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https://www.readbyqxmd.com/read/28735109/design-and-rationale-for-a-real-world-observational-cohort-of-patients-with-nonalcoholic-fatty-liver-disease-the-target-nash-study
#1
A Sidney Barritt, Norman Gitlin, Samuel Klein, Anna S Lok, Rohit Loomba, Laura Malahias, Margaret Powell, Miriam B Vos, L Michael Weiss, Kenneth Cusi, Brent A Neuschwander-Tetri, Arun Sanyal
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent and can lead to cirrhosis, hepatocellular carcinoma, and end-stage liver disease. NAFLD comprises the spectrum from simple steatosis (nonalcoholic fatty liver, NAFL), to steatosis with inflammation (nonalcoholic steatohepatitis, NASH). Current primary therapy recommended for NAFLD is weight loss induced by lifestyle modification. The difficulty in achieving this has led to robust pharmacological therapy development. While new drugs may show efficacy in selected phase II/III clinical trial populations, their real-world effectiveness is unknown...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28729180/symptom-and-quality-of-life-improvement-in-lux-lung-8-an-open-label-phase-iii-study-of-second-line-afatinib-versus-erlotinib-in-patients-with-advanced-squamous-cell-carcinoma-of-the-lung-after-first-line-platinum-based-chemotherapy
#2
Enriqueta Felip, Vera Hirsh, Sanjay Popat, Manuel Cobo, Andrea Fülöp, Charles Dayen, José M Trigo, Richard Gregg, Cornelius F Waller, Jean-Charles Soria, Glenwood D Goss, James Gordon, Bushi Wang, Michael Palmer, Eva Ehrnrooth, Shirish M Gadgeel
INTRODUCTION: In the phase III LUX-Lung 8 trial, afatinib significantly improved progression-free survival (PFS) and overall survival (OS) versus erlotinib in patients with squamous cell carcinoma (SCC) of the lung progressing during or after platinum-based chemotherapy. Patient-reported outcomes (PROs) and health-related quality of life (QoL) in these patients are presented. PATIENTS AND METHODS: Patients (n = 795) were randomized 1:1 to oral afatinib (40 mg/d) or erlotinib (150 mg/d)...
June 23, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28724523/savolitinib-heads-for-phase-iii-trial-in-prcc
#3
(no author information available yet)
A phase II trial of savolitinib, a MET inhibitor, found that the drug induced partial responses in some patients with papillary renal cell carcinoma and was well tolerated, prompting drug makers Chi-Med and AstraZeneca to launch a phase III study.
July 19, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28724419/real-life-clinical-practice-results-with-vinflunine-in-patients-with-relapsed-platinum-treated-metastatic-urothelial-carcinoma-an-italian-multicenter-study-movie-goirc-01-2014
#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
https://www.readbyqxmd.com/read/28723741/characterization-of-small-%C3%A2-3%C3%A2-cm-hepatic-lesions-with-atypical-enhancement-feature-and-hypointensity-in-hepatobiliary-phase-of-gadoxetic-acid-enhanced-mri-in-cirrhosis-a-stard-compliant-article
#5
Seung Kak Shin, Yun Soo Kim, Seung Joon Choi, Young Sup Shim, Dong Hae Jung, Oh Sang Kwon, Duck Joo Choi, Ju Hyun Kim
It is difficult to characterize the nodular lesions in cirrhotic liver if typical enhancement pattern is not present on dynamic contrast-enhanced imagings. Although the signal intensity of the hepatobiliary phase in gadoxetic acid-enhanced magnetic resonance imaging (MRI) is helpful for characterization of the lesions, some dysplastic nodules may also exhibit low signal intensity in the hepatobiliary phase. We aimed to assess the usefulness of gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI including diffusion-weighted imaging (DWI) for differentiation between atypical small hepatocellular carcinomas (HCCs) and dysplastic nodules showing low signal intensity (SI) in the hepatobiliary phase, and to evaluate the MRI findings in determining the histological grade of atypical HCCs in patients with cirrhosis...
July 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28721881/final-report-of-a-prospective-randomized-trial-to-evaluate-the-dose-response-relationship-for-postoperative-radiation-therapy-and-pathologic-risk-groups-in-patients-with-head-and-neck%C3%A2-cancer
#6
David I Rosenthal, Abdallah S R Mohamed, Adam S Garden, William H Morrison, Adel K El-Naggar, Mona Kamal, Randal S Weber, Clifton D Fuller, Lester J Peters
PURPOSE: To present the long-term and final report of a phase 3 trial designed to assess dose-response relationship for postoperative radiation therapy (PORT) and pathologic risk groups in head and neck cancer. METHODS AND MATERIALS: Patients who underwent primary surgery for American Joint Committee on Cancer stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx and who required PORT were eligible. Patients' primary sites and involved necks were independently assigned to higher- or lower-risk categories based on a cumulative point score representing increasing risk of recurrence...
August 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28719890/effect-of-neoadjuvant-nab-paclitaxel-plus-gemcitabine-therapy-on-overall-survival-in-patients-with-borderline-resectable-pancreatic-cancer-a-prospective-multicenter-phase-ii-trial-nac-ga-trial
#7
Ken-Ichi Okada, Toshio Shimokawa, Seiko Hirono, Manabu Kawai, Masayuki Sho, Sohei Satoi, Ippei Matsumoto, Hidetoshi Eguchi, Yoshiaki Murakami, Suguru Yamada, Mariko Doi, Hiroki Yamaue
We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy on overall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), morbidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version)...
July 19, 2017: Oncology
https://www.readbyqxmd.com/read/28711490/long-term-response-to-sunitinib-treatment-in-metastatic-renal-cell-carcinoma-a-pooled-analysis-of-clinical-trials
#8
Nizar M Tannir, Robert A Figlin, Martin E Gore, M Dror Michaelson, Robert J Motzer, Camillo Porta, Brian I Rini, Caroline Hoang, Xun Lin, Bernard Escudier
BACKGROUND: We characterized clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib who were long-term responders (LTRs), defined as patients having progression-free survival (PFS) > 18 months. PATIENTS AND METHODS: A retrospective analysis of data from 5714 patients with mRCC treated with sunitinib in 8 phase II/III clinical trials and the expanded access program. Duration on-study and objective response rate (ORR) were compared between LTRs and patients with PFS ≤ 18 months ("others")...
June 20, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28709816/-current-knowledge-on-perioperative-treatments-of-non-small-cell-lung-carcinomas
#9
REVIEW
S Brosseau, C Naltet, M Nguenang, V Gounant, P Mordant, B Milleron, Y Castier, G Zalcman
Surgery is still the main treatment in early-stage of non-small cell lung cancer with 5-year survival of stage IA patients exceeding 80%, but 5-year survival of stage II patients rapidly decreasing with tumor size, N status, and visceral pleura invasion. The major metastatic risk in such patients has supported clinical research assessing systemic or loco-regional perioperative treatments. Modern phase 3 trials clearly validated adjuvant or neo-adjuvant platinum-based chemotherapy in resected stage I-III patients as a standard treatment of which value has been reassessed several independent meta-analyses, showing a 5% benefit in 5y-survival, and a decrease of the relative risk for death around from 12 to 25%...
July 11, 2017: Revue des Maladies Respiratoires
https://www.readbyqxmd.com/read/28702409/phase-iib-trial-comparing-two-concurrent-cisplatin-schedules-in-locally-advanced-head-and-neck-cancer
#10
Lekha Madhavan Nair, R Rejnish Kumar, Kainickal Cessal Thomachan, Malu Rafi, Preethi Sara George, K M Jagathnath Krishna, Kunnambath Ramadas
BACKGROUND: Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m(2)) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens. OBJECTIVES: The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m(2)) with weekly cisplatin (40 mg/m(2)) concurrently with radiation in patients with locally advanced head and neck cancer...
April 2017: South Asian Journal of Cancer
https://www.readbyqxmd.com/read/28688693/very-accelerated-radiotherapy-or-concurrent-chemoradiotherapy-for-n3-head-and-neck-squamous-cell-carcinoma-pooled-analysis-of-two-gortec-randomized-trials
#11
Yungan Tao, Anne Aupérin, Pierre Graff, Michel Lapeyre, Vincent Grégoire, Philippe Maingon, Lionel Geoffrois, Pierre Verrelle, Gilles Calais, Bernard Gery, Laurent Martin, Marc Alfonsi, Patrick Deprez, Etienne Bardet, Thierry Pignon, Michel Rives, Christian Sire, Jean Bourhis
OBJECTIVE: To analyze the outcome of N3 patients treated with very accelerated radiotherapy (VART) or different schedules of concurrent chemoradiotherapy (CRT) within two phase III trials. PATIENTS AND METHODS: Data of 179 patients with N3 HNSCC from two GORTEC randomized trials (96-01 and 99-02) were pooled. Patients received either VART: 64.8Gy/3.5weeks or one of the 3 following CRT regimens: Conventional CRT: 70Gy/7weeks+3 cycles carboplatin-5FU; Moderately accelerated CRT: 70Gy/6weeks+2 cycles carboplatin-5FU; Strongly intensified CRT: 64Gy/5weeks+cisplatin (days 2, 16, 30) and 5 FU (days 1-5, 29-33) followed by 2 cycles adjuvant cisplatin-5FU...
August 2017: Oral Oncology
https://www.readbyqxmd.com/read/28683746/multi-omics-of-34-colorectal-cancer-cell-lines-a-resource-for-biomedical-studies
#12
Kaja C G Berg, Peter W Eide, Ina A Eilertsen, Bjarne Johannessen, Jarle Bruun, Stine A Danielsen, Merete Bjørnslett, Leonardo A Meza-Zepeda, Mette Eknæs, Guro E Lind, Ola Myklebost, Rolf I Skotheim, Anita Sveen, Ragnhild A Lothe
BACKGROUND: Colorectal cancer (CRC) cell lines are widely used pre-clinical model systems. Comprehensive insights into their molecular characteristics may improve model selection for biomedical studies. METHODS: We have performed DNA, RNA and protein profiling of 34 cell lines, including (i) targeted deep sequencing (n = 612 genes) to detect single nucleotide variants and insertions/deletions; (ii) high resolution DNA copy number profiling; (iii) gene expression profiling at exon resolution; (iv) small RNA expression profiling by deep sequencing; and (v) protein expression analysis (n = 297 proteins) by reverse phase protein microarrays...
July 6, 2017: Molecular Cancer
https://www.readbyqxmd.com/read/28680957/health-related-quality-of-life-as-a-prognostic-measure-of-clinical-outcomes-in-renal-cell-carcinoma-a-review-of-the-checkmate-025-trial
#13
EDITORIAL
Marc-Oliver Grimm, Viktor Grünwald
The phase III, randomized, open-label CheckMate 025 study showed an overall survival benefit in patients with advanced renal cell carcinoma treated with nivolumab versus everolimus. Here, we review the health-related quality of life (HRQoL) results of this trial, in which nivolumab was associated with significant improvements in HRQoL, with more patients having a clinically meaningful HRQoL improvement and a shorter time to onset of improvement compared with everolimus. Further exploratory analysis suggests a positive correlation between baseline HRQoL scores and overall survival...
2017: Oncology and Therapy
https://www.readbyqxmd.com/read/28679776/phase-i-trial-of-intravenous-oncolytic-vaccinia-virus-gl-onc1-with-cisplatin-and-radiotherapy-in-patients-with-locoregionally-advanced-head-and-neck-carcinoma
#14
Loren K Mell, Kevin T Brumund, Gregory A Daniels, Sunil J Advani, Kaveh Zakeri, Mary E Wright, Sara-Jane Onyeama, Robert A Weisman, Parag R Sanghvi, Peter J Martin, Aladar A Szalay
Pre-clinical models have shown that the effectiveness of GL-ONC1, a modified <p>oncolytic vaccinia virus, is enhanced by radiation and chemotherapy. The purpose of this study</p> <p>was to determine the safety of GL-ONC1 when delivered intravenously with chemoradiotherapy</p> <p>to patients with primary, non-metastatic head and neck cancer.</p> <p>EXPERIMENTAL DESIGN: Patients with locoregionally advanced unresected, non-metastatic</p> <p>carcinoma of the head/neck, excluding stage III-IVA p16-positive oropharyngeal cancers, were</p> <p>treated with escalating doses and cycles of intravenous GL-ONC1, along with radiotherapy and</p> <p>chemotherapy...
July 5, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28662677/a-phase-i-ii-trial-of-fixed-dose-stereotactic-body-radiotherapy-with-sequential-or-concurrent-pembrolizumab-in-metastatic-urothelial-carcinoma-evaluation-of-safety-and-clinical-and-immunologic-response
#15
Nora Sundahl, Katrien De Wolf, Sylvie Rottey, Karel Decaestecker, Daan De Maeseneer, Annabel Meireson, Els Goetghebeur, Valérie Fonteyne, Sofie Verbeke, Pieter De Visschere, Dries Reynders, Mireille Van Gele, Lieve Brochez, Piet Ost
BACKGROUND: Current first-line standard of therapy for metastatic urothelial carcinoma is platinum-based combination chemotherapy. Pembrolizumab in phase III has demonstrated a promising overall response rate of 21.1% in patients with progression or recurrence after platinum-based chemotherapy. Preclinical and clinical evidence suggests that radiotherapy has a systemic anti-cancer immune effect and can increase the level of PD-L1 and tumor infiltrating lymphocytes in the tumor microenvironment...
June 29, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28659128/cmisg1701-a-multicenter-prospective-randomized-phase-iii-clinical-trial-comparing-neoadjuvant-chemoradiotherapy-to-neoadjuvant-chemotherapy-followed-by-minimally-invasive-esophagectomy-in-patients-with-locally-advanced-resectable-esophageal-squamous-cell-carcinoma
#16
Han Tang, Lijie Tan, Yaxing Shen, Hao Wang, Miao Lin, Mingxiang Feng, Songtao Xu, Weigang Guo, Cheng Qian, Tianshu Liu, Zhaochong Zeng, Yingyong Hou, Zhentao Yu, Hongjing Jiang, Zhigang Li, Chun Chen, Changhong Lian, Ming Du, Hecheng Li, Deyao Xie, Jun Yin, Naiqing Zhao, Qun Wang
BACKGROUND: Neoadjuvant chemoradiation is not recommended as an approach for treatment of esophageal squamous cell carcinoma due to its significant postoperative mortality. However, it is assumed the combination of neoadjuvant chemoradiation with minimally invasive esophagectomy (MIE) may reduce postoperative mortality, which can revive preoperative chemoradiation. No randomized controlled studies comparing neoadjuvant chemoradiation plus MIE with neoadjuvant chemotherapy plus MIE have been performed so far...
June 28, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28651338/evaluation-of-the-impact-of-tumor-hpv-status-on-outcome-in-patients-with-locally-advanced-unresectable-head-and-neck-squamous-cell-carcinoma-hnscc-receiving-cisplatin-5-fluorouracil-with-or-without-docetaxel-a-subset-analysis-of-eortc-24971-study
#17
A Psyrri, C Fortpied, G Koutsodontis, M Avgeris, C Kroupis, N Goutas, J Menis, L Herman, L Giurgea, E Remenar, M Degardin, I S Pateras, J A Langendijk, C van Herpen, A Awada, J R Germà-Lluch, H R Kienzer, L Licitra, J B Vermorken
Background: EORTC 24971 was a phase III trial demonstrating superiority of induction regimen TPF over PF, in terms of progression-free (PFS) and overall survival (OS) in locoregionally advanced unresectable HNSCC. We conducted a retrospective analysis of prospectively collected data aiming to evaluate whether only HPV(-) patients (pts) benefit from adding docetaxel to PF, in which case de-intensifying induction treatment in HPV(+) pts could be considered. Methods: Pre-therapy tumor biopsies (blocks or slides) were assessed for high-risk HPV by p16 immunohistochemistry, PCR and qPCR...
June 23, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28651158/prospective-validation-of-a-lymphocyte-infiltration-prognostic-test-in-stage-iii-colon-cancer-patients-treated-with-adjuvant-folfox
#18
Jean-François Emile, Catherine Julié, Karine Le Malicot, Come Lepage, Josep Tabernero, Enrico Mini, Gunnar Folprecht, Jean-Luc Van Laethem, Stéphanie Dimet, Camille Boulagnon-Rombi, Marc-Antoine Allard, Frédérique Penault-Llorca, Jaafar Bennouna, Pierre Laurent-Puig, Julien Taieb
BACKGROUND: The prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use. PATIENTS AND METHODS: According to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study...
June 23, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28650002/cabozantinib-use-in-renal-cell-carcinoma
#19
A J Neuwelt, S Mathur, A T Johnson, E R Kessler, D W Bowles
In the last several years, many new drugs have been approved to treat metastatic renal cell carcinoma (RCC). Cabozantinib is a novel multikinase inhibitor with activity against vascular endothelial growth factor receptor (VEGFR), proto-oncogene tyrosine-protein kinase receptor Ret and other kinases that recently joined this impressive list of approved agents. Cabozantinib is an active agent in the preclinical and clinical setting, having recently demonstrated superiority over everolimus in a blinded, randomized phase III study of patients with progressive RCC after at least one prior line of antiangiogenic therapy...
May 2017: Drugs of Today
https://www.readbyqxmd.com/read/28645482/proton-pump-inhibitors-and-survival-outcomes-in-patients-with-metastatic-renal-cell-carcinoma
#20
Aly-Khan A Lalani, Rana R McKay, Xun Lin, Ronit Simantov, Marina D Kaymakcalan, Toni K Choueiri
INTRODUCTION: Proton pump inhibitors (PPIs) are potent inhibitors of gastric acid secretion and can affect the optimal absorption of concomitant oral medications, such as vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKIs). The purpose of this study was to investigate the effect of PPI use on survival in metastatic renal cell carcinoma (mRCC) patients treated in the targeted therapy era. MATERIALS AND METHODS: We conducted a pooled analysis of mRCC patients treated in phase II and III clinical trials...
May 31, 2017: Clinical Genitourinary Cancer
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