A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted,membrane-disrupting peptide,versus paclitaxel alone for refractory or recurrent ovarian cancer

ObjectiveThis randomized open-label phase II study evaluated the safety and clinical activity of EP-100 plus weekly paclitaxel in patients with recurrent ovarian cancer expressing positive LHRH receptor.MethodsIn a limited “run-in” dose escalation phase for EP-100, six patients were treated with ascending dose levels (13 mg/m², 20 mg/m², 30 mg/m²). In the randomized phase, patients received weekly paclitaxel (80 mg/m² intravenously) plus twice weekly EP-100 (30 mg/m² intravenously; combination arm) or weekly paclitaxel alone (80 mg/m² intravenously; paclitaxel arm). The primary study endpoint was overall response rate (ORR).ResultsForty-four patients were then randomized to either the experimental combination arm (n = 23) or the standard of care paclitaxel monotherapy arm (n = 21). The ORR was 35% (95%CI 16%–57%) for the combination arm and 33% (95% CI 15%–57%) for the paclitaxel arm. An interesting observation from an unplanned analysis was that a subset of patients with target liver lesions showed a greater overall response rate to the combination (69%) compared to paclitaxel alone (16%). The frequency of treatment-related grade 3–4 adverse events was similar between treatment arms: 48% vs 43% for the combination and paclitaxel arms, respectively.ConclusionsORR in the EP-100 combination arm was similar to that in the group treated with paclitaxel alone; however, a subset of patients with liver metastases appeared to benefit from the combination. The addition of EP-100 did not appear to augment the adverse event profile of paclitaxel and was well tolerated.     

Social capital and the research agenda in epidemiology

Social capital refers to those features of social organization that enable participants to act together and more effectively pursue common goals. A growing body of evidence suggests that societies with high levels of social capital have lower morbidity and mortality rates and higher life expectancy and are less violent. The main goal of this article is to review the relationship between social capital and health. First, the main concepts and criticisms of social capital theory are discussed. Next, commonly used assessment tools are elucidated. Then, the relationship between social capital and health is analyzed. Finally, the article comments on the theory's application to Brazilian reality. If scientific rigor is applied to social capital research, recognizing theoretical and methodological difficulties, it can expand the research agenda and contribute to a better understanding of how to effectively deal with health inequalities.     

Correlation of ductal lavage cytology with ductoscopy-directed duct excision histology in women at high risk for developing breast cancer: a prospective, single-institution trial

Objectives  

The study was designed to determine which histological lesions produce cellular atypia in lavage specimens and whether ductoscopy adds useful information for the evaluation of high-risk patients with atypical lavage cytology.     

Successful management of Listeria monocytogenes pericarditis: case report and review of the literature

Listeria monocytogenes, although an uncommon cause of illness in the general population, is feared principally because of the morbidity and mortality associated with CNS infections. Cardiovascular involvement with L. monocytogenes is very rare, and has been limited to endocarditis. We describe a case of Listeria pericarditis, which occurred in a 60-year-old man with Child-Pugh B cirrhosis who presented to the emergency department with asthenia, anorexia, and respiratory distress. The echocardiogram showed severe pericardial effusion and after pericardiocentesis, L. monocytogenes was isolated in the culture of pericardial fluid. After surgical pericardiectomy with draining of the pericardial effusion and antibiotic treatment with ampicillin, the patient experienced a slow, but full recovery. Documentation of L. monocytogenes pericarditis is an extremely rare entity with very scarce reports in medical literature, and is usually associated with a very poor prognosis. A case report is presented together with a review of the literature.