Apalutamide for prostate cancer: Multicentre and multidisciplinary real-world study of 227 patients.

OBJECTIVE: To evaluate the efficacy and safety of apalutamide prostate cancer compared to the pivotal trials patients and to identify the first subsequent therapy in a real-world setting. METHODS: The study is prospective and observational based on real-world evidence, performed by different medical disciplines and eight academics centres around Barcelona, Spain. It included all patients with metastatic hormone-sensitive prostate cancer (mHSPC) and high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide from June 2018 to December 2022. RESULTS: Of 227 patients treated with apalutamide, 10% had ECOG-PS 2, and 41% were diagnosed with new-generation imaging. In the mHSPC group (209 patients), 75 years was the median age, 53% had synchronous metastases, and 22% were M1a. In the nmCRPC (18 patients), 82 years was the median age, and 81% ≤6 months had PSA doubling time. Patients achieved PSA90 in 92% of mHSPC and 50% of nmCRPC and PSA ≤0.2 in 71% of mHSPC and 39% of nmCRPC. Treatment-related adverse events occurred in 40.1% of mHSPC and 44.4% of nmCRPC. After discontinuation of apalutamide due to disease progression, 54.5% in mHSPC and 75% in nmCRPC started chemotherapy, while after discontinuation because of adverse events, 73.3% in mHSPC and 100% in nmCRPC continued with other hormonal-therapies. CONCLUSIONS: The efficacy and safety of apalutamide were similar to that described in the pivotal trials, despite including an older and more comorbid population. Usually, subsequent therapies after apalutamide differed depending on the reason for discontinuation: by disease progression started chemotherapy and by adverse events hormonal sequencing.

Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26.

PURPOSE: To assess the validity, reliability, and responsiveness of the Spanish version of the Expanded Prostate cancer Index Composite (EPIC) with 26 items. METHODS: Multicentric longitudinal study of patients diagnosed with localized or locally advanced prostate cancer (any T, any N, M0) treated with active surveillance, surgery, external radiotherapy, or brachytherapy. The EPIC-50 was administered initially to the cohort (n = 324 patients), until it was replaced in November 2019 by the EPIC-26 (n = 543), in both groups before treatment and 12 months after. We assessed confirmatory factor analysis (CFA), reliability with Cronbach's alpha coefficient, criterion validity with the intraclass correlation coefficient (ICC), and responsiveness by testing a priori hypotheses on deterioration effect size (ES). RESULTS: The CFA confirmed the five-domain structure of the EPIC-26 proposed by the original instrument (comparative fit index = 0.95). The agreement between EPIC-50 (gold standard) and EPIC-26 domains was excellent (ICC > 0.90). Cronbach's alpha was > 0.7 in almost all domains, and the floor effect was near zero, although ceiling effect was higher than 50% in urinary incontinence and bowel domains. Hypothesized changes between before and 12 months after treatment were confirmed: ES > 0.8 in both urinary incontinence and sexual domains among patients who underwent surgery; and ES ranging 0.44-0.48 for bowel and sexual domains in patients treated with external radiotherapy. CONCLUSION: The Spanish version of the EPIC-26 has demonstrated adequate metric properties, similar to those of the original version, with acceptable goodness-of-fit indices, good criterion validity, reliability, and responsiveness to detect changes after radical prostatectomy or external radiotherapy.

Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study.

To compare the effectiveness at ten years of follow-up of radical prostatectomy, brachytherapy and external radiotherapy, in terms of overall survival, prostate cancer-specific mortality and biochemical recurrence. Cohort of men diagnosed with localized prostate cancer (T1/T2 and low/intermediate risk) from ten Spanish hospitals, followed for 10 years. The treatment selection was decided jointly by patients and physicians. Of 704 participants, 192 were treated with open radical retropubic prostatectomy, 317 with 125I brachytherapy alone, and 195 with 3D external beam radiation. We evaluated overall survival, prostate cancer-specific mortality, and biochemical recurrence. Kaplan-Meier estimators were plotted, and Cox proportional-hazards regression models were constructed to estimate hazard ratios (HR), adjusted by propensity scores. Of the 704 participants, 542 patients were alive ten years after treatment, and a total of 13 patients have been lost during follow-up. After adjusting by propensity score and Gleason score, brachytherapy and external radiotherapy were not associated with decreased 10-year overall survival (aHR = 1.36, p = 0.292 and aHR = 1.44, p = 0.222), but presented higher biochemical recurrence (aHR = 1.93, p = 0.004 and aHR = 2.56, p < 0.001) than radical prostatectomy at ten years of follow-up. Higher prostate cancer-specific mortality was also observed in external radiotherapy (aHR = 9.37, p = 0.015). Novel long-term results are provided on the effectiveness of brachytherapy to control localized prostate cancer ten years after treatment, compared to radical prostatectomy and external radiotherapy, presenting high overall survival, similarly to radical prostatectomy, but higher risk of biochemical progression. These findings provide valuable information to facilitate shared clinical decision-making.Study identifier at ClinicalTrials.gov: NCT01492751.

Horseshoe kidney splitting technique for transplantation.

Shortage of donors has led to an expansion of the criteria for acceptability of deceased-donor organs including the use of kidneys with anatomical variations such us horseshoe kidneys (HSKs). Transplantation can be accomplished either en bloc or after division of the HSK. Little is known about the most appropriate technique to split the kidney and minimize risk of bleeding or urinary fistula. In this report we present two renal transplants after division of a HSK with a different splitting technique.

Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study.

PURPOSE: Long-term comparative effectiveness research on localized prostate cancer treatments is scarce, and evidence is lacking especially for brachytherapy. The aim of this study was to assess the long-term impact of the side effects of radical prostatectomy, brachytherapy, and external radiation therapy on patients with localized prostate cancer at 10 years, using propensity score analyses. METHODS AND MATERIALS: This was a prospective observational study of a cohort of men who received a diagnosis of clinically localized prostate cancer (clinical stage T1 or T2, low and intermediate risk group) and were treated with radical prostatectomy (n = 139), brachytherapy (n = 317), or external radiation therapy (n = 194). Treatment decisions were jointly made by patients and physicians. Patient-reported outcome (PRO) evaluation included the Expanded Prostate Cancer Index Composite and Short Form-36, administered centrally by telephone interviews before and annually after treatment. The Expanded Prostate Cancer Index Composite covers urinary, bowel, sexual, and hormonal domains. To assess PRO changes over time, while accounting for correlation among repeated measures, generalized estimating equation models adjusted by propensity scores were constructed. RESULTS: The PRO completion rate at 10 years was 85.8%. Generalized estimating equation models showed that the pattern of radical prostatectomy side effects, with substantial urinary incontinence and sexual dysfunction, remained until 10 years after treatment (standard deviation [SD], -1.1 and -1.3, respectively). Brachytherapy produced late deterioration in urinary continence (SD, -0.4) and sexual function (SD, -0.9) that appeared midterm, but the differences from radical prostatectomy remained statistically significant at 10 years (P < .001 after adjusting by propensity score). External radiation therapy showed similar results to brachytherapy, but with bowel bother (SD, -0.3). CONCLUSIONS: Although late deterioration in radiation therapy groups attenuated differences from radical prostatectomy, relevant PRO differences still remained after 10 years. Our findings support that brachytherapy is the treatment option that causes the least impact on PROs; it is therefore an alternative to be considered when making evidence-based decisions on localized prostate cancer treatment.

Recommendations of the Spanish Association of Neurogastroenterology and Motility (ASENEM) to restart the activity of gastrintestinal motility laboratories after the state of alarm called due to the Covid-19 pandemic. / Recomendaciones de la Asociación Española de Neurogastroenterología y Motilidad (ASENEM) para el reinicio de la actividad de los laboratorios de motilidad digestiva, tras el confinamiento por el estado de alarma decretado a raíz de la pandemia por COVID-19.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was responsible for the outbreak of the 2019 coronavirus disease (COVID-19), which is now considered as a pandemic. The prevention strategies adopted have included social distancing measures and the modification, reduction or interruption of a large proportion of routine healthcare activity. This has had a significant impact on the care provided in Gastrointestinal Motility Units. Having passed the peak, in terms of mortality and infections, a gradual reduction in transmission figures has been observed in Spain and other European countries. The risk of reactivation, however, remains high, so it is necessary to have a plan in place that allows healthcare centres to safely resume, for their patients and professionals, instrumental examinations linked to the management of motor pathology. Based on the available scientific evidence and the consensus of a panel of experts, the Spanish Association of Neurogastroenterology and Motility (ASENEM) has drawn up a series of practical recommendations, which have been adapted to the risks inherent in each activity. These include individual protection proposals, as well as organisational and structural measures, which are conceived to allow for the gradual resumption of examinations while minimising the possibility of contagion.

A prospective study of patient reported urinary incontinence among American, Norwegian and Spanish men 1 year after prostatectomy.

OBJECTIVE: To compare pre- and post-radical prostatectomy (RP) responses in the urinary incontinence domain of Expanded Prostate Cancer Index Composite-26 (EPIC-26) in cohorts from the USA, Norway and Spain. METHODS: A prospective study of pre- and 1-year post-treatment responses in American (n=537), Norwegian (n=520) and Spanish (n=111) patients, establishing the prevalence of urinary incontinence defined according to published dichotomization. Thereafter we focused on the response alternatives "occasional dribbling", pad use and problem experience. A multivariate logistic regression analysis (significance level ≤ 0.01) considered risk factors for "not retaining total control". RESULTS: Compared to the European men, the American patients were younger, healthier and more presented with lower risk tumors. Before RP no inter-country differences emerged the prevalence of urinary incontinence (6%). One-year post-treatment urinary incontinence was described by 30% of the American and 41% of the European patients, occasional dribbling being the most frequent type of urinary leakage. In the multivariate analysis the risk of "not retaining total control" increased almost 3-fold in European compared to American patients, with age and co-morbidity being additional independent risk factor. CONCLUSION: After RP patients from Spain and Norway reported more unfavorable outcomes by EPIC-26 than the American patients to most of the urinary incontinence items, the difference between the European and American patients remaining in the multivariate analysis. The most frequent post-RP response alternative "occasional dribbling" needs to be validated with pad weighing as "gold standard".

Recomendaciones de la Asociación Española de Neurogastroenterología y Motilidad (ASENEM) para el reinicio de la actividad de los laboratorios de motilidad digestiva, tras el confinamiento por el estado de alarma decretado a raíz de la pandemia por COVID-19 / Recommendations of the Spanish Association of Neurogastroenterology and Motility (ASENEM) to restart the activity of gastrintestinal motility laboratories after the state of alarm called due to the Covid-19 pandemic

El coronavirus del síndrome respiratorio agudo severo tipo 2 (conocido por sus siglas en inglés, SARS-CoV-2) ha sido responsable del brote de la denominada enfermedad por coronavirus de 2019 (COVID-19), que ha llegado a tener la consideración de pandemia. Las estrategias adoptadas para su prevención han incluido medidas de distanciamiento social, así como la modificación, reducción o interrupción de gran parte de la actividad sanitaria habitual. Esto ha afectado de forma muy notable a la asistencia prestada en las Unidades de Motilidad Digestiva.Superado el pico de mortalidad y contagios por la infección, se ha observado durante las últimas semanas en España y otros países europeos una reducción paulatina en las cifras de transmisión. Sin embargo, el riesgo de reactivación sigue siendo alto, por lo que es necesario disponer de una planificación que permita a los centros sanitarios reiniciar con seguridad para pacientes y profesionales, las exploraciones instrumentales vinculadas al manejo de la patología motora. La Asociación Española de Neurogastroenterología y Motilidad (ASENEM) ha elaborado una serie de recomendaciones prácticas basadas en la evidencia científica disponible y en el consenso de un panel de expertos, y adaptadas a los riesgos inherentes a cada actividad. Se incluyen propuestas de protección individual, pero también medidas organizativas y estructurales, cuyo objetivo es permitir reanudar progresivamente las exploraciones, minimizando la posibilidad de contagio

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was responsible for the outbreak of the 2019 coronavirus disease (COVID-19), which is now considered as a pandemic. The prevention strategies adopted have included social distancing measures and the modification, reduction or interruption of a large proportion of routine healthcare activity. This has had a significant impact on the care provided in Gastrointestinal Motility Units. Having passed the peak, in terms of mortality and infections, a gradual reduction in transmission figures has been observed in Spain and other European countries. The risk of reactivation, however, remains high, so it is necessary to have a plan in place that allows healthcare centres to safely resume, for their patients and professionals, instrumental examinations linked to the management of motor pathology. Based on the available scientific evidence and the consensus of a panel of experts, the Spanish Association of Neurogastroenterology and Motility (ASENEM) has drawn up a series of practical recommendations, which have been adapted to the risks inherent in each activity. These include individual protection proposals, as well as organisational and structural measures, which are conceived to allow for the gradual resumption of examinations while minimising the possibility of contagion

[Consensus on castration-resistant prostate cancer management in Spain.] / Consenso sobre el manejo del cáncer de próstata resistente a la castración avanzado en España.

OBJECTIVES: To move towards a more standardized approach in clinical practice to manage patients with castration-resistant prostate cancer (CRPC) in Spain. METHODS: A panel of 18 Spanish experts in Urology with expertise managing CRPC followed a modified Delphi process with two rounds and a final face-to-face consensus meeting. The panel considered a total of 106 clinical questions divided into the following 6 sections: definition of CRPC, diagnosis of metastases by imaging techniques, symptoms of CRPC, progression of CRPC, M0 and M1 management and therapeutic sequencing. RESULTS: A bone scan (BS) is recommended at diagnosis, at the onset of bone pain, and depending on PSA levels, but it is not sensitive enough to confirm or exclude bone metastases if there is bone pain. Whole-body MRI and axial MRI are more sensitive than BS and plain X-rays, but more expensive, so they have to be used in certain situations. There is CRPC progression when there is radiologic, clinical or confirmed PSA progression. Flare phenomenon appears in treatment with taxanes and abiraterone. It was agreed that in M0 CRPC patients no drug treatment is currently recommended, although in M1 CRPC patients the first-line therapy would be mainly enzalutamide/abiraterone and/or docetaxel, depending on the symptom burden. CONCLUSION: After the consensus, we provide a series of recommendations for Spanish physicians treating CRPC to address the disease characteristics,how to tailor patient management decisions, the use of imaging techniques, and how to handle disease progression appropriately to improve patients' quality of life.

Erectile Dysfunction and Sexual Problems Two to Three Years After Prostatectomy Among American, Norwegian, and Spanish Patients.

BACKGROUND: The incidence of erectile dysfunction (ED) and sexual problems after radical prostatectomy has differed greatly in reports from different centers and countries; however, few studies have taken baseline factors into account. We compared the incidence of ED and sexual problems 2 to 3 years after radical prostatectomy in American, Norwegian, and Spanish men for whom selected clinically relevant demographic and medical pretreatment variables were available. PATIENTS AND METHODS: From 2003 to 2009, 1077 men (United States, n = 494; Norway, n = 472; and Spain, n = 111) scheduled for prostatectomy responded to an Expanded Prostate Cancer Index Composite questionnaire before treatment and 2 to 3 years after prostatectomy. On multivariate analysis, the odds ratios for ED and sexual problems were calculated, adjusted for the pretreatment variables found significant (P < .01) on univariate analysis. RESULTS: For all patients and for those without ED preoperatively, no statistically significant association was detected between the country of prostatectomy and the likelihood of reporting post-prostatectomy ED or sexual problems despite the significant differences among the 3 countries in the unadjusted analyses. CONCLUSION: Adjusting for important pretreatment variables, no intercountry differences were detected. Thus, a thorough knowledge about the pretreatment medical and demographic factors is essential for valid comparisons of the incidence of postprostatectomy ED and sexual problems among different studies.

Permanent seed brachytherapy for clinically localized prostate cancer: long-term outcomes in a 700 patient cohort.

PURPOSE: Few large European studies have evaluated long-term outcomes for permanent prostate brachytherapy (PPB) as monotherapy for clinically localized prostate cancer. The objective of the present study was to evaluate long-term survival in this patient profile. METHODS AND MATERIALS: Retrospective study of 700 patients who underwent transperineal ultrasound-guided iodine-125 PPB (145 Gy) between January 2000 and July 2012. Median age was 64.8 years (range, 35-79). Most patients (638 of 700; 91%) had low-risk disease (D'Amico criteria). Eighty-five patients (12%) received hormonal treatment. Overall survival, cause-specific survival, and biochemical relapse-free survival were calculated and estimated using actuarial and Kaplan-Meier methods. Differences between groups were assessed using the log-rank test. RESULTS: Median followup was 63 months (range, 6-164). At 5- and 10-year followup, respectively, overall survival was 94% (95% confidence interval [CI], 92-96) and 84% (95% CI, 78-90); cause-specific survival was 100% and 97% (95% CI, 95-99); and biochemical relapse-free survival was 95% (95% CI, 93-97) and 85% (95% CI, 79-91). CONCLUSIONS: The long-term results presented in this report confirm previous studies and provide additional support for the use of PPB in patients with favorable-risk prostate cancer. Seed brachytherapy provides excellent long-term results in this patient profile.

Estimating preferences for treatments in patients with localized prostate cancer.

PURPOSE: Studies of patients' preferences for localized prostate cancer treatments have assessed radical prostatectomy and external radiation therapy, but none of them has evaluated brachytherapy. The aim of our study was to assess the preferences and willingness to pay of patients with localized prostate cancer who had been treated with radical prostatectomy, external radiation therapy, or brachytherapy, and their related urinary, sexual, and bowel side effects. METHODS AND MATERIALS: This was an observational, prospective cohort study with follow-up until 5 years after treatment. A total of 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited from 2003 to 2005. The estimation of preferences was conducted using time trade-off, standard gamble, and willingness-to-pay methods. Side effects were measured with the Expanded Prostate Index Composite (EPIC), a prostate cancer-specific questionnaire. Tobit models were constructed to assess the impact of treatment and side effects on patients' preferences. Propensity score was applied to adjust for treatment selection bias. RESULTS: Of the 580 patients reporting preferences, 165 were treated with radical prostatectomy, 152 with external radiation therapy, and 263 with brachytherapy. Both time trade-off and standard gamble results indicated that the preferences of patients treated with brachytherapy were 0.06 utilities higher than those treated with radical prostatectomy (P=.01). Similarly, willingness-to-pay responses showed a difference of €57/month (P=.004) between these 2 treatments. Severe urinary incontinence presented an independent impact on the preferences elicited (P<.05), whereas no significant differences were found by bowel and sexual side effects. CONCLUSIONS: Our findings indicate that urinary incontinence is the side effect with the highest impact on preferences and that brachytherapy and external radiation therapy are more valued than radical prostatectomy. These time trade-off and standard gamble preference assessments as well as the willingness-to-pay estimation could be useful to perform respectively cost-utility or cost-benefit analyses, which can guide health policy decisions.

External beam radiotherapy plus single-fraction high dose rate brachytherapy in the treatment of locally advanced prostate cancer.

PURPOSE: To evaluate the efficacy and toxicity of external beam radiation therapy (EBRT) plus high-dose-rate brachytherapy (HDRB) as a boost in patients (pts) with intermediate or high-risk prostate cancer. METHODS AND MATERIALS: From 2002 to July 2012, 377 pts with a diagnosis of intermediate or high-risk prostate cancer were treated with EBRT plus HDRB. Median patient age was 66 years (range, 41-86). Most patients (347 pts; 92%) were classified as high-risk (stage T2c-T3, or PSA>20 ng/mL, or GS ⩾ 8), with 30 patients (8%) considered intermediate risk. All patients underwent EBRT at a prescribed dose of 60.0 Gy (range, 45-70 Gy) to the prostate and seminal vesicles. A total of 120 pts (31%) received a dose of 46 Gy (45-50 Gy) to the true pelvis. All pts received a single-fraction 9 Gy (9-15 Gy) HDR boost. Most patients (353; 94%) were prescribed complete androgen deprivation therapy (ADT). Overall survival (OS), cause-specific survival (CSS), and biochemical relapse-free survival (BRFS) rates were calculated. In the case of BRFS, patients with <26 months of follow-up (n=106) were excluded to minimize the impact of ADT. RESULTS: The median follow-up for the entire sample was 50 months (range, 12-126), with 5-year actuarial OS and CSS, respectively, of 88% (95% confidence interval [CI]: 84-92) and 98% (95% CI: 97-99). The 5-year BRFS was 91% (95% CI: 87-95) in the 271 pts with ⩾ 26 months (median, 60 months) of follow-up. Late toxicity included grade 2 and 3 gastrointestinal toxicity in 17 (4.6%) and 6 pts (1.6%), respectively, as well as grades 2 and 3 genitourinary toxicity in 46 (12.2%) and 3 pts (0.8%), respectively. CONCLUSION: These long-term outcomes confirm that EBRT plus a single-fraction HDRB boost provides good results in treatment-related toxicity and biochemical control. In addition to the excellent clinical results, this fractionation schedule reduces physician workload, treatment-related expenses, patient discomfort and risks associated with anaesthesia. We believe these findings support the use of single-fractionation boost techniques.

Quality of life impact of treatments for localized prostate cancer: cohort study with a 5 year follow-up.

PURPOSE: To assess long-term quality of life (QoL) impact of treatments in localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy or brachytherapy. MATERIAL AND METHODS: Observational, prospective cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment. 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003-2005. QoL was measured by the EPIC questionnaire, with urinary irritative-obstructive, incontinence, bowel, sexual, and hormonal scores (ranging 0-100). RESULTS: Brachytherapy's QoL impact was restricted to the urinary domain, Generalized Estimating Equation models showed score changes at five years of -12.0 (95% CI=-15.0, -9.0) in incontinence and -5.3 (95% CI=-7.5, -3.1) in irritative-obstructive scales. Compared to brachytherapy, radical prostatectomy fared +3.3 (95% CI=+0.0, +6.5) points better in irritative-obstructive but -17.1 (95% CI=-22.7, -11.5) worse in incontinence. Sexual deterioration was observed in radical prostatectomy (-19.1; 95% CI=-25.1, -13.1) and external radiotherapy groups (-7.5; 95% CI=-12.5, -2.5). CONCLUSIONS: Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative-obstructive symptoms. Our study provides novel long-term valuable information for clinical decision making, supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment, while limiting the risk for urinary incontinence and sexual impact on QoL.

Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer.

BACKGROUND: As the long-term efficacy of stereotactic body radiation therapy (SBRT) becomes established and other prostate cancer treatment approaches are refined and improved, examination of quality of life (QOL) following prostate cancer treatment is critical in driving both patient and clinical treatment decisions. We present the first study to compare QOL after SBRT and radical prostatectomy, with QOL assessed at approximately the same times pre- and post-treatment and using the same validated QOL instrument. METHODS: Patients with clinically localized prostate cancer were treated with either radical prostatectomy (n = 123 Spanish patients) or SBRT (n = 216 American patients). QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) grouped into urinary, sexual, and bowel domains. For comparison purposes, SBRT EPIC data at baseline, 3 weeks, 5, 11, 24, and 36 months were compared to surgery data at baseline, 1, 6, 12, 24, and 36 months. Differences in patient characteristics between the two groups were assessed using Chi-squared tests for categorical variables and t-tests for continuous variables. Generalized estimating equation (GEE) models were constructed for each EPIC scale to account for correlation among repeated measures and used to assess the effect of treatment on QOL. RESULTS: The largest differences in QOL occurred in the first 1-6 months after treatment, with larger declines following surgery in urinary and sexual QOL as compared to SBRT, and a larger decline in bowel QOL following SBRT as compared to surgery. Long-term urinary and sexual QOL declines remained clinically significantly lower for surgery patients but not for SBRT patients. CONCLUSIONS: Overall, these results may have implications for patient and physician clinical decision making which are often influenced by QOL. These differences in sexual, urinary and bowel QOL should be closely considered in selecting the right treatment, especially in evaluating the value of non-invasive treatments, such as SBRT.

[Cost comparison of three treatments for localized prostate cancer in Spain: radical prostatectomy, prostate brachytherapy and external 3D conformal radiotherapy]. / Comparación de costes de tres tratamientos del cáncer de próstata localizado en España: prostatectomía radical, braquiterapia prostática y radioterapia conformacional externa 3D.

OBJECTIVE: To compare the initial costs of the three most established treatments for clinically localized prostate cancer according to risk, age and comorbidity groups, from the healthcare provider's perspective. METHODS: We carried out a cost comparison study in a sample of patients consecutively recruited between 2003 and 2005 from a functional unit for prostate cancer treatment in Catalonia (Spain). The use of services up to 6 months after the treatment start date was obtained from hospital databases and direct costs were estimated by micro-cost calculation. Information on the clinical characteristics of patients and treatments was collected prospectively. Costs were compared by using nonparametric tests comparing medians (Kruskall-Wallis) and a semi-logarithmic multiple regression model. RESULTS: Among the 398 patients included, the cost difference among treatments was statistically significant: medians were € 3,229.10, € 5,369.00 and € 6,265.60, respectively, for the groups of patients treated with external 3D conformal radiotherapy, brachytherapy and radical retropublic prostatectomy, (p<0.001). In the multivariate analysis (adjusted R(2)=0.8), the average costs of brachytherapy and external radiotherapy were significantly lower than that of prostatectomy (coefficient -0.212 and -0.729, respectively). CONCLUSIONS: Radical prostatectomy proved to be the most expensive treatment option. Overall, the estimated costs in our study were lower than those published elsewhere. Most of the costs were explained by the therapeutic option and neither comorbidity nor risk groups showed an effect on total costs independent of treatment.

Quality-of-life impact of primary treatments for localized prostate cancer in patients without hormonal treatment.

PURPOSE: Earlier studies evaluating the effect on quality of life (QoL) of localized prostate cancer interventions included patients receiving adjuvant hormone therapy, which could have affected their outcomes. Our objective was to compare the QoL impact of the three most common primary treatments on patients who were not receiving adjuvant hormonal treatment. PATIENTS AND METHODS: This was a prospective study of 435 patients treated with radical prostatectomy, external-beam radiotherapy, or brachytherapy. QoL was assessed before and after treatment with the Short Form-36 and the Expanded Prostate Cancer Index Composite. Differences between groups were tested by analysis of variance. Distribution of outcome at 3 years was examined by stratifying according to baseline status. Generalized estimating equation models were constructed to assess the effect of treatment over time. RESULTS: Compared with the brachytherapy group, the prostatectomy group showed greater deterioration on urinary incontinence and sexual scores but better urinary irritative-obstructive results (-18.22, -13.19, and +6.38, respectively, at 3 years; P < .001). In patients with urinary irritative-obstructive symptoms at baseline, improvement was observed in 64% of those treated with nerve-sparing radical prostatectomy. Higher bowel worsening (-2.87, P = .04) was observed in the external radiotherapy group, with 20% of patients reporting bowel symptoms. CONCLUSION: Radical prostatectomy caused urinary incontinence and sexual dysfunction but improved pre-existing urinary irritative-obstructive symptoms. External radiotherapy and brachytherapy caused urinary irritative-obstructive adverse effects and some sexual dysfunction. External radiotherapy also caused bowel adverse effects. Relevant differences between treatment groups persisted for up to 3 years of follow-up, although the difference in sexual adverse effects between brachytherapy and prostatectomy tended to decline over long-term follow-up. These results provide valuable information for clinical decision making.

Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer.

PURPOSE: To compare treatment impact on health-related quality of life (HRQL) in patients with localized prostate cancer, from before treatment to 2 years after the intervention. METHODS AND MATERIALS: This was a longitudinal, prospective study of 614 patients with localized prostate cancer treated with radical prostatectomy (134), three-dimensional external conformal radiotherapy (205), and brachytherapy (275). The HRQL questionnaires administered before and after treatment (months 1, 3, 6, 12, and 24) were the Medical Outcomes Study 36-Item Short Form, the Functional Assessment of Cancer Therapy (General and Prostate Specific), the Expanded Prostate Cancer Index Composite (EPIC), and the American Urological Association Symptom Index. Differences between groups were tested by analysis of variance and within-group changes by univariate repeated-measures analysis of variance. Generalized estimating equations (GEE) models were constructed to assess between-group differences in HRQL at 2 years of follow-up after adjusting for clinical variables. RESULTS: In each treatment group, HRQL initially deteriorated after treatment with subsequent partial recovery. However, some dimension scores were still significantly lower after 2 years of treatment. The GEE models showed that, compared with the brachytherapy group, radical prostatectomy patients had worse EPIC sexual summary and urinary incontinence scores (-20.4 and -14.1; p < 0.001), and external radiotherapy patients had worse EPIC bowel, sexual, and hormonal summary scores (-3.55, -5.24, and -1.94; p < 0.05). Prostatectomy patients had significantly better EPIC urinary irritation scores than brachytherapy patients (+4.16; p < 0.001). CONCLUSIONS: Relevant differences between treatment groups persisted after 2 years of follow-up. Radical prostatectomy had a considerable negative effect on sexual functioning and urinary continence. Three-dimensional conformal radiotherapy had a moderate negative impact on bowel functioning, and brachytherapy caused moderate urinary irritation. These results provide relevant information for clinical decision making.

Tissue imprints or primary cultures: which strategy to use to study cytogenetic clonality?

Touch preparations or imprints have been extensively used in cytogenetics to avoid primary cultures, especially when studying solid tumors which are hard to grow in vitro. Interphase nuclei studies by FISH have been validated in several sample types; however, to our knowledge, a comparison between both methods when studying clonality has not yet been published. We have performed a comparative FISH study between touch preparations and cultured cells to assess their reliability when studying the aneuploidy of chromosome Y in mosaicism. Our results in 23 samples indicate that aneuploidy of chromosome Y assessed in cells from tissue cultures versus cells obtained from touch preparations from seminal vesicles of patients with prostate cancer is not comparable. The percentage of aneuploid cells is higher in cultured cells. Attention, therefore, must be paid not to overestimating or underestimating the number of aneuploid cells detected when using interphase FISH studies, especially in solid tumors where clonality is very frequent. Also, according to our results, it is reasonable to extrapolate that when performing interphase nuclei studies in paraffin sections or tissue microarray, and therefore underestimations of aneuploidy could be reported. This might be of special relevance if the aneuploidy detected correlates with the tumor progression or might be used as a prognostic factor.

Infeccíon nosocomial por hongos en el paciente quirúrgico en Colombia

Para identificar la incidencia de la infección nosocomial por hongos en el paciente quirurgico, el comite de Infecciones de la Sociedad Colombiana de Cirugía diseño una encuesta Nacional que fue repartida entre 20 hospitales del país. Nueve de ellos contestaron la información requerida para el período de enero de 1995 a enero de 1996. Los datos analizados provenían de 94.364 procedimientos quirurgicos pacticados en 69.612 egresos hospitalarios de cirugía en los que se encontro una tasa de infección nosocomial global del 6.43 porciento. De las 4.476 infecciones nosocomiales reportadas, 3.2822 aplican para el presente estudio, de estas, 158 (4.81 porciento) fueron por hongos/1000 egresos. Candida fue el hongo mayormente aislado, (123 casos, 77.85 porciento) y entre los hongos de género Cndida, Candida Albicans tuvo una incidencia de 69 casos (56 porciento) seguidas por otras Candida no Albicans (43.91 porciento)