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https://www.readbyqxmd.com/read/28719715/long-term-recurrence-free-survival-after-an-unplanned-reduction-in-radiotherapy-for-hpv-positive-oropharyngeal-scc-two-cases-and-a-review-of-the-literature
#1
Jason Liu, David Goldenberg, Salah Almokadem, Henry Crist, Heath B Mackley
There is currently no clear distinction between the treatment of HPV-positive and HPV-negative oropharyngeal squamous cell carcinoma (OPSCC). HPV-positive OPSCC has been demonstrated to be more radiosensitive than its HPV-negative counterpart. Despite this, patients with HPV-positive OPSCC continue to receive a full dose of radiation (70 Gy) outside clinical trials. However, this high dose comes with considerable morbidities, including severe mucositis, dysphagia, and xerostomia. We describe the cases of 2 patients with HPV-positive OPSCC who received two cycles of high-dose cisplatin at 100 mg/m(2) on 3 separate days, along with concurrent radiotherapy at 50 Gy in 25 fractions for one and 46 Gy in 23 fractions for the other...
July 2017: Ear, Nose, & Throat Journal
https://www.readbyqxmd.com/read/28719152/a-first-in-human-phase-i-multicenter-open-label-dose-escalation-study-of-the-oral-raf-vegfr-2-inhibitor-raf265-in-locally-advanced-or-metastatic-melanoma-independent-from-braf-mutation-status
#2
Benjamin Izar, William Sharfman, F Stephen Hodi, Donald Lawrence, Keith T Flaherty, Ravi Amaravadi, Kevin B Kim, Igor Puzanov, Jeffrey Sosman, Reinhard Dummer, Simone M Goldinger, Lyhping Lam, Shefali Kakar, Zhongwen Tang, Oliver Krieter, David F McDermott, Michael B Atkins
To establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), safety profile, and anti-tumor efficacy of RAF265. We conducted a multicenter, open-label, phase-I, dose-escalation trial of RAF265, an orally available RAF kinase/VEGFR-2 inhibitor, in patients with advanced or metastatic melanoma. Pharmacokinetic (PK) analysis, pharmacodynamics (PD) and tumor response assessment were conducted. We evaluated metabolic tumor response by 18[F]-fluorodeoxyglucose-positron-emission tomography (FDG-PET), tissue biomarkers using immunohistochemistry (IHC), and modulators of angiogenesis...
July 18, 2017: Cancer Medicine
https://www.readbyqxmd.com/read/28717396/intraoperative-radiotherapy-review-of-techniques-and-results
#3
REVIEW
Avinash Pilar, Meetakshi Gupta, Sarbani Ghosh Laskar, Siddhartha Laskar
Intraoperative radiotherapy (IORT) is a technique that involves precise delivery of a large dose of ionising radiation to the tumour or tumour bed during surgery. Direct visualisation of the tumour bed and ability to space out the normal tissues from the tumour bed allows maximisation of the dose to the tumour while minimising the dose to normal tissues. This results in an improved therapeutic ratio with IORT. Although it was introduced in the 1960s, it has seen a resurgence of popularity with the introduction of self-shielding mobile linear accelerators and low-kV IORT devices, which by eliminating the logistical issues of transport of the patient during surgery for radiotherapy or building a shielded operating room, has enabled its wider use in the community...
2017: Ecancermedicalscience
https://www.readbyqxmd.com/read/28717037/impact-of-a-carbapenem-antimicrobial-stewardship-program-on-patient-outcomes
#4
Valerie Xue Fen Seah, Rina Yue Ling Ong, Ashley Shi Yuan Lim, Chia Yin Chong, Natalie Woon Hui Tan, Koh Cheng Thoon
Antimicrobial stewardship programs (ASPs) aim to improve appropriate antimicrobials use. However, concerns of the negative consequences from accepting ASP interventions exist, particularly when de-escalation or discontinuation of broad-spectrum antibiotics are recommended. Hence, we sought to evaluate the impact on clinical outcomes when ASP interventions for inappropriate carbapenem use were accepted or rejected by primary providers.We retrospectively reviewed all carbapenem prescriptions deemed inappropriate according to institutional guidelines with ASP interventions between July 2011 and December 2014...
July 17, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28712934/donor-lymphocyte-infusions-used-to-treat-mixed-chimeric-and-high-risk-patient-populations-in-the-relapsed-and-non-relapsed-settings-after-allogeneic-transplant-for-hematologic-malignancies-are-associated-with-high-5-year-survival-if-persistent-full-donor-chimerism
#5
Lauren E Caldemeyer, Luke P Akard, John R Edwards, Anand Tandra, Dawn R Wagenknecht, Michael J Dugan
Mixed chimerism (MC), a persistent or increasing number of host cells after allogeneic hematopoietic stem cell transplant (HSCT), is a predictor of disease relapse. Donor lymphocyte infusions (DLI) have the potential to enhance the graft vs. malignancy (GvM) effect, reducing the risk of relapse in patients with MC. Hence, in addition to utilizing DLI in the relapsed setting, there is a motivation to pursue pre-emptive DLI for patients in complete remissions (CR) after HSCT. To assess the safety and efficacy of DLI, records of 86 patients who received DLI between 2003 and 2015 at a single institution were studied retrospectively...
July 13, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28712586/platelet-testing-to-guide-aspirin-dose-adjustment-in-pediatric-patients-after-cardiac-surgery
#6
Sirisha Emani, David Zurakowski, Michelle Mulone, James A DiNardo, Cameron C Trenor, Sitaram M Emani
OBJECTIVES: Thrombosis is associated with increased morbidity and mortality in pediatric patients undergoing cardiac surgery. Although aspirin commonly is used for thromboprophylaxis, the utility of laboratory-based tests that assess aspirin efficacy have not been evaluated. We sought to determine the relationship between platelet aggregation testing and aspirin dose adjustment on thrombosis rates in this population. METHODS: Pediatric patients undergoing cardiac surgery who received aspirin and underwent platelet testing were studied retrospectively...
June 20, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28711582/a-novel-wnt-pathway-inhibitor-sm04690-for-the-treatment-of-moderate-to-severe-osteoarthritis-of-the-knee-results-of-a-24-week-randomized-controlled-phase-1-study
#7
Yusuf Yazici, Timothy E McAlindon, Roy Fleischmann, Allan Gibofsky, Nancy E Lane, Alan J Kivitz, Nebojsa Skrepnik, Eddie Armas, Christopher J Swearingen, Anita DiFrancesco, Jeyanesh R S Tambiah, John Hood, Marc C Hochberg
OBJECTIVE: To assess the safety, pharmacokinetics, and exploratory efficacy of SM04690, a novel Wnt pathway inhibitor, as a potential disease modifying treatment for knee OA. DESIGN: Subjects with Kellgren-Lawrence grade 2-3 knee OA were randomized in successive dose-escalation cohorts to receive a knee intra-articular injection with 0.03, 0.07, or 0.23 mg SM04690, or placebo (PBO) (4:1 ratio). Safety, pharmacokinetics, efficacy (WOMAC Total/Function/Pain, Pain VAS, Physician Global Assessment [MDGA], and OMERACT-OARSI Response), OA-related biomarker (P1NP, ß-CTX, and COMP), and radiographic/imaging data were collected at baseline and during 24-week follow-up...
July 12, 2017: Osteoarthritis and Cartilage
https://www.readbyqxmd.com/read/28708962/open-label-phase-i-clinical-trial-of-ad5-ebov-in-africans-in-china
#8
Lihua Wu, Zhe Zhang, Hainv Gao, Yuhua Li, Lihua Hou, Hangping Yao, Shipo Wu, Jian Liu, Ling Wang, You Zhai, Huilin Ou, Meihua Lin, Xiaoxin Wu, Jingjing Liu, Guanjing Lang, Qian Xin, Guolan Wu, Li Luo, Pei Liu, Jianzhong Shentu, Nanping Wu, Jifang Sheng, Yunqing Qiu, Wei Chen, Lanjuan Li
BACKGROUND: To determine the safety and immunogenicity of a novel recombinant adenovirus type 5 vector based Ebola virus disease vaccine (Ad5-EBOV) in Africans in China. METHODS: A phase 1, dose-escalation, open-label trial was conducted. 61 healthy Africans were sequentially enrolled, with 31 participants receiving one shot intramuscular injection and 30 participants receiving a double-shot regimen. Primary and secondary end points related to safety and immunogenicity were assessed within 28 days after vaccination...
July 14, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28708802/characterization-and-expansion-of-autologous-gmp-ready-regulatory-t-cells-for-treg-based-cell-therapy-in-patients-with-ulcerative-colitis
#9
Caroline J Voskens, Anika Fischer, Susanne Roessner, Carmen Lorenz, Simon Hirschmann, Raja Atreya, Clemens Neufert, Imke Atreya, Markus F Neurath, Gerold Schuler
BACKGROUND: A local imbalance between regulatory (Treg) and effector T cells is believed to play a major role in gut-specific inflammation, including ulcerative colitis (UC). Restoration of this balance through an adoptive Treg transfer is an attractive new treatment approach in patients who are refractory to current standard therapies. It was our goal to develop a Good Manufacturing Practices (GMP)-conform protocol for expansion of UC Treg cells as a rational backbone for future studies on Treg therapy in UC...
August 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28706139/a-phase-i-study-of-foretinib-plus-erlotinib-in-patients-with-previously-treated-advanced-non-small-cell-lung-cancer-canadian-cancer-trials-group-ind-196
#10
Natasha B Leighl, Ming-Sound Tsao, Geoffrey Liu, Dongsheng Tu, Cheryl Ho, Frances A Shepherd, Nevin Murray, John R Goffin, Garth Nicholas, Shingo Sakashita, Zhuo Chen, Lucia Kim, Jean Powers, Lesley Seymour, Glenwood Goss, Penelope A Bradbury
PURPOSE: MET and AXL mediate resistance to EGFR TKI in NSCLC. Foretinib, a MET/RON/AXL/TIE-2/VEGFR kinase inhibitor may overcome EGFR kinase resistance. This dose escalation study combined foretinib and erlotinib in advanced pretreated NSCLC patients. EXPERIMENTAL DESIGN: The primary endpoint was to define the RP2D of foretinib plus erlotinib as continuous oral daily dosing. Secondary objectives included safety, pharmacokinetics, response and potential biomarkers of response including EGFR, KRAS genotype, MET, AXL expression, and circulating HGF levels...
June 28, 2017: Oncotarget
https://www.readbyqxmd.com/read/28705789/treatment-of-peritoneal-dissemination-in-stomach-cancer-patients-with-cytoreductive-surgery-and-hyperthermic-intraperitoneal-chemotherapy-hipec-rationale-and-design-of-the-periscope-study
#11
Rosa T van der Kaaij, Hidde Jw Braam, Henk Boot, Maartje Los, Annemieke Cats, Cecile Grootscholten, Jan Hm Schellens, Arend Gj Aalbers, Alwin Dr Huitema, Catherijne Aj Knibbe, Djamila Boerma, Marinus J Wiezer, Bert van Ramshorst, Johanna W van Sandick
BACKGROUND: Patients with gastric cancer and peritoneal carcinomatosis have a very poor prognosis; median survival is 3 to 4 months. Palliative systemic chemotherapy is currently the only treatment available in the Netherlands. Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) has an established role in the treatment of peritoneal carcinomatosis originating from colorectal cancer, appendiceal cancer, and pseudomyxoma peritonei; its role in gastric cancer is uncertain. Currently, there is no consensus on the choice of chemotherapeutic agents used in HIPEC for gastric cancer...
July 13, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28704211/how-to-emerge-from-the-conservatism-in-clinical-research-methodology
#12
Nuria Kotecki, Nicolas Penel, Ahmad Awada
PURPOSE OF REVIEW: Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. RECENT FINDINGS: Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed...
July 12, 2017: Current Opinion in Oncology
https://www.readbyqxmd.com/read/28699641/nilotinib-dose-optimization-in-newly-diagnosed-chronic-myeloid-leukaemia-in-chronic-phase-final-results-from-enestxtnd
#13
Timothy P Hughes, Eduardo Munhoz, Marco Aurelio Salvino, Tee Chuan Ong, Alaa Elhaddad, Jake Shortt, Hang Quach, Carolina Pavlovsky, Vernon J Louw, Lee-Yung Shih, Anna G Turkina, Luis Meillon, Yu Jin, Sandip Acharya, Darshan Dalal, Jeffrey H Lipton
The Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Extending Molecular Responses (ENESTxtnd) study was conducted to evaluate the kinetics of molecular response to nilotinib in patients with newly diagnosed chronic myeloid leukaemia in chronic phase and the impact of novel dose-optimization strategies on patient outcomes. The ENESTxtnd protocol allowed nilotinib dose escalation (from 300 to 400 mg twice daily) in the case of suboptimal response or treatment failure as well as dose re-escalation for patients with nilotinib dose reductions due to adverse events...
July 12, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28699134/intraoperative-tumor-detection-using-a-ratiometric-activatable-fluorescent-peptide-a-first-in-human-phase-1-study
#14
Jonathan T Unkart, Steven L Chen, Irene L Wapnir, Jesús E González, Alec Harootunian, Anne M Wallace
BACKGROUND: Positive surgical margins remain a significant challenge in breast cancer surgery. This report describes the use of a novel, first-in-human ratiometric activatable cell-penetrating peptide in breast cancer surgery. METHODS: A two-part, multi-institutional phase 1 trial of AVB-620 with a 3+3 dose escalation and dose-expansion cohorts was conducted. The patients received an infusion of AVB-620 2-20 h before planned lumpectomy/mastectomy and sentinel node biopsy/axillary dissection...
July 11, 2017: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/28698920/prevention-and-reversal-of-social-stress-escalated-cocaine-self-administration-in-mice-by-intra-vta-crfr1-antagonism
#15
Xiao Han, Joseph F DeBold, Klaus A Miczek
BACKGROUND: A history of brief intermittent social defeat stress can escalate cocaine self-administration and induce long-term adaptations in the mesolimbic dopamine system. Extra-hypothalamic corticotrophin releasing factor (CRF) has been shown to be closely associated with stress-induced escalation of drug use. How repeated stress modulates CRF release in the ventral tegmental area (VTA) and the roles of CRF receptors during different phases of stress-induced cocaine self-administration remain to be defined...
July 11, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28698408/dose-escalation-by-image-guided-intensity-modulated-radiotherapy-leads-to-an-increase-in-pain-relief-for-spinal-metastases-a-comparison-study-with-a-regimen-of-30-gy-in-10-fractions
#16
Jinlan He, Jianghong Xiao, Xingchen Peng, Baofeng Duan, Yan Li, Ping Ai, Min Yao, Nianyong Chen
PURPOSE: Under the existing condition that the optimum radiotherapy regimen for spinal metastases is controversial, this study investigates the benefits of dose escalation by image-guided intensity-modulated radiotherapy (IG-IMRT) with 60-66 Gy in 20-30 fractions for spinal metastases. RESULTS: In the dose-escalation group, each D50 of planning gross tumor volume (PGTV) was above 60 Gy and each Dmax of spinal cord planning organ at risk volume (PRV) was below 48 Gy...
July 4, 2017: Oncotarget
https://www.readbyqxmd.com/read/28696783/course-of-neuropsychiatric-symptoms-after-introduction-and-removal-of-nonsteroidal-anti-inflammatory-drugs-a-pediatric-observational-study
#17
Ellen J Spartz, G Mark Freeman, Kayla Brown, Bahare Farhadian, Margo Thienemann, Jennifer Frankovich
OBJECTIVE: Accumulating evidence suggests that anti-inflammatory interventions can modulate neuropsychiatric symptoms. Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) is characterized by an abrupt and dramatic onset of obsessive-compulsive (OC) symptoms and/or severely restrictive food intake and at least two coinciding, equally debilitating neuropsychiatric symptoms. When associated with group A Streptococcus, the syndrome is labeled Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infections (PANDAS)...
July 11, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28696175/venetoclax-a-novel-b-cell-lymphoma-2-inhibitor-for-chronic-lymphocytic-leukemia-and-other-hematologic-malignancies
#18
Jacqueline L Olin, Carrie L Griffiths, Morgan B Smith
Patients with chronic lymphocytic leukemia with the 17p deletion have a poor prognosis and treatment options are limited. Venetoclax, a novel B-cell lymphoma-2 inhibitor, has been approved for treatment-experienced chronic lymphocytic leukemia patients with the 17p deletion. A phase 1 dose-escalation study to 400 mg daily showed overall response rates across all doses of 79% with a complete response achieved in 20%. A phase 2 multicenter open-label study demonstrated overall response rate of 79.4% of patients (95% confidence interval 70...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28695483/diagnosis-and-management-of-treatment-refractory-hypothyroidism-an-expert-consensus-report
#19
REVIEW
M Centanni, S Benvenga, I Sachmechi
There is a frequently encountered subset of hypothyroid patients who are refractory to standard thyroid hormone replacement treatment and require unexpectedly high doses of levothyroxine. In addition to clinical situations where hypothyroid patients are non-compliant, or where there is the possibility of excipient-induced disease exacerbation (gluten/celiac disease), therapeutic failure may be due to impaired absorption of the administered drug. The common approach to managing patients with unusual thyroxine needs is to escalate the dose of levothyroxine until targeted TSH levels are achieved...
July 10, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28692182/gsk2878175-a-pan-genotypic-non-nucleoside-ns5b-polymerase-inhibitor-in-healthy-and-treatment-na%C3%A3-ve-chronic-hepatitis-c-subjects
#20
Stephen D Gardner, Joseph Kim, Sharon Baptiste-Brown, Vincent Lopez, Robert Hamatake, Jianjun Gan, Stephen Edwards, Lucinda Elko-Simms, Etienne F Dumont, Martin Leivers, Zhi Hong, Melanie T Paff
GSK2878175 is a potent, pan-genotypic, non-nucleoside, non-structural protein 5B palm polymerase inhibitor being developed for the treatment of chronic hepatitis C (CHC). A first-in-human, randomized, placebo-controlled, dose escalation study, evaluated the safety and pharmacokinetics of GSK2878175 administered as single and repeat oral doses (once daily for 14 days) to healthy volunteers. A separate proof-of-concept, placebo-controlled, repeat dose (once daily for 2 days) study evaluated the safety, pharmacokinetics, and antiviral activity of GSK2878175 monotherapy in treatment naïve, non-cirrhotic, subjects with HCV genotype 1 [1a and 1b], 2, or 3...
July 10, 2017: Journal of Viral Hepatitis
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