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Mackey J.R.,University of Alberta | Ramos-Vazquez M.,Centro Oncologico Of Galicia Jose Antonio Quiroga Y Pineiro | Lipatov O.,Republican Clinical Oncology Dispensary | McCarthy N.,ICON Cancer Care Wesley | And 15 more authors.
Journal of Clinical Oncology | Year: 2015

Purpose: Currently, antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival (PFS) but not improved quality or duration of survival, warranting evaluation of new agents in a placebo-controlled setting. Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation. The ROSE/TRIO-012 trial evaluated ramucirumab with docetaxel in unresectable, locally recurrent, or metastatic breast cancer. Patients and Methods: In this double-blind, placebo-controlled, randomized, multinational phase III trial, 1,144 patients with human epidermal growth factor receptor 2 (HER2) -negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting were randomly assigned at a two-to-one ratio to receive docetaxel 75 mg/m2 plus ramucirumab 10 mg/kg or docetaxel 75 mg/m2 plus placebo once every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria. Patients were stratified by previous taxane therapy, visceral metastasis, hormone receptor status, and geographic region. An independent data monitoring committee oversaw the trial. The primary end point was investigator-assessed PFS. Results: Median PFS in patients treated with ramucirumab plus docetaxel was 9.5 months, compared with 8.2 months in patients who received placebo plus docetaxel (hazard ratio [HR], 0.88; P = .077). Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel, compared with 27.2 months in patients who received placebo plus docetaxel (HR, 1.01; P = .915). Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue, hypertension, febrile neutropenia, palmar-plantar erythrodysesthesia syndrome, and stomatitis. Conclusion: Addition of ramucirumab to docetaxel in HER2-negative advanced breast cancer did not meaningfully improve important clinical outcomes. © 2014 by American Society of Clinical Oncology. Source

Otrock Z.K.,American University of Beirut | Saab J.,American University of Beirut | Aftimos G.,Institute National Of Pathologie | Nasr F.,Hotel Dieu Of France University Hospital | And 28 more authors.
Pathology and Oncology Research | Year: 2013

Incidence of various Hodgkin (HL) and non-Hodgkin lymphoma (NHL) subtypes and association with viruses in Lebanon are not known. We undertook a nationwide study of 272 patients diagnosed with lymphoma in 2007. HL comprised 32.7 % (n = 89) of cases while NHL represented 67.3 % (n = 183). Consistent with the literature, nodular sclerosis was the most predominant HL subtype (n = 57/89). Among NHL, B-cell NHL represented 88 % (n = 161/183), T-cell NHL 9 % (n = 17/183), whereas in 2.7 % it was not classifiable. The B-cell NHL comprised predominantly diffuse large B-cell lymphoma (46 %) and follicular lymphoma (23 %). 81 cases were reviewed by a panel of pathologists with 87.6 % concordance rate. Serology was negative for hepatitis C in 122 tested cases. HIV was positive in 2 cases. Two adult T-cell leukemia/lymphoma were HTLV-I positive. EBV IgG were positive in 88.5 % of cases. 38 EBV seropositive cases [27 NHL (24 B-cell, 3 T-cell) and 11 HL] were studied for EBV genome expression using EBV-encoded RNA (EBER)-in situ hybridization. EBER expression was positive in 8 (21 %) cases (6 HL, 2 T-cell NHL). The distribution of lymphoma subtypes in Lebanon appears similar to that of Western countries. The high rate of EBV positivity in HL and T-cell lymphoma by EBER deserves further investigation. © 2013 Arányi Lajos Foundation. Source

Issa I.,Rafik Hariri University | Taha A.,Rafik Hariri University | Azar C.,Middle East Institute of Health
Obesity Research and Clinical Practice | Year: 2015

Obesity represents a global hazard that predisposes to many serious health problems. Various solutions have been proposed to overcome obesity ranging from dietary balance to bariatric surgery. Intragastric balloons are a widely used measure to decrease weight, although they are advocated as safe devices, some major complications have been reported. We report a case of acute pancreatitis after insertion of a gastric balloon for weight reduction. Abdominal pain associated with nausea and vomiting maybe due to acute pancreatitis caused by compression of the pancreas by the balloon. It is advisable that physicians recognise these complications early to avoid serious and severe end-results. © 2015 Asian Oceanian Association for the Study of Obesity. Source

Rosales R.,Rush University Medical Center | Abou Jaoude E.,Middle East Institute of Health | Al-Arouj M.,Dasman Diabetes Institute | Fawwad A.,Baqai Medical University | And 5 more authors.
Diabetes, Obesity and Metabolism | Year: 2015

The present GUARD study was a prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin with or without metformin in adult patients with type 2 diabetes mellitus (T2DM) studied in routine clinical practice. Patients were enrolled from countries across four geographical regions. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline after 24weeks of treatment with vildagliptin with or without metformin. Of 19331 patients analysed, 3511 received vildagliptin and 15820 received vildagliptin plus metformin. At week 24, the mean HbA1c was reduced significantly from baseline by -1.27% (vildagliptin: -1.17%; vildagliptin plus metformin: -1.29%; p<0.0001). Significant reductions in HbA1c from baseline were consistently reported regardless of patient age, body mass index (BMI) or baseline HbA1c. Weight and BMI were also significantly reduced from baseline. Vildagliptin treatment with or without metformin was generally well tolerated. It provided clinically relevant glycaemic and weight control, and was well tolerated in a large multi-ethnic population of patients with T2DM studied in routine clinical practice. © 2015 John Wiley & Sons Ltd. Source

Elhajj I.H.,American University of Beirut | Dib N.,American University of Beirut | Antoun S.,American University of Beirut | Al-Hajj G.,Middle East Institute of Health
Journal of Medical Devices, Transactions of the ASME | Year: 2010

Sleeve gastrectomy, which is based on reducing the size of the stomach, is one of the most successful bariatric surgeries and is yet to be standardized. One of the reasons is the lack of a method to obtain an accurate remnant stomach volume. The weight loss obtained postsurgery is highly correlated with the remnant stomach volume. Therefore, it is important to get consistently an accurate remnant stomach volume to be able to compare sleeve gastrectomy with other surgeries and in order to predict the weight loss. In addition, the measurement of the pyloric pressure is important for understanding the mechanism of weight loss and predicting complication postsurgery. A surgical assistive device for sleeve gastrectomy surgery is presented in this paper. The purpose of this instrument is to assist surgeons in obtaining an accurate remnant stomach volume and in measuring the pyloric pressure. The device consists of several inflatable compartments controllable by the surgeon. Prototype laboratory test results gave an accuracy of 96.7% and a repeatability of 97.6% for different desired volumes using air for compartment inflation, and an accuracy of 96.3% and a repeatability of 98.4% for different desired volumes using water for compartment inflation. The pressure measurement accuracies obtained are 96.8% using air and 99.7% using water. It is worth noting that these accuracies are expected to differ when the device is tested in vivo. Copyright © 2010 by ASME. Source

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