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Oettle H.,Charite - Medical University of Berlin | Neuhaus P.,Charite - Medical University of Berlin | Hochhaus A.,Universitatsklinikum Jena | Hartmann J.T.,University of Kiel | And 9 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

IMPORTANCE: The prognosis for patients with pancreatic cancer is poor, even after resection with curative intent. Gemcitabine-based chemotherapy is standard treatment for advanced pancreatic cancer, but its effect on survival in the adjuvant setting has not been demonstrated. OBJECTIVE: To analyze whether previously reported improvement in disease-free survival with adjuvant gemcitabine therapy translates into improved overall survival. DESIGN, SETTING, AND PATIENTS: CONKO-001 (Charité Onkologie 001), a multicenter, open-label, phase 3 randomized trial to evaluate the efficacy and toxicity of gemcitabine in patients with pancreatic cancer after complete tumor resection. Patients with macroscopically completely removed pancreatic cancer entered the study between July 1998 and December 2004 in 88 hospitals in Germany and Austria. Follow-up ended in September 2012. INTERVENTIONS: After stratification for tumor stage, nodal status, and resection status, patients were randomly assigned to either adjuvant gemcitabine treatment (1g/m2 d 1, 8, 15, q 4 weeks) for 6 months or to observation alone. MAIN OUTCOMES AND MEASURES: The primary end point was disease-free survival. Secondary end points included treatment safety and overall survival, with overall survival defined as the time from date of randomization to death. Patients lost to follow-up were censored on the date of their last follow-up. RESULTS: A total of 368 patients were randomized, and 354 were eligible for intention-to-treat-analysis. By September 2012, 308 patients (87.0%[95% CI, 83.1%-90.1%]) had relapsed and 316 patients (89.3% [95% CI, 85.6%-92.1%]) had died. The median follow-up time was 136 months. The median disease-free survival was 13.4 (95% CI, 11.6-15.3) months in the treatment group compared with 6.7 (95% CI, 6.0-7.5) months in the observation group (hazard ratio, 0.55 [95% CI, 0.44-0.69]; P < .001). Patients randomized to adjuvant gemcitabine treatment had prolonged overall survival compared with those randomized to observation alone (hazard ratio, 0.76 [95%CI, 0.61-0.95]; P = .01), with 5-year overall survival of 20.7% (95% CI, 14.7%-26.6%) vs 10.4% (95% CI, 5.9%-15.0%), respectively, and 10-year overall survival of 12.2% (95% CI, 7.3%-17.2%) vs 7.7% (95% CI, 3.6%-11.8%). CONCLUSIONS AND RELEVANCE: Among patients with macroscopic complete removal of pancreatic cancer, the use of adjuvant gemcitabine for 6 months compared with observation alone resulted in increased overall survival as well as disease-free survival. These findings provide strong support for the use of gemcitabine in this setting. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN34802808. Source


Cross N.C.P.,University of Southampton | Cross N.C.P.,Wessex Regional Genetics Laboratory | White H.E.,Wessex Regional Genetics Laboratory | Muller M.C.,Universitatsmedizin Mannheim | And 2 more authors.
Leukemia | Year: 2012

The International Randomized Study of Interferon and STI571 (IRIS) demonstrated long-term cytogenetic responses in patients with chronic-phase chronic myeloid leukemia (CML-CP) treated with the tyrosine kinase inhibitor (TKI) imatinib. However, deep molecular responses (MRs), as measured by reductions in BCR-ABL transcript levels below the threshold of major MR, were achieved only by a small proportion of patients. With the advent of the second-generation TKIs nilotinib and dasatinib for the treatment of patients with newly diagnosed CML-CP, the proportion of patients who achieve the deepest levels of MR is likely to increase significantly. With these changes, the potential for patient eligibility in TKI cessations studies is becoming a more widely discussed topic and area for research. These developments highlight the need for robust, standardized and workable definitions of deep MRs. Specifically, it is critical that the measurement of MR is standardized in a manner to withstand both intra- and inter-laboratory variability, as well as new methodological developments. This review summarizes the relevant clinical background and proposes a framework within which standardization of MR can be taken forward. © 2012 Macmillan Publishers Limited. Source


Children who require mechanical ventilation represent a high risk population with high morbidity and mortality. Experienced handling of conventional therapies, including high frequency oscillation ventilation and initiation of newer treatment options, such as therapy with surfactant or nitric oxide has led to some improvements. Nevertheless, extracorporeal membrane oxygenation (ECMO) is a life-saving technology for patients with respiratory failure refractory to maximum medical therapy. This article demonstrates the clinical management and selection criteria for ECMO in childhood contributing to the incidence and of acquired or inborn diseases which may lead to acute respiratory distress syndrome (ARDS). © 2011 Springer-Verlag. Source


Refractive surgery includes all procedures which are primarily targeted at changing the refractive power of the eye. Currently laser-assisted in situ keratomileusis (LASIK) is indicated to correct myopia of up to - 8 D, hyperopia up to + 3 D and astigmatism up to 5 D. Photorefractive keratectomy (PRK) and laser epithelial keratomileusis (LASEK) are primarily recommended for myopia up to - 6 D and for greater refractive errors, phakic intraocular lenses (IOL) are the first choice (myopia greater than - 6 D and hyperopia greater than + 3 D). If presbyopia is present in addition to the high refractive error, refractive lens exchange is another alternative. © Springer-Verlag Berlin Heidelberg 2013. Source


Hammes H.-P.,Universitatsmedizin Mannheim
Therapeutic Advances in Endocrinology and Metabolism | Year: 2013

Diabetic retinopathy (DRP) is a common complication caused by multiple biochemical abnormalities of the underlying metabolic disease. While the incidence of DRP appears to decline due to evidence-based changes in diabetes management, the predicted increase in patients affected in particular by type 2 diabetes may outweigh the positive trend. The diagnosis is based on the alterations of the vessels, usually indicating abnormalities of the blood-retinal barrier and increased vasoregression, but the neuroglial elements appear equally vulnerable to the diabetic condition. Control of blood glucose, blood pressure and timely identification of coincident nephropathy are important to prevent progression to vision-threatening stages. Guidelines give specific indications for laser photocoagulation, in particular when euglycemia is no longer effective in preventing progression to advanced stages. Intravitreal administration of antibodies directed against the single best characterized propagator of clinically significant macular edema, vascular endothelial growth factor (VEGF), has become popular despite uncertainty about the patient subgroups which benefit best and the optimum administration schedule. Multifactorial intervention beyond glycemic control includes antihypertensive, lipid-lowering and antiaggregatory and is effective in type 2 diabetic patients with high-risk profiles, in particular coincident nephropathy. © The Author(s), 2013. Source

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