A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

Background

Combination of erlotinib and bevacizumab is a promising regimen in advanced non-squamous non-small-cell lung cancer (NSCLC). We are conducting a single arm phase II trial which aims to evaluate the efficacy and safety of this regime as a second- or third-line chemotherapy.

Methods

Key eligibility criteria were histologically or cytologically confirmed non-squamous NSCLC, stage III/IV or recurrent NSCLC not indicated radical chemoradiation, prior one or two regimen of chemotherapy, age 20 years or more, and performance status of two or less. The primary endpoint is objective response rate. The secondary endpoints include overall survival, progression-free survival, disease control rate and incidence of adverse events. This trial plans to accrue 80 patients based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status is planned.

Discussion

We have presented the design of a single arm phase II trial to evaluate the efficacy and safety of combination of bevacizumab and erlotinib in advanced non-squamous NSCLC patients. In particular we are interested in determining the merit of further development of this regimen and whether prospective patient selection using EGFR gene is necessary in future trials.

Trial registration

This trial was registered at the UMIN Clinical Trials Registry as UMIN000004255 (http://www.umin.ac.jp/ctr/index.htm).     

Increased secretion of lignolytic enzymes by the Lentinus tigrinus fungus after addition of butanol and toluene in submerged cultivation

We studied the effects of butanol and toluene on secretion of lignolytic enzymes by the Lentinus tigrinus fungus during submerged cultivation. Addition of butanol and toluene during the trophophase was followed by an increase in laccase and peroxidase activity of the culture and change in the composition of phospholipids and fatty acids. The ratio of phosphatidylcholine and phosphatidic acid decreased, while the amount of lysophosphatidylcholine, phosphatidylethanolamine, phosphoinositides, phosphatidylserine, and unsaturated fatty acids decreased. These changes resulted in an increase in the unsaturation index.     

Potential risk of biologic pollution associated to the introduction of <i>Pinus radiata</i> in grassland areas

Afforestation is a recommended practice to mitigate global warming. However, their implementation may generate undesirable impacts, mostly if exotic species are used. Plantations of Pinus radiata D Don in Ventania (Bs. As., Argentina) soils showed notorious increments of extractable P (Pe), which could affect the dynamic of this element as well as the degree of phosphorus saturation (GSP_Bray). The objectives of this study were: i) to quantify the GSP_Bray in Mollisols afforested with P. radiata comparing the results with those coming from adjacent, natural grassland areas (base line); ii) to evaluate the potential environmental risk induced by afforestation through the identification of a change point (PC) in the GSP_Bray indicative of a phosphate leaching increment. Treatments included mature stands of P. radiata (TB) and adjacent areas with natural grassland vegetation (TP). Samples were taken at 0-15; 15-30 and 30-45 cm soil depth, and texture, pH, total organic carbon (COT), Pe, soluble reactive phosphorus (PSR), phosphorus sorption index (ISP) and GSP_Bray were determined. The results showed a significant acidification in TB and an increase in the COT stock, indicating an additional atmospheric CO₂ sequestration by the trees. The Pe and PSR values were notoriously higher in TB, and they were reflected in a significant increment in the GSP_Bray with respect to TP. The detection of a significant PC in the GSP_Bray-PSR regression indicates higher chances of phosphate leaching in the forest stands, which could reach water courses, lakes and artificial reservoirs promoting their eutrophication. Because of the potential environmental pollution risk of biologic origin derived from the afforestation with P. radiata in Mollisols areas, their inclusion in clean development practices must be reconsidered.     

The role of laccase and peroxidase of <Emphasis Type="Italic">Lentinus (Panus) tigrinus</Emphasis> fungus in biodegradation of high phenol concentrations in liquid medium

The possibility of the usage of Lentinus tigrinus fungus strain VKM F-3616D for biodegradation of high (up to 5%) phenol concentrations in liquid medium and the involvement of laccase and peroxidase in this process have been studied. L. tigrinus fungus was demonstrated to effectively degrade phenol with easy biomass deletion from the liquid. Decrease in phenol concentration was accompanied by increased secretion level and laccase activity at the preliminary stages of biodegradation, while that of peroxidase was at the latest stages of biodegradation. These enzyme secretions in distinct ratios and consequences are necessary for effective phenol biodegradation. An effective approach for phenol concentration decrease in the waste water of smoking shops in meat-processing factories using L. tigrinus fungus was described.     

Interrelation between the composition of lipids and their peroxidation products and the secretion of ligninolytic enzymes during growth of Lentinus (Panus) tigrinus

Lipid composition, intracellular products of lipid peroxidation (LPO), and the activities of extracellular enzymes were studied during submerged cultivation of the xylotrophic fungus Lentinus (Panus) tigrinus VKMF-3616D. The maximum secretion of ligninolytic enzymes during the phase of active mycelium growth correlated with increased content of readily oxidized phospholipids and unsaturated fatty acids and with low content of the LPO products. In the idiophase, which was characterized by lower excretion of extracellular ligninolytic enzymes, the content of more stable phospholipids, saturated fatty acids, and LPO products increased. A relationship between the composition of mycelial lipids and the secretion of ligninolytic enzymes was revealed.     

Interrelation between the composition of lipids and products of their peroxidation and the secretion of ligninolytic enzymes during growth of Lentinus (Panus) tigrinus

Lipid composition, intracellular products of lipid peroxidation (LPO), and the activities of extracellular enzymes were studied during submerged cultivation of the xylotrophic fungus Lentinus (Panus) tigrinus VKM F-3616D. The maximum secretion of ligninolytic enzymes during the phase of active mycelium growth correlated with increased content of readily oxidized phospholipids and unsaturated fatty acids and with low content of the LPO products. In the idiophase, which was characterized by lower excretion of extracellular ligninolytic enzymes, the content of more stable phospholipids, saturated fatty acids, and LPO products increased. A relationship between the composition of mycelial lipids and the secretion of ligninolytic enzymes was revealed.     

Hematopoiesis during remote period after acute radiation syndrome

Based on the long (19.7 +/- 1.8 year) hemopoiesis follow-up study in 152 patients after acute radiation syndrome (ARS) as a result of exposure to gamma-, gamma-beta and gamma-eta radiation in a wide dose range (1.2-9.8 Gy) it was detected that cytopenia appears in the late consequences period: thrombocytopenia was found in 26.9% cases, leukocytopenia, neutropenia and lymphocytopenia--in 13.1% patients. A higher ARS degree causes the increase of various disorders (cytopenia and cytosis) in the late period. It reflects a tight interrelation between blood cell contents and radiation dose. Frequency of cytopenias increases if such somatic disorders: persistent hepatitis, hepatic cirrhosis and late radiation ulcers as appear.     

The usage of marker traits in plants for evaluation of resistance of the winter wheat to pest insects

A new method of selection of the winter wheat varieties has been tested for resistance to the pest insects' complex by the traits of plants that are the markers of plant resistance. It makes it possible to use this method from year to year independently of the pests' density.