The purpose of this trial is to determine the benefit of the combination of nab-paclitaxel plus gemcitabine given for 6 cycles, followed by maintenance
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The use of hyperoncotic albumin (HA) for shock resuscitation is controversial given concerns about its cost, effectiveness, and potential for nephrotoxicity. We evaluated the association between early exposure to hyperoncotic albumin (within the first 48 h of onset of shock) and acute organ dysfunction in post-surgical patients with shock. This retrospective, cohort study included 11,512 perioperative patients with shock from 2009 to 2012. Shock was defined as requirement for vasopressors to maintain adequate mean arterial pressure and/or elevated lactate (| 2.2 mmol/L). Subsets of 3600 were selected after propensity score and exact matching on demographics, comorbidities, and treatment variables (| 30). There was a preponderance of cardiac surgery patients. Proportional odds logistic regression, multivariable logistic regression or Cox proportional hazard regression models measured association between hyperoncotic albumin and acute kidney injury (AKI), hepatic injury, ICU days, and mortality.
OBJECT: Human albumin is used to induce hypervolemia (central venous pressure [CVP] , 8 mm Hg) after subarachnoid hemorrhage (SAH). Unfortunately, human albumin may increase the mortality rate in critically ill patients; because of this, its use became restricted in the authors hospital in May 1999. The goal of this study was to determine the effect of human albumin on outcome and cost in patients with SAH before and after this restriction was put into place. METHODS: All patients with aneurysmal SAH who were admitted to the authors institution between May 1998 and May 2000 were studied. Basic demographic information, dosage of human albumin given, length of stay, and the incidence of in-hospital deaths and complications were collected. The authors obtained Glasgow Outcome Scale (GOS) scores at 3 months after SAH (good outcome, GOS , or = 4). Data were analyzed using t-test and chi-square analysis. Logistic regression was used to identify independent associations between use of human albumin ...
5438 Background: Docetaxel (Taxotere) is currently formulated in the surfactant Tween 80. Removal of surfactants from taxane formulations e.g., in the case of nanoparticle albumin-bound paclitaxel (Abraxane) resulted in significantly higher response rates and greater safety (Gradishar, JCO, 2005, 23:7794). Tween 80 strongly inhibited the binding of taxanes to albumin, possibly inhibiting albumin based drug transport via the gp60 endothelial receptor (Desai, EORTC-NCI-AACR, 2004) and consequent reduction of albumin-binding to tumor secreted SPARC. Herein, we compared the efficacy, toxicity, and pharmacokinetics (PK) of nab-docetaxel vs Taxotere. Methods: Nanoparticle nab-docetaxel was prepared using nab technology and characterized. Nab-docetaxel and Taxotere were tested in vivo against HCT-116 human colon carcinoma xenograft in nude mice (n=10/group) at equitoxic doses of 22 mg/kg of nab-docetaxel and 15 mg/kg of Taxotere, on a q4dx3 schedule. Single dose toxicity (TOX) of nab-docetaxel was ...
article{8d460a00-2713-4df9-af4f-6169013fd070, author = {Bakoush, Omran and Tencer, Jan and Torffvit, Ole and Tenstad, Olav and Skogvall, Ingela and Rippe, Bengt}, issn = {1460-2385}, language = {eng}, number = {7}, pages = {1724--1731}, publisher = {Oxford University Press}, series = {Nephrology Dialysis Transplantation}, title = {Increased glomerular albumin permeability in old spontaneously hypertensive rats.}, url = {http://dx.doi.org/10.1093/ndt/gfh276}, volume = {19}, year = {2004 ...
Preclinical studies have recently shown that albumin has neuroprotective effects for stroke in animal models. Thus, we sought to evaluate the effects of albumin therapy in patients with acute cerebral infarcts. We prospectively studied 49 patients with moderate-to-severe cerebral infarcts within the middle cerebral arterial territory into one of two groups: the control group (N = 18) received saline, whereas the albumin group (N = 31) received either 40 g or 80 g of albumin within 24 h from symptom onset.. The modified National Institutes of Health Stroke Scale (mNIHSS) and diffusion-weighted imaging (DWI) were serially checked. There was no adverse effect related to albumin therapy. Although there was no significant difference in both baseline mNIHSS score and DWI lesion volume on admission, the mNIHSS scores at the 14(th) day after treatment and the increase in DWI lesion volume 72-96 h after treatment were significantly reduced in patients of the albumin group (p = 0.001 and 0.012, ...
[126 Pages Report] Check for Discount on Global Albumin-based Sealants Sales Market Report 2016 report by QYResearch Group. Notes: Sales, means the sales volume of Albumin-based Sealants...
Purpose: Circulating Tumor cells (CTC) are prognostic in metastatic breast cancer (MBC). We tested whether EpCAM based capture system (CellSearch®) is effective in patients with triple negative (TN) MBC, and whether CTC-apoptosis and clustering enhances the prognostic role of CTC. Experimental Design: CTC enumeration and apoptosis was determined using the CXC CellSearch® kit at baseline and days 15 and 29 in blood drawn from TN MBC patients who participated in a prospective randomized phase II trial of nanoparticle albumin-bound paclitaxel (nab-PAC) with or without tigatuzumab (TIG). Association between levels of CTC and patient outcomes was assessed using logistic regression, Kaplan Meier curves, and Cox proportional hazards modeling. Results: Nineteen of 52 (36.5%), 14/52 (26.9%), and 13/49 (26.5%) patients who were evaluable had elevated CTC (≥5CTC/7.5 ml WB) at baseline, days 15 and 29, respectively. Patients with elevated vs. not elevated CTC at each time point had worse progression ...
this section was added after the table:. Description of selected adverse reactions Blood and lymphatic system disorders. Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients. Grade 4 neutropenia (, 0.5 x 109/l) occurred in 9% of patients treated with Abraxane. Febrile neutropenia occurred in four patients on Abraxane. Anaemia (Hb , 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb , 8 g/dl) in three cases. Lymphopenia was observed in 45% of the patients.. Nervous system disorders In general, the frequency and severity of neurotoxicity was dose‑dependent in patients receiving Abraxane. Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.. Gastrointestinal disorders Nausea occurred in 29% of the patients and diarrhoea in 25% of the ...
Pancreatic cancer is a hypoperfused tumor, characterized by a high stroma density precluding cytotoxics delivery to the epithelial tumoral compartment. There is thus a rationale for combining chemotherapy and antistromal drugs like nab-paclitaxel (Abraxane), a solvent (Cremophor® EL)-free, albumin-bound form of paclitaxel that has been initially developed to reduce the toxicities associated with Taxol injection while maintaining or improving its chemotherapeutic effect. This unique protein formulation provides a novel approach of increasing intra-tumoral concentrations of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell.. Abraxane has been approved for commercialization in 38 countries, including the US, Canada, the EU, Australia, China, India and Korea for the treatment of women with metastatic breast cancer. Abraxane alone and in combination is being evaluated in a number of cancers, including metastatic melanoma, non-small cell lung cancer, ...
Biocon Limited, Indias pioneering biotechnology company, and Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced the launch of ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration). In October 2007, ABRAXANE was approved by the Drug Controller General of India. The approval was based on the clinical trial data that was the basis of approval in the United States. The Phase III clinical trial in the U.S. demonstrated that ABRAXANE nearly doubled the response rate, significantly prolonged time to progression, and significantly improved overall survival in the second-line setting versus solvent-based Taxol(R) in the ...
Introduction- Exercise-induced plasma volume (PV) expansion is typically associated with an increase in plasma albumin content. Increased hepatic albumin synthesis, a transcriptionally regulated process, is thought to contribute to the increase in albumin content. Objective- We tested the hypothesis that exercise training induces an increase in albumin gene expression in relationship to the increase in PV. Methods and Results- 40 adult male Sprague-Dawley rats weighing between 245-350 grams were randomly assigned to one of four groups: cage control (CC); sham exercise 10 min/day at 48% VO2max (NE); continuous exercise training, 60 min /day at 72% VO2max (LI); and high intensity, intermittent exercise training, 8 bouts of 4 min at 98% VO2max followed by 5 min at 48% VO2max (HI). The training period lasted for two weeks with 12 training sessions with equalized training volumes in the exercise groups. 24 hours after the last training session the rats were anesthetized and a jugular catheter was placed for
Decreased albumin synthesis by hepatocytes in liver injury is thought to occur in response to Kupffer cell-derived acute-phase cytokines. In this study we used hepatocytes maintained in a differentiated phenotype, by culture on a laminin-rich gel substratum (Engelbreth-Holm-Swarm matrix), to investigate the effects of Kupffer cell-conditioned medium and purified cytokines (interleukin-1, interleukin-6 and tumor necrosis factor-a) on albumin synthesis. Kupffer cell-conditioned medium caused a reversible decrease in albumin synthesis to 64.7% of control (p , 0.01, Wilcoxons rank sum test, n = 11) on day 2. Repeated doses caused further dose-dependent reversible responses. The same result was obtained when protease inhibitors (α1-antitrypsin and α2-macroglobulin) were added to Kupffer cell-conditioned medium (n = 3), thus eliminating the potential effect of matrix degradation. Pure interleukin-1, interleukin-6 and tumor necrosis factor-α also inhibited albumin synthesis (p , 0.05, Wilcoxons ...
The phase III clinical trials in the US and China on which this approval was based demonstrated that Abraxane doubled the response rate, significantly prolonged time to tumour progression, and in the US trial, significantly improved overall survival versus Taxol in the approved indication.. Data from the US pivotal head-to-head trial demonstrated that Abraxane nearly doubled the overall response rate versus Taxol (33% vs. 19%; P = .001) and achieved a 25% percent improvement in time to tumour progression when compared to Taxol. Furthermore, patients receiving Abraxane in the second-line setting had a significantly prolonged survival by an additional 27% compared to solvent-based Taxol. The tolerability with Abraxane and Taxol was comparable, despite the 50% greater dose of paclitaxel administered as Abraxane.. A second head-to-head trial in Chinese patients with metastatic breast cancer further demonstrated the improved efficacy of Abraxane compared to solvent-based Paclitaxel Injection. ...
Next article in issue: Detection of albumin messenger RNA in blood is not restricted to hepatocellular carcinoma Next article in issue: Detection of albumin messenger RNA in blood is not restricted to hepatocellular carcinoma ...
Abraxane® (nab-paclitaxel) prolonged life in patients with metastatic pancreatic cancer by an average of two months longer than chemotherapy and significantly increased the percentage of patients who survived for up to two years, according to the results of a study presented at the 2013 Gastrointestinal Cancers Symposium in San Francisco.. Pancreatic cancer is one of the deadliest forms of cancer. Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and close to 37,000 die from the disease. The disease is often diagnosed at an advanced stage, and treatment of advanced disease remains challenging.. Gemzar® (gemcitabine) has been a standard chemotherapy drug for the treatment of advanced pancreatic cancer for some time. Abraxane is a novel form of the widely used cancer drug Taxol (paclitaxel). In Abraxane, the paclitaxel is bound to albumin, a human protein in tiny particles. This formulation improves the delivery of the drug directly to cancer cells ...
Rabbit plasma albumin was labelled with I131, injected intravenously, and measurements were made of the radioactivity in plasma, urine, and feces over many days. In some experiments plasma radioactivity was fractionated into I131-albumin activity and that of labelled breakdown products. Curves of these radioactivities were compared with corresponding curves predicted by four mathematical models. Each model included a vascular and extravascular albumin compartment in transfer equilibrium, a radioactive breakdown products compartment, and an excretion compartment; but model A supposed I131-albumin catabolism to occur within the vascular system, model B within the extravascular compartment, model C within both, and model D within a separate compartment receiving albumin for catabolism from the plasma. The experimental data were reasonably well predicted by models A and C. However, model D, though data were insufficient for its complete validation, gave the best predictions and agrees with present ...
TY - JOUR. T1 - Treatment Rationale and Design for J-AXEL. T2 - A Randomized Phase 3 Study Comparing Nab-Paclitaxel With Docetaxel in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer. AU - Yoneshima, Yasuto. AU - Morita, Satoshi. AU - Ando, Masahiko. AU - Miura, Satoru. AU - Yoshioka, Hiroshige. AU - Abe, Tetsuya. AU - Kato, Terufumi. AU - Kondo, Masashi. AU - Hosomi, Yukio. AU - Hotta, Katsuyuki. AU - Yamamoto, Nobuyuki. AU - Kishimoto, Junji. AU - Nakanishi, Yoichi. AU - Okamoto, Isamu. PY - 2017/1/1. Y1 - 2017/1/1. N2 - Background Nanoparticle albumin-bound (nab) paclitaxel is a promising new therapeutic agent for all histologic types of non-small-cell lung cancer (NSCLC). We recently performed a phase 2 study of weekly nab-paclitaxel in patients with previously treated advanced NSCLC, finding promising activity and acceptable toxicity for this regimen. We have now designed a randomized phase 3 intergroup study (J-AXEL, UMIN000017487) to examine the clinical benefit and ...
The review by Wilkes and Navickis is the 13th meta-analysis evaluating the effect of fluids on mortality in seriously ill patients. The strengths of this meta-analysis are the comprehensive search strategies used to identify primary studies, which minimised publication and English language bias; the explicit selection criteria used; the use of methodological quality, such as random assignment, as an inclusion criterion; extraction of data in duplicate; and rating of treatment allocation, crossovers, and blinding for each included study. However, all relevant co-interventions, such as blood products, were not well reported in the original trials. 23 of 78 potentially eligible studies were excluded because no mortality data were available, highlighting how many trials were designed to address short term physiological endpoints.. In this meta-analysis, the relative risk (RR) of mortality for all patients was 1.11 (table⇑). Subgroup analyses were planned a priori, and included surgery or trauma ...
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Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq® (atezolizumab) in combination with chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive NSCLC. This decision is based on results from the Phase III IMpower130 study, which demonstrated that the Tecentriq combination therapy helped people live significantly longer, compared with chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months; hazard ratio [HR]=0.79; 95% CI: 0.64-0.98; p=0.033) in the intention-to-treat (ITT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (median ...
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Although gemcitabine exhibits potent cytotoxicity against PDA cells in vitro, its short half-life may contribute to its relatively weak antitumor activity in vivo. Indeed, methods that increase gemcitabine delivery (3) or stability (22) have been proposed to circumvent this problem clinically. Taxanes are also active in pancreatic cancer xenografts and patients, although treatment is limited by systemic toxicity (23, 24). nab-Paclitaxel is a solvent-free formulation composed of paclitaxel and human albumin with a mean particle size of 130 nm. It offers several advantages over solvent-based paclitaxel, including increased water solubility that obviates Cremophor EL-based toxicities. In addition, albumin is hypothesized to target paclitaxel to stromal-rich tumors and thereby increase the local concentration. Although combinations of gemcitabine and taxanes have demonstrated antitumor activity in patients with PDA, its toxicity has limited its use in the clinic (25). Accumulating clinical data ...
The Therapeutic Goods Administration (TGA) has taken steps today to quarantine CSL Human Albumin solutions from further use while an asse
Relationship between ischemia/reperfusion-induced albumin clearance across the mucosa of the small intestine and the reduction in oxygen consumption induced during the ischemic period. Used with permission from Gastroenterology 1985; 89: pp. 852-857.
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TY - JOUR. T1 - Macromolecule uptake into the cultured endothelial cells and the cell morphology in separated flow. AU - Kudo, Susumu. AU - Sato, Masashi. AU - Machida, Kazutoshi. AU - Yamaguchi, Ryuhei. AU - Kurokawa, Motoyoshi. AU - Matsuzawa, Teruo. AU - Ikeda, Mariko. AU - Oka, Kotaro. AU - Tanishita, Kazuo. PY - 1999/11. Y1 - 1999/11. N2 - One purpose of this study is to investigate the morphological change of endothelial cells in a separated flow area. The other is to reveal the albumin uptake into endothelial cells, the albumin uptake area, and the its content per unit area in the separated flow area. After 24 hr of exposure to flow induced in a back step flow channel, the endothelial cells were incubated in 37°C for 60 minutes in PBS containing tetramethylrhodamine isothiocyanate conjugated albumin (TRITC-albumin). Thereafter, the cell morphology, the density, and the albumin uptake were observed by a confocal laser scanning microscope (CLSM). In low shear stress areas (stagnant and ...
The National Institute for Health and Care Excellence has published new recommendations rejecting the use of Celgene’s Abraxane (nab-paclitaxel) on the National Health Service to treat patients with advanced pancreatic cancer. - News - PharmaTimes
This trial will investigate the efficacy and tolerability of everolimus [RAD001] and paclitaxel [Abraxane] in women with locally advanced or metastatic breast
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Paclitaxel, Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline co
Phase II LAPACT trial results reported on the safety and efficacy of ABRAXANE + gemcitabine induction therapy on tumor burden, disease control, and symptoms SUMMIT, N.J.--(BUS...
Sorry for this but I feel I should ask a different question related to my other Thread. Here it is: Is anyone here aware of an insurance company refusing to cover Abraxane for Stage IV Pancreatic Cancer based in whether it was to be the first or second treatment?
Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-. -First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-Continue reading→. ...
Renal failure commonly develops in the setting of SBP, and its development is a sensitive predictor of in-hospital mortality. The renal impairment is thought to stem from decreased effective arterial blood volume secondary to the systemic inflammatory response to the infection. In our current practice, there are certain circumstances in which we administer albumin early in the SBP disease course in order to reduce the risk of renal failure and mortality. Ultimately, our current protocol originated from the 1999 study of albumin in SBP by Sort et al.. The trial enrolled adults with SBP and randomized them to treatment with either cefotaxime and albumin infusion 1.5 gm/kg within 6hrs of enrollment, followed by 1 gm/kg on day 3 or cefotaxime alone. The primary outcome was the development of "renal impairment" (a "nonreversible" increase in BUN or Cr by more than 50% to a value greater than 30 mg/dL or 1.5 mg/dL, respectively) during hospitalization. The secondary outcome was in-hospital ...
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Kaplan-Meier plots of overall survival in the full analysis set of patients with unresectable or recurrent gastric cancer receiving nanoparticle albumin-bound
BSA, or bovine serum albumin, has a molecular weight of 66 kilodaltons. BSA is a serum albumin protein that is derived from cows. This protein is utilized in research laboratories as a protein...
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Urine albumin trace - Hi my mom just did a nlood test and the results are HDL 35 Mg/dl LDL 103Mg/dl Albumin (+) (traces in urine) Are they related in some way please help? No. The results of cholesterol in the blood have no relation with the urine results. HDL is borderline low and LDL is slightly high, depending on the reference ranges of the lab you used. Also you did not mention how high the total cholesterol is, and if there is family history of heart disease. Trace albumin in the urine is commonly seen, not significantmay need repeat if your doctor is concerned.
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Comparison of the supercooling preservation of rat hepatocytes with other preservation modalities in long term plate culture.Albumin secretion of cells preserve
Theres no detailed assessment of that. The investigators can argue that they have more context to interpret what perhaps will be ambiguous imaging findings. On the other hand, they (we) may also be more biased to interpret results as favorable because they want their patients to be doing well; they may also allow their clinical perception of how a patient is doing to affect their judgment of the findings on the scans. Its not completely clear whos more right or wrong, but we generally rely on the professional radiologists who comprise the independent reviewing committee as being more objective.. The company suggested that additional efficacy data would be available later this year. Ill admit that it makes me skeptical when a company has response rate data in March but doesnt have progression-free survival data, at least. There isnt that long of a lag between the first few scans and a detection of progression in many patients (unfortunately). Since we generally see that companies will shout ...
Boudry, Switzerland: Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III...
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