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Antonio, Italy

Demetri G.D.,Dana-Farber Cancer Institute | Reichardt P.,Oncology | Kang Y.-K.,University of Ulsan | Blay J.-Y.,University of Lyon | And 20 more authors.
The Lancet | Year: 2013

Background Until now, only imatinib and sunitinib have proven clinical benefi t in patients with gastrointestinal stromal tumours (GIST), but almost all metastatic GIST eventually develop resistance to these agents, resulting in fatal disease progression. We aimed to assess effi cacy and safety of regorafenib in patients with metastatic or unresectable GIST progressing after failure of at least imatinib and sunitinib. Methods We did this phase 3 trial at 57 hospitals in 17 countries. Patients with histologically confi rmed, metastatic or unresectable GIST, with failure of at least previous imatinib and sunitinib were randomised in a 2:1 ratio (by computergenerated randomisation list and interactive voice response system; preallocated block design (block size 12); stratifi ed by treatment line and geographical region) to receive either oral regorafenib 160 mg daily or placebo, plus best supportive care in both groups, for the fi rst 3 weeks of each 4 week cycle. The study sponsor, participants, and investigators were masked to treatment assignment. The primary endpoint was progression-free survival (PFS). At disease progression, patients assigned placebo could crossover to open-label regorafenib. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01271712. Results From Jan 4, to Aug 18, 2011, 240 patients were screened and 199 were randomised to receive regorafenib (n=133) or matching placebo (n=66). Data cutoff was Jan 26, 2012. Median PFS per independent blinded central review was 4.8 months (IQR 1.4-9.2) for regorafenib and 0.9 months (0.9-1.8) for placebo (hazard ratio [HR] 0.27, 95% CI 0.19-0.39; p7lt;0.0001). After progression, 56 patients (85%) assigned placebo crossed over to regorafenib. Drug-related adverse events were reported in 130 (98%) patients assigned regorafenib and 45 (68%) patients assigned placebo. The most common regorafenib-related adverse events of grade 3 or higher were hypertension (31 of 132, 23%), hand-foot skin reaction (26 of 132, 20%), and diarrhoea (seven of 132, 5%). Interpretation The results of this study show that oral regorafenib can provide a signifi cant improvement in progression-free survival compared with placebo in patients with metastatic GIST after progression on standard treatments. As far as we are aware, this is the fi rst clinical trial to show benefi t from a kinase inhibitor in this highly refractory population of patients. Source

Korsager A.S.,University of Aalborg | Carl J.,Oncology | Ostergaard L.R.,University of Aalborg
Medical Physics | Year: 2013

Purpose: In image-guided radiotherapy of prostate cancer defining the clinical target volume often relies on magnetic resonance (MR). The task of transferring the clinical target volume from MR to standard planning computed tomography (CT) is not trivial due to prostate mobility. In this paper, an automatic local registration approach is proposed based on a newly developed removable Ni-Ti prostate stent. Methods: The registration uses the voxel similarity measure mutual information in a two-step approach where the pelvic bones are used to establish an initial registration for the local registration. Results: In a phantom study, the accuracy was measured to 0.97 mm and visual inspection showed accurate registration of all 30 data sets. The consistency of the registration was examined where translation and rotation displacements yield a rotation error of 0.41° ± 0.45° and a translation error of 1.67 ± 2.24 mm. Conclusions: This study demonstrated the feasibility for an automatic local MR-CT registration using the prostate stent. © 2013 American Association of Physicists in Medicine. Source

Glasziou P.,Bond University | Ogrinc G.,White River Junction Medical Center | Goodman S.,Oncology
BMJ Quality and Safety | Year: 2011

The considerable gap between what we know from research and what is done in clinical practice is well known. Proposed responses include the Evidence-Based Medicine (EBM) and Clinical Quality Improvement. EBM has focused more on 'doing the right things' - based on external research evidence - whereas Quality Improvement (QI) has focused more on 'doing things right' - based on local processes. However, these are complementary and in combination direct us how to 'do the right things right'. This article examines the differences and similarities in the two approaches and proposes that by integrating the bedside application, the methodological development and the training of these complementary disciplines both would gain. Source

Stark D.,Oncology | Lewis I.,AlderHey Childrens Hospital
Klinische Padiatrie | Year: 2013

The management of TYA with cancer is characterized by biological features in comparison to children. Therefore specialized treatment units have been established within professional structures of care for this group, and a European multidisciplinary framework for the treatment of TYA with cancer was founded. Objectives are to promote interdisciplinary collaboration and provide strategic concepts to improve patient care centered to the special needs of this age group. Access to clinical trials for all TYA in the EU will be improved and research initiated, examining biology, epidemiology and health services. Special goals of the interprofessional cooperation are: Improvement in survival and the quality of survival, where TYA are disadvantaged by existing structures of care. Provision of all the required expertise in dedicated and effective multiprofessional teams, sometimes across traditional healthcare boundaries. Provision of an environment for care that meets the specific needs of TYA. Different measurements are discussed improving outcomes for TYA is proceeding at different speeds in different parts of the world. In some there are established teams, bringing together paediatric and adult specialists from many healthcare professions, reviewing and contributing to the optimal care of all TYA with cancer as part of national health policy. © Georg Thieme Verlag KG Stuttgart, New York. Source

Mathew J.,Oncology
Diseases of the Esophagus | Year: 2011

Summary: Obesity is a risk factor for the development of esophageal malignancy. We report a case of the development of esophageal adenocarcinoma after placement of an adjustable gastric band for obesity. A 66-year-old male was referred to our clinic for findings of an obstructing mass at the gastroesophageal junction after previously undergoing a laparoscopic adjustable gastric band placement. Investigations confirmed a locally advanced poorly differentiated esophageal adenocarcinoma. The patient underwent chemotherapy and gastric band removal with improvement of his dysphagia. However, his disease progressed and he died of metastatic disease. We discuss the diagnosis of esophageal carcinoma after gastric banding procedure. © 2010 © the Authors. Journal compilation © 2010, Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus. Source

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