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- Parker, C., et al.
(author)
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Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer
- 2013
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 369:3, s. 213-223
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Journal article (peer-reviewed)abstract
- Background Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. Methods In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. Results At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P=0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. Conclusions In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. (Funded by Algeta and Bayer HealthCare Pharmaceuticals; ALSYMPCA ClinicalTrials.gov number, NCT00699751.)
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- Forss, A, et al.
(author)
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'I got a letter ...' a qualitative study of women's reasoning about attendance in a cervical cancer screening programme in urban Sweden
- 2001
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In: Psycho-Oncology. - 1057-9249 .- 1099-1611. ; 10:1, s. 76-87
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Journal article (peer-reviewed)abstract
- Objective: This explorative study aims at investigating how 'healthy' women describe and reason about participation in a cervical cancer screening programme in Sweden. The study is part of a multidisciplinary research project studying a population-based cervical cancer-screening programme from the perspective of different actors. Setting and methods: Data collection took place at three ante-natal health centres (ANHCs) in demographically diverse areas in the Stockholm region in spring 1995. Interviews were conducted and audiotaped with 66 'healthp' women at the ANHCs immediately before taking a Papanicolau test. Open questions such as 'Why have you come here today?' and 'What kind of test will you take?' were used to initiate the interview. Verbatim transcripts were analysed with a modified phenomenographical method to identify and describe qualitatively different ways of understanding cervical cancer screening. Results: Four different ways of reasoning about cervical cancer screening are described, with only one similar to the biomedical rationale for screening with focus on attending for the test/results. Two types of reasoning refer to the invitation letter as a catalyst, with one emphasizing benefits in attendance and the second emphasizing hinders to attendance. A final way of reasoning focuses on the individual's own proactive role in prevention. Common themes are also identified. Implications: This study complements the research literature by providing a better knowledge base of the variations in reasoning among women attending screening, often seen as a homogenous group. It can contribute to better adapting the screening situation to the varied needs and expectations of the women who attend. Copyright (C) 2001 John Wiley & Sons, Ltd.
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- Forss, A., et al.
(author)
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Women's experiences of cervical cellular changes : An unintentional transition from health to liminality?
- 2004
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In: Sociology of Health and Illness. - : Wiley. - 0141-9889 .- 1467-9566. ; 26:3, s. 306-325
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Research review (peer-reviewed)abstract
- Cervical cancer screening is a preventive intervention directed towards women to both detect cervical cancer and identify those at risk for developing this disease. It has been argued that participation in screening programmes and early detection situations may lead to new kinds of sickness experiences. This article is based on qualitative phenomenological hermeneutical analysis of interviews with women who have received abnormal Pap smear test results through a population-based outreach screening programme in urban Sweden. The aim of this article is to illuminate the meaning, for the participating women, of the lived experience of receiving notification about an abnormal Pap smear result. The data are presented in terms of two themes: Pap smear for routine and recurrent confirmation of health and unexpected and ambiguous communication about Pap smear results. The findings are discussed as an unintentional transition from confirmation of health to liminality. Whereas medical diagnosis has been discussed as structuring the inchoate, an abnormal Pap smear did not create order for the interviewed women. On the contrary, the notification of an abnormal Pap smear created disorder as the women had expected to be confirmed as healthy but instead neither health nor disease were confirmed or excluded. Even 'simple' technology is shown to have an ontological dimension, with the ability to transform daily taken-for-grantedness of ourselves as primarily healthy to (potentially) unhealthy.
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- Fransson, P., et al.
(author)
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Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, 3 trial
- 2021
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In: Lancet Oncology. - : Elsevier BV. - 1470-2045. ; 22:2, s. 235-245
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Journal article (peer-reviewed)abstract
- Background The HYPO-RT-PC trial compared conventionally fractionated radiotherapy with ultra-hypofractionated radiotherapy in patients with localised prostate cancer. Ultra-hypofractionation was non-inferior to conventional fractionation regarding 5-year failure-free survival and toxicity. We aimed to assess whether patient-reported quality of life (QOL) differs between conventional fractionation and ultra-hypofractionation up to 6 years after treatment in the HYPO-RT-PC trial. Methods HYPO-RT-PC is a multicentre, open-label, randomised, controlled, non-inferiority, phase 3 trial done in 12 centres (seven university hospitals and five county hospitals) in Sweden and Denmark. Inclusion criteria were histologically verified intermediate-to-high-risk prostate cancer (defined as T1c-T3a with one or two of the following risk factors: stage T3a; Gleason score >= 7; and prostate-specific antigen 10-20 ng/mL with no evidence of lymph node involvement or distant metastases), age up to 75 years, and WHO performance status 0-2. Participants were randomly assigned (1:1) to conventional fractionation (78.0 Gy in 39 fractions, 5 days per week for 8 weeks) or ultra-hypofractionation (42.7 Gy in seven fractions, 3 days per week for 2.5 weeks) via a minimisation algorithm with stratification by trial centre, T-stage, Gleason score, and prostate-specific antigen. QOL was measured using the validated Prostate Cancer Symptom Scale (PCSS) and European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) at baseline, the end of radiotherapy, months 3, 6, 12, and 24 after radiotherapy, every other year thereafter up to 10 years, and at 15 years. The primary endpoint (failure-free survival) has been reported elsewhere. Here we report QOL, a secondary endpoint analysed in the perprotocol population, up to 6 years after radiotherapy. The HYPO-RT-PC trial is registered with the ISRCTN registry, ISRCTN45905321. Findings Between July 1, 2005, and Nov 4, 2015, 1200 patients were enrolled and 1180 were randomly assigned (conventional fractionation n=591, ultra-hypofractionation n=589); 1165 patients (conventional fractionation n=582, ultra-hypofractionation n=583) were included in this QOL analysis. 158 (71%) of 223 patients in the conventional fractionation group and 146 (66%) of 220 in the ultra-hypofractionation group completed questionnaires at 6 years. The median follow-up was 48 months (IQR 25-72). In seven of ten bowel symptoms or problems the proportion of patients with clinically relevant deteriorations at the end of radiotherapy was significantly higher in the ultra-hypofractionation group than in the conventional fractionation group (stool frequency [p<0.0001], rush to toilet [p=0.0013], flatulence [p=0.0013], bowel cramp [p<0.0001], mucus [p=0.0014], blood in stool [p<0.0001], and limitation in daily activity [p=0.0014]). There were no statistically significant differences in the proportions of patients with clinically relevant acute urinary symptoms or problems (total 14 items) and sexual functioning between the two treatment groups at end of radiotherapy. Thereafter, there were no clinically relevant differences in urinary, bowel, or sexual functioning between the groups. At the 6-year followup there was no difference in the incidence of clinically relevant deterioration between the groups for overall urinary bother (43 [33%] of 132 for conventional fractionation vs 33 [28%] of 120 for ultra-hypofractionation; mean difference 5.1% [95% CI -4.4 to 14.6]; p=0.38), overall bowel bother (43 [33%] of 129 vs 34 [28%] of 123; 5.7% [-3.8 to 15.2]; p=0.33), overall sexual bother (75 [60%] of 126 vs 59 [50%] of 117; 9.1% [-1.4 to 19.6]; p=0.15), or global health/QOL (56 [42%] of 134 vs 46 [37%] of 125; 5.0% [-5.0 to 15.0]; p=0.41). Interpretation Although acute toxicity was higher for ultra-hypofractionation than conventional fractionation, this long-term patient-reported QOL analysis shows that ultra-hypofractionation was as well tolerated as conventional fractionation up to 6 years after completion of treatment. These findings support the use of ultra-hypofractionation radiotherapy for intermediate-to-high-risk prostate cancer.
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- Lundgren, EL, et al.
(author)
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Midwives' descriptions of their familiarity with cancer - A qualitative study of midwives working with population-based cervical cancer screening in urban Sweden
- 2000
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In: Cancer Nursing. - 0162-220X .- 1538-9804. ; 23:5, s. 392-400
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Journal article (peer-reviewed)abstract
- Nurse-midwives are responsible for taking Papanicolaou (Pap) smears in Swedish population-based cervical cancer screening programs. A research project examining the screening program from the perspective of different stakeholders includes an interview study of 21 midwives working in Stockholm. This article explores the way the midwives describe cancer-related knowledge and aspects of screening, contrasting this with relevant findings from a substudy of 66 healthy women participating in screening. A semistructured interview guide with open-ended questions was used to investigate ideas about benefits and risks in the screening program, risk factors for cervical cancer, the reliability of the test itself, sources of information/knowledge relevant for cervical cancer screening, and the manner in which the midwife described her role in the screening program. The transcripts of the audiotaped interviews were analyzed thematically using a team approach. The interviewed midwives showed a great deal of consensus in their descriptions of lacking familiarity with cervical cancer and its prevention and treatment. The midwives said they lack recent education and knowledge, often avoiding use of the word "cancer" with women attending screening. It seems that the midwives experienced little professional guidance in discussing cancer-related issues with women attending the screening program. In this study, they appeared to rely on personal knowledge, valves, and experience instead.
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- Widmark, A., et al.
(author)
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Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial
- 2019
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In: Lancet. - : Elsevier BV. - 0140-6736. ; 394:10196, s. 385-395
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Journal article (peer-reviewed)abstract
- Background Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RTPC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation. Methods In this open-label, randomised, phase 3 non-inferiority trial done in 12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2. Patients were randomly assigned to ultra-hypofractionation (42.7 Gy in seven fractions, 3 days per week for 2.5 weeks) or conventional fractionated radiotherapy (78.0 Gy in 39 fractions, 5 days per week for 8 weeks). No androgen deprivation therapy was allowed. The primary endpoint was time to biochemical or clinical failure, analysed in the per-protocol population. The prespecified non-inferiority margin was 4% at 5 years, corresponding to a critical hazard ratio (HR) limit of 1.338. Physician-recorded toxicity was measured according to the Radiation Therapy Oncology Group (RTOG) morbidity scale and patient-reported outcome measurements with the Prostate Cancer Symptom Scale (PCSS) questionnaire. This trial is registered with the ISRCTN registry, number ISRCTN45905321. Findings Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionation (n=602) or ultra-hypofractionation (n=598), of whom 1180 (591 conventional fractionation and 589 ultra-hypofractionation) constituted the per-protocol population. 1054 (89%) participants were intermediate risk and 126 (11%) were high risk. Median follow-up time was 5.0 years (IQR 3.1-7.0). The estimated failure-free survival at 5 years was 84% (95% CI 80-87) in both treatment groups, with an adjusted HR of 1.002 (95% CI 0.758-1.325; log-rank p=0.99). There was weak evidence of an increased frequency of acute physician-reported RTOG grade 2 or worse urinary toxicity in the ultra-hypofractionation group at end of radiotherapy (158 [28%] of 569 patients vs 132 [23%] of 578 patients; p=0.057). There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0.0037). We observed no differences between groups in frequencies at 5 years of RTOG grade 2 or worse urinary toxicity (11 [5%] of 243 patients for the ultra-hypofractionation group vs 12 [5%] of 249 for the conventional fractionation group; p=1.00) and bowel toxicity (three [1%] of 244 patients vs nine [4%] of 249 patients; p=0.14). Patient-reported outcomes revealed significantly higher levels of acute urinary and bowel symptoms in the ultra-hypofractionation group compared with the conventional fractionation group but no significant increases in late symptoms were found, except for increased urinary symptoms at 1-year follow-up, consistent with the physician-evaluated toxicity. Interpretation Ultra-hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy for intermediate-to-high risk prostate cancer regarding failure-free survival. Early side-effects are more pronounced with ultra-hypofractionation compared with conventional fractionation whereas late toxicity is similar in both treatment groups. The results support the use of ultra-hypofractionation for radiotherapy of prostate cancer. Copyright (C) 2019 Elsevier Ltd. All rights reserved.
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- Widmark, C., et al.
(author)
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Obstetric care at the intersection of science and culture : Swedish doctors' perspectives on obstetric care of women who have undergone female genital cutting
- 2010
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In: Journal of Obstetrics and Gynaecology. - : Informa UK Limited. - 0144-3615 .- 1364-6893. ; 30:6, s. 553-558
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Journal article (peer-reviewed)abstract
- Providing healthcare for women having undergone female genital cutting can present challenges. The women might require special obstetric care, including an anterior episiotomy (defibulation) for infibulated women. This paper explores how Swedish doctors caring for these women describe, explain and reason about their care and relevant policies in a Swedish context. A qualitative study was carried out with 13 chief/senior obstetricians and seven senior house officers. There was little consensus among the interviewed doctors on what constitutes good obstetric care for women with FGC or how care should be provided. Major problems include: inconsistent policy and praxis; uncoordinated care trajectories; diffuse professional role responsibilities; difficulties in monitoring labour and fetal status; and inhibited communication. The data highlight the need for increased awareness and reflective praxis both on the part of individual practitioners, and on an organisational level, which takes account of the special needs of different users.
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