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https://www.readbyqxmd.com/read/29352703/inotuzumab-ozogamicin-in-combination-with-low-intensity-chemotherapy-for-older-patients-with-philadelphia-chromosome-negative-acute-lymphoblastic-leukaemia-a-single-arm-phase-2-study
#1
Hagop Kantarjian, Farhad Ravandi, Nicholas J Short, Xuelin Huang, Nitin Jain, Koji Sasaki, Naval Daver, Naveen Pemmaraju, Joseph D Khoury, Jeffrey Jorgensen, Yesid Alvarado, Marina Konopleva, Guillermo Garcia-Manero, Tapan Kadia, Musa Yilmaz, Gautam Bortakhur, Jan Burger, Steven Kornblau, William Wierda, Courtney DiNardo, Alessandra Ferrajoli, Jovitta Jacob, Rebecca Garris, Susan O'Brien, Elias Jabbour
BACKGROUND: Inotuzumab ozogamicin, an anti-CD22 monoclonal antibody bound to a toxin, calicheamicin, has shown single-agent activity in relapsed or refractory acute lymphoblastic leukaemia. We aimed to assess the activity and safety of inotuzumab ozogamicin in combination with low-intensity chemotherapy in older patients with acute lymphoblastic leukaemia. METHODS: We did a single-arm, phase 2 study at the MD Anderson Cancer Center (Houston, TX, USA). Eligible patients were aged 60 years or older and had newly diagnosed, Philadelphia chromosome-negative, acute lymphoblastic leukaemia, and an Eastern Cooperative Oncology Group performance status of 3 or lower...
January 15, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29351594/sero-efficacy-of-vi-polysaccharide-tetanus-toxoid-typhoid-conjugate-vaccine-typbar-tcv
#2
Merryn Voysey, Andrew J Pollard
Background: Salmonella Typhi is the major cause of enteric fever in lower income countries. New conjugate vaccines show promise as public health interventions, however there are no efficacy data available from endemic areas. Methods: Data were obtained from a previously published phase 3 randomised controlled trial comparing Vi-polysaccharide tetanus-toxoid conjugate vaccine (Typbar-TCV; Bharat Biotech Intl Ltd, India): (Vi-TT) with Vi-polysaccharide (Typbar; Bharat Biotech Intl Ltd, India): (Vi-PS) in participants aged 2- 45 years...
January 17, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29350840/a-phase-3-trial-of-mometasone-furoate-sinus-implants-for-chronic-sinusitis-with-recurrent-nasal-polyps
#3
Robert C Kern, J Pablo Stolovitzky, Stacey L Silvers, Ameet Singh, Jivianne T Lee, David M Yen, Alfred M C Iloreta, Francis P J Langford, Boris Karanfilov, Keith E Matheny, James W Stambaugh, Anna K Gawlicka
BACKGROUND: Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. METHODS: A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery...
January 19, 2018: International Forum of Allergy & Rhinology
https://www.readbyqxmd.com/read/29350344/the-relationship-between-exercise-dose-and-health-related-quality-of-life-with-a-phase-iii-cardiac-rehabilitation-program
#4
Borja Del Pozo-Cruz, Graeme Carrick-Ranson, Stacey Reading, Paul Nolan, Lance C Dalleck
PURPOSE: To quantify the relationship between the change in exercise dose and health-related quality of life (HRQoL) in a cohort of patients participating in a community-based phase-3 cardiac rehabilitation (CR) program. METHODS: A retrospective, pre-experimental (no control group) design of 58 participants that completed a phase-3, 12-week exercise-based CR program was used to test the current hypothesis. Self-reported HRQoL (36-Item Short Form Health Survey Version 2, SF-36v2) was assessed prior and after completing the CR program...
January 19, 2018: Quality of Life Research
https://www.readbyqxmd.com/read/29344777/giant-cell-arteritis-practical-pearls-and-updates
#5
REVIEW
Swati Pradeep, Jonathan H Smith
PURPOSE OF REVIEW: The purpose of this review is to summarize recent updates and distill practical points from the literature which can be applied to the care of patients with suspected and confirmed giant cell arteritis (GCA). RECENT FINDINGS: Contemporary thinking implicates a fundamental failure of T regulatory cell function in GCA pathophysiology, representing opportunity for novel therapeutic avenues. Tocilizumab has become the first Food and Drug Administration-approved treatment for GCA following demonstration of efficacy and safety in a phase 3 clinical trial...
January 17, 2018: Current Pain and Headache Reports
https://www.readbyqxmd.com/read/29344579/prognostic-significance-of-cytogenetic-heterogeneity-in-patients-with-newly-diagnosed-multiple-myeloma
#6
Maximilian Merz, Anna Jauch, Thomas Hielscher, Tilmann Bochtler, Stefan Olaf Schönland, Anja Seckinger, Dirk Hose, Uta Bertsch, Kai Neben, Marc Steffen Raab, Jens Hillengass, Hans Salwender, Igor Wolfgang Blau, Hans-Walter Lindemann, Ingo G H Schmidt-Wolf, Christof Scheid, Mathias Haenel, Katja C Weisel, Hartmut Goldschmidt
We investigated subclonal cytogenetic aberrations (CA) detected by interphase fluorescence in situ hybridization (iFISH) in patients with newly diagnosed multiple myeloma (MM) enrolled in the Haemato Oncology Foundation for Adults in the Netherlands (HOVON)-65/German-Speaking MM Group (GMMG)-HD4 phase 3 trial. Patients were either treated with 3 cycles of vincristine, Adriamycin, and dexamethasone or bortezomib, Adriamycin, and dexamethasone and then thalidomide or bortezomib maintenance after tandem autologous transplantation...
January 9, 2018: Blood Advances
https://www.readbyqxmd.com/read/29343507/early-and-sustained-efficacy-with-apremilast-monotherapy-in-biological-na%C3%A3-ve-patients-with-psoriatic-arthritis-a-phase-iiib-randomised-controlled-trial-active
#7
Peter Nash, Kamal Ohson, Jessica Walsh, Nikolay Delev, Dianne Nguyen, Lichen Teng, Juan J Gómez-Reino, Jacob A Aelion
OBJECTIVE: Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA. METHODS: Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52. RESULTS: Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38...
January 17, 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29343290/finemav-prioritizing-candidate-genetic-variants-driving-local-adaptations-in-human-populations
#8
Michał Szpak, Massimo Mezzavilla, Qasim Ayub, Yuan Chen, Yali Xue, Chris Tyler-Smith
We present a new method, Fine-Mapping of Adaptive Variation (FineMAV), which combines population differentiation, derived allele frequency, and molecular functionality to prioritize positively selected candidate variants for functional follow-up. We calibrate and test FineMAV using eight experimentally validated "gold standard" positively selected variants and simulations. FineMAV has good sensitivity and a low false discovery rate. Applying FineMAV to the 1000 Genomes Project Phase 3 SNP dataset, we report many novel selected variants, including ones in TGM3 and PRSS53 associated with hair phenotypes that we validate using available independent data...
January 17, 2018: Genome Biology
https://www.readbyqxmd.com/read/29343266/identification-of-pain-categories-associated-with-change-in-pain-in-patients-receiving-placebo-data-from-two-phase-3-randomized-clinical-trials-in-symptomatic-knee-osteoarthritis
#9
Asger Reinstrup Bihlet, Inger Byrjalsen, Anne-Christine Bay-Jensen, Jeppe Ragnar Andersen, Claus Christiansen, Bente Juel Riis, Ivo Valter, Morten A Karsdal, Marc C Hochberg
BACKGROUND: Pain is the principal clinical symptom of osteoarthritis (OA), and development of safe and effective analgesics for OA pain is needed. Drug development of new analgesics for OA pain is impaired by substantial change in pain in patients receiving placebo, and more data describing clinical characteristics and pain categories particularly associated with this phenomenon is needed. The purpose of this post-hoc analysis was to investigate clinical characteristics and pain categories and their association with radiographic progression and placebo pain reduction (PPR) in OA patients as measured the Western Ontario and McMasters Arthritis (WOMAC)...
January 17, 2018: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/29343131/safety-and-tolerability-of-plecanatide-in-patients-with-chronic-idiopathic-constipation-long-term-evidence-from-an-open-label-study
#10
Charles F Barish, Patrick Griffin
OBJECTIVE: This multicenter, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC). METHODS: Eligible patients completed a phase 2b or phase 3 double-blind study of plecanatide, or had not previously been treated with plecanatide. Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks. Safety and tolerability were assessed by the incidence, nature, and severity of spontaneously reported treatment-emergent adverse events (TEAEs)...
January 17, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29342393/hyperthermic-intraperitoneal-chemotherapy-in-ovarian-cancer
#11
Willemien J van Driel, Simone N Koole, Karolina Sikorska, Jules H Schagen van Leeuwen, Henk W R Schreuder, Ralph H M Hermans, Ignace H J T de Hingh, Jacobus van der Velden, Henriëtte J Arts, Leon F A G Massuger, Arend G J Aalbers, Victor J Verwaal, Jacobien M Kieffer, Koen K Van de Vijver, Harm van Tinteren, Neil K Aaronson, Gabe S Sonke
BACKGROUND: Treatment of newly diagnosed advanced-stage ovarian cancer typically involves cytoreductive surgery and systemic chemotherapy. We conducted a trial to investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer. METHODS: In a multicenter, open-label, phase 3 trial, we randomly assigned 245 patients who had at least stable disease after three cycles of carboplatin (area under the curve of 5 to 6 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area) to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin (100 mg per square meter)...
January 18, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29340500/respiratory-evaluation-through-volumetric-capnography-among-grade-iii-obese-and-eutrophic-individuals-a-comparative-study
#12
Débora Aparecida Oliveira Modena, Marcos Mello Moreira, Ilma Aparecida Paschoal, Mônica Corso Pereira, Luiz Cláudio Martins, Everton Cazzo, Elinton Adami Chaim
BACKGROUND: Excess trunk body fat in obese individuals influences respiratory physiological function. The aims of this study were to compare volumetric capnography findings (VCap) between severely obese patients and normal-weight subjects and to assess whether there is any association between neck circumference (NC), waist-hip ratio (WHR) and VCap among grade III obese individuals. DESIGN AND SETTING: Analytical observational case-matched cross-sectional study, University of Campinas...
January 15, 2018: São Paulo Medical Journal, Revista Paulista de Medicina
https://www.readbyqxmd.com/read/29339702/efficacy-and-safety-of-oral-anticoagulation-in-elderly-patients-with-atrial-fibrillation
#13
Ilaria Cavallari, Giuseppe Patti
Elderly patients with atrial fibrillation are at a higher risk of both ischemic and bleeding events compared with younger patients; therefore, balancing risks and benefits of antithrombotic strategies in this population is crucial. Recent studies have shown that because the risk of stroke increases with age more than the risk of bleeding, the absolute benefit of oral anticoagulation is the highest in elderly patients in whom it outweighs the risk of bleeding. Direct oral anticoagulants (DOACs) have been developed as a treatment for the prevention of cardioembolic stroke to overcome some limitations of warfarin, such as the need for frequent monitoring, labile INR values requiring frequent dose adjustment, dietary and drugs interactions, and increased risk of intracranial bleeding...
January 2018: Anatolian Journal of Cardiology
https://www.readbyqxmd.com/read/29339046/stereotactic-body-radiation-therapy-sbrt-for-high-risk-prostate-cancer-where-are-we-now
#14
REVIEW
Alejandro Gonzalez-Motta, Mack Roach
PURPOSE: Stereotactic body radiation therapy (SBRT) is increasingly being used for the management of localized prostate cancer. This trend combined with declining use of brachytherapy (BT) has pushed issues and questions regarding the use of SBRT to the forefront. A systematic literature review was conducted to review the current evidence of biochemical disease-free survival (bDFS) and toxicity of SBRT in high-risk (HR) prostate cancer. METHODS AND MATERIALS: A search was carried out on the PubMed and Embase databases...
December 2, 2017: Practical Radiation Oncology
https://www.readbyqxmd.com/read/29338540/efficacy-and-safety-of-frontline-rituximab-cyclophosphamide-doxorubicin-and-prednisone-plus-bortezomib-vr-cap-or-vincristine-r-chop-in-a-subset-of-newly-diagnosed-mantle-cell-lymphoma-patients-medically-eligible-for-transplantation-in-the-randomized-phase-3
#15
Johannes Drach, Huiqiang Huang, Olga Samoilova, Andrew Belch, Charles Farber, André Bosly, Jan Novak, Jan Zaucha, Angela Dascalescu, Udomsak Bunworasate, Zvenyslava Masliak, Kateryna Vilchevskaya, Tadeusz Robak, Lixia Pei, Brendan Rooney, Helgi van de Velde, Franco Cavalli
This post-hoc subanalysis of the LYM-3002 phase 3 study assessed the efficacy and safety of substituting vincristine in rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHOP; n = 42) for bortezomib (VR-CAP; n = 38) in a subgroup of 80 mantle cell lymphoma (MCL) patients aged <60 years who did not receive stem cell transplantation (SCT) despite medical eligibility. Complete response (CR)/unconfirmed CR (CRu) rates were 67 vs. 39% (odds ratio 3.69 [95% CI(confidence interval): 1.31, 10...
January 17, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29337653/safety-and-immunogenicity-of-a-meningococcal-b-recombinant-vaccine-when-administered-with-routine-vaccines-to-healthy-infants-in-taiwan-a-phase-3-open-label-randomized-study
#16
Nan-Chang Chiu, Li-Min Huang, Arnold Willemsen, Chiranjiwi Bhusal, Ashwani Kumar Arora, Zenaida Reynoso Mojares, Daniela Toneatto
Neisseria meningitidis is associated with high mortality and morbidity in infants and children worldwide. This phase 3 study (NCT02173704) evaluated safety and immunogenicity of a 4-component serogroup B recombinant meningococcal vaccine (4CMenB) co-administered with routine vaccines in Taiwanese infants. In total, 225 healthy infants were randomized (2:1) to receive 4CMenB and routine vaccines (4CMenB+Routine) or routine vaccines only (Routine group) at 2, 4, 6 and 12 months of age. Routine vaccines were diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b, 13-valent pneumococcal, hepatitis B, measles-mumps-rubella and varicella vaccines...
January 16, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29337197/brain-perfusion-alterations-in-tick-borne-encephalitis-preliminary-report
#17
Zuzanna Tyrakowska-Dadełło, Eugeniusz Tarasów, Dariusz Janusek, Anna Moniuszko-Malinowska, Joanna Zajkowska, Sławomir Pancewicz
BACKGROUND: Magnetic resonance imaging (MRI) changes in Tick-borne encephalitis (TBE) are nonspecific and pathophysiologic mechanisms leading to their formation remain unclear. This study aimed to investigate brain perfusion in TBE patients using dynamic susceptibility contrast (DSC) MR perfusion imaging. METHODS: MRI scans were performed in 12 patients in the acute phase, 3-5days after TBE diagnosis, with conventional MR images and DSC-MRI perfusion studies. Cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT) and time to peak (TTP) parametric maps were created...
January 11, 2018: International Journal of Infectious Diseases: IJID
https://www.readbyqxmd.com/read/29336835/standard-whole-prostate-gland-radiotherapy-with-and-without-lesion-boost-in-prostate-cancer-toxicity-in-the-flame-randomized-controlled-trial
#18
Evelyn M Monninkhof, Juliette W L van Loon, Marco van Vulpen, Linda G W Kerkmeijer, Floris J Pos, Karin Haustermans, Laura van den Bergh, Sofie Isebaert, Gill M McColl, Robert Jan Smeenk, Juus Noteboom, Iris Walraven, Petra H M Peeters, Uulke A van der Heide
PURPOSE: To compare toxicity rates in patients with localized prostate cancer treated with standard fractionated external beam radiotherapy (EBRT) with or without an additional integrated boost to the macroscopically visible tumour. MATERIAL AND METHODS: FLAME is a phase 3 multicentre RCT (NCT01168479) of patients with pathologically confirmed localized intermediate or high-risk prostate cancer. The standard treatment arm (n = 287) received a dose to the entire prostate of 77 Gy in 35 fractions...
January 11, 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29336205/prediction-of-natalizumab-anti-drug-antibodies-persistency
#19
Florian Deisenhammer, Marlies Jank, Anna Lauren, Anders Sjödin, Malin Ryner, Anna Fogdell-Hahn, Claudia Sievers, Raija Lindberg, Poul Erik Jensen, Finn Sellebjerg, Louis Christodoulou, Mary Birchler, Marc Pallardy, Michael Auer, Roland Liblau
BACKGROUND: Anti-drug antibodies (ADA) against natalizumab develop early during treatment. ADA persistency is defined by two consecutive positive results as performed by the current qualitative ELISA assay (positive/negative). Very little is known about the magnitude of the natalizumab ADA response and persistency. DESIGN/METHODS: We developed a highly sensitive natalizumab ADA titration assay on the Meso Scale Discovery (MSD) platform and a pharmacokinetic (PK) assay...
January 1, 2018: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/29336187/efficacy-and-safety-of-sirukumab-in-japanese-patients-with-moderate-to-severe-rheumatoid-arthritis-inadequately-controlled-by-disease-modifying-anti-rheumatic-drugs-subgroup-analysis-of-a-phase-3-study
#20
Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Masayoshi Harigai, Toshikazu Nakano, Koshiro Akagi, Yoshifumi Ukyo, Benjamin Hsu
Objective To evaluate the efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis uncontrolled by disease modifying antirheumatic drugs. Methods This subgroup analysis based on a double-blind, placebo-controlled, 52-week phase 3 study (SIRROUND-D) assessed American College of Rheumatology (ACR)20 response at week 16 and van der Heijde-modified Sharp score (vdH-S) at week 52 (coprimary endpoints). Results A total of 168 (Japanese)/1670 patients received sirukumab 50 mg/4 weeks (q4w, n = 58), 100 mg/every 2 weeks (q2w, n = 54), or placebo (n = 56) subcutaneously...
January 16, 2018: Modern Rheumatology
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