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22:59 EDT 24th September 2018 | BioPortfolio

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Showing "Curtana granted Orphan designation gliomas treatment" PubMed Articles 1–25 of 28,000+

Comprehensive evaluation of treatment and outcomes of low-grade diffuse gliomas.

Low-grade gliomas affect younger adults and carry a favorable prognosis. They include a variety of biological features affecting clinical behavior and treatment. Having no guidelines on treatment established, we aim to describe clinical and treatment patterns of low-grade gliomas across the largest cancer database in the United States.

Orphan drugs: trends and issues in drug development.

Research in rare diseases has contributed substantially toward the current understanding in the pathophysiology of the common diseases. However, medical needs of patients with rare diseases have always been neglected by the society and pharmaceutical industries based on their small numbers and unprofitability. The Orphan Drug Act (1983) was the first serious attempt to address the unmet medical needs for patients with rare diseases and to provide impetus for the pharmaceutical industry to promote orphan dru...

What's New in Grade II and Grade III Gliomas?

The majority of World Health Organization grade II and grade III gliomas harbor heterozygous mutations in the metabolic enzyme isocitrate dehydrogenase 1 (IDH1), and tumors with an IDH wild-type status show molecular features of a glioblastoma and simply may constitute a separate disease entity. This discovery has led to a profound shift in the way that gliomas are classified and, consequently, how treatment decisions are made. We will review the current understanding ofmutant gliomagenesis and the preclini...

FDA Expectations for Demonstrating Interchangeability.

There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expec...

Effectiveness of Stereotactic Radiotherapy and Bevacizumab for Recurrent High-grade gliomas -A Potential Therapy for IDH Wild-type Recurrent High-grade Gliomas.

This study aimed to evaluate the efficacy of stereotactic radiotherapy combined with bevacizumab (SRT-Bv) compared with Bv treatment for recurrent high-grade gliomas (HGGs).

Laser Interstitial Thermal Therapy as a Primary Treatment for Deep Inaccessible Gliomas.

Treatment strategies for deep intracranial gliomas remain limited to stereotactic biopsy in many cases due to the morbidity of aggressive surgical resection. Since no cytoreductive therapy is offered, outcomes have been demonstrably poor compared to patients who are able to undergo primary surgical resection.

Targeting metabotropic glutamate receptors in the treatment of primary brain tumors.

In spite of the recent advancement in the molecular characterization of malignant gliomas and medulloblastomas, the treatment of primary brain tumors remains suboptimal. The use of small molecule inhibitors of intracellular signaling pathways, inhibitors of angiogenesis, and immunotherapic agents is limited by systemic adverse effects, limited brain penetration, and, in some cases, lack of efficacy. Thus, adjuvant chemo-therapy and radiotherapy still remain the gold standard in the treatment of grade-IV ast...

Basic principles of diagnosis and treatment of gliomas.

Traditionally, gliomas were classified based on histopathological features alone. The revised World Health Organization (WHO) classification of tumors of the central nervous system from 2016 integrated molecular features into the histopathological diagnosis.

Perilesional apparent diffusion coefficient in the preoperative evaluation of glioma grade.

Preoperative identification of high-grade gliomas is critical to optimize treatment strategy and to predict prognosis. To determine whether perilesional apparent diffusion coefficient (ADC) values differ between high- and low-grade tumors, we assessed water diffusivity within normal-appearing brain parenchyma (NABP) surrounding gliomas in twenty-one treatment-naïve patients. This showed significantly lower mean and 25th percentile (Q1) ADC values in high- grade compared to low-grade gliomas respectively in...

Gliomas in Children.

Gliomas are the most common primary central nervous system (CNS) neoplasms in children and adolescents and are thought to arise from their glial progenitors or stem cells. Although the exact cells of origin for most pediatric gliomas remain to be identified, our current understanding is that specific cell populations during CNS development are susceptible to particular oncogenic events during certain time windows and thus give rise to pediatric gliomas with distinct histological, molecular, and clinical fea...

Stereotactic Cryodestruction of Gliomas.

Surgical resection of gliomas affecting functionally important brain structures is associated with high risk of permanent postoperative neurological deficit and deterioration of the patient's quality of life. The availability of modern neuroimaging and neuronavigation permits the application of minimally invasive stereotactic cryodestruction of the tumor in such cases. The authors used this treatment in 88 patients with supratentorial gliomas of various WHO histopathological grades not suitable for microsur...

F-FET-PET as a biomarker for therapy response in non-contrast enhancing glioma following chemotherapy.

Monitoring treatment response after chemotherapy of gadolinium-(Gd)-negative gliomas is challenging as conventional MRI often indicates no radiological changes. We hypothesize that F-FET-PET can be used as a biomarker for response assessment in Gd-negative gliomas undergoing chemotherapy.

Features of diffuse gliomas that are misdiagnosed on initial neuroimaging: a case control study.

The neuroimaging diagnosis of diffuse gliomas can be challenging owing to their variable clinical and radiologic presentation. The purpose of this study was to identify factors that are associated with imaging errors in the diagnosis of diffuse gliomas.

Endoscopic Transsphenoidal Surgery for an Adult Patient With Giant Exophytic Chiasmatic/Hypothalamic Glioma.

Optic pathway hypothalamic gliomas are intrinsic low-grade gliomas involving the optic nerve, chiasm, optic tract, and hypothalamus. The rarity of these tumors and their unpredictable course make assessment and standardization of treatment modalities difficult. Tumor debulking via various transcranial approaches was considered to be effective at controlling tumor growth, but with high rates of severe surgery-related complications. In the present case, endoscopic transsphenoidal surgery was initiated to debu...

Photodynamic Therapy of Malignant Gliomas.

Recently, the clinical applications of photodynamic therapy (PDT) in the management of malignant brain tumors have attracted significant attention. Meta-analysis of the observational studies on this treatment in high-grade gliomas (Eljamel, 2010) included more than 1,000 patients and reported median survival in cases of newly diagnosed and recurrent glioblastoma multiforme (GBM) of 16.1 and 10.3 months, respectively. In some series, increase in the long-term survival rates was also observed. Few controlled ...

Using smaller-than-standard radiation treatment margins does not change survival outcomes in patients with high-grade gliomas.

The number of studies that evaluate treatment margins for high grade gliomas (HGG) are limited. We hypothesize that patients with HGG who are treated with a gross tumor volume (GTV) to planning tumor volume (PTV) expansion of ≤1 cm will have progression-free survival (PFS) and overall survival (OS) rates similar to those treated in accordance with standard protocols by the Radiation Therapy Oncology Group or European Organisation for Research and Treatment of Cancer. Furthermore, the PFS and OS of subgrou...

Novel and Prospective Molecular Targets for Therapy of Intracranial Gliomas.

Multiple alterations in the expression levels of genes or proteins have been identified in gliomas, including activation of oncogenes and silencing of tumor suppressor genes. Illuminating these molecular mechanisms of tumorigenesis and treatment resistance is necessary for the development of new therapies. With the promise of better effectiveness and less toxicity, the emphasis in drug development has moved from cytotoxic, non-specific chemotherapies to molecular targeted agents. However, despite progress i...

Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis.

In the development process for new drugs, dose-finding studies are of major importance. Absence of these studies may lead to failed phase 3 trials and delayed marketing authorization. In our study we investigated to what extent dose-finding studies are performed in the case of orphan drugs for metabolic and oncologic indications. We identified all orphan drugs that were authorized until August 1, 2017. European Public Assessment Reports were used to extract the final dose used in the summary of product char...

Characteristics and outcomes of elderly patients with diffuse gliomas: a multi-institutional cohort study by Kansai Molecular Diagnosis Network for CNS Tumors.

This study investigates the current state of clinical practice and molecular analysis for elderly patients with diffuse gliomas and aims to elucidate treatment outcomes and prognostic factors of patients with glioblastomas.

Temozolomide-associated Hypermutation in Gliomas.

Low-grade gliomas cause considerable morbidity and most will recur after initial therapy. At recurrence, low-grade gliomas can undergo transformation to high-grade gliomas (grade III or grade IV), which are associated with worse prognosis. Temozolomide (TMZ) provides survival benefit in patients with glioblastomas (GBMs) but its value in patients with low-grade gliomas is less clear. A subset of TMZ-treated, IDH-mutant, low-grade astrocytomas recur as more malignant tumors with thousands of de novo, coding ...

Demethylation and epigenetic modification with 5-Azacytidine reduces IDH1 mutant glioma growth in combination with Temozolomide.

Isocitrate Deyhydrogenase (IDH) mutant gliomas are comprised of the majority of grade II-III gliomas and nearly all secondary glioblastomas. These progressive gliomas arise from mutations in IDH1 or IDH2 that pathologically produces D-2-hydroxyglutarate (2HG). 2-HG interferes with cell reactions using alpha ketoglutarate leading to a hypermethylated genome and epigenetic dysregulation of gene expression initiating tumorigenesis.

Insights into the Pharmaceuticals and Mechanisms of Neurological Orphan Diseases: Current Status and Future Expectations.

Several rare or orphan diseases have been characterized that singly affect low numbers of people, but cumulatively reach ∼6% - 10% of the population in Europe and in the United States. Human genetics has shown to be broadly effective when evaluating subjacent genetic defects such as orphan genetic diseases, but on the other hand, a modest progress has been achieved toward comprehending the molecular pathologies and designing new therapies. Chemical genetics, placed at the interface of chemistry and geneti...

Retrospective study of nivolumab for patients with recurrent high grade gliomas.

Patients with recurrent high-grade gliomas (HGG) have limited treatment options. HGG utilize the PD-1 pathway to evade immune responses. Checkpoint inhibitors have demonstrated safety and clinical activity in patients with recurrent glioblastoma. We explored the efficacy of nivolumab in recurrent HGG with a primary objective of progression free survival (PFS) and overall survival (OS).

Proton and Carbon Ion Therapy of Intracranial Gliomas.

In comparison to photon irradiation, particle therapy of cancer performed either with protons or with carbon ions, offers the advantage of their distinct physical characteristics, and through delivery of high linear energy transfer (LET) particles, exploits greater relative biological effectiveness (RBE). There is strong rationale for applying such treatment in patients with intracranial gliomas. In cases of low-grade tumors, the main benefits may be related to potential decrease of long-term morbidity, whe...

Combining Clinical and Molecular Data to Predict the Benefits of Carmustine Wafers in Newly Diagnosed High-Grade Gliomas.

The purpose of this study was to retrospectively evaluate the use of carmustine wafers (CWs) in the management of high-grade gliomas (HGGs). The data from our monoinstitutional series was compared with studies reported in the literature. Special emphasis was placed on the evaluation of side effects and the analysis of extent of resection and molecular profile as risk factors.

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