| 1. |
- Hedlund, Pe rOlov, et al.
(författare)
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Significance of pretreatment cardiovascular morbidity as a risk factor during treatment with parenteral oestrogen or combined androgen deprivation of 915 patients with metastasized prostate cancer: Evaluation of cardiovascular events in a randomized trial
- 2011
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Ingår i: Scandinavian Journal of Urology and Nephrology. - London : Informa Healthcare. - 0036-5599 .- 1651-2065. ; 45:5, s. 346-353
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Tidskriftsartikel (refereegranskat)abstract
- Objective. This study aimed to evaluate prognostic risk factors for cardiovascular events during treatment of metastatic prostate cancer patients with high-dose parenteral polyoestradiol phosphate (PEP, Estradurin (R)) or combined androgen deprivation (CAD) with special emphasis on pretreatment cardiovascular disease. Material and methods. Nine-hundred and fifteen patients with T0-4, Nx, M1, G1-3, hormone- naive prostate cancer were randomized to treatment with PEP 240 mg i.m. twice a month for 2 months and thereafter monthly, or to flutamide (Eulexin (R)) 250 mg per os three times daily in combination with either triptorelin (Decapeptyl (R)) 3.75 mg i.m. per month or on an optional basis with bilateral orchidectomy. Pretreatment cardiovascular morbidity was recorded and cardiovascular events during treatment were assessed by an experienced cardiologist. A multivariate analysis was done using logistic regression. Results. There was a significant increase in cardiovascular events during treatment with PEP in patients with previous ischaemic heart disease (p = 0.008), ischaemic cerebral disease (p = 0.002), intermittent claudication (p = 0.031) and especially when the whole group of patients with pretreatment cardiovascular diseases was analysed together (p andlt; 0.001). In this group 33% of the patients had a cardiovascular event during PEP treatment. In the multivariate analysis PEP stood out as the most important risk factor for cardiac complications (p = 0.029). Even in the CAD group there was a significant increase in cardiovascular events in the group with all previous cardiovascular diseases taken together (p = 0.036). Conclusions. Patients with previous cardiovascular disease are at considerable risk of cardiovascular events during treatment with high-dose PEP and even during CAD therapy. Patients without pretreatment cardiovascular morbidity have a moderate cardiovascular risk during PEP treatment and could be considered for this treatment if the advantages of this therapy, e. g. avoidance of osteopenia and hot flushes and the low price, are given priority.
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| 2. |
- Iversen, Peter, et al.
(författare)
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Bicalutamide 150 mg in addition to standard care for patients with early non-metastatic prostate cancer : updated results from the Scandinavian Prostate Cancer Period Group-6 Study after a median follow-up period of 7.1 years
- 2006
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Ingår i: Scandinavian Journal of Urology and Nephrology. - London : Taylor & Francis. - 0036-5599 .- 1651-2065. ; 40:6, s. 441-452
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The Early Prostate Cancer (EPC) programme is evaluating the efficacy and tolerability of bicalutamide following standard care (radiotherapy, radical prostatectomy or watchful waiting) in patients with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N + ) non-metastatic prostate cancer. Herein we report the latest findings after a median follow-up period of 7.1 years from the Scandinavian Prostate Cancer Group (SPCG)-6 study, one of three trials in the EPC programme. MATERIAL AND METHODS: A total of 1218 patients were randomized on a 1:1 basis to either bicalutamide 150 mg/day (n=607) or placebo (n=611) following standard care; 81.4% were followed conservatively (watchful waiting). The primary endpoints were objective progression-free survival (PFS) and overall survival (OS). RESULTS: In patients with localized disease there was no significant difference in PFS [hazard ratio (HR) 0.85; 95% CI 0.69-1.06; p=0.15] and a trend towards decreased OS with bicalutamide plus standard care compared with standard care alone (HR 1.23; 95% CI 0.96-1.58; p=0.11). In patients with locally advanced disease, bicalutamide significantly improved PFS, reducing the risk of progression by 53% compared with standard care alone (HR 0.47; 95% CI 0.37-0.59; p<0.001). The median time to progression was 8.8 years for bicalutamide plus standard care and 7.1 years for standard care alone. There was a significant improvement in OS with bicalutamide plus standard care, with a reduction in the risk of death of 35% versus standard care alone (HR 0.65; 95% CI 0.50-0.85; p=0.001). CONCLUSION: This analysis of the SPCG-6 study showed that bicalutamide plus standard care offers significant PFS and OS benefits for patients with locally advanced disease, but not for those with localized disease.
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| 3. |
- Axcrona, Karol, et al.
(författare)
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Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide.
- 2012
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Ingår i: BJU international. - 1464-410X. ; 110:11
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Tidskriftsartikel (refereegranskat)abstract
- Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Androgen deprivation therapy (ADT) is commonly used as a primary treatment for patients with prostate cancer (PCa) who are not eligible for radical treatment options. ADT is also used in patients with PCa as neo-adjuvant hormone therapy to reduce prostate volume and down-stage the disease before radiotherapy with curative intent. The present study showed that ADT with the gonadotropin hormone-releasing hormone (GhRH) antagonist degarelix is non-inferior to combined treatment with the LHRH agonist goserelin and bicalutamide in terms of reducing prostate volume during the treatment period of 3 months. Degarelix treatment evokes, however, significantly better relief of lower urinary tract symptoms in patients having moderate and severe voiding problems. OBJECTIVE: • To assess the efficacy of monthly degarelix treatment for reduction of total prostate volume (TPV), relief of lower urinary tract symptoms (LUTS) and improvement of quality of life (QoL) in patients with prostate cancer (PCa) using monthly goserelin as active control. METHODS: • This was a randomized, parallel-arm, active-controlled, open-label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks. • For flare protection, goserelin-treated patients also received daily bicalutamide (50 mg) during the initial 28 days. • Key trial variables monitored monthly were TPV (primary endpoint), serum testosterone, prostate-specific antigen (PSA), the International Prostate Symptom Score (IPSS) and the Benign Prostate Hyperplasia Impact Index. RESULTS: • In all, 175 patients completed the trial (96.1%). • At week 12, changes in TPV for degarelix and goserelin were similar (-37.2% vs -39.0%) and met the predefined non-inferiority criterion. • Decreases in IPSS were greater in degarelix than in goserelin-treated patients, differences being statistically significant in patients with baseline IPSS > 13 (-6.7 ± 1.8 vs -4.0 ± 1.0; P= 0.02). • The number of patients with an IPSS change of ≥3 over baseline was also significantly higher in patients treated with degarelix (61.0 vs 44.3%, P= 0.02). • Both treatments were safe and well tolerated. CONCLUSIONS: • Medical castration reduces TPV and could also improve LUTS in patients with PCa. • While the short-term efficacy of degarelix and goserelin + bicalutamide was the same in terms of TPV reduction, degarelix showed superiority in LUTS relief in symptomatic patients, which could highlight the different actions of these drugs on extrapituitary gonadotrophin-releasing hormone (GnRH) receptors in the bladder and/or the prostate.
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| 4. |
- Tibaek, Sigrid, et al.
(författare)
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Are activity limitations associated with lower urinary tract symptoms in stroke patients? A cross-sectional, clinical survey.
- 2009
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Ingår i: Scandinavian Journal of Urology and Nephrology. - : Informa UK Limited. - 0036-5599 .- 1651-2065. ; 43:5, s. 383-389
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Tidskriftsartikel (refereegranskat)abstract
- Objective . To assess self-reported activity limitations in a clinical sample of stroke patients and to identify their association with prevalence, severity and impact on daily life of lower urinary tract symptoms (LUTS). Material and methods . A cross-sectional, clinical survey was initiated whereby stroke patients were invited to complete four activity limitations measurements: Barthel Index, mobility velocity, mobility distance, mobility aids and one LUTS measurement: the Danish Prostatic Symptom Score (DAN-PSS-1) questionnaire. Of 519 stroke patients, 482 subjects were eligible. Results . The response rate was 84%. The activity limitations were reported by 17-34% depending on the measurement. Mobility velocity was highly significantly associated (p=0.01) with severity of LUTS. In the LUTS incontinence symptom group, Barthel Index and mobility velocity were significantly associated with prevalence [p=0.03, odds ratio (OR) 2.08 and p=0.05, OR 1.87, respectively]. Barthel Index and mobility distance were also associated with severity (p=0.03 and p=0.04, respectively) and Barthel Index was associated with the prevalence of bother (p=0.02, OR 2.12). Conclusion . This study indicate for the first time that activity limitations are closely related to LUTS in stroke patients and that rehabilitation should also be directed towards the treatment of LUTS.
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| 5. |
- Tibaek, Sigrid, et al.
(författare)
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Is well-being associated with lower urinary tract symptoms in patients with stroke?
- 2011
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Ingår i: Scandinavian Journal of Urology and Nephrology. - : Informa UK Limited. - 0036-5599 .- 1651-2065. ; 45:2, s. 134-142
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Tidskriftsartikel (refereegranskat)abstract
- Objective. This study aimed to assess self-reported well-being in a clinical sample of stroke patients and to identify possible associations with prevalence, severity and bother of lower urinary tract symptoms (LUTS). Material and methods. A cross-sectional, clinical survey was initiated whereby stroke patients were invited to complete The WHO-Five Well-Being Index (WHO-5) and a LUTS instrument, the Danish Prostatic Symptom Score (DAN-PSS-1) questionnaire. Of 519 stroke patients invited, 482 subjects were eligible and 407 (84%) respondents answered the questionnaires. Results. Poor well-being (sum score < 13) was reported by 22% of all stroke patients, for women 29% and for men 14%. Depression (sum score < 8) was reported by 10%, for women 11% and for men 8%. Poor well-being was significantly (p < 0.01) associated with severity and bother of LUTS. Likewise, poor well-being was significantly (p < 0.001) associated with the prevalence of four different symptom groups of LUTS. Conclusions. The results indicate that poor well-being is present in stroke patients with LUTS, especially in women. Likewise, the data showed significant association between poor well-being and LUTS. Screening for well-being and LUTS in stroke patients is strongly recommended.
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| 6. |
- Tibaek, Sigrid, et al.
(författare)
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Prevalence of Lower Urinary Tract Symptoms (LUTS) in stroke patients: A cross-sectional, clinical survey.
- 2008
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Ingår i: Neurourology and Urodynamics. - : Wiley. - 0733-2467 .- 1520-6777. ; Jun 12, s. 763-771
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: The aims of this study were primarily to investigate the prevalence, severity and impact on daily life of Lower Urinary Tract Symptoms (LUTS) in a clinical sample of stroke patients and secondly to identify factors associated with LUTS. MATERIALS AND METHODS: This was a cross-sectional, hospital based survey whereby stroke patients were invited by letter to complete The Danish Prostatic Symptom Score (DAN-PSS-1) questionnaire at least 1 month following their stroke. Subjects were asked to report the frequency and severity of their symptoms (symptom score) and the impact of each symptom on their daily life (bother score) over the previous fortnight. Of 519 stroke patients invited, 482 subjects were eligible. RESULTS: The response rate was 84%. The period prevalence of at least one symptom was 94%; the most frequent symptom was nocturia (76%) followed by urgency (70%) and daytime frequency (59%). The most severe symptom was urgency followed by nocturia and daytime frequency. Among respondents who had at least one symptom, the prevalence of bother was 78%. Likewise the most frequent bothersome symptom was nocturia (53%), followed by urgency (48%) and daytime frequency (40%). Paresis in legs, symptoms of urinary incontinence on admission, and use of analgesics were significantly associated with severity, whereas the prevalence and bother of LUTS could not be associated with other patient characteristics. CONCLUSION: LUTS are highly prevalent in stroke patients and have a major impact on daily life. Neurourol. Urodynam. (c) 2008 Wiley-Liss, Inc.
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| 7. |
- Tibaek, Sigrid, et al.
(författare)
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The Danish Prostatic Symptom Score (DAN-PSS-1) questionnaire is reliable in stroke patients
- 2006
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Ingår i: Neurourology and Urodynamics. - : Wiley. - 0733-2467 .- 1520-6777. ; 25:4, s. 319-323
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To investigate the test-retest reliability of Danish Prostatic Symptom Score (DAN-PSS-1) questionnaire in a sample of stroke patients. Methods: A prospective study design was used in which the stroke patients were invited to complete a postal self-administrated DAN-PSS-1 questionnaire twice. The questionnaire consists of 12 questions related to lower urinary tract symptoms (LUTS). The participants were asked to state the frequency and severity of their symptoms (symptom score) and its impact on their daily life (bother score). Seventy-one stroke patients were included and 59 (83%) answered the questionnaire twice. The reliability test was done in two aspects: (a) detecting the frequency of each symptom and its bother factor, the scores were reduced to a two-category scale (=0, > 0) and simple kappa statistics was used; (b) detecting the severity of each symptom and its bother factor, the total scale (0-3) and weighted kappa statistics was used. Results: The proportion of agreement for the frequency symptom scores ranged from 76% to 97% and the simple kappa coefficient ranged from poor (kappa = 0.00) to excellent (kappa = 0.91). The proportion of agreement for the corresponding bother scores ranged from 76% to 95% and the simple kappa coefficient ranged from good (kappa = 0.61) to excellent (kappa = 0.84). The weighted kappa coefficient for the severity symptom scores ranged from moderate (kappa(w) = 0.43) to good (kappa(w) = 0.75) and the corresponding bother scores ranged from moderate (kappa(w) = 0.48) to good (kappa(w) = 0.68). Conclusions: The DAN-PSS-1 questionnaire had acceptable test-retest reliability and may be suitable for measuring the frequency and severity of LUTS and its bother factor in stroke patients.
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| 8. |
- Wedge, Eileen, et al.
(författare)
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Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Myelomonocytic Leukemia : Clinical and Molecular Genetic Prognostic Factors in a Nordic Population
- 2021
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Ingår i: Transplantation and Cellular Therapy. - : Elsevier. - 2666-6375 .- 2666-6367. ; 27:12, s. 991.e1-991.e9
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Tidskriftsartikel (refereegranskat)abstract
- Chronic myelomonocytic leukemia (CMML) is an aggressive disease in which survival after allogeneic hematopoietic stem cell transplantation (HCT) remains relatively poor. An assessment of prognostic factors is an important part of treatment decision making and has the potential to be greatly improved by the inclusion of molecular genetics. However, there is a significant knowledge gap in the interpretation of mutational patterns. This study aimed to describe outcomes of allogeneic HCT in patients with CMML in relation to clinical and molecular genetic risk factors. This retrospective study included 64 patients with CMML who underwent allogeneic HCT between 2008 and 2018, with a median follow-up of 5.4 years. Next-generation sequencing using targeted myeloid panels was carried out on saved material from 51 patients from the time of transplantation. Kaplan-Meier and Cox regression were used for analysis of overall survival (OS), and cumulative incidence with competing risks and Fine and Gray models were used for analysis of relapse and nonrelapse mortality (NRM). Mutations were detected in 48 patients (94%), indicating high levels of minimal residual disease (MRD) positivity at transplantation, even among those in complete remission (CR) (n = 14), 86% of whom had detectable mutations. The most frequently mutated genes were ASXL1 (37%), TET2 (37%), RUNX1 (33%), SRSF2 (26%), and NRAS (20%). Risk stratification using the CMML-specific Prognostic Scoring System molecular score (CPSS-Mol) resulted in 45% of patients moving to a higher risk-group compared with risk stratification using the CPSS. High leucocyte count (>= 13 x 10(9)/L), transfusion requirement, and previous intensive chemotherapy were associated with higher incidence of relapse. Being in CR was not linked to better outcomes. Neither ASXL1 nor RUNX1 mutation was associated with a difference in OS, relapse, or NRM, despite being high risk in the nontransplantation setting. TET2 mutations were associated with a significantly higher 3-year OS (73% versus 40%; P =.039). Achieving MRD-negative CR was rare in this CMML cohort, which may explain why we did not observe better outcomes for those in CR. This merits further investigation. Our analyses suggest that the negative impact of ASXL1 and RUNX1 mutations can be overcome by allogeneic HCT; however, risk stratification is complex in CMML and requires larger cohorts and multivariate models, presenting an ongoing challenge in this rare disease.
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