21 results found
Palmieri C, Stein RC, Liu X, et al., 2017, IRIS study: a phase II study of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER-positive breast cancer patients, Breast Cancer Research and Treatment, Vol: 165, Pages: 343-353, ISSN: 0167-6806
Purpose Irosustat is a first-generation, orally active, irreversiblesteroid sulfatase inhibitor. We performed a multicentre,open label phase II trial of the addition of Irosustatto a first-line aromatase inhibitor (AI) in patients withadvanced BC to evaluate the safety of the combination andto test the hypothesis that the addition of Irosustat to AImay further suppress estradiol levels and result in clinicalbenefit.Experimental design Postmenopausal women with ERpositivelocally advanced or metastatic breast cancer whohad derived clinical benefit from a first-line AI and whosubsequently progressed were enrolled. The first-line AIwas continued and Irosustat (40 mg orally daily) added.The primary endpoint was clinical benefit rate (CBR).Secondary endpoints included safety, tolerability, andpharmacodynamic end points.Results Twenty-seven women were recruited, four discontinuedtreatment without response assessment. Basedon local reporting, the CBR was 18.5% (95% CI6.3–38.1%) on an intent to treat basis, increasing to 21.7%(95% CI 7.4–43.7%) by per-protocol analysis. In thosepatients that achieved clinical benefit (n = 5), the median(interquartile range) duration was 9.4 months (8.1–11.3)months. The median progression-free survival time was2.7 months (95% CI 2.5–4.6) in both the ITT and perprotocolanalyses. The most frequently reported grade 3/4toxicities were dry skin (28%), nausea (13%), fatigue(13%), diarrhoea (8%), headache (7%), anorexia (7%) andlethargy (7%).Conclusions The addition of Irosustat to aromatase inhibitortherapy resulted in clinical benefit with an acceptablesafety profile. The study met its pre-defined successcriterion by both local and central radiological assessments.
Uthaya S, Liu X, Modi N, 2016, Nutritional Evaluation and Optimisation in Neonates trial: is the protein-to-energy ratio important? Reply, AMERICAN JOURNAL OF CLINICAL NUTRITION, Vol: 104, Pages: 1721-1722, ISSN: 0002-9165
Palmieri C, Stein RC, Liu X, et al., 2016, A Phase II study to assess the safety and efficacy of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER positive locally advanced or metastatic breast cancer patients (IRIS) - Trial Results., Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Publisher: AMER SOC CLINICAL ONCOLOGY, ISSN: 0732-183X
Uthaya SN, Liu X, Babalis D, et al., 2016, Nutritional Evaluation and Optimisation in Neonates (NEON): a randomised double-blind controlled trial of amino-acid regimen and intravenous lipid composition in preterm parenteral nutrition, American Journal of Clinical Nutrition, Vol: 103, Pages: 1443-1452, ISSN: 1938-3207
BackgroundParenteral nutrition is central to the care of very immature infants. Current international recommendations favour higher amino-acid intakes and fish oil-containing lipid emulsions. ObjectiveThe aim of this two-by-two factorial, double-blind multicentre randomised controlled trial was to compare the effect of high (immediate Recommended Daily Intake: Imm-RDI) versus low (incremental introduction: Inc-AA) parenteral amino-acid delivery, commenced within 24 hours of birth, on body composition, and a multi-component lipid emulsion containing 30% soy bean oil, 30% medium chain triglycerides, 25% olive oil and 15% fish oil (SMOF) versus soybean oil based lipid emulsion (SO) on Intra-Hepato-Cellular Lipid (IHCL) content. ResultsWe randomised 168 infants born <31 weeks gestation. We evaluated outcomes at term in 133 infants. There were no significant differences between Imm-RDI and Inc-AA groups for non-adipose mass (adjusted mean difference (95% CI): 1.0g (-108, 111) p=0.98) or between SMOF and SO groups for IHCL (adjusted mean ratio SMOF:SO (95% CI): 1.1 (0.8, 1.6) p=0.58). SMOF does not affect IHCL content. There was a significant interaction (p=0.05) between the two interventions for non-adipose mass. There were no significant interactions between group differences for either primary outcome measure after adjusting for additional confounders. Imm-RDI infants were more likely than Inc-AA infants to have blood urea nitrogen levels greater than 7mmol/l or 10mmol/l respectively (75% vs 49%; p<0.01 and 49% vs 18%; p<0.01). Head circumference at term was smaller in the Imm-RDI group (mean difference (95% CI): -0.8cm (-1.5, -0.1) p= 0.02). There were no significant differences in any pre-specified secondary outcomes including adiposity, liver function tests, incidence of conjugated hyperbilirubinaemia, weight, length, mortality and brain volumes. ConclusionsImmediate delivery of Recommended Daily Intake of parenteral amino-acids does not benefit body compo
Shariff MK, Varghese S, O'Donovan M, et al., 2016, Pilot randomized crossover study comparing the efficacy of transnasal disposable endosheath with standard endoscopy to detect Barrett's esophagus, ENDOSCOPY, Vol: 48, Pages: 110-116, ISSN: 0013-726X
di Pietro M, Bird-Lieberman EL, Liu X, et al., 2015, Autofluorescence-Directed Confocal Endomicroscopy in Combination With a Three-Biomarker Panel Can Inform Management Decisions in Barrett's Esophagus, AMERICAN JOURNAL OF GASTROENTEROLOGY, Vol: 110, Pages: 1549-1558, ISSN: 0002-9270
Brown R, Timms K, Paul J, et al., 2015, Homologous recombination (HR) deficiency, tumor BRCA1/2 mutations (tmBRCA) and association with response and outcome following platinum monotherapy in high grade serous ovarian cancer (HGSOC)., Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO) / Clinical Science Symposium on Predicting and Improving Adverse Outcomes in Older Adults with Cancer, Publisher: American Society of Clinical Oncology, ISSN: 0732-183X
Worster E, Liu X, Richardson S, et al., 2014, The Impact of Prophylactic Total Gastrectomy on Health-Related Quality of Life A Prospective Cohort Study, ANNALS OF SURGERY, Vol: 260, Pages: 87-93, ISSN: 0003-4932
di Pietro M, Bird-Lieberman EL, Liu X, et al., 2014, Autofluorescence-Targeted Optical Biopsy Accurately Diagnoses Dysplasia in Barrett's Esophagus and Can Detect the Field of Molecular Change, 55th Annual Meeting of the Society-for-Surgery-of-the-Alimentary-Tract (SSAT) / Digestive Disease Week (DDW), Publisher: W B SAUNDERS CO-ELSEVIER INC, Pages: S312-S312, ISSN: 0016-5085
Liu X, Wong A, Kadri SR, et al., 2014, Gastro-Esophageal Reflux Disease Symptoms and Demographic Factors as a Pre-Screening Tool for Barrett’s Esophagus, PLOS One, Vol: 9, ISSN: 1932-6203
BackgroundBarrett’s esophagus (BE) occurs as consequence of reflux and is a risk factor for esophageal adenocarcinoma. The current “gold-standard” for diagnosing BE is endoscopy which remains prohibitively expensive and impractical as a population screening tool. We aimed to develop a pre-screening tool to aid decision making for diagnostic referrals.Methodology/Principal FindingsA prospective (training) cohort of 1603 patients attending for endoscopy was used for identification of risk factors to develop a risk prediction model. Factors associated with BE in the univariate analysis were selected to develop prediction models that were validated in an independent, external cohort of 477 non-BE patients referred for endoscopy with symptoms of reflux or dyspepsia. Two prediction models were developed separately for columnar lined epithelium (CLE) of any length and using a stricter definition of intestinal metaplasia (IM) with segments ≥2 cm with areas under the ROC curves (AUC) of 0.72 (95%CI: 0.67–0.77) and 0.81 (95%CI: 0.76–0.86), respectively. The two prediction models included demographics (age, sex), symptoms (heartburn, acid reflux, chest pain, abdominal pain) and medication for “stomach” symptoms. These two models were validated in the independent cohort with AUCs of 0.61 (95%CI: 0.54–0.68) and 0.64 (95%CI: 0.52–0.77) for CLE and IM≥2 cm, respectively.ConclusionsWe have identified and validated two prediction models for CLE and IM≥2 cm. Both models have fair prediction accuracies and can select out around 20% of individuals unlikely to benefit from investigation for Barrett’s esophagus. Such prediction models have the potential to generate useful cost-savings for BE screening among the symptomatic population.
di Pietro M, Boerwinkel DF, Shariff MK, et al., 2014, The combination of autofluorescence endoscopy and molecular biomarkers is a novel diagnostic tool for dysplasia in Barrett's oesophagus, Gut, Vol: 64, Pages: 49-56, ISSN: 0017-5749
Objective Endoscopic surveillance for Barrett's oesophagus (BO) is limited by sampling error and the subjectivity of diagnosing dysplasia. We aimed to compare a biomarker panel on minimal biopsies directed by autofluorescence imaging (AFI) with the standard surveillance protocol to derive an objective tool for dysplasia assessment.Design We performed a cross-sectional prospective study in three tertiary referral centres. Patients with BO underwent high-resolution endoscopy followed by AFI-targeted biopsies. 157 patients completed the biopsy protocol. Aneuploidy/tetraploidy; 9p and 17p loss of heterozygosity; RUNX3, HPP1 and p16 methylation; p53 and cyclin A immunohistochemistry were assessed. Bootstrap resampling was used to select the best diagnostic biomarker panel for high-grade dysplasia (HGD) and early cancer (EC). This panel was validated in an independent cohort of 46 patients.Results Aneuploidy, p53 immunohistochemistry and cyclin A had the strongest association with dysplasia in the per-biopsy analysis and, as a panel, had an area under the receiver operating characteristic curve of 0.97 (95% CI 0.95 to 0.99) for diagnosing HGD/EC. The diagnostic accuracy for HGD/EC of the three-biomarker panel from AFI+ areas was superior to AFI− areas (p<0.001). Compared with the standard protocol, this panel had equal sensitivity for HGD/EC, with a 4.5-fold reduction in the number of biopsies. In an independent cohort of patients, the panel had a sensitivity and specificity for HGD/EC of 100% and 85%, respectively.Conclusions A three-biomarker panel on a small number of AFI-targeted biopsies provides an accurate and objective diagnosis of dysplasia in BO. The clinical implications have to be studied further.
Talsma AK, Ong C-AJ, Liu X, et al., 2014, Location of Lymph Node Involvement in Patients with Esophageal Adenocarcinoma Predicts Survival, WORLD JOURNAL OF SURGERY, Vol: 38, Pages: 106-113, ISSN: 0364-2313
Levine DM, Ek WE, Zhang R, et al., 2013, A genome-wide association study identifies new susceptibility loci for esophageal adenocarcinoma and Barrett's esophagus, NATURE GENETICS, Vol: 45, Pages: 1487-U119, ISSN: 1061-4036
Liu X, Wong A, Kadri SR, et al., 2013, GORD Symptoms and Demographic Factors As a Pre-Screening Tool for Barrett's Oesophagus, Publisher: W B SAUNDERS CO-ELSEVIER INC, Pages: S687-S688, ISSN: 0016-5085
Ong C-AJ, Shapiro J, Nason KS, et al., 2013, Three-Gene Immunohistochemical Panel Adds to Clinical Staging Algorithms to Predict Prognosis for Patients With Esophageal Adenocarcinoma, JOURNAL OF CLINICAL ONCOLOGY, Vol: 31, Pages: 1576-1582, ISSN: 0732-183X
Alvi MA, Liu X, O'Donovan M, et al., 2013, DNA Methylation as an Adjunct to Histopathology to Detect Prevalent, Inconspicuous Dysplasia and Early-Stage Neoplasia in Barrett's Esophagus, CLINICAL CANCER RESEARCH, Vol: 19, Pages: 878-888, ISSN: 1078-0432
Liu X, Zhang J, Liu Y, et al., 2012, The Association between Cesarean Delivery on Maternal Request and Method of Newborn Feeding in China, PLOS One, Vol: 7, ISSN: 1932-6203
BackgroundCesarean delivery has increased significantly during the last decades. This study aimed to investigate the association between planned mode of delivery and method of feeding.Methodology/Principal FindingsA cohort was created retrospectively using data from a population-based maternal and child health surveillance system, which covers 27 study sites in China from 1993 to 2006. The cohort consisted of 431,704 women for analysis, including 22,462 women with planned cesarean delivery on maternal request (CDMR) and 409,242 women with planned vaginal delivery (VD). Logistic regression models were used to examine the association between mode of delivery and method of feeding adjusting for selected covariates. In this cohort, 398,176 (92.2%) women exclusively breastfed their baby, 28,798 (6.7%) women chose mixed feeding, and 4,730 (1.1%) women chose formula feeding before hospital discharge. Women who planned CDMR were less likely to exclusively breastfeed and more likely to formula feed their babies than those who planned VD. After adjusting for covariates, the odds ratios were 0.85 (95% CI: 0.81–0.89) for exclusive breastfeeding and 1.61 (95% CI: 1.45–1.79) for formula feeding. Associations between planned mode of delivery and method of feeding in the south, north, rural and urban areas yielded similar results.ConclusionThis study demonstrated that planned CDMR was associated with a lower rate of exclusive breastfeeding and a higher rate of formula feeding in a low-risk Chinese population.
Shariff KM, di Pietro M, Boerwinkel DF, et al., 2012, Time: A Prospective Study Combining Endoscopic Trimodal Imaging and Molecular Endpoints to Improve Risk Stratification in Barrett's Esophagus, Digestive Disease Week (DDW), Publisher: W B SAUNDERS CO-ELSEVIER INC, Pages: S165-S165, ISSN: 0016-5085
Shariff MK, Bird-Lieberman EL, O'Donovan M, et al., 2012, Randomized crossover study comparing efficacy of transnasal endoscopy with that of standard endoscopy to detect Barrett's esophagus, GASTROINTESTINAL ENDOSCOPY, Vol: 75, Pages: 954-961, ISSN: 0016-5107
Alvi MA, Liu X, O'Donovan M, et al., 2012, DNA Methylation is a Biomarker for Dysplasia and Early-Stage Neoplasia in Barrett's Esophagus: From Discovery to a Phase 4 Prospective Validation Study, Digestive Disease Week (DDW), Publisher: W B SAUNDERS CO-ELSEVIER INC, Pages: S443-S443, ISSN: 0016-5085
Cummings NM, Rassl DM, Boobier HC, et al., 2011, EPITHELIAL MESENCHYMAL TRANSITION OCCURS EARLY IN SQUAMOUS CELL LUNG CANCER DEVELOPMENT, JOURNAL OF THORACIC ONCOLOGY, Vol: 6, Pages: S1083-S1083, ISSN: 1556-0864
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