The research highlights the potential risk of cancer in nonsmokers

The research highlights the potential risk of cancer in nonsmokers -

Research by the University of York highlighted the potential risk of cancer non-smokers - especially young children - from tobacco smoke gases and particles deposited on surfaces and dust in the house.

So far, the risks of this exposure known as "third-hand tobacco smoke" were highly uncertain and not reflected in public policy.

However, a new study published in the journal Environment International, said for the first time the potential risk of cancer by age group and by ingestion non-food dermal exposure to the smoke of third hand. The results indicate potentially serious long-term consequences, especially for children.

The research was done by Wolfson Atmospheric Chemistry Laboratories of York, the National Centre for Atmospheric Sciences, and chromatography and the research group on environmental applications at the Universitat Rovira i Virgili, Spain.

study, which was backed by the UK Natural Environment Research Council (NERC) and the Directorate General Research of the Government of Catalonia, also shows for the first time the widespread presence of carcinogenic tobacco-related to house dust, even in "smoke-free" environment.

scientists collected dust samples from private dwellings occupied by smokers and non-smokers. Using the observations of house dust composition, they estimated the cancer risk by applying the latest official toxicology information.

They found that for children aged one to six years, cancer risk exceeded the limit recommended by the US Environmental Protection Agency (EPA) in the three quarters of smokers homes and two third non-smoking homes. . The maximum risk predicted from the third level of smoke in a house occupied smoker equated to an additional cancer case per one thousand population exposed

The lead researcher, Dr Jacqueline Hamilton, of Wolfson Atmospheric Chemistry Laboratories of York, said: "the risk of tobacco exposure does not end when a cigarette is extinguished nonsmokers, especially children, are also at risk through contact with surfaces and dust contaminated with gas. and residual smoke particles, the so-called third-hand smoke. This risk should not be overlooked and its impact should be included in future educational programs and public health policies related to tobacco. "

Every year 0,000 people die worldwide by passive inhalation of environmental tobacco smoke, also known as secondhand smoke. . As many countries have introduced smoking bans in public places, the house has become the main source of exposure to passive smoking

Professor Alastair Lewis, atmospheric York Wolfson Chemistry Laboratories and the National Centre for atmospheric sciences, said: "More than 40 percent of children have at least one smoking parent and it is an awareness of the general public about the harms of secondhand smoke, there is little knowledge about the dangers smoke third hand. carcinogenic materials can be passed from smokers to non-smokers in a shared contact, such as between clothing and surfaces and also enter houses transport suspended in the smoke from air cigarette. "

researchers examined exposure to carcinogenic N-nitrosamines and tobacco specific nitrosamines (TSNA) in dust samples. These are produced when nicotine deposits on the inner surfaces, and is then again released to the gas phase or reacts with ozone, nitrous acid and other atmospheric oxidants. They are classified as human carcinogens.

The measurements were performed using a chromatography system with full two-dimensional gas phase, which was initially funded by NERC to study particles in the atmosphere.

Professor Rosa Maria Marcé, of the Universitat Rovira i Virgili, Tarragona, said: "This very selective and sensitive instrument allowed small quantities of TSNAs glued to house dust surface to be measured for the first time."

Dr. Noelia Ramirez, a Wolfson Atmospheric Chemistry Laboratories postdoctoral researcher York that began this line of research, said: "Although TSNAs were suspected of being part of the smoke of third hand following laboratory studies, we demonstrated for the first time the presence of specific compounds of tobacco carcinogens, such as TSNAs, in settled dust found home in a panel of smokers and non-smoking homes.

"the TSNA concentrations found in smoke-free homes suggests that TSNAs trained in smoking environments can persist for extended periods, perhaps because of the separation of ambient particles, and then be transported into the homes of non-smokers from outside. "

Researchers examine how many fruits and vegetables students eat

Researchers examine how many fruits and vegetables students eat -

Less than one in four children in Europe have enough fruits and vegetables included in their daily diet, a study by Swedish researchers at the Karolinska Institutet and University örebro watch. The results are part of a study funded by the EU and are presented in public health nutrition today

-. It is time for action, says Agneta Yngve, professor of culinary arts and science of eating örebro University who with Christel Lynch, Bettina Ehrenblad and Eric Poortvliet Karolinska Institutet, and researchers from nine European countries examined how many fruits and vegetables to school children eat.

including many fruits and vegetables in your diet reduces the risk of heart disease, stroke, diabetes and even some forms of cancer. The World Health Organization, WHO recommends a daily intake of at least 400 grams of fruit and vegetables

-. Not even half of the children in this study eat fruit every day. The picture is a little clearer bit when it comes to vegetables. 55 percent add vegetables to their diet on a daily basis, says Agneta Yngve.

On average, school children in this European study eat between 220-345 grams of fruit and vegetables a day. Norway and Bulgaria have daily intake the highest average with 345 grams and 320 grams respectively. In Sweden, children consume 291 grams per day. Finland is at the bottom of the table with 220 grams. Sweden stands out as the country where school children eat the most vegetables

-. We believe this is down to the Swedish school lunches. A good selection of salads and vegetables are commonly offered. At the same time, Swedish children are far from getting enough vegetables. An average of 141 grams per day is simply not enough. All children should eat at least 0 grams of vegetables to live up to the WHO recommendations.

In all European countries, including Sweden, children do however eat more fruits than vegetables. Researchers believe this is due to fruit being more readily available, such as a snack, and the children to find the tastiest fruits. Most fruits are eaten by children in Norway, followed by Bulgaria and Greece

-. In addition to differences between countries, we have also found that girls generally eat more fruits and vegetables than boys, Agneta Yngve continues.

This cross-sectional study is the first part of the study intervention Pro Greens. The information material has been prepared for schools in cooperation with the Swedish Ica supermarket chain with the help of which children from all over Europe can learn to become friends with their bodies. How many fruits and vegetables should I eat and how can I best go about it

- The next step for us is to assess whether the intervention has had the desired effect, says Agneta Yngve

HPV test can provide better comfort against the cervical cancer than the Pap test

HPV test can provide better comfort against the cervical cancer than the Pap test

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In the United States, cotesting for the human papillomavirus (HPV) and Pap test for cervical cancer every 5 years for women aged 30-65 years is now recommended. However, the only HPV test can provide better comfort against the cervical cancer than Pap testing alone and reassure similar to cotesting, according to a study published in the July 18 Journal of the National Cancer Institute .

In a comparison of the three strategies, Julia C. Gage, Ph.D., MPH, of the Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, and colleagues analyzed data from the Kaiser Permanente Northern California (KPNC) large integrated health delivery system, which screened women aged 30-64 since 03 with both the HPV and Pap test. Data were available until 2012, and more than 1 million women were examined at intervals of about 3 years, with an average follow-up time of 4.36 years. For each test strategy, they estimated the cumulative risk of cervical cancer after a negative test result.

The researchers found that the risk of cancer 3 years after a negative HPV test result alone were lower than Pap -alone negative. In addition, the risk of cancer 3 years after a negative HPV test result-alone were similar to the risk of cancer for 5 years of negative co-test. Gage et al. write "In conclusion, we find that the primary HPV test every 3 years could provide as much if not more reassurance against precancerous and cancer, compared to primary Pap test every 3 years and cotesting every 5 years." However, the authors note that a screening program based on any single test, rather than a program like that cotesting KPNC could give slightly different estimates. They ask for studies of screening programs in different contexts and health communities to identify the optimal screening strategy and interval.

In an accompanying editorial, Jane J. Kim of the Harvard School of Public Health, Department of Health Policy and Management, Center for Health Decision Science, Boston, MA, also warns that the data reflect management based on cotesting and notes that the HPV test approved for primary screening assays specifically the two types of HPV highest risk (16 and 18) which represent 70% of cervical cancers, but analysis of pools for the other 12 strains of HPV. However, despite these caveats, Dr. Kim concludes that the authors' -Ensure timely evidence of the United States as the primary screening HPV can reassure equal to or against the risk of cancer than currently recommended strategies by guidelines. "

telecare approach improves the management of chronic musculoskeletal pain

telecare approach improves the management of chronic musculoskeletal pain -

By Lucy Piper, Senior medwireNews Reporter

A collaborative approach to care by phone effective in relieving chronic musculoskeletal pain, show the results of the Stepped care to optimize the effectiveness of pain care (SCOPE) study.

patients who received the intervention, which is to automate the monitoring of symptoms with a stepped care approach guided algorithm optimization to painkillers, were two times more likely than those receiving usual care from their doctor attending to experience at least a 30% improvement in their pain score of 12 months (51.7 vs 27.1%).

The researchers, led by Kurt Kroenke (Regenstrief Institute, Indianapolis, Indiana, USA), also note that patients who received the intervention were half as likely to experience a worsening of pain 6 months than those in the usual care group (19.2 vs 36.0%).

"Our results demonstrate both the effectiveness of telecare and the risk of patient deterioration in the absence of systematic approaches to optimize pain therapy," Kroenke said in a Press release.

The study participants had experienced chronic pain of at least moderate intensity (Brief Pain Inventory [BPI] score? 5) for at least 3 months before surgery. For more than two thirds of patients with symptoms of pain lasted for more than 5 years.

At the end of 12 months of treatment, 124 patients randomly assigned to the telecare intervention had a score of 1.02 point lower BPI that 126 patients receiving usual care (3.57 vs. 4.59).

"The improvement of more than 1 point of BPI total score to 12 months is clinically important and represents an effect size of 0.57 moderate treatment," the researchers report JAMA .

The number needed to treat for an improvement of 30% was 4.1. And patient satisfaction with treatment was superior to the telecare approach than usual care.

At the beginning of the study, one third of patients were taking opioid therapy, but some patients in both groups were started on opioids or had their dose escalation.

"The intervention was effective, even though most trial participants reported pain that had been present for many years, which involved multiple sites, and who had been unsuccessfully treated with many painkillers, "the researchers comment.

They conclude: "The results of SCOPE, coupled with the results of a previous test conducted with cancer patients, show that the optimization of the algorithm-guided analgesic therapy can be delivered effectively through a telephone and mainly based on Internet approach. "

in a related editorial, Michael Ohl and Gary Rosenthal, University of Iowa Hospitals and Clinics in Iowa City, United States, highlight the interesting features of the intervention telecare. These include the provision of phone, which makes it more accessible to patients, and the use of nurse care managers to oversee the monitoring of symptoms, allowing the implementation without need extra time or effort of primary care clinicians and the ability to meet the strong demand in already overburdened primary care practices.

But the editorialists noted the need for further studies "to determine the generalizability, sustainability and the profitability of this strategy. "

medwireNews licensed by permission of Springer Healthcare Ltd. © Springer Healthcare Ltd. All rights reserved. None of these parties endorse or recommend any commercial products, services or equipment.

Other sunitinib treatment programs for MRCC may be worth the switch

Other sunitinib treatment programs for MRCC may be worth the switch -

By Afsaneh Gray, medwireNews Reporter

Some patients with renal cell carcinoma metastatic (MRCC), which are moved from a traditional sunitinib treatment program at an hourly rate better alternative to survival measures and suffer fewer side effects, a Japanese study has found.

The transition from traditional to alternative schedules was recently shown to be effective. But "Japanese patients with mRCC significantly different experience [adverse events] than do patients in many other countries, probably because of genetic differences underlying" the authors write.

They retrospectively reviewed the medical records of 54 patients with MRCC who received treatment sunitinib as first-line treatment between May 06 and June 2012.

Thirty-two patients received traditional 4 weeks, 2 weeks off (4/2) the processing schedule, while 22 received an alternative program. The group of alternative schedule included 17 patients s who started the therapy on the 4/2 schedule but changed due to adverse events shortly after the start of treatment.

At the time of administration of sunitinib, five patients were considered to have a favorable prognosis, according to the assessment of the risk classification Memorial Sloan Kettering Cancer Center, while 42 had intermediate and seven predictions had a poor prognosis.

average observation periods differ between traditional and alternative planning groups, with those on another calendar with an average of 20 months of follow-up compared to 16.3 months.

survival measures were significantly improved in patients on replacement schedules, compared to those on traditional schedules, and adverse events were significantly less common, including many effects more serious treatment.

The median time to treatment failure was 11.6 months on the replacement schedule compared to 4.1 months on the traditional calendar, while the median PFS was 11, three months against 4.1 months and the median overall survival was 32.1 months against 12.0 months.

"Each of these measures was better in the group of patients who received an alternative treatment schedule, suggesting that the individual changes to the schedule of administration of sunitinib may be effective," study researcher Takeshi Ueda (Chiba Cancer Center) and colleagues write in the International Journal of Urology .

They note that sunitinib has been shown previously to provide robust therapeutic effects in patients were first experience adverse events, which may partly explain the better survival in the alternative planning group.

"We believe that the transition to [alternative schedule] reduces [adverse events] and periods prolonged treatment, which could provide additional benefits, "the researchers explain

But they warn :.". these results should be interpreted with caution, and larger prospective studies are needed to other institutions to validate these results "

licensed medwireNews with Springer Healthcare Ltd. permission © Springer Healthcare Ltd. All rights reserved. None of these parties endorse or recommend any commercial products, services or equipment.

combined risk score improves radiation pneumonitis prediction

combined risk score improves radiation pneumonitis prediction -

By Laura Cowen, medwireNews Reporter

The combination of dose-volume histogram (DVH) parameters with age and baseline lung fibrosis score creates a new predictive risk score that enhances radiation pneumonitis prediction (RP) in patients receiving concomitant chemoradiation for lung cancer non-small cell (NSCLC), the research shows.

The risk of RP, a potentially fatal dose limiting side effect of chemoradiation, is currently estimated using individual DVH parameters such as the percentage of lung volume receiving doses greater than 20 Gy (V20) and the mean lung dose (MLD), explain Kayoko Tsujino (Hyogo Cancer Center, Akashi, Japan) and colleagues.

In this study, the researchers investigated whether RP severe (grade 3 or higher) could be predicted more accurately by combining the DVH measurements with clinical factors.

They examined the medical records of 122 patients (median age 63 years, 89% men) with locally advanced NSCLC treated with chemoradiotherapy and found that, for a median of 14.6 months of follow up, 14 (11.5%) developed severe ROP.

in univariate analysis, the total lung volume, V5, V20, absolute lung volume spared a dose of 5 Gy (VS5), MLD, sex and pulmonary fibrosis on CT baseline were significantly associated to severe RP. Age and smoking showed a significant association limit.

In multivariate analysis, a VS5 less than 1500 cc, pulmonary fibrosis score from baseline of 2 or more, V20 of at least 26% to the age of 68 years or more were significant predictors severe RP.

based on the coefficient beta multivariate analysis, these four variables were assigned a score of 6, 5, 3 and 3, respectively, to create a predictive risk score combined (PRS).

Tsujino and team report that the cumulative incidence of severe RP to 12 months was 0%, 7.8%, 26.6% and 71.4% when the PRS was 0, 3-5, 6-8 and 9-14, respectively. No patient had a PRS score above 14.

In addition, the PRS predicted severe RP with more precision than V20 and VS5 combined, or V20 alone, with respective areas under the ROC curve of 0.888 against 0.779 and 0.678.

"Currently, we recommend that PRS should be less than eight and V20 dose constraint should be less than 30-35% in the final administration [concurrent chemoradiotherapy] for NSCLC," write the researchers in Journal of Thoracic Oncology .

However, they conclude that the continued validation of the PRS is required before it can be adapted for clinical use.

medwireNews licensed by permission of Springer Healthcare Ltd. © Springer Healthcare Ltd. All rights reserved. None of these parties endorse or recommend any commercial products, services or equipment.

Clinical study aims to validate a preventive treatment against tumor metastasis

Clinical study aims to validate a preventive treatment against tumor metastasis -

Metastasis, the strategy adopted by the tumor cells to turn into an aggressive form of cancer, are often associated with poor prognosis. Management to block the metastasis or better yet, prevent their formation would be a giant step towards the fight against cancer. The Catholic Universit- researchers in Leuven (Belgium) this world first successfully performed on human tumor models in mice. The results of their study are published online July 24 in the prestigious journal Cell Reports .

The work of the team of Professor Pierre Sonveaux at the Institute Catholique de Louvain Universit- of Experimental and Clinical Research (IREC), managed to spot a family of pharmaceutical compounds whose action prevents the onset of tumor metastases. The researchers performed this feat by studying mitochondria in tumor cells. These organelles are considered the powerhouse of cells. But when operation is altered, the UCL researchers observed in tumor cells, the mitochondria can promote the migration of cells, thus leading to the formation of metastases.

Paolo E. Porporato, postdoctoral researcher, and other young researchers in the team of Professor Pierre Sonveaux, examined the molecular mechanism responsible for the ability of mitochondria to promote metastasis. They managed to demonstrate that, under certain conditions, mitochondria produce more free radical called superoxide ions (O2.-). It is this overproduction of superoxide that results in the formation of metastases and, therefore, the growth of a tumor.

implicated in other human diseases such as Parkinson's disease and Alzheimer's disease, superoxide production by mitochondria can be blocked by antioxidants such as very specific MitoTEMPO. Used in models of murine and human tumors, these compounds have proven to be very effective in blocking the migration of tumor cells and prevent spontaneous formation of human tumor metastases in mice! The discovery of a treatment that blocks the head of metastasis formation mechanism and the existence of a family of promising compounds, is an encouragement for future evaluation in a clinical study to validate a preventive treatment against metastasis tumor.

Medicine Foundation provides support to cancer patients, families seeking access to targeted therapies

Medicine Foundation provides support to cancer patients, families seeking access to targeted therapies -

Medicine Foundation, Inc. (NASDAQ: IMF) announced today ' hui that it has entered a partnership with the lawyer's patients Foundation (PAF) on a national program to provide assistance to cancer patients and their families seeking access to targeted therapies. The program, called FoundationOne® CareLine, offers personalized case management services to patients who are uninsured, underinsured or face other challenges that affect their access to care, and increases the ability of physicians to act on the FoundationOne results.

Adoption of FoundationOne by academic and community oncologists supports the clinical utility needed to improve outcomes and quality of life for certain groups of patients who may benefit from targeted health treatment. However, it can sometimes be difficult for patients and their doctors to have access to appropriate treatment and potentially save lives.

"The rapid evolution of genomics and the scientific understanding of cancer in recent years have fundamentally changed the way cancer can be treated, but sometimes progress evidenced by new medical and scientific data exceeded access to treatment, "said Deborah Morosini, MD, Vice President clinical development, Medicine Foundation." Through this partnership with the lawyer's patients Foundation, FoundationOne CareLine connects patients in case of resources management that help them navigate through the proper channels to get treatments by harnessing the peer reviewed literature supporting its use. "

The FoundationOne CareLine is an expansion of a pilot effort between Medicine Foundation and the PAF has supported patients from some great doctors, and resulted in nearly $ 400,000 in reimbursement guaranteed medical expenses for patients. Under the expanded program, clinical case managers will continue to provide comprehensive case management services to uninsured patients, underinsured and insured who face obstacles obtaining prescribed targeted therapies that are approved in an indication other than the type of patient's tumor. Other services include assistance navigating the reimbursement system to help cover the costs associated with FoundationOne test and the costs of auxiliary treatment, education and clinical trials of screening and assistance for patients seeking access to experimental treatments under compassionate use.

"for case managers Foundation patients improve the lives of patients and help ensure that the required medical care is within reach by providing the appropriate evidence to payers to ensure access to treatment" said Alan Balch, CEO of counsel patients Foundation. "Through this partnership, Medicine Foundation supports the valuable case management services that make a significant difference in the lives of cancer patients seeking access to targeted therapies that their doctors believe will have a significant impact in the treatment of their disease. "

Researchers find way to diagnose cancer aggressiveness of the mouth

Researchers find way to diagnose cancer aggressiveness of the mouth -

oral cancer study in mice, the researchers found a way to predict the aggressiveness Similar tumors in people, a first step towards a diagnostic test that could guide treatment, according to researchers at Washington University School of Medicine in St. Louis.

"All patients with advanced head and neck get similar treatment," said Ravindra Uppaluri, MD, PhD, associate professor of otolaryngology. "We have patients who do well on combinations standard surgery, radiotherapy and chemotherapy, and patients who are not good. We are interested to know why. "

Reporting in Clinical Cancer Research , the investigators found a consistent pattern of gene expression associated with tumor spread in mice. Analysis of genetic data from human samples of oral cancer, they also found that genetic signature in people with aggressive metastatic tumors.

"We automatically assume this mouse model would be relevant to cancer of the human mouth," said Uppaluri, which performs head and neck surgery at Barnes-Jewish Hospital. "But it turns out be very reflective of the disease in people. "

Rather than using genetic methods to induce tumors in mice, the research team applied repeatedly a known carcinogen, in the same way that humans develop oral cancer.

"patients often have a history of tobacco and alcohol, which cause the development of these tumors," said Uppaluri. "We felt that exposure mouse to a carcinogen would be most likely to produce the same kind of tumors. "

the researchers, including first author Michael D. Onken, PhD, research assistant professor of cell biology and physiology, showed that this exhibition has sometimes produced tumors in mice that did not spread, but sometimes led to aggressive metastatic tumors, similar to the variety of tumors observed in people. Uppaluri team then worked with Elaine Mardis, PhD, co-director of the Genomics Institute of the University of Washington, whether the mouse and human tumors were also genetically similar. They compared their mouse sequences with human data sets of The Cancer Genome Atlas (TCGA).

"When we sequenced these tumors, we found that many genetic mutations present in the mouse tumors were also found in human head and neck," said Uppaluri.

further analysis identified a common signature in the expression of 0 genes that have been associated with more aggressive tumors, whether in mice or humans. the researchers confirmed this signature using data collected from 324 human patients. subsequently, using oral cancer samples from patients treated at the University of Washington, they have developed a proof of concept test from their signature that identified tumors aggressive with about 93 percent accuracy.

in collaboration with the Office of technology management at the University of Washington, Uppaluri has a patent pending on this technology and has recently received funding from the Fund Frontier Siteman cancer to develop a laboratory test that predicts an aggressive disease and would be readily available for all patients diagnosed with head and neck.

"These types of tests are available for other types of cancer, including breast cancer," he said. "They are genetic tests transformation that may alter the clinical management of patients, tailoring therapies for them. Our goal is to develop something for the head and neck. "

Zydelig obtient l'approbation de la FDA pour le traitement de patients avec trois types de cancers du sang [1945001

Zydelig obtient l'approbation de la FDA pour le traitement de patients avec trois types de cancers du sang [1945001 - ]

La Food and Drug Administration des États-Unis a approuvé aujourd'hui Zydelig (idélalisib) pour traiter les patients avec trois types de sang cancers.

Zydelig est accordée l'approbation traditionnelle pour traiter les patients dont la leucémie lymphoïde chronique (LLC) est retourné (rechute). Utilisé en combinaison avec Rituxan (rituximab), Zydelig doit être utilisé chez les patients pour lesquels Rituxan lui seul être considéré comme un traitement approprié en raison d'autres conditions médicales existantes (co-morbidités). Zydelig est le cinquième nouveau médicament avec la désignation de thérapie révolutionnaire pour être approuvé par la FDA et le troisième médicament avec cette désignation approuvé pour le traitement CLL.

La FDA accorde également Zydelig l'approbation accélérée pour traiter les patients avec folliculaire récidivant B- cellule lymphome non hodgkinien (FL) et le lymphome lymphoblastique petite rechute (SLL), un autre type de lymphome non hodgkinien. Zydelig est destiné à être utilisé chez les patients qui ont reçu au moins deux traitements systémiques antérieurs.

"En moins d'un an, nous avons vu des progrès considérables dans la disponibilité des traitements pour la leucémie lymphoïde chronique", a déclaré Richard Pazdur , MD, directeur du Bureau d'hématologie et d'oncologie Produits dans le Centre de la FDA pour l'évaluation et de recherche sur les médicaments. «L'approbation de Zydelig pour traiter la LLC reflète la promesse du programme de désignation de thérapie innovante et représente l'engagement de la FDA à travailler en collaboration avec les entreprises pour accélérer le développement, l'examen et l'approbation d'un médicament."

La FDA a approuvé Gazyva (obinutuzumab) dans novembre 2013, Imbruvica (Ibrutinib) en Février 2014 et une nouvelle utilisation pour Arzerra (ofatumumab) en Avril 2014 pour traiter la LLC. Les deux Gazyva et Arzerra ont également reçu la désignation de thérapie révolutionnaire pour cette indication. Comme les deux autres médicaments, Zydelig a également accordé la désignation de produit orphelin, car il est destiné à traiter une maladie rare.

La sécurité et l'efficacité pour traiter la LLC en rechute de Zydelig ont été établies dans un essai clinique de 220 participants qui ont été assignés au hasard pour recevoir Zydelig et Rituxan ou un placebo et Rituxan. L'essai a été arrêté pour l'efficacité suivant le premier point d'analyse intermédiaire pré-spécifiée, qui a montré aux participants traités avec Zydelig et Rituxan vécu 10,7 mois sans progression de la maladie (survie sans progression) par rapport à environ 5,5 mois pour les participants traités avec le placebo et Rituxan. Les résultats d'une deuxième analyse intermédiaire a continué à montrer une amélioration statistiquement significative pour Zydelig et Rituxan par rapport au placebo et Rituxan.

La sécurité et l'efficacité de Zydelig pour traitent l'retombèrent FL et retombèrent SLL ont été établies dans un essai clinique avec 123 participants lente -growing (indolent) les lymphomes non hodgkiniens. Tous les participants ont été traités avec Zydelig et ont été évalués pour la disparition complète ou partielle de leur cancer après traitement (taux de réponse objective ou TRG). Les résultats ont montré 54 pour cent des participants ayant rechuté FL et 58 pour cent des participants avec SLL vécus ORR.

La FDA est d'approuver Zydelig pour traiter FL et SLL au titre du programme d'approbation accélérée de l'agence, qui permet l'approbation d'un médicament pour traiter une maladie grave, voire mortelle, sur la base des données cliniques montrant le médicament a un effet sur un critère de substitution raisonnablement susceptible de prédire un bénéfice clinique aux patients. Ce programme offre un accès plus rapide des patients de promettre de nouveaux médicaments alors que l'entreprise mène des essais cliniques de confirmation.

Zydelig porte une mise en garde encadrée alerter les patients et les professionnels de soins de santé des mortels et des toxicités graves, y compris la toxicité hépatique, la diarrhée et une inflammation du côlon (colite ), une inflammation des poumons (pneumonie) et une perforation intestinale qui peut survenir chez les patients traités par Zydelig. Zydelig est également approuvé avec une stratégie risque d'évaluation et d'atténuation (REMS) composé d'un plan de communication pour assurer que les fournisseurs de soins de santé qui sont susceptibles de prescrire Zydelig soient pleinement informés au sujet de ces risques.

Les effets secondaires courants comprennent la diarrhée, la fièvre (pyrexie), la fatigue, des nausées, la toux, la pneumonie, des douleurs abdominales, des frissons et des éruptions cutanées. Les anomalies de laboratoire courantes comprennent les niveaux de globules blancs (neutropénie), des niveaux élevés de triglycérides ont diminué dans le sang (hypertriglycéridémie), taux de sucre sanguin élevé (hyperglycémie) et des niveaux élevés d'enzymes hépatiques.

Zydelig est commercialisée par Foster City , Californie-basées Gilead Sciences. Rituxan et Gazyva sont commercialisés par Genentech, un membre du Groupe Roche, basée à South San Francisco, Californie. Imbruvica est commercialisé conjointement par Sunnyvale, en Californie basée Pharmacyclics et Raritan, basée au New Jersey Janssen Biotech, Inc. Arzerra est commercialisé par Research Triangle Park, Caroline du Nord-fondé GlaxoSmithKline.

Pfizer à licence cellules BCRP-MDCK de systèmes d'absorption [1945001

Pfizer à licence cellules BCRP-MDCK de systèmes d'absorption [1945001 - ]

Systèmes d'absorption, un chef de file dans de nouveaux systèmes de test pour les transporteurs de drogue, annonce un accord de licence avec Pfizer Inc., dans lequel Pfizer cellules BCRP-MDCK 'Systèmes d'absorption en licence. Cette lignée cellulaire est transfectée de manière stable avec le gène ABCG2 humain, qui code pour une protéine connue sous le nom BCRP (sein protéine de résistance du cancer).

Ce système de dosage de BCRP humaine exclusive est conçue pour permettre à l'essai de nouveaux médicaments candidats pour interactions avec la protéine BCRP, qui est impliqué dans la clairance de la drogue, la pénétration de la barrière hémato-encéphalique, la résistance des tumeurs aux médicaments anticancéreux, et les interactions médicamenteuses. En conséquence des interactions BCRP, des composés qui montrent une efficacité prometteuse in vitro peut être inaccessible à l'organe d'intérêt au cours des essais cliniques.

«Nous croyons que, en raison de leur expression robuste de la protéine BCRP, BCRP-MDCK les cellules peuvent permettre aux utilisateurs de mieux prédire les résultats humains lors de tests précliniques de leurs médicaments candidats, ayant ainsi la possibilité de réduire l'attrition au cours du développement de la drogue », a déclaré Ismael J. Hidalgo, Ph.D., CSO, systèmes d'absorption.