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- 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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| 4. |
- Thellenberg Karlsson, Camilla, 1972-
(författare)
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Prostate cancer : epidemiological studies of risk factors
- 2008
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- In spite of the fact that prostate cancer is the most common male cancer in both Sweden and many other countries in the developed world, little is known of risk factors and predisposing conditions. The only well recognized risk factors are age, race and familial aggregation. More knowledge about risk factors could lead to better preventive measures together with better treatments. One way to evaluate this is to study second primary cancers; the connection between two different cancers can give valuable insight in etiology or clues to shared risk factors. This thesis aims at evaluating risk factors for prostate cancer. We constructed a cohort of 135,713 men diagnosed with prostate cancer and reported to the Swedish Cancer Registry 1958-1996. The cohort was followed for second primary cancers and a doubled risk of male breast cancer was found. We also noted increased risks for small intestine cancers and melanoma. As a follow-up on the increased risk of male breast cancer, we performed a nested case – control study. Included cases were men with first prostate and then breast cancer (n = 41) matched to men with only prostate cancer (n =81). For these men, we collected medical records and extracted data regarding treatment. Furthermore, all men diagnosed with both prostate and breast cancer irrespective which came first (n = 83) were used as probands. To both these sets of cases with breast and prostate cancer, we identified first degree relatives and grandchildren from parish offices throughout Sweden. Linking to the Cancer Registry retrieved all cancer diagnoses amongst relatives. Results from this study show a relation between estrogen treatment of prostate cancer and the risk of developing breast cancer. We also found that a small part of the cases with both cancers appeared in families with inheritance patterns possibly attributed to BRCA2. As estrogen treatment seemed involved in increased risk of breast cancer after prostate cancer, we wanted to investigate the newly discovered Estrogen receptor β and the relation to prostate cancer risk. Previous reports have shown that ERβ acts as a negative regulator of proliferation. ERβ expression occurs mainly in prostatic epithelial cells and the expression gradually diminishes when cancer develops and aggravates. We used a single nucleotide polymorphism (SNP) association study approach to evaluate genetic variation in ERβ as a risk factor for prostate cancer. One SNP, located in the promoter region associated with a small increased risk of prostate cancer whereas variation in the rest of the gene did not. In the last paper, we investigated trans-urethral resection (TURP) of the prostate due to benign prostate hyperplasia (BPH) as a risk factor for later development of prostate cancer. Evidence has gathered that both BPH and prostate cancer are associated to inflammation. By comparing incidence and mortality in a cohort of 7,901 men with the general population there appeared to be an increased risk of prostate cancer but decreased mortality. Analyzing this increased risk further, we conducted a nested case - control study with men extracted from the cohort. Cases had a TURP and later developed prostate cancer and controls just had a TURP. We then evaluated the specimens from TURP regarding extent of inflammation, degree of androgen receptor down regulation and expression of p53, all factors previous associated with prostate cancer. None of these parameters differed between cases and controls and they can therefore not explain the increased risk. Decreased mortality but increased risk might be explained by surveillance bias, which means more medical attention to these patients, resulting in diagnosing clinically non-significant cancers. In summary, our results show a doubled risk of male breast cancer following prostate cancer. A risk that can be attributed to the use of estrogen to treat prostate cancer or to some extent a possible mutation in BRCA2. We also propose that a SNP change in the ERβ promoter confer a small increased risk of prostate cancer. A small risk elevation of prostate cancer following TURP most probable could depend on surveillance bias.
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| 5. |
- 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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- 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. |
- Tyrrell, Chris J., et al.
(författare)
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Tolerability, efficacy and pharmacokinetics of bicalutamide 300 mg, 450 mg or 600 mg as monotherapy for patients with locally advanced or metastatic prostate cancer, compared with castration
- 2006
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Ingår i: BJU International. - 1464-4096. ; 98:3, s. 563-572
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE To evaluate the pharmacokinetics, tolerability and effect on endocrinology of bicalutamide given as once-daily monotherapy at doses of > 150 mg to patients with locally advanced (MO) or metastatic (M1) prostate cancer, with efficacy as a secondary endpoint. PATIENTS AND METHODS Patients were initially enrolled to receive bicalutamide 300 mg in a non-randomized phase, after which further patients were randomized to higher bicalutamide doses (in 150 mg increments) or castration. Overall, 248 patients received bicalutamide at 300 mg (21), 450 mg (95) or 600 mg (42), or castration (90). RESULTS Systemic exposure to bicalutamide stabilised at a dose of approximate to 300 mg, as determined by pharmacokinetic analysis. The tolerability of high doses of bicalutamide was similar to that of the 150 mg dose, with no increase in the incidence of adverse events. Patients receiving bicalutamide had early increases in the mean levels of oestradiol, testosterone and luteinizing hormone, which were maintained throughout the study. Levels of these hormones rapidly decreased in the castration group and remained low. From baseline (first day of treatment) to 12 weeks there was an equivalent reduction in prostate-specific antigen (PSA) levels across all four groups. At a median follow-up of 5 years, there was no significant survival difference between patients who received bicalutamide and those who received castration, either in M0 or M1 disease. CONCLUSION The low median PSA level (180 ng/mL) of patients with M1 disease might account for the lack of survival difference between the treatment groups. Further studies are needed to assess whether high-dose bicalutamide monotherapy can provide equivalent efficacy to castration in patients with M1 prostate cancer.
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