure were produced using the fast microwave synthesis technique and were fully characterized by several complementary methods (transmission electron microscopy [TEM], X-ray diffraction [XRD], dynamic light scattering [DLS], X-ray photoelectron spectroscopy [XPS], X-ray absorption near edge structure [XANES], Mossbauer spectroscopy, and HeLa cells toxicity testing)...
2017: International Journal of Nanomedicine
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