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BACKGROUND: Population-based survival results after radical cystectomy (RC) are limited. Our objective was to report short and long-term survival results after RC for bladder cancer from Finland in a population-based setting. MATERIALS AND METHODS: The Finnish National Cystectomy Database containing retrospectively collected essential RC data covering the years 2005-2017 was combined with the survival data from the Finnish Cancer Registry. Kaplan-Meier plots were used to estimate survival and the survival graphs were illustrated according to the final pathological staging. Centers were divided according to operational volume, and the results were then compared using Pearsons's Chi-squared test. RESULTS: A total of 2047 patients were included in the study. 30-, and 90-day mortality was 1.3%, and 3.8%, respectively. The OS of the entire RC population at 5- and 10 years was 66% and 55%, and CSS was 74% and 72%, respectively. Center volume did not significantly associate with surgical mortality or long-term survival. The 5- and 10-year OS according to pT-category was 87% and 74% for pT0, 85% and 69% for pTa-pTis-pT1, 70% and 58% for pT2, 50% and 42% for pT3 and 41% and 30% for pT4. The corresponding 5- and 10-year CSS rates were 96% and 93% for pT0, 91% and 90% for pTa-pTis-pT1, 78% and 75% for pT2, 56% and 55% for pT3 and 47% and 44% for pT4. The 5- and 10-year OS rates in patients with no lymph node metastases (pN-) were 74% and 62%, and CSS 82% and 80%, respectively. If lymph nodes were positive (pN+), the corresponding OS rates were 44% and 34% and CSS 49% and 48%, respectively. CONCLUSION: RC survival results have improved in contemporary series and are associated with the pTNM-status. The nationwide results from Finland demonstrate outcome comparable to high volume single-center series.
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Cistectomía , Neoplasias de la Vejiga Urinaria , Humanos , Cistectomía/métodos , Finlandia/epidemiología , Estudios Retrospectivos , Vejiga Urinaria/patología , Estadificación de Neoplasias , Resultado del Tratamiento , Tasa de SupervivenciaRESUMEN
AIMS: This study aims to measure any changes in the marital relationship during the first year after a diagnosis of prostate cancer, identify the demographic characteristics that influenced such changes, and measure changes related to health-related quality of life (HRQoL). BACKGROUND: Knowledge is limited on the impact of a diagnosis of prostate cancer on the marital relationship and HRQoL of patients and their spouses. DESIGN: A 1-year longitudinal study. METHODS: Data were collected from five Finnish hospitals between October 2013 and January 2017. Of the 350 recruited couples (N = 700), 179 patients and 166 spouses completed the Marital Questionnaire and the RAND 36-Item Health Survey 1 year after diagnosis. RESULTS: No major changes were found in the marital relationship during the follow-up period. The spouses reported statistically significant changes in their marital relationships, but the patients did not. Furthermore, changes in the marital relationship were not associated with the patients' HRQoL. Among spouses, emotional well-being was associated with changes in the marital relationship. CONCLUSION: The marital relationship was relevant in terms of the spouses' HRQoL during the first year after a diagnosis of prostate cancer. Nurses and other healthcare providers should assess counselling and support provided to spouses individually.
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Neoplasias de la Próstata , Esposos , Masculino , Humanos , Esposos/psicología , Matrimonio/psicología , Calidad de Vida/psicología , Estudios Prospectivos , Estudios Longitudinales , Adaptación Psicológica , Neoplasias de la Próstata/psicologíaRESUMEN
AIMS AND OBJECTIVES: To examine changes in the marital relationship 6 months after the diagnosis and the effects of these changes on the health-related quality of life of the patients with prostate cancer and their spouses. BACKGROUND: There is limited knowledge on the impact of a diagnosis of prostate cancer on the marital relationship and health-related quality of life of patients and their spouses. DESIGN: Survey with longitudinal descriptive and comparative elements. METHODS: Of 350 recruited couples (N = 700), 186 couples (n = 372) completed the Marital Questionnaire and RAND 36-Item Health Survey at the two measurement points: time of diagnosis and 6 months later. Changes in the marital relationship were analysed statistically using descriptive statistics and nonparametric tests. The influence of changes in the marital relationship on health-related quality of life was evaluated using linear regression analyses. RESULTS: The patients and their spouses reported lower marital satisfaction 6 months after the diagnosis than at the time of diagnosis. The summary score for marital satisfaction of the spouses significantly decreased during the follow-up period. In contrast, decreasing changes in the marital relationship of the patients were not statistically significant. Furthermore, the marital relationship of the patients and their spouses was not statistically significantly associated with changes in the health-related quality of life of the patients and their spouses within 6 months. CONCLUSIONS: The results of this study add to current knowledge of the marital relationship of patients with prostate cancer and their spouses. The spouses reported that their marital relationship had suffered, whereas the patients reported that the marital relationship remained unchanged. RELEVANCE TO CLINICAL PRACTICE: These findings may be useful when counselling of patients with prostate cancer and their spouses.
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Matrimonio/psicología , Satisfacción Personal , Neoplasias de la Próstata/psicología , Calidad de Vida/psicología , Esposos/psicología , Adaptación Psicológica , Adulto , Anciano , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Encuestas y CuestionariosRESUMEN
PURPOSE: We investigated the tolerability, safety and antitumor effects of a novel intraprostatic depot formulation of antiandrogen 2-hydroxyflutamide (in NanoZolid®) in men with localized prostate cancer. MATERIALS AND METHODS: Two clinical trials, LPC-002 and LPC-003, were performed in a total of 47 men. The formulation was injected transrectally into the prostate under ultrasound guidance. In LPC-002 the effects on prostate specific antigen and prostate volume were measured for 6 months in 24 patients. In LPC-003 antitumor effects were evaluated by histopathology and magnetic resonance imaging including spectroscopy during 6 or 8 weeks in 23 patients. In each study testosterone and 2-hydroxyflutamide in plasma were measured as well as quality of life parameters. RESULTS: In LPC-002 (mean dose 690 mg) a reduction was observed in prostate specific antigen and prostate volume. Average nadir prostate specific antigen and prostate volume were 24.9% and 14.0% below baseline, respectively. When increasing the dose in LPC-003 to 920 and 1,740 mg, average prostate specific antigen decreased 16% and 23% after 6 and 8 weeks, respectively. Magnetic resonance imaging and magnetic resonance spectroscopy showed morphological changes and a global reduction in metabolite concentrations following treatment, indicating an antitumor response. Injections did not result in hormone related side effects. Three serious adverse events were reported and all resolved with oral antibiotic treatment. CONCLUSIONS: Intraprostatic injections of 2-hydroxyflutamide depot formulations showed antitumor effects, and proved to be safe and tolerable. However, for better anticancer effects higher doses and better dose distribution are suggested.
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Antagonistas de Andrógenos/administración & dosificación , Flutamida/análogos & derivados , Neoplasias de la Próstata/tratamiento farmacológico , Anciano , Preparaciones de Acción Retardada , Flutamida/administración & dosificación , Humanos , Inyecciones Intralesiones , Masculino , Persona de Mediana Edad , Neoplasias de la Próstata/patologíaRESUMEN
AIMS: To describe the health-related quality of life (HRQOL) of patients with prostate cancer and their spouses in comparison with the Finnish general population, using the RAND 36-Item Health Survey. An additional purpose was to describe the associations between the background variables of the participants and their HRQOL. BACKGROUND: The HRQOL of patients with prostate cancer and especially their spouses at the time of diagnosis is not well known. DESIGN: A cross-sectional study. METHODS: Responses were received from 232 patients and 229 spouses at 5 central hospitals in Finland between October 2013 and January 2016. RESULTS: Compared to the Finnish general population mean, the HRQOL of the patients and their spouses was, on average, better for all dimensions. Patients' age, the presence of disease, and the treatment method were associated with the dimensions of HRQOL. The dimensions of HRQOL were also associated with spouses' age, basic and vocational education, and the presence of disease. CONCLUSION: The patients and their spouses experienced their HRQOL as very similar; however, on average, it is better than the general population mean. However, the evidence suggests that support from the nurses should focus on emotional well-being, the dimension that received the lowest scores in both groups.
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Neoplasias de la Próstata/psicología , Calidad de Vida , Esposos/psicología , Factores de Edad , Anciano , Anciano de 80 o más Años , Estudios Transversales , Escolaridad , Femenino , Finlandia , Humanos , Masculino , Persona de Mediana EdadRESUMEN
PURPOSE: To evaluate the biocompatibility of a new muraglitazar-eluting polylactide copolymer stent and investigate its ability to prevent the formation of intimal hyperplasia. MATERIALS AND METHODS: Ten self-expandable muraglitazar-eluting poly-96 L/4D-lactic acid (PLA96) stents and 10 self-expandable control PLA96 stents were implanted into porcine common iliac arteries. After 28 days follow-up, all stent-implanted iliac arteries were harvested and prepared for quantitative histomorphometric analysis. RESULTS: Angiographic analysis revealed that one control PLA96 stent had occluded and one had migrated. Histomorphometric analysis demonstrated that, with the control PLA96 stent, the luminal diameter and area were decreased versus the muraglitazar-eluting PLA96 stents (means ± standard error of the mean, 3.58 mm ± 0.34 vs 4.16 mm ± 0.14 and 9.83 mm(2) ± 2.41 vs 13.75 mm(2) ± 0.93, respectively). The control PLA96 stent induced more intimal hyperplasia than the bioactive muraglitazar-eluting PLA96 stent (557 µm ± 122 vs 361 µm ± 32). Vascular injury scores demonstrated only mild vascular trauma for both stents (muraglitazar-eluting, 0.68 ± 0.07; control, 0.75 ± 0.08). Inflammation scores also showed mild inflammation for both stents (muraglitazar-eluting, 1.05 ± 0.17; control, 1.23 ± 0.19). CONCLUSIONS: This new muraglitazar-eluting PLA96 stent was shown to be biocompatible with a tendency for better patency and less intimal hyperplasia compared with the control PLA96 stents.
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Stents Liberadores de Fármacos , Glicina/análogos & derivados , Arteria Ilíaca/patología , Arteria Ilíaca/cirugía , Oxazoles/uso terapéutico , Túnica Íntima/patología , Animales , Materiales Biocompatibles Revestidos , Glicina/uso terapéutico , Hiperplasia/prevención & control , PorcinosRESUMEN
The local distribution of 2-hydroxyflutamide (2-HOF) in prostate tissue after a single intraprostatic injection of a novel parenteral modified-release (MR) formulation in patients with localized prostate cancer was estimated using a semiphysiologically based biopharmaceutical model. Plasma concentration-time profiles for 2-HOF were acquired from a phase II study in 24 patients and the dissolution of the MR formulation was investigated in vitro. Human physiological values and the specific physicochemical properties of 2-HOF were obtained from the literature or calculated via established algorithms. A compartmental modeling approach was adopted for tissue and blood in the prostate gland, where the compartments were modeled as a series of concentric spherical shells contouring the centrally positioned depot formulation. Discrete fluid connections between the blood compartments were described by the representative flow of blood, whereas the mass transport of drug from tissue to tissue and tissue to blood was described by a one-dimensional diffusion approximation. An empirical dissolution approach was adopted for the release of 2-HOF from the formulation. The model adequately described the plasma concentration-time profiles of 2-HOF. Predictive simulations indicated that the local tissue concentration of 2-HOF within a distance of 5 mm from the depot formulation was approximately 40 times higher than that of unbound 2-HOF in plasma. The simulations also indicated that spreading the formulation throughout the prostate gland would expose more of the gland and increase the overall release rate of 2-HOF from the given dose. The increased release rate would initially increase the tissue and plasma concentrations but would also reduce the terminal half-life of 2-HOF in plasma. Finally, an in vitro-in vivo correlation of the release of 2-HOF from the parenteral MR formulation was established. This study shows that intraprostatic 2-HOF concentrations are significantly higher than systemic plasma concentrations and that increased distribution of 2-HOF throughout the gland, using strategic imaging-guided administration, is possible. This novel parenteral MR formulation, thus, facilitates good pharmacological effect while minimizing the risk of side effects.
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Preparaciones de Acción Retardada/farmacocinética , Flutamida/análogos & derivados , Próstata/efectos de los fármacos , Área Bajo la Curva , Química Farmacéutica/métodos , Preparaciones de Acción Retardada/uso terapéutico , Flutamida/sangre , Flutamida/farmacocinética , Flutamida/uso terapéutico , Semivida , Humanos , Masculino , Modelos Biológicos , Neoplasias de la Próstata/tratamiento farmacológicoRESUMEN
INTRODUCTION: The European Association of Urology committee in 2020 suggested a new classification, intraoperative adverse incident classification (EAUiaiC), to grade intraoperative adverse events (IAE) in urology. AIMS: We applied and validated EAUiaiC, for kidney tumor surgery. PATIENTS AND METHODS: A retrospective multicenter study was conducted based on chart review. The study group comprised 749 radical nephrectomies (RN) and 531 partial nephrectomies (PN) performed in 12 hospitals in Finland during 2016-2017. All IAEs were centrally graded for EAUiaiC. The classification was adapted to kidney tumor surgery by the inclusion of global bleeding as a transfusion of ≥3 units of blood (Grade 2) or as ≥5 units (Grade 3), and also by the exclusion of preemptive conversions. RESULTS: A total of 110 IAEs were recorded in 13.8% of patients undergoing RN, and 40 IAEs in 6.4% of patients with PN. Overall, bleeding injuries in major vessels, unspecified origin and parenchymal organs accounted for 29.3, 24.0, and 16.0% of all IEAs, respectively. Bowel (n = 10) and ureter (n = 3) injuries were rare. There was no intraoperative mortality. IAEs were associated with increased tumor size, tumor extent, age, comorbidity scores, surgical approach and indication, postoperative Clavien-Dindo (CD) complications and longer stay in hospital. 48% of conversions were reactive with more CD-complications after reactive than preemptive conversion (43 vs. 25%). CONCLUSIONS: The associations between IAEs and preoperative variables and postoperative outcome indicate good construct validity for EAUiaiC. Bleeding is the most important IAE in kidney tumor surgery and the inclusion of transfusions could provide increased objectivity.
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Neoplasias Renales , Urología , Humanos , Complicaciones Intraoperatorias/epidemiología , Complicaciones Intraoperatorias/etiología , Neoplasias Renales/complicaciones , Neoplasias Renales/cirugía , Nefrectomía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND/AIM: Non-muscle invasive bladder carcinoma (NMIBC) is highly recurrent. We studied if 5-aminolevulinic acid (5-ALA) instillations before transurethral resection of bladder tumours (TURBT) and cystoscopy extend the time to recurrence during follow-up with NMIBC patients. PATIENTS AND METHODS: A prospective multicenter study enrolled 328 NMIBC patients. All TURBTs and control cystoscopies during the one-year study period were done with or without 5-ALA instillations. The primary endpoint was time to recurrence. The secondary endpoints were time to recurrence after 7.5, 10.5, and 13.5 months and the number of patients with progressive disease. RESULTS: The overall median follow-up time was 80.4 and 87.0 months for the control and study groups, respectively. There was no statistical difference in time to first recurrence between the two groups. CONCLUSION: We could not obtain significant differences between the control and 5-ALA groups in tumour recurrence among patients with NMIBC.
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Neoplasias de la Vejiga Urinaria , Ácido Aminolevulínico , Estudios de Seguimiento , Humanos , Invasividad Neoplásica , Recurrencia Local de Neoplasia/tratamiento farmacológico , Estudios Prospectivos , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/cirugíaRESUMEN
BACKGROUND: There is huge variation in Clavien-Dindo (CD) complication rates in urology. We sought to optimize the use of the CD system in kidney tumor surgery. METHODS: We retrospectively analyzed 1,286 patients undergoing kidney tumor operations in 12 Finnish hospitals during 2016-2017. Primary CD assignments were made by site urologists. Data were centrally reviewed by two authors in consensus meetings. Consistency of the primary assignments was assessed by the number of cases requiring correction. Complication load was compared as different outcome rates between five university hospital regions. RESULTS: The overall complication rate in primary data was 40% (517/1286) and varied significantly from 32 to 62% (p < 0.001) between the regions. The need for corrections in central review was significantly greater for CD1 (54%) compared to CD2 (16%, p < 0.001) and CD3-5 (11%, p < 0.001) categories. The final data comprised 500 CD complications after 390 surgeries. The most frequent pathologies were bleeding (8.4%), urological complications (5.9%) and postoperative fever (4.7%). The overall CD2 complications rate was statistically (p < 0.001) higher in region D and that of CD3-5 was higher (p = 0.007) in region B. In multivariable analysis, university hospital region, male sex, BMI ≥ 27, ECOG ≥ 1, partial nephrectomy type and open surgery significantly increased the risk of complications. CONCLUSIONS: Comparative use of CD1 complications may be too inconsistent and only CD2-5 complications should be reported. Central review of the primary data and detailed guidelines are necessary.
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Neoplasias Renales , Complicaciones Posoperatorias , Humanos , Riñón , Neoplasias Renales/cirugía , Masculino , Nefrectomía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios RetrospectivosRESUMEN
OBJECTIVE: To evaluate, in a pilot study, the efficacy and safety of combining a braided poly(lactic-co-glycolic acid) (PLGA, a copolymer of l-lactide and glycolide) urethral stent and dutasteride in the treatment of acute urinary retention (AUR) due to benign prostatic enlargement (BPE). PATIENTS AND METHODS: Ten men with AUR due to BPE were treated as outpatients. A biodegradable braided PLGA urethral stent was inserted into the prostatic urethra, using a specially designed insertion device under visual control. Dutasteride treatment was started and the patients were followed up for 3 months after insertion of the stents. RESULTS: In all patients the stents were placed successfully with the new insertion device. All men were able to void after inserting the stent. At 1 month five patients voided freely with a low residual urine volume (<150 mL), two voided but had a high residual urine volume and a suprapubic catheter was placed, and three needed a suprapubic or an indwelling catheter before 1 month, due to AUR or comorbidities. At 3 months five patients were voiding with no problems. CONCLUSIONS: We have developed a new and effective insertion device for biodegradable braided prostatic stents. The new braided-pattern stent overcomes the earlier problems of migration and sudden breakage into large particles associated with biodegradable spiral stents. However, the mechanical properties of the new stent need to be improved and tested in a longer follow-up. We consider that this new biodegradable braided-pattern urethral stent could provide a new option in the future treatment of AUR.
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Azaesteroides/uso terapéutico , Inhibidores Enzimáticos/uso terapéutico , Ácido Láctico/uso terapéutico , Ácido Poliglicólico/uso terapéutico , Hiperplasia Prostática/complicaciones , Stents , Retención Urinaria/terapia , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Materiales Biocompatibles , Dutasterida , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Copolímero de Ácido Poliláctico-Ácido Poliglicólico , Resultado del Tratamiento , Uretra , Retención Urinaria/etiologíaRESUMEN
OBJECTIVE: To assess the effect of drug-eluting properties on the degradation process and the biocompatibility of biodegradable drug-eluting urethral stents. MATERIALS AND METHODS: Braided biodegradable 80 L/20D-PLGA (copolymer of polylactide and polyglycolide) stents with drug-eluting properties were used as the test material. The drugs analysed were indomethacin, dexamethasone and ciprofloxacine. 80 L/20D-PLGA stents without a drug coating served as controls. In all, 16 male rabbits were used and divided into four groups. The stents were inserted under general anaesthesia into the posterior urethra. After 1 month, the rabbits were killed and the urethra removed for histological and optic microscopy analyses. RESULTS: Control stents and the dexamethasone-eluting stents degraded totally during the follow-up period. Conversely, in both indomethacin- and ciprofloxacine-eluting stent groups, the degradation process was significantly delayed and they induced an increase in epithelial hyperplasia. Histological analysis showed that all the stents induced eosinophilia, but there were no significant differences in the intensity of acute or chronic inflammatory reactions and fibrosis. CONCLUSIONS: A drug-eluting capacity can be added to biodegradable stents. The addition of a drug influences the biodegradation time of PLGA urethral stents. Further studies are needed, to find the proper concentrations and releasing profiles of the drugs to achieve the desired bioactivity and biocompatibility properties.
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Stents Liberadores de Fármacos , Uretra/cirugía , Estrechez Uretral/tratamiento farmacológico , Implantes Absorbibles , Animales , Antiinfecciosos/administración & dosificación , Antiinflamatorios/administración & dosificación , Ciprofloxacina/administración & dosificación , Dexametasona/administración & dosificación , Indometacina/administración & dosificación , Ácido Láctico , Masculino , Ácido Poliglicólico , Copolímero de Ácido Poliláctico-Ácido Poliglicólico , Diseño de Prótesis , ConejosRESUMEN
BACKGROUND: It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy. OBJECTIVE: To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy. DESIGN, SETTING, AND PARTICIPANTS: This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion. INTERVENTION: A total of 126 patients received adjuvant radiotherapy at 66.6Gy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints. RESULTS AND LIMITATIONS: The median follow-up time for patients who were alive when the follow-up ended was 9.3yr in the adjuvant group and 8.6yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and 61% in the observation group (hazard ratio [HR] 0.26 [95% confidence interval {CI} 0.14-0.48], p<0.001), and for overall survival 92% and 87%, respectively (HR 0.69 [95% CI 0.29-1.60], p=0.4). Two and four metastatic cancers occurred, respectively. Out of the 43 patients with biochemical recurrence in the observation group, 37 patients received salvage radiotherapy. In the adjuvant group, 56% experienced grade 3 adverse events, versus 40% in the observation group (p=0.016). Only one grade 4 adverse event occurred (adjuvant group). A limitation of this study was the number of patients. CONCLUSIONS: Adjuvant radiotherapy following radical prostatectomy is generally well tolerated and prolongs biochemical recurrence-free survival compared with radical prostatectomy alone in patients with positive margins or extracapsular extension. PATIENT SUMMARY: Radiotherapy given immediately after prostate cancer surgery prolongs prostate-specific antigen progression-free survival, but causes more adverse events, when compared with surgery alone.
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Próstata , Prostatectomía , Neoplasias de la Próstata , Radioterapia Adyuvante , Anciano , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Márgenes de Escisión , Persona de Mediana Edad , Estadificación de Neoplasias , Evaluación de Resultado en la Atención de Salud , Modelos de Riesgos Proporcionales , Próstata/metabolismo , Próstata/patología , Antígeno Prostático Específico/análisis , Prostatectomía/efectos adversos , Prostatectomía/métodos , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/cirugía , Radioterapia Adyuvante/efectos adversos , Radioterapia Adyuvante/métodos , Análisis de SupervivenciaRESUMEN
PURPOSE: The biodegradable PLGA (a copolymer of L-lactide and glycolide) urethral stent with a spiral configuration has been used clinically for the prevention of postoperative urinary retention after different types of thermal therapy for benign prostatic hyperplasia. A new braiding pattern for this stent has recently been developed by our group. The aim here was to investigate the in situ degradation and biocompatibility of the new braided stent in the rabbit urethra. MATERIALS AND METHODS: PLGA stents with a one-over-one braiding pattern and steel stents served as controls that were inserted into the posterior urethras of 24 male rabbits using a special delivery instrument. The animals were sacrificed after 1 week, 1 month, 2 months, or 4 months, and light microscopy and histologic analyses were performed. RESULTS: The delivery instrument worked well and cystoscopy was not needed in the insertion process. The braided PLGA stents degraded smoothly in 1 to 2 months. The metallic stents induced more epithelial hyperplasia and epithelial changes than the biodegradable stents at all time points analyzed. These differences increased during follow-up. CONCLUSION: The degradation process was well controlled and the biodegradable stents were more biocompatible than the metallic stents. The new stent can be inserted into the posterior urethra without cystoscopic aid.
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Implantes Absorbibles , Ensayo de Materiales , Stents , Uretra/patología , Uretra/cirugía , Animales , Materiales Biocompatibles , Epitelio/patología , Ácido Láctico , Masculino , Modelos Animales , Ácido Poliglicólico , Copolímero de Ácido Poliláctico-Ácido Poliglicólico , Próstata/cirugía , Diseño de Prótesis , ConejosRESUMEN
PURPOSE: The purpose of this study was to explore changes in HRQoL (health-related quality of life) and identify the associated factors in patients with prostate cancer and their spouses during the year following their diagnosis of prostate cancer. METHODS: The longitudinal study design consisted of 179 patients and 166 spouses, using discretionary sampling, at five Finnish central hospitals. Participants completed a self-reported RAND-36-Item Health Survey at three time-points: time of diagnosis and 6 and 12 months later. Changes in HRQoL were analysed using descriptive statistics and non-parametric tests. Linear mixed-effects models were used to identify the factors associated with the changes in HRQoL in the patients and their spouses. RESULTS: On average, the HRQoL of patients with prostate cancer changed in physical functioning (pâ¯=â¯0.015), emotional well-being (pâ¯=â¯0.029) and general health (pâ¯=â¯0.038) were statistically significant over the 12-month study period. In spouses, statistically significant changes in HRQoL were not observed. Interaction between the age of participants and changes in HRQoL were statistically significant. CONCLUSIONS: Findings in this study suggest that interventions aimed at improving the HRQoL of patients should support a few different dimensions of HRQoL for the patients themselves than for their spouses. Nurses should pay more attention to elderly couples.
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Neoplasias de la Próstata/psicología , Calidad de Vida , Esposos/psicología , Anciano , Femenino , Finlandia , Encuestas Epidemiológicas , Humanos , Modelos Lineales , Estudios Longitudinales , Masculino , Salud Mental , Persona de Mediana Edad , Autoinforme , Encuestas y CuestionariosRESUMEN
We tested whether intervention with atorvastatin affects the prostate beneficially compared with placebo in men with prostate cancer in a randomized clinical trial. A total of 160 statin-naïve prostate cancer patients scheduled for radical prostatectomy were randomized to use 80mg atorvastatin or placebo daily from recruitment to surgery for a median of 27 d. Blinding was maintained throughout the trial. In total, 158 men completed the follow-up, with 96% compliance. Overall, atorvastatin did not significantly lower tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA) compared with placebo. In subgroup analyses, after a minimum of 28 d of atorvastatin use, Ki-67 was 14.1% lower compared with placebo (p = 0.056). Among high-grade cases (International Society of Urological Pathology Gleason grade 3 or higher), atorvastatin lowered PSA compared with placebo: median change -0.6 ng/ml; p = 0.024. Intraprostatic inflammation did not differ between the study arms (p = 0.8). Despite a negative overall result showing no effect of statins on Ki67 or PSA overall, in post hoc exploratory analyses, there appeared to be benefit after a minimum duration of 28 d. Further studies are needed to verify this. PATIENT SUMMARY: Cholesterol-lowering atorvastatin does not lower prostate cancer proliferation rate compared with placebo overall, but exploratory analyses suggest a benefit in longer exposure.
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Antineoplásicos/administración & dosificación , Atorvastatina/administración & dosificación , Terapia Neoadyuvante , Prostatectomía/métodos , Neoplasias de la Próstata/tratamiento farmacológico , Anciano , Antineoplásicos/efectos adversos , Atorvastatina/efectos adversos , Proliferación Celular/efectos de los fármacos , Quimioterapia Adyuvante , Método Doble Ciego , Finlandia , Humanos , Calicreínas/sangre , Antígeno Ki-67/metabolismo , Masculino , Persona de Mediana Edad , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Neoadjuvant chemotherapy (NAC) is underutilized in the treatment of bladder cancer (BC). OBJECTIVE: To investigate the effect of NAC on the risk of surgical complications for radical cystectomy (RC) in a population-based setting. DESIGN, SETTING, AND PARTICIPANTS: All radical cystectomies performed in Finland during 2005-2014 were included in the study. Data were collected retrospectively using a web-based data collection platform. Complications were recorded for 90 d using the Clavien classification. Patients treated with NAC were compared to patients receiving RC alone using three cohorts and approaches: the entire cohort, a neoadjuvant period cohort, and a matched cohort. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: For all three cohorts, odds ratios (ORs) were estimated using simple binary logistic regression. In addition, a multivariable stratified logistic model with propensity score was used. For the matched cohort analysis, both univariate and adjusted analyses were carried out. RESULTS AND LIMITATIONS: During 2005-2014, 1427 RCs were performed in Finland, of which 1385 were included in the analyses. NAC was introduced in 2008, and 231 patients (16%) were assigned to NAC and 214 (15%) received two or more cycles of chemotherapy. Within 90 d, 61% of patients experienced complications and mortality was 4% (1.9% in the NAC group, and 4.4% in the RC-alone group). In simple binary logistic regression, NAC patients had significantly fewer complications, but this was not observed in multivariable or propensity score analyses. In the matched cohort analyses, no differences in complication rates could be observed. None of the analyses demonstrated higher complication rates in the NAC group. CONCLUSIONS: Our retrospective study reports on nationwide use of NAC for BC and demonstrates that NAC does not increase RC morbidity. PATIENT SUMMARY: Chemotherapy given before radical surgery does not increase severe postoperative complications in the treatment of bladder cancer.
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Cistectomía/efectos adversos , Terapia Neoadyuvante/efectos adversos , Complicaciones Posoperatorias/epidemiología , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/cirugía , Anciano , Cistectomía/estadística & datos numéricos , Femenino , Finlandia/epidemiología , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Morbilidad , Terapia Neoadyuvante/estadística & datos numéricos , Oportunidad Relativa , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Neoplasias de la Vejiga Urinaria/epidemiologíaRESUMEN
AIM: The aim of the study was to evaluate the prognostic significance of tumour-infiltrating lymphocytes (TILs) in local prostate cancer (PC). MATERIALS AND METHODS: TILs were counted and routine histological variables were assessed from radical prostatectomy specimens in 188 cases of PC. Immunohistochemical (IHC) characterisation of the lymphocytes was done by using CD4 and CD8 antibodies for detection of T lymphocytes and CD20 antibody for B lymphocytes in tissue microarray construction. The results of the lymphocyte analyses were compared to other prognostic factors and PSA recurrence-free survival (RFS). RESULTS: Strong expression of TILs, CD4, CD8 and CD20 lymphocytes were seen in 28%, 33%, 35% and 15% of the cases, respectively. CD4 and CD8, as well as CD4 and CD20, lymphocytes were correlated to each other (p < 0.0001), but not to clinical or histopathological parameters. Weak expression of TILs was correlated with intracapsular carcinoma (p = 0.004), while perineural invasion (p = 0.017) and capsular invasion (p < 0.0001) were related to strong expression of TILs. Shortened PSA RFS was associated with strong expression of TILs (p = 0.005). In Cox regression analysis, independent predictors of shortened PSA RFS were strong expression of TILs (p = 0.012) and high Gleason score (p < 0.001). CONCLUSION: TILs are an independent predictor of short PSA RFS in patients with local PC treated by radical prostatectomy.
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Linfocitos Infiltrantes de Tumor/inmunología , Neoplasias de la Próstata/inmunología , Neoplasias de la Próstata/cirugía , Linfocitos T CD8-positivos/inmunología , Supervivencia sin Enfermedad , Humanos , Inmunohistoquímica , Masculino , Persona de Mediana Edad , Antígeno Prostático Específico/sangre , Prostatectomía , Neoplasias de la Próstata/sangreRESUMEN
BACKGROUND AND PURPOSE: Interstitial laser coagulation of the prostate (ILCP) induces necrosis, edema, and an increased risk of postoperative urinary retention. The object here was to evaluate the efficacy, safety, and utility of a new self-expandable self-reinforced (SR) PLGA copolymer(lactic:glycolic ratio 80/20) spiral stent inserted after ILCP to promote voiding. The SR-PLGA stent has a degradation time of 2 to 2.5 months. PATIENTS AND METHODS: Fifty men with a mean age of 70.5 years (range 52-85 years), suffering from lower urinary tract symptoms secondary to benign prostatic enlargement underwent ILCP. A suprapubic catheter was inserted, ILCP performed, and an SR-PLGA 80/20 spiral stent inserted on completion of the operation. The suprapubic catheter was removed when voiding commenced. As prophylactic antibiotic, ciprofloxacin was used in a single dose before ILCP, followed by trimethoprim or nitrofurantoin for 2 weeks. RESULTS: All except three patients started to void on the first postoperative day. In two of the three cases, the stent had moved proximally and had to be relocated, whereafter voiding succeeded. The mean maximum and average flow rates increased, while DAN-PSS-1 symptom score and post voiding residual urine volume decreased statistically significantly. At 2 months, the stent was still intact in the urethra in all except three patients. At 4 months, it had been degraded into small fragments, and at 6 months, it had been completely eliminated. The only exceptions were three patients with an uncalcified piece of the stent in the bladder. Half of the patients had irritative symptoms caused at least partly by ILCP itself; 10% had asymptomatic urinary infection postoperatively. CONCLUSIONS: The self-expandable SR-PLGA copolymer stent is safe and highly biocompatible. It ensures voiding in the case of temporary obstruction caused by prostatic edema. The degradation time is long enough in all patients to cover the need for postprocedure urinary drainage.
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Materiales Biocompatibles , Complicaciones Posoperatorias/prevención & control , Hiperplasia Prostática/cirugía , Stents , Retención Urinaria/prevención & control , Anciano , Anciano de 80 o más Años , Biodegradación Ambiental , Humanos , Coagulación con Láser/efectos adversos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Poliglactina 910 , Resultado del Tratamiento , Retención Urinaria/etiologíaRESUMEN
Percutaneous transluminal angioplasty (PTA) with stenting is widely used in the treatment of vascular disorders, but restenosis remains a significant problem. Drug-eluting stents (DES) have been developed as an attempt to reduce the intimal response leading to restenosis. Drugs used in DES include mainly immunosuppressive and anti-proliferative compounds. Glucocorticoids are also an interesting possibility for those purposes because they have anti-proliferative effects in vascular smooth muscle cells and down-regulate the production of cytokines and growth factors driving inflammation and fibrosis. In this MiniReview, feasibility and safety of drug-eluting metal and biodegradable vascular stents are discussed with special emphasis on dexamethasone-eluting stents.