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- Hoffmann, V S, et al.
(författare)
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Treatment and outcome of 2904 CML patients from the EUTOS population-based registry
- 2017
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Ingår i: Leukemia. - : Springer Science and Business Media LLC. - 0887-6924 .- 1476-5551. ; 31:3, s. 593-601
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Tidskriftsartikel (refereegranskat)abstract
- The European Treatment and Outcome Study (EUTOS) population-based registry includes data of all adult patients newly diagnosed with Philadelphia chromosome-positive and/or BCR-ABL1+ chronic myeloid leukemia (CML) in 20 predefined countries and regions of Europe. Registration time ranged from 12 to 60 months between January 2008 and December 2013. Median age was 55 years and median observation time was 29 months. Eighty percent of patients were treated first line with imatinib, and 17% with a second-generation tyrosine kinase inhibitor, mostly according to European LeukemiaNet recommendations. After 12 months, complete cytogenetic remission (CCyR) and major molecular response (MMR) were achieved in 57% and 41% of patients, respectively. Patients with high EUTOS risk scores achieved CCyR and MMR significantly later than patients with low EUTOS risk. Probabilities of overall survival (OS) and progression-free survival for all patients at 12, 24 and 30 months was 97%, 94% and 92%, and 95%, 92% and 90%, respectively. The new EUTOS long-term survival score was validated: the OS of patients differed significantly between the three risk groups. The probability of dying in remission was 1% after 24 months. The current management of patients with tyrosine kinase inhibitors resulted in responses and outcomes in the range reported from clinical trials. These data from a large population-based, patient sample provide a solid benchmark for the evaluation of new treatment policies.Leukemia advance online publication, 23 September 2016; doi:10.1038/leu.2016.246.
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| 3. |
- Hoffmann, V. S., et al.
(författare)
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The EUTOS population-based registry : incidence and clinical characteristics of 2904 CML patients in 20 European Countries
- 2015
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Ingår i: Leukemia. - : Springer Science and Business Media LLC. - 0887-6924 .- 1476-5551. ; 29:6, s. 1336-1343
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Tidskriftsartikel (refereegranskat)abstract
- This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months. 94.3% of the 2904 CML patients were diagnosed in chronic phase (CP). Median age was 56 years. 55.5% of patients had comorbidities, mainly cardiovascular (41.9%). High-risk patients were 24.7% by Sokal, 10.8% by EURO, and 11.8% by EUTOS risk scores. The raw incidence increased with age from 0.39/100 000/year in people 20-29 years old to 1.52 in those >70 years old, and showed a maximum of 1.39 in Italy and a minimum of 0.69 in Poland (all countries together: 0.99). The proportion of Sokal and Euro score high-risk patients seen in many countries indicates that trial patients were not a positive selection. Thus from a clinical point of view the results of most trials can be generalized to most countries. The incidences observed among European countries did not differ substantially. The estimated number of new CML cases per year in Europe is about 6370.
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| 5. |
- Björling, Gunilla, Docent, et al.
(författare)
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Risk Evaluation of Therapy Medical Devices and Implants for Increased Patient Safety : REMISS Horizon 2020 Research and Innovation Action
- 2017
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Konferensbidrag (refereegranskat)abstract
- Current knowledge in the area of medical devices remains insufficiently complete, and many of the established test methods and international standards (ISO (International Organization for Standardization) standards) open up to individual interpretation on how the test should be performed and the results reported. Treating long-term diseases such as cancer imposes a stringent sequence of various treatments on patients. For instance, cancer may be treated with radiation and chemotherapy; the latter in many treatment protocols requiring the implantation of an intravascular catheter during a prolonged period of time. To maximize the effect of such measures, as well as issues related to the patient Health Related Quality of Life (HRQoL), integrated and validated methodologies are needed as decisional basis for appropriate risk management and patient safety with regard to clinical use of intravascular catheters.The ambition of the REMISS project is to: Establish integrated and validated methodologies for risk management of the clinical use of intravascular catheters with respect to the clinical service lifetime, improved patient treatment, safety and HRQoL. This is assumed to reduce patient suffering due to complications associated with material deployment and degradation associated side effects for e.g. cancer patients receiving treatment with chemotherapeutical drugs using an intravascular catheter.The main vision is to improve the standards for eliminating side effects (complications) caused by deployment from and degradation of intravascular catheters, as well as loss of performance due to material-drug-biological system interactions, compared to the current state-of-the-art. Realising the project goals the rate of catheter-associated complications can be lowered by 40-50%, which in turn will improve patient treatment, safety and HRQoL, as well as health care related costs.Package integrally developed methodologies, predictive models, databases, and other project findings, as a potential product with a holistic coverage. It is believed that commercialisation of (selected) results will be the best option in order to create sustainable availability of this service based on continued research on intravascular catheters according to integrated and validated methodologies.REMISS answer the call NMBP-12-2017 Development of a Reliable Methodology for Better Risk Management of Engineered Biomaterials Advanced Therapy Medicinal Products and/or Medical Devices Marcy, P. Central venous access: techniques and indications in oncology. European Society of Radiology, 2008; 18; 2333-44 Maki DG, et al The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc 2006: 81 (9): 1159-71. Frostell, C., Björling, G., Strömberg, E., Karlsson, S., and Aune, R. E., Tracheal Implants Revisited, The Lancet (2017), 389(10075) pp.1191
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