| 1. |
- Bjerner, Johan, et al.
(författare)
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Baseline Serum Prostate-specific Antigen Value Predicts the Risk of Subsequent Prostate Cancer Death-Results from the Norwegian Prostate Cancer Consortium.
- 2023
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Ingår i: European urology. - 1873-7560 .- 0302-2838.
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Tidskriftsartikel (refereegranskat)abstract
- Prostate-specific antigen (PSA) levels in midlife are strongly associated with the long-term risk of lethal prostate cancer in cohorts not subject to screening. This is the first study evaluating the association between PSA levels drawn as part of routine medical care in the Norwegian population and prostate cancer incidence and mortality.To determine the association between midlife PSA levels <4.0 ng/ml, drawn as part of routine medical care, and long-term risk of prostate cancer death.The Norwegian Prostate Cancer Consortium collected >8 million PSA results from >1 million Norwegian males ≥40 yr of age. We studied 176099 men (predefined age strata: 40-54 and 55-69 yr) without a prior prostate cancer diagnosis who had a nonelevated baseline PSA level (<4.0 ng/ml) between January 1, 1995 and December 31, 2005.Baseline PSA.We assessed the 16-yr risk of prostate cancer mortality. We calculated the discrimination (C-index) between predefined PSA strata (<0.5, 0.5-0.9, 1.0-1.9, 2.0-2.9, and 3.0-3.9 ng/ml) and subsequent prostate cancer death. Survival curves were plotted using the Kaplan-Meier method.The median follow-up time of men who did not get prostate cancer was 17.9 yr. Overall, 84% of men had a baseline PSA level of <2.0 ng/ml and 1346 men died from prostate cancer, with 712 deaths (53%) occurring in the 16% of men with the highest baseline PSA of 2.0-3.9 ng/ml. Baseline PSA levels were associated with prostate cancer mortality (C-index 0.72 for both age groups, 40-54 and 55-69 yr). The fact that the reason for any given PSA measurement remains unknown represents a limitation.We replicated prior studies that baseline PSA at age 40-69 yr can be used to stratify a man's risk of dying from prostate cancer within the next 15-20 yr.A prostate-specific antigen level obtained as part of routine medical care is strongly associated with a man's risk of dying from prostate cancer in the next two decades.
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| 2. |
- Parker, Christopher C., et al.
(författare)
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Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial
- 2018
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Ingår i: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 73:3, s. 427-435
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Tidskriftsartikel (refereegranskat)abstract
- Background: In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment. Objective: To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection. Design, setting, and participants: Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving >= 1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr. Outcome measurements and statistical analysis: All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics. Results and limitations: During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non-treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up. Conclusions: Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns.
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| 3. |
- Dahl, Christian A. Falk, et al.
(författare)
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A Study of Body Image in Long-Term Breast Cancer Survivors
- 2010
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Ingår i: Cancer. - : Wiley. - 0008-543X .- 1097-0142. ; 116:15, s. 3549-3557
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In this controlled postdiagnosis study, the authors examined various aspects of body image of breast cancer survivors in cross-sectional and longitudinal designs. METHODS: In 2004 and 2007 the Body Image Scale (BIS) was completed by the same 248 disease-free women who had been treated for stage II and III breast cancer between 1998 and 2002. "Poorer" body image was defined as greater than the 70th percentile (N = 76 women) of the BIS scores in contrast to "better" body image (N = 172 women). Breast cancer survivors were examined clinically in 2004, and their BIS scores were compared with the scores from an age-matched group of women from the general population. RESULTS: In this cross-sectional study, poorer body image in 2004 was associated significantly with modified radical mastectomy, undergoing or planning to undergo breast-reconstructive surgery, a change in clothing, poor physical and mental health, chronic fatigue, and reduced quality of life (QoL). In univariate analyses, most of these factors and manually planned radiotherapy were significant predictors of poorer body image in 2007. In multivariate analyses, manually planned radiotherapy, poor physical QoL and high BIS score in 2004 remained independent predictors of a poorer body image in 2007. Body image ratings were relatively stable from 2004 to 2007. Twenty-one percent of breast cancer survivors reported body image dissatisfaction, similar to the proportion of dissatisfaction in controls. CONCLUSIONS: In this cross-sectional analysis, body image in breast cancer survivors was associated with the types of surgery and radiotherapy and with mental distress, reduced health, and impaired QoL. Body image ratings were relatively stable over time, and the antecedent body image score was a strong predictor of body image at follow-up. Body image in breast cancer survivors differed very little from that in controls.
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| 4. |
- Edvardsen, Hege, et al.
(författare)
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SNP in TXNRD2 Associated With Radiation-Induced Fibrosis : A Study of Genetic Variation in Reactive Oxygen Species Metabolism and Signaling.
- 2013
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Ingår i: International journal of radiation oncology, biology, physics. - : Elsevier BV. - 1879-355X .- 0360-3016. ; 86:4, s. 791-9
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: The aim of the study was to identify noninvasive markers of treatment-induced side effects. Reactive oxygen species (ROS) are generated after irradiation, and genetic variation in genes related to ROS metabolism might influence the level of radiation-induced adverse effects (AEs).METHODS AND MATERIALS: 92 breast cancer (BC) survivors previously treated with hypofractionated radiation therapy were assessed for the AEs subcutaneous atrophy and fibrosis, costal fractures, lung fibrosis, pleural thickening, and telangiectasias (median follow-up time 17.1 years). Single-nucleotide polymorphisms (SNPs) in 203 genes were analyzed for association to AE grade. SNPs associated with subcutaneous fibrosis were validated in an independent BC survivor material (n=283). The influence of the studied genetic variation on messenger ribonucleic acid (mRNA) expression level of 18 genes previously associated with fibrosis was assessed in fibroblast cell lines from BC patients.RESULTS: Subcutaneous fibrosis and atrophy had the highest correlation (r=0.76) of all assessed AEs. The nonsynonymous SNP rs1139793 in TXNRD2 was associated with grade of subcutaneous fibrosis, the reference T-allele being more prevalent in the group experiencing severe levels of fibrosis. This was confirmed in another sample cohort of 283 BC survivors, and rs1139793 was found significantly associated with mRNA expression level of TXNRD2 in blood. Genetic variation in 24 ROS-related genes, including EGFR, CENPE, APEX1, and GSTP1, was associated with mRNA expression of 14 genes previously linked to fibrosis (P≤.005).CONCLUSION: Development of subcutaneous fibrosis can be associated with genetic variation in the mitochondrial enzyme TXNRD2, critically involved in removal of ROS, and maintenance of the intracellular redox balance.
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| 5. |
- Fosså, Sophie D., et al.
(författare)
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Reduction of quality of life in prostate cancer patients : experience among 6200 men in the Nordic countries
- 2016
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 50:5, s. 330-337
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Although many studies have dealt with adverse effects (AEs) and quality of life (QoL) in prostate cancer (PCa) patients, the quantification of the patients’ perspective on AE-related reduction in QoL has been less studied. This study describes the impact of self-reported local (erectile, bowel, urinary dysfunction) or systemic (mental distress, fatigue, virility loss) AEs on QoL reduction. Materials and methods: Nordic PCa patients completed a questionnaire containing 84 multiple-choice questions. The main outcome variable of the survey was patient-reported PCa-induced QoL reduction, assessed by descriptive and regression analyses. The level of significance was p
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| 6. |
- Hernes, Eivor, et al.
(författare)
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High prostate cancer mortality in Norway evaluated by automated classification of medical entities.
- 2008
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Ingår i: European Journal of Cancer Prevention. - 0959-8278 .- 1473-5709. ; 17:4, s. 331-335
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Tidskriftsartikel (refereegranskat)abstract
- The new standard of cause of death classification is an automated selection of the underlying cause of death using the international software Automated Classification of Medical Entities (ACME). Norwegian mortality rates are, however, based on manual classification of deaths. The aim of this study was to investigate how the use of ACME would influence Norwegian prostate cancer mortality rates. A previously described cohort of Norwegian prostate cancer patients deceased during 1996 was applied. Multiple causes of death data based on information from death certificates, autopsies and queries was coded according to ACME specifications, thereby ACME selected the underlying cause of death. In addition, the underlying cause of death that originally was manually classified for the official mortality statistics was retrieved from Statistics Norway in all cases. Age-standardized prostate cancer mortality rates (world population) per 100,000 person-years were calculated. A total of 2012 cases were included. On the basis of ACME classification, the age-standardized prostate cancer mortality rate in Norway for 1996 would have been 24.4 (95% confidence interval: 22.9-26.0) as compared with the rate based on manual classification for the official mortality statistics of 24.9 (95% confidence interval: 23.4-26.5). Thus, automated classification by ACME does not significantly influence the age-adjusted Norwegian prostate cancer mortality rate for the year 1996. There is reason to assume that the use of manual classification of deaths is not a major explanation of the high prostate cancer mortality rates in Norway.
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| 7. |
- Kvåle, Rune, et al.
(författare)
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Concordance between Gleason scores of needle biopsies and radical prostatectomy specimens : a population-based study
- 2009
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Ingår i: BJU International. - 1464-4096 .- 1464-410X. ; 103:12, s. 1647-1654
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To study the concordance between the Gleason scores of needle biopsies and radical prostatectomy (RP) specimens in a population-based registry, to clarify whether the concordance depends on the annual number of RP specimens assessed in the pathology unit, and to identify preoperative clinical factors that predict upgrading from a Gleason score of or=7 in the RP specimen. PATIENTS AND METHODS: Through the Cancer Registry of Norway, we identified 1116 patients with available Gleason scores from biopsy and RP specimens. Concordance was evaluated using the kappa coefficient, and predictors of concordance were assessed in univariate and multivariate logistic regression analyses. RESULTS: The Gleason scores were identical in biopsy and RP specimens in 591 of the 1116 (53%) patients. The biopsy-based Gleason score more often under-graded (38%) than over-graded (9%) the RP-based Gleason score. Pathology units that examined >40 RP specimens annually had a higher concordance between the Gleason score in the biopsy and RP specimen than did lower-volume units. The rate of upgrading from a Gleason score of or=7 in the RP specimen increased with increasing preoperative prostate-specific antigen serum levels, and with increasing intervals between biopsy and RP. CONCLUSIONS: The concordance in Gleason score between biopsy and RP was highest among the pathology departments that regularly evaluated RP specimens. Careful consideration of clinical factors and biopsy grading might improve the identification of patients considered as suitable for active surveillance.
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| 8. |
- Reidunsdatter, Randi J., et al.
(författare)
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Validation of the intestinal part of the prostate cancer questionnaire "QUFW94": psychometric properties, responsiveness, and content validity
- 2010
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Ingår i: International Journal of Radiation Oncology, Biology, Physics. - : Elsevier. - 0360-3016 .- 1879-355X. ; 77:3, s. 793-804
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: Several treatment options are available for patients with prostate cancer. Applicable and valid self-assessment instruments for assessing health-related quality of life (HRQOL) are of paramount importance. The aim of this study was to explore the validity and responsiveness of the intestinal part of the prostate cancer-specific questionnaire QUFW94. METHODS AND MATERIALS: The content of the intestinal part of QUFW94 was examined by evaluation of experienced clinicians and reviewing the literature. The psychometric properties and responsiveness were assessed by analyzing HRQOL data from the randomized study Scandinavian Prostate Cancer Group 7 (SPCG)/Swedish Association for Urological Oncology 3 (SFUO). Subscales were constructed by means of exploratory factor analyses. Internal consistency was assessed by Cronbach's alpha. Responsiveness was investigated by comparing baseline scores with the 4-year posttreatment follow-up. RESULTS: The content validity was found acceptable, but some amendments were proposed. The factor analyses revealed two symptom scales. The first scale comprised five items regarding general stool problems, frequency, incontinence, need to plan toilet visits, and daily activity. Cronbach's alpha at 0.83 indicated acceptable homogeneity. The second scale was less consistent with a Cronbach's alpha at 0.55. The overall responsiveness was found to be very satisfactory. CONCLUSION: Two scales were identified in the bowel dimension of the QUFW94; the first one had good internal consistency. The responsiveness was excellent, and some modifications are suggested to strengthen the content validity.
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| 9. |
- Steinsvik, E Andreas Svaboe, et al.
(författare)
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Do perceptions of adverse events differ between patients and physicians? Findings from a randomized, controlled trial of radical treatment for prostate cancer
- 2010
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Ingår i: Journal of Urology. - : Elsevier. - 0022-5347 .- 1527-3792. ; 184:2, s. 525-531
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: Previous cross-sectional studies show considerable discrepancies between patient and physician ratings of adverse events after prostate cancer treatment. We used data from a randomized, controlled trial to examine such discrepancies.MATERIAL AND METHODS: The Scandinavian Prostate Cancer Groups Study 7 randomized men with locally advanced prostate cancer to antiandrogen monotherapy or to the same hormone treatment combined with external beam radiotherapy after 3 months of total androgen blockade. We selected a subsample of 333 men with valid ratings at baseline, and at 12 and 24-month followup for this prospective substudy. We also examined a cross-sectional sample of 305 men at the end of radiotherapy. We compared patient and physician ratings of frequency of daytime and nighttime urination, urinary incontinence, erectile dysfunction, bowel problems, nausea/vomiting, breast tenderness and gynecomastia.RESULTS: Perfect agreement between patient and physician ratings was observed in 70% to 100% of cases at baseline, in 73% to 98% at 12 months and in 65% to 97% at 24 months. There were 1% to 20% changes in perfect agreement with time. With patient ratings as the gold standard physicians more often underrated than overrated adverse events, except bowel problems, which were overrated at all posttreatment points.CONCLUSIONS: In a randomized, controlled trial of external beam radiotherapy and hormone manipulation physicians recorded pelvis related adverse events in acceptable accordance with their patients with prostate cancer. The oncologist tendency to overestimate bowel problems after radiotherapy needs further investigation. Our positive findings from a formal trial should not be transferred to daily clinical practice without further studies of discrepancies in routine clinical practice.
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| 10. |
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