Mackey J.R.,University of Alberta |
Ramos-Vazquez M.,Centro Oncologico Of Galicia Jose Antonio Quiroga Y Pineiro |
Lipatov O.,Bashkortostan Republic Ministry of Health |
McCarthy N.,ICON Cancer Care Wesley |
And 16 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.
PubMed | Surgery Academy, CUF Porto Hospital Estrada da Circunvalacao 14341, Middle East Institute of Health and Aretaeio hospital Andrea Avraamidi 55 57
Type: Journal Article | Journal: Facts, views & vision in ObGyn | Year: 2016
The efficiency of suturing training and testing (SUTT) model by laparoscopy was evaluated, measuring the suturingskill acquisition of trainee gynecologists at the beginning and at the end of a teaching course. During a workshop organized by the European Academy of Gynecological Surgery (EAGS), 25 participants with three different experience levels in laparoscopy (minor, intermediate and major) performed the 4 exercises of the SUTT model (Ex 1: both hands stitching and continuous suturing, Ex 2: right hand stitching and intracorporeal knotting, Ex 3: left hand stitching and intracorporeal knotting, Ex 4: dominant hand stitching, tissue approximation and intracorporeal knotting). The time needed to perform the exercises is recorded for each trainee and group and statistical analysis used to note the differences. Overall, all trainees achieved significant improvement in suturing time (p < 0.005) as measured before and after completion of the training. Similar significantly improved suturing time differences (p < 0.005) were noted among the groups of trainees with different laparoscopic experience. In conclusion a short well-guided training course, using the SUTT model, improves significantly surgeons laparoscopic suturing ability, independently of the level of experience in laparoscopic surgery.Endoscopy, laparoscopic suturing, psychomotor skills, surgery, teaching, training suturing model.
A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer
Mubarak N.,Eli Lilly and Company |
Gaafar R.,Cairo University |
Shehata S.,Assiut University |
Hashem T.,Menoufia University |
And 5 more authors.
BMC Cancer | Year: 2012
Background: Maintenance therapy for non-small cell lung cancer (NSCLC) aims to extend disease control after first-line chemotherapy with active and well-tolerated agents. The utility of continuation maintenance therapy requires further research.Methods: This multicenter, randomized, phase 2 study compared continuation maintenance therapy with pemetrexed (500 mg/m2 every 21 days) and best supportive care (BSC) versus BSC alone in patients with advanced, non-squamous NSCLC who had not progressed after 4 cycles of induction chemotherapy with pemetrexed (500 mg/m2) and cisplatin (75 mg/m2). The primary endpoint was progression-free survival (PFS) from randomization, was analyzed using a Cox model, stratified for the tumor response at the end of induction therapy, at a one-sided alpha of 0.2. Secondary endpoints: response and disease control rates, overall survival (OS), one year survival rates, and treatment-emergent adverse events (TEAEs).Results: A total of 106 patients commenced induction therapy, of whom 55 patients were randomized to maintenance pemetrexed/BSC (n = 28) or BSC (n = 27). Although the median PFS time for maintenance phase for both arms was 3.2 months, the one-sided p-value for the PFS HR comparison was less than the prespecified limit of 0.2 (HR = 0.76, two-sided 95% confidence interval [CI]: 0.42 to 1.37; one-sided p-value = 0.1815), indicating that PFS was sufficiently long in the pemetrexed/BSC arm to warrant further investigation. Similar PFS results were observed for the overall study period (induction plus maintenance) and when the PFS analysis was adjusted for sex, baseline disease stage, and the ECOG PS prior to randomization. The median OS for the maintenance phase was 12.2 months (95%CI: 5.6 to 20.6) for the pemetrexed/BSC arm and 11.8 months (95% CI: 6.3 to 25.6) for BSC arm. The one-year survival probabilities were similar for both arms for the maintenance phase and the overall study period. Both the induction and continuation maintenance therapies were generally well-tolerated, and similar proportion of patients in each arm experienced at least 1 grade 3/4 TEAE (pemetrexed/BSC, 17.9%; BSC, 18.5%).Conclusions: Continuation pemetrexed maintenance therapy resulted in promising PFS with an acceptable safety profile in a Middle Eastern population with advanced non-squamous NSCLC and is worthy of further investigation.Trial registration: NCT00606021. © 2012 Mubarak et al.; licensee BioMed Central Ltd.
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.
PubMed | Rafik Hariri University, Hotel Dieu Of France Hospital, American University of Beirut, University of Balamand and 12 more.
Type: | Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases | Year: 2016
Antimicrobial resistance is closely linked to antimicrobial use and is a growing concern worldwide. Antimicrobial resistance increases healthcare costs substantially in many countries, including Lebanon. National data from Lebanon have, in the most part, been limited to a few academic hospitals. The Lebanese Society of Infectious Diseases conducted a retrospective study to better describe the antimicrobial susceptibility patterns of bacterial isolates in Lebanon. Data were based on records retrieved from the bacteriology laboratories of 16 different Lebanese hospitals between January 2011 and December 2013. The susceptibility results of a total 20684 Gram-positive and 55594 Gram-negative bacteria were analyzed. The prevalence rate of methicillin-resistant Staphylococcus aureus was 27.6% and of vancomycin-resistant Enterococcus spp was 1%. Streptococcus pneumoniae had susceptibilities of 46% to oxacillin, 63% to erythromycin, and 98% to levofloxacin. Streptococcus pyogenes had susceptibilities of 94% to erythromycin and 95% to clindamycin. The mean ampicillin susceptibility of Haemophilus influenzae, Salmonella spp, and Shigella spp isolates was 79%, 81.3%, and 62.2%, respectively. The extended-spectrum beta-lactamase production rate for Escherichia coli was 32.3% and for Klebsiella spp was 29.2%. Acinetobacter spp showed high resistance to most antimicrobials, with low resistance to colistin (17.1%). Pseudomonas spp susceptibilities to piperacillin-tazobactam and imipenem were lower than 80% (79.7% and 72.8%, respectively). This study provides population-specific data that are valuable in guiding antimicrobial use in Lebanon and neighbouring countries and will help in the establishment of a surveillance system for antimicrobial resistance following the implementation of a nationwide standardization of laboratory methods and data entry.
Saadeh C.,Notre Dame University - Louaize |
Saadeh C.,Lebanese University |
Saadeh C.,Sacre Coeur Hospital |
Saadeh C.,Middle East Institute of Health |
And 4 more authors.
Journal of Vascular Surgery | Year: 2013
Objective The optimal management of preoperative clopidogrel remains controversial, as vascular surgeons are increasingly encountering patients treated with clopidogrel as part of dual antiplatelet therapy. Current practice differs considerably, from cessation of the medication at least 5 days before surgery to proceeding with surgery without delay. The purpose of this prospective, nonrandomized, comparative study was to determine the effect of preoperative exposure to clopidogrel and aspirin on perioperative bleeding complications in patients undergoing open arterial surgery. Methods Data were collected prospectively on 647 consecutive major arterial procedures from 2005 through mid-2012. Patients were classified into two groups: the clopidogrel group consisted of 305 procedures performed in 269 patients who were maintained, after obtaining informed consent, on dual clopidogrel and aspirin up to the time of surgery and the no-clopidogrel group consisted of 342 procedures completed in 298 patients who were taking neither medication together or were taking aspirin alone. The primary composite end point was reoperation for bleeding and bleeding-related death. Secondary end points included blood transfusion requirements, hematoma formation, the procedure duration, as well as hospital and intensive care unit length of stay. Results The patients taking clopidogrel had a higher cardiovascular risk profile and a higher prevalence of prior peripheral and coronary stents (P <.0001). Clopidogrel use was common across all operation categories: 59% of carotid endarterectomy patients (104 of 177), 43% of lower extremity bypass patients (147 of 344), and 43% of abdominal aortic bypass patients (54 of 126). The difference in the primary end point between the clopidogrel and no-clopidogrel groups was not statistically significant (0.65% and 0.3%, respectively; P =.55). No bleeding-related deaths were observed. Further analysis revealed a similar incidence of stable hematomas. Blood transfusions were mainly required by patients undergoing aortic surgery, at similar rates and volumes in the clopidogrel and no-clopidogrel groups: abdominal aortic bypass cohort (a mean of 1.6 units packed red blood cells needed in 72% vs a mean of 1.6 units in 69%, respectively; P =.76); lower extremity bypass cohort (a mean of 1.5 units needed in 15% vs 1.3 units needed in 11%; P <.004). The mean operative time and intensive care unit and hospital lengths of stay were not longer in clopidogrel recipients. Conclusions Combined therapy with clopidogrel and aspirin up to the day of surgery is not associated with increased bleeding complications or transfusion requirements. Data from this study do not validate the perceived higher risk of perioperative bleeding in clopidogrel patients and do support the strategy of continued clopidogrel use in patients undergoing peripheral arterial surgery. Copyright © 2013 by the Society for Vascular Surgery.
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.
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.
PubMed | Middle East Institute of Health and Rafik Hariri University
Type: Journal Article | Journal: Obesity research & clinical practice | Year: 2016
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.
PubMed | Middle East Institute Of Health
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016
17149 Background: Erlotinib has shown good activity in lung cancer.Brain metastases remain a major problem in lung cancer treatment because of the blood brain barrier.We report three cases of adenocarcinoma of the lung metastatic to the brain treated with erlotinib100 mg daily.Two males (age 54 and 57 years) and one female (age 50 years). The two male patients received combination chemotherapy for stage IV disease (carboplatine, gemcitabine, docetaxel) and recurred after initial response. Both have been irradiated to brain with relapse. The female patient received adjuvant chemotherapy (carboplatine and gemcitabine) and adjuvant radiation to the mediastinum and presented one month after the end of radiation with right upper limb paralysis and clonic crisis.The three patients presented very rapid response to erlotinib, with almost disappearance of neurological signs within the first two weeks. MRI of the brain showed partial response after 15 days in two patients and after one month in the third. The female patient is still responding and well doing after four months on erlotinib without radiation nor corticosteroids or antiepileptics, the later treatments being refused by the patient. One male patient died from pulmonary embolism 40 days after the initiation of erlotinib while he was still presenting tumor response. The other two patients are still alive with partial response and no neurological symptoms, four months after the initiation of erlotinib.We believe that erlotinib deserves further evaluation in non small cell lung cancer metastatic to the brain. The very quick response to treatment can select responders very early because of the cost of the drug. No significant financial relationships to disclose.