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1.
  • Margolin, Sara, et al. (författare)
  • A randomised feasibility/phase II study (SBG 2004-1) with dose-dense/tailored epirubicin, cyclophoshamide (EC) followed by docetaxel (T) or fixed dosed dose-dense EC/T versus T, doxorubicin and C (TAC) in node-positive breast cancer.
  • 2011
  • Ingår i: Acta Oncologica. - 0284-186X. ; 50:1, s. 35-41
  • Tidskriftsartikel (refereegranskat)abstract
    • The aim of the study was to evaluate the feasibility of tailored and dose-dense epirubicin and cyclophosphamide followed by docetaxel as adjuvant breast cancer therapy. Material and methods. Patients with node-positive breast cancer received either four cycles of biweekly and tailored EC (epirubicin 38-60-75-90-105-120 mg/m(2), cyclophosphamide 450-600-900-1200 mg/m(2)) followed by four cycles of docetaxel (60-75-85-100 mg/m(2)) (arm A) or the same regimen with fixed doses (E(90)C(600) + 4 → T(75) + 4) (arm B) or docetaxel, doxorubicin and cyclophosphamide (T(75)A(50)C(500)) every three weeks for six cycles (arm C). All patients received G-CSF support and prophylactic ciprofloxacin. Results. One-hundred and twenty-four patients were randomised in the study. In the A, B and C arm, 17% 19% and 3% of the patients had one or more cycles delayed due to side-effects whereas 24%, 5% and 15% experienced a grade 3 infection or febrile neutropenia. After the introduction of an extra week between the EC and T parts in the A and B arms, grade 3 hand-foot-skin reactions were reduced from 5 to 0.2%. Twenty-nine percent (A and B) and 20% (C) of the patients were hospitalised due to side-effects. Discussion. Dose-dense and tailored EC/T can be given with manageable toxicity and is after adjustment presently studied in the phase III Panther trial.
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2.
  • Matikas, Alexios, et al. (författare)
  • Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer
  • 2018
  • Ingår i: Breast Cancer Research and Treatment. - SPRINGER. - 0167-6806 .- 1573-7217. ; 168:2, s. 349-355
  • Tidskriftsartikel (refereegranskat)abstract
    • Although adjuvant polychemotherapy improves outcomes for early breast cancer, the significant variability in terms of pharmacokinetics results in differences in efficacy and both short and long-term toxicities. Retrospective studies support the use of dose tailoring according to the hematologic nadirs. The SBG 2004-1 trial was a randomized feasibility phase II study which assessed tailored dose-dense epirubicin and cyclophosphamide (EC) followed by docetaxel (T) (group A), the same regimen with fixed doses (group B) and the TAC regimen (group C). Women aged 18-65 years, ECOG PS 0-1 with at least one positive axillary lymph node were randomized 1:1:1. The primary endpoint of the study was the safety and feasibility of the treatment. Toxicity was graded according to CTC-AE version 3.0. The design and short-term toxicity have been previously published. Here, we report safety and efficacy data after 10 years of follow-up. A total of 124 patients were included in the study. After a median follow-up of 10.3 years, the probability for 10-year survival was 78.5, 75.1, and 63.4% and for relapse free survival 64.1, 71.0, and 59.5% for groups A, B, and C, respectively. There were no cases of clinically diagnosed cardiotoxicity or hematologic malignancies. No patient was lost to follow-up. In this randomized phase II trial, tailored dose adjuvant chemotherapy was feasible, without an increased risk for long-term adverse events after a median follow-up of 10 years.
3.
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4.
  • Bäckman, Karin, et al. (författare)
  • Vårdens alltför svåra val? kartläggning av prioriteringsarbete och analys av riksdagens principer och riktlinjer för prioriteringar i hälso- och sjukvården
  • 2007
  • Rapport (övrigt vetenskapligt)abstract
    • PrioriteringsCentrum har på uppdrag av Socialstyrelsen genomfört en kartläggning av på vilket sätt hälso- och sjukvårdens huvudmän och andra centrala aktörer arbetar med prioriteringar och har utvärderat hur detta arbete överensstämmer med intentionerna i riksdagens beslut om prioriteringar. Vi har även analyserat innehållet i och tillämpningen av riksdagens riktlinjer för prioriteringar i hälso- och sjukvården. Det har skett genom en etisk analys och mot bakgrund av ett stort antal intervjuer i landsting och kommuner samt med representanter för statliga myndigheter och yrkesorganisationer och med ledning av vad som framkommit i tidigare uppföljningar. Vi föreslår i rapporten ett anta förändringar och förtydliganden av riktlinjerna.Vi kan konstatera att sättet att arbeta med prioriteringar i landsting och kommuner inte är helt olikt det som gällde när Prioriteringsdelegationen redovisade en motsvarande uppföljning år 2001. Fortfarande finns knappast några öppna beslut om fördelning och prioritering av resurser om man med öppenhet avser att beslutsfattaren medvetet överväger flera alternativ och att grunderna för besluten är kända för dem som önskar ta del av dem.I situationer då tillgängliga resurser inte befinner sig i paritet med  önskvärda ambitioner får sjukvårdspersonalen ta det största ansvaret för att besluta om och genomföra ransonering av vården. Förutom på chefsnivå tycks dock sjukvårdpersonal fortfarande i liten utsträckning vara medveten om de etiska principer som enligt riksdagsbeslutet ska styra prioriteringar i vården. Få känner till den etiska plattformen med de tre etiska principerna. Lokala mallar eller styrdokument för prioriteringar är ovanliga. Det saknas nödvändiga förutsättningar för att tillämpa riksdagens prioriteringsbeslut och det finns inte heller några tydliga strategier för hur man vill skapa sådana förutsättningar inom landstingen.Den kommunala vård- och omsorgsverksamheten upplever sig fortfarande i ringa utsträckning berörd av den etiska plattformen och prioriteringsprinciperna. Någon gemensam prioritering mellan huvudmännen sker knappast alls.Medborgarna är i mycket liten utsträckning involverade i prioriteringsarbetet. Den ökade öppenheten gentemot brukare innebär oftast att viss information om prioriteringar sker genom traditionella kanaler som patientorganisationer, pensionärsråd och handikappråd och synpunkter inhämtas via allmänna patientenkäter medan klagomål hanteras genom patientnämnder.Vi har också funnit tydliga skillnader när det gäller hur arbetet med prioriteringar bedrivs idag jämfört med för sex år sedan. Genom Socialstyrelsen och Läkemedelsförmånsnämnden har staten tagit  ledningen när det gäller att visa hur prioriteringar kan göras på ett systematiskt och öppet sätt. Detta arbete har resulterat i en tydlig metodutveckling. Idag finns det dessutom flera exempel på konkret utvecklingsarbete och samverkan mellan huvudmän kring det vidare begreppet kunskapsstyrd vård till vilket systematiska prioriteringar är starkt relaterat. Vi kan också notera olika initiativ till vertikala prioriteringar i verksamheten där det framförallt är läkarkåren som engagerat sig; men också enstaka försök med systematiska politiska prioriteringar. Det finns dessutom flera lovande utvecklingsprojekt rörande prioriteringar som initierats av och drivs av sjukvårdspersonal både lokalt och nationellt. Yrkesförbunden är också mer aktiva idag när det gäller att sprida kunskap om prioriteringar....
5.
  • Chen, Xu, et al. (författare)
  • A genome-wide association study of IgM antibody against phosphorylcholine : Shared genetics and phenotypic relationship to chronic lymphocytic leukemia
  • 2018
  • Ingår i: Human Molecular Genetics. - Oxford University Press. - 0964-6906. ; 27:10, s. 1809-1818
  • Tidskriftsartikel (refereegranskat)abstract
    • Phosphorylcholine (PC) is an epitope on oxidized low-density lipoprotein (oxLDL), apoptotic cells and several pathogens like Streptococcus pneumoniae. Immunoglobulin M against PC (IgM anti-PC) has the ability to inhibit uptake of oxLDL by macrophages and increase clearance of apoptotic cells. From our genome-wide association studies (GWASs) in four Europeanancestry cohorts, six single nucleotide polymorphisms (SNPs) in 11q24.1 were discovered (in 3002 individuals) and replicated (in 646 individuals) to be associated with serum level of IgM anti-PC (the leading SNP rs35923643-G, combined β=0.19, 95% confidence interval 0.13-0.24, P=4.3×10-11). The haplotype tagged by rs35923643-G (or its proxy SNP rs735665-A) is also known as the top risk allele for chronic lymphocytic leukemia (CLL), and a main increasing allele for general IgM. By using summary GWAS results of IgM anti-PC and CLL in the polygenic risk score (PRS) analysis, PRS on the basis of IgM anti-PC risk alleles positively associated with CLL risk (explained 0.6% of CLL variance, P=1.2×10-15). Functional prediction suggested that rs35923643-G might impede the binding of Runt-related transcription factor 3, a tumor suppressor playing a central role in the immune regulation of cancers. Contrary to the expectations from the shared genetics between IgM anti-PC and CLL, an inverse relationship at the phenotypic level was found in a nested case-control study (30 CLL cases with 90 age- and sexmatched controls), potentially reflecting reverse causation. The suggested function of the top variant as well as the phenotypic association between IgM anti-PC and CLL risk needs replication and motivates further studies.
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6.
  • Glimelius, Bengt, et al. (författare)
  • U-CAN a prospective longitudinal collection of biomaterials and clinical information from adult cancer patients in Sweden.
  • 2018
  • Ingår i: Acta Oncologica. - 0284-186X .- 1651-226X. ; 57:2, s. 187-194
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Progress in cancer biomarker discovery is dependent on access to high-quality biological materials and high-resolution clinical data from the same cases. To overcome current limitations, a systematic prospective longitudinal sampling of multidisciplinary clinical data, blood and tissue from cancer patients was therefore initiated in 2010 by Uppsala and Umeå Universities and involving their corresponding University Hospitals, which are referral centers for one third of the Swedish population.Material and Methods: Patients with cancer of selected types who are treated at one of the participating hospitals are eligible for inclusion. The healthcare-integrated sampling scheme encompasses clinical data, questionnaires, blood, fresh frozen and formalin-fixed paraffin-embedded tissue specimens, diagnostic slides and radiology bioimaging data.Results: In this ongoing effort, 12,265 patients with brain tumors, breast cancers, colorectal cancers, gynecological cancers, hematological malignancies, lung cancers, neuroendocrine tumors or prostate cancers have been included until the end of 2016. From the 6914 patients included during the first five years, 98% were sampled for blood at diagnosis, 83% had paraffin-embedded and 58% had fresh frozen tissues collected. For Uppsala County, 55% of all cancer patients were included in the cohort.Conclusions: Close collaboration between participating hospitals and universities enabled prospective, longitudinal biobanking of blood and tissues and collection of multidisciplinary clinical data from cancer patients in the U-CAN cohort. Here, we summarize the first five years of operations, present U-CAN as a highly valuable cohort that will contribute to enhanced cancer research and describe the procedures to access samples and data.
7.
  • Johansson, Karl-Axel, et al. (författare)
  • The quality assurance process for the ARTSCAN head and neck study - a practical interactive approach for QA in 3DCRT and IMRT.
  • 2008
  • Ingår i: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. - 0167-8140. ; 87:2, s. 290-9
  • Tidskriftsartikel (refereegranskat)abstract
    • AIM: This paper describes the quality assurance (QA) work performed in the Swedish multicenter ARTSCAN (Accelerated RadioTherapy of Squamous cell CArcinomas in the head and Neck) trial to guarantee high quality in a multicenter study which involved modern radiotherapy such as 3DCRT or IMRT.MATERIALS AND METHODS: The study was closed in June 2006 with 750 randomised patients. Radiation therapy-related data for every patient were sent by each participating centre to the QA office where all trial data were reviewed, analysed and stored. In case of any deviation from the protocol, an interactive process was started between the QA office and the local responsible clinician and/or physicist to increase the compliance to the protocol for future randomised patients. Meetings and workshops were held on a regular basis for discussions on various trial-related issues and for the QA office to report on updated results.RESULTS AND DISCUSSION: This review covers the 734 patients out of a total of 750 who had entered the study. Deviations early in the study were corrected so that the overall compliance to the protocol was very high. There were only negligible variations in doses and dose distributions to target volumes for each specific site and stage. The quality of the treatments was high. Furthermore, an extensive database of treatment parameters was accumulated for future dose-volume vs. endpoint evaluations.CONCLUSIONS: This comprehensive QA programme increased the probability to draw firm conclusions from our study and may serve as a concept for QA work in future radiotherapy trials where comparatively small effects are searched for in a heterogeneous tumour population.
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8.
  • Kanter-Smoler, Gunilla, et al. (författare)
  • Novel findings in Swedish patients with MYH-associated polyposis: mutation detection and clinical characterization
  • 2006
  • Ingår i: Clin Gastroenterol Hepatol. - 1542-3565 (Print). ; 4:4, s. 499-506
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND & AIMS: Biallelic mutations in the base-excision repair gene MYH have recently been associated with recessive inheritance of multiple colorectal adenomas. An investigation and characterization of MYH mutations in Swedish patients were therefore carried out. METHODS: A set of 15 unrelated adenomatous polyposis coli (APC)-mutation negative patients from the Swedish Polyposis Registry was screened for germline mutations in the MYH gene. The patients were clinically characterized and compared with 43 APC-mutation positive probands diagnosed during the same period. RESULTS: Disease-causing biallelic MYH mutations were identified in 6 patients (40%). The mean age at diagnosis was 47.8 years versus 34.1 years in APC-mutation positive patients (P = .015). Colorectal cancer at diagnosis of polyposis was present in 67% (4/6) of the patients, and all were right-sided, compared with only 19% versus 12.5% right-sided cancer in APC-mutation positive patients. Upper gastrointestinal manifestations were diagnosed in 1 of 5 compared with 23 of 27 in APC-mutation positive patients (odds ratio, 23; 95% confidence interval, 2-263; P = .0086). One family exhibited apparent dominant inheritance of colorectal adenomatous polyposis. Two new pathogenic mutations, MYH p.G175E and p.P391L, were identified. The mutations are argued to introduce profound changes in substrate-recognizing domains of the protein. CONCLUSIONS: Biallelic MYH mutations, including 2 novel mutations, were found in a substantial number of the patients with multiple colorectal adenomas who were negative for APC-mutation. The examined MYH-mutation positive patients were found to have higher risks of colorectal cancer at diagnosis, right-sided location of cancers, and a significantly lower incidence of upper gastrointestinal manifestations, compared with APC-mutation positive patients.
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