ABSTRACT
Aim: Darolutamide significantly prolonged metastasis-free survival (MFS) versus placebo in the Phase III ARAMIS study. We analyzed outcomes in Spanish participants in ARAMIS. Patients & methods: Patients with high-risk nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide 600 mg twice daily or placebo, plus androgen-deprivation therapy. The primary end point was MFS. Descriptive statistics are reported for this post hoc analysis. Results: In Spanish participants, darolutamide (n = 75) prolonged MFS versus placebo (n = 42): hazard ratio 0.345, 95% confidence interval 0.175-0.681. The incidence and type of treatment-emergent adverse events were comparable between treatment arms. Conclusion: For Spanish participants in ARAMIS, efficacy outcomes favored darolutamide versus placebo, with a similar safety profile, consistent with the overall ARAMIS population. Clinical Trials Registration: NCT02200614 (ClinicalTrials.gov).
Darolutamide is an oral treatment for a type of prostate cancer that has stopped responding to other treatments and is at risk of spreading to other parts of the body (termed "nonmetastatic castration-resistant prostate cancer" or "nmCRPC"). In the international ARAMIS study, patients treated with darolutamide lived longer without their cancer spreading than patients who were given placebo (sugar) pills. We wanted to know whether Spanish patients in ARAMIS had similar characteristics and treatment outcomes to other patients in the study. We found that the 75 Spanish patients who were treated with darolutamide had a significantly lower risk of their cancer spreading than the 42 Spanish patients who received placebo. The two groups of Spanish patients had similar side effects.
Subject(s)
Prostatic Neoplasms, Castration-Resistant , Male , Humans , Prostatic Neoplasms, Castration-Resistant/pathology , Androgen Receptor Antagonists/adverse effects , Androgen Antagonists/adverse effects , Pyrazoles/adverse effectsABSTRACT
INTRODUCTION: Working in surgery while pregnant is challenging. Navigating this period safely is of paramount importance. Anecdotal observation suggests that there exists great variation among European nations in regard to maternity leave and radiation safety. The aim of this article was to gain insight into policy patterns and variations across Europe regarding these issues. METHODS: A series of core question items was distributed to representatives across 12 nations Austria, Belgium, Germany, Greece, Iceland, Italy, Netherlands, Norway, Poland, Republic of Ireland, Spain and the United Kingdom). RESULTS: The total number of weeks with full pay ranged from as little as 4 weeks in Belgium to 32 and Iceland. All countries included in this study give the option of additional weeks beyond the initial period, however at reduced pay. Some offer unpaid leave beyond this. Only 5/12 countries had a specific policy on when the pregnant surgeon should come off the on-call rota. Only Austria, Italy and Poland stipulate a requirement for the pregnant clinician to be replaced or be completely exempt in cases involving radiation. Only Germany, Iceland, Norway and Poland highlight the need to limit radiation dose in the first trimester. Beyond this, Germany alone provides written guidance for reduction in gown weight and along with Poland, display arguably the most forward-thinking approach to resting. CONCLUSION: There is a marked range in maternal leave policies across Europe. There also exists a lack of universal guidance on radiation safety for the pregnant urologist. There is urgent need for this void to be addressed.
Subject(s)
Occupational Health , Physicians, Women , Pregnant Women , Austria , Europe , Female , Health Policy , Humans , Netherlands , Pregnancy , Spain , United KingdomABSTRACT
BACKGROUND: In May 2012 the US Preventive Task Force issued a 'D' recommendation against routine PSA-based early detection of prostate cancer. This recommendation was implemented progressively in our health system. The aim of this study is to define its impact on prostate cancer staging at a tertiary care institution. METHODS: A retrospective analysis was performed from 2012 until 2015 at a single center. We analyzed the total number of biopsies performed per year and the positive biopsy rate. For those patients with positive biopsies we recorded diagnostic PSA, clinical stage, ISUP grade group, nodal involvement and metastatic status at diagnosis. RESULTS: A total of 1686 biopsies were analyzed. The positive biopsy rate increased from 25% in 2012 to 40% in 2015 (p < 0.05). No change in median PSA was noticed (p = 0.627). The biopsies detected higher ISUP grades (p = 0.000). In addition, newly diagnosed prostate cancer presented a higher clinical stage (p = 0.005), higher metastatic rates (p = 0.03) and a tendency to higher lymph node involvement although not statistically significant (p = 0.09). CONCLUSION: After the 2012 recommendation, patients presented a higher probability of a prostate cancer diagnosis, with a more adverse ISUP group, clinical stage and metastatic disease. These results should be taken into consideration to implement a risk adapted strategy for prostate cancer screening.
Subject(s)
Prostatic Neoplasms/pathology , Aged , Early Detection of Cancer , Humans , Male , Middle Aged , Neoplasm Staging , Retrospective Studies , Tertiary Care CentersABSTRACT
Penile squamous cell carcinoma (PSCC) is a rare but aggressive neoplasm with dual pathogenesis (human papillomavirus (HPV)-associated and HPV-independent). The development of targeted treatment is hindered by poor knowledge of the molecular landscape of PSCC. We performed a thorough review of genetic alterations of PSCC focused on somatic mutations and/or copy number alterations. A total of seven articles have been identified which, overall, include 268 PSCC. However, the series are heterogeneous regarding methodologies employed for DNA sequencing and HPV detection together with HPV prevalence, and include, in general, a limited number of cases, which results in markedly different findings. Reported top-ranked mutations involve TP53, CDKN2A, FAT1, NOTCH-1 and PIK3CA. Numerical alterations involve gains in MYC and EGFR, as well as amplifications in HPV integration loci. A few genes including TP53, CDKN2A, PIK3CA and CCND1 harbor both somatic mutations and copy number alterations. Notch, RTK-RAS and Hippo pathways are frequently deregulated. Nevertheless, the relevance of the identified alterations, their role in signaling pathways or their association with HPV status remain elusive. Combined targeting of different pathways might represent a valid therapeutic approach in PSCC. This work calls for large-scale sequencing studies with robust HPV testing to improve the genomic understanding of PSCC.
Subject(s)
Carcinoma, Squamous Cell/etiology , Carcinoma, Squamous Cell/genetics , Penile Neoplasms/etiology , Penile Neoplasms/genetics , Carcinoma, Squamous Cell/pathology , Carcinoma, Squamous Cell/virology , DNA Copy Number Variations/genetics , Geography , Humans , Male , Molecular Targeted Therapy , Mutation/genetics , Papillomaviridae/physiology , Penile Neoplasms/pathology , Penile Neoplasms/virology , Prognosis , Signal TransductionABSTRACT
INTRODUCTION: Prostate cryotherapy is an available treatment option for localized prostate cancer (PC) included on minimal invasive therapies but still under evaluation. We started our cryotherapy program in 2008 for selected patients with localized PC. Our objective is to evaluate the oncologic and functional outcomes of primary cryotherapy in men with clinically localized PC. SUBJECTS AND METHODS: We retrospectively evaluated all patients who underwent primary cryotherapy for localized PC treatment at our center between January 2008 and December 2017. In order to downsize prostates between 40 and 60cc neoadjuvant 3-month hormonal therapy was administered. Primary endpoint was biochemical progression-free survival (BPFS) rate as defined by the Phoenix criteria. Secondary endpoints were cancer-specific survival (CSS), overall survival (OS), patient reported functional outcomes and complication rates. Factors influencing de BPFS were evaluated individually using Kaplan-Meyer and Cox regression models and in a multivariate model using Cox regression. RESULTS: During the mentioned period, a total of 177 men were treated with cryotherapy. With a mean follow-up of 60 months (SD 32.9), the Kaplan-Meier analysis shows an overall BPFS rate was 67%. BPFS by risk group was 70.2%, 70.3% and 50.0% for the low, intermediate and high risk groups, respectively (p = 0.925). Overall time to BR was 93.67 months (SD 2.84, IC95%: 88.10-99.24): 95.91 (SD 3,44), 93.23 (SD 4.81) and 89.77 (SD 6.67) months for the low, intermediate and high risk groups, respectively. In both univariate and multivariate analysis, the only predictor of biochemical progression was de PSA nadir (HR 1.56 IC95%: 1.50-1.63). Continence was fully maintained in 95% of patients after the procedure. Postoperative complications included UTI (17.5%), hematuria (9.6%), perineal hematoma (11%) and postoperative pain (4.5%). No fistulas were reported. 8.5% of patients had acute urinary retention solved conservatively. CONCLUSION: Cryotherapy is a safe option for selected patients with localized prostate cancer that provides competitive oncologic outcomes and a low morbidity profile.
Subject(s)
Cryosurgery , Prostatic Neoplasms , Cryotherapy , Humans , Male , Prostate-Specific Antigen , Prostatic Neoplasms/surgery , Retrospective StudiesABSTRACT
CONTEXT: Pelvic organ-preserving radical cystectomy (POPRC) for women may improve postoperative sexual and urinary functions without compromising the oncological outcome compared with standard radical cystectomy (RC). OBJECTIVE: To determine the effect of POPRC on sexual, oncological and urinary outcomes compared with RC in women who undergo standard curative surgery and orthotopic neobladder substitution for bladder cancer. EVIDENCE ACQUISITION: Medline, Embase, Cochrane controlled trials databases and clinicaltrial.gov were systematically searched for all relevant publications. Women with bladder cancer who underwent POPRC or standard RC and orthotopic neobladder substitution with curative intent were included. Prospective and retrospective comparative studies and single-arm case series were included. The primary outcomes were sexual function at 6-12 months after surgery and oncological outcomes including disease recurrence and overall survival (OS) at >2 years. Secondary outcomes included urinary continence at 6-12 months. Risk of bias (RoB) assessment was performed using standard Cochrane review methodology including additional domains based on confounder assessment. EVIDENCE SYNTHESIS: The searches yielded 11 941 discrete articles, of which 15 articles reporting on 15 studies recruiting a total of 874 patients were eligible for inclusion. Three papers had a matched-pair study design and the rest of the studies were mainly small, retrospective case series. Sexual outcomes were reported in seven studies with 167/194 patients (86%) having resumed sexual activity within 6 months postoperatively, with median (range) patients' sexual satisfaction score of 88.5 (80-100)%. Survival outcomes were reported in seven studies on 197 patients, with a mean follow-up of between 12 and 132 months. At 3 and 5 years, cancer-specific survival was 70-100% and OS was 65-100%. In all, 11 studies reported continence outcomes. Overall, the daytime and night-time continence rates were 58-100% and 42-100%, respectively. Overall, the self-catheterisation rate was 9.5-78%. Due to poor reporting and large heterogeneity between studies, instead of subgroup-analysis, a narrative synthesis approach was used. The overall RoB was high across all studies. CONCLUSION: For well-selected patients, POPRC with orthotopic neobladder may potentially be comparable to standard RC for oncological outcomes, whilst improving sexual and urinary function outcomes. However, in women undergoing RC, oncological and functional data regarding POPRC remain immature and require further evaluation in a prospective comparative setting.
Subject(s)
Cystectomy/methods , Organ Sparing Treatments/methods , Sexual Dysfunction, Physiological/prevention & control , Urinary Bladder Neoplasms/surgery , Urinary Bladder/pathology , Urinary Diversion/methods , Urinary Incontinence/prevention & control , Female , Humans , Postoperative Complications , Treatment Outcome , Urinary Bladder Neoplasms/physiopathologyABSTRACT
PURPOSE: Androgen deprivation therapy may promote the development of the metabolic syndrome in patients with prostate cancer. We assessed the prevalence of the full metabolic syndrome and its components during the first year of androgen deprivation therapy. MATERIALS AND METHODS: This observational, multicenter, prospective study included 539 patients with prostate cancer scheduled to receive 3-month depot luteinizing hormone-releasing hormone analogs for more than 12 months. Waist circumference, body mass index, lipid profile, blood pressure and fasting glucose were evaluated at baseline and after 6 and 12 months. The metabolic syndrome was assessed according to NCEP ATP III criteria (2001) and 4 other definitions (WHO 1998, AACE 2003, AHA/NHLBI 2005 and IDF 2005). RESULTS: At 6 and 12 months after the initiation of androgen deprivation therapy, significant increases were observed in waist circumference, body mass index, fasting glucose, triglycerides, total cholesterol, and high-density and low-density lipoprotein cholesterol. No significant changes in blood pressure 130/85 or greater were detected. A nonsignificant increase of 3.9% in the prevalence of the full metabolic syndrome (ATP III) was observed (22.9% at baseline vs 25.5% and 26.8% at 6 and 12 months, respectively). The prevalence of the metabolic syndrome at baseline varied according to the definition used, ranging from 9.4% (WHO) to 50% (IDF). At 12 months significant increases in prevalence were observed with the WHO (4.1%) and AHA/NHLBI (8.1%) definitions. CONCLUSIONS: Androgen deprivation therapy produces significant early effects on waist circumference, body mass index, fasting glucose, triglycerides and cholesterol. The prevalence of and increase in the metabolic syndrome depend on the defining criteria. Counseling patients on the prevention, early detection and treatment of specific metabolic alterations is recommended.
Subject(s)
Androgen Antagonists/adverse effects , Gonadotropin-Releasing Hormone/agonists , Metabolic Syndrome/chemically induced , Prostatic Neoplasms/drug therapy , Aged , Aged, 80 and over , Humans , Male , Metabolic Syndrome/epidemiology , Middle Aged , Prevalence , Prospective StudiesABSTRACT
PURPOSE: There is a concern about the impact that this surgery could have on a patient's sexuality, although this has not been well documented. The objective of our study is to describe the surgical results and assess sexual function and patient satisfaction after transvaginal NOTES-assisted laparoscopic radical and living donor nephrectomy. METHODS: Between March 2008 and October 2014, 100 women underwent transvaginal NOTES-assisted nephrectomy (78 living donor and 22 radical nephrectomy) in our centre. The procedure was performed using two different techniques depending on the indication as described previously, but using the same vaginal approach. Variables evaluated were operative time, blood loss, intra-operative complications, hospital stay, satisfaction, first-month creatinine and warm ischaemia time in donors. Sexual function was assessed with the Female Sexual Function Index questionnaire before and after surgery. All variables were accrued in a prospective database. RESULTS: The procedure was completed in all cases. Mean age and body mass index was higher in the radical nephrectomy group. Mean operative time and hospital stay were similar for both techniques. All sexually active women reported unaltered sexual function after surgery and satisfaction with the results. The pre- and post-FSFI scores for living donor (n = 54) and radical nephrectomy (n = 4) were 27.47 ± 1.02/27.27 ± 1.10 (p > 0.05) and 31.17 ± 0.81/31.87 ± 0.97 (p > 0.05). CONCLUSIONS: Transvaginal NOTES-assisted or hybrid NOTES nephrectomy offers a safe technique with excellent cosmetic results and no sexual effect. Despite promising results, randomized controlled studies with longer follow-up are warranted to further elucidate the potential of this novel technique.
Subject(s)
Kidney Neoplasms/surgery , Laparoscopy , Natural Orifice Endoscopic Surgery , Nephrectomy , Sexuality , Cohort Studies , Female , Humans , Length of Stay , Middle Aged , Operative Time , Patient Satisfaction , Sex Factors , Treatment OutcomeABSTRACT
PURPOSE: We estimate the annual incidence of bladder cancer in Spain and describe the clinical profile of patients with bladder cancer enrolled in a population based study. MATERIALS AND METHODS: Using the structure of the Spanish National Health System as a basis, in 2011 the AEU (Spanish Association of Urology) conducted this study with a representative sample from 26 public hospitals and a reference population of 10,146,534 inhabitants, comprising 21.5% of the Spanish population. RESULTS: A total of 4,285 episodes of bladder cancer were diagnosed, of which 2,476 (57.8%) were new cases and 1,809 (42.2%) were cases of recurrence, representing an estimated 11,539 new diagnoses annually in Spain. The incidence of bladder cancer in Spain, age adjusted to the standard European population, was 20.08 cases per 100,000 inhabitants (95% CI 13.9, 26.3). Of patients diagnosed with a first episode of bladder cancer 84.3% were male, generally older than 59 years (81.7%) with a mean ± SD age of 70.5 ± 11.4 years. Of these patients 87.5% presented with some type of clinical symptom, with macroscopic hematuria (90.8%) being the most commonly detected. The majority of primary tumors were nonmuscle invasive (76.7%) but included a high proportion of high grade tumors (43.7%). According to the ISUP (International Society of Urologic Pathology)/WHO (2004) classification 51.1% was papillary high grade carcinoma. Carcinoma in situ was found in 2.2% of primary and 5.8% of recurrent cases. CONCLUSIONS: The incidence of bladder cancer in Spain, age adjusted to the standard European population, confirms that Spain has one of the highest incidences in Europe. Most primary nonmuscle invasive bladder cancer corresponded to high risk patients but with a low detected incidence of carcinoma in situ.
Subject(s)
Urinary Bladder Neoplasms/epidemiology , Administration, Intravesical , Adult , Aged , Aged, 80 and over , Antibiotics, Antineoplastic/administration & dosage , Comorbidity , Female , Hematuria/epidemiology , Humans , Incidence , Male , Middle Aged , Mitomycin/administration & dosage , Neoplasm Invasiveness , Neoplasm Staging , Population Surveillance , Smoking/epidemiology , Spain/epidemiology , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgery , Young AdultABSTRACT
Bladder cancer is a significant global health concern owing to its prevalence, negative impact on quality of life, and high treatment costs. Treatment for metastatic urothelial carcinoma (mUC) traditionally relies on platinum-based chemotherapy regimens. However, clinical trial results have led to the approval of immune checkpoint inhibitors (ICIs) as viable treatment options. We assessed the escalating costs and economic viability of mUC treatment guidelines in Europe. We used a pragmatic approach that involved: (1) collection of the costs of the recommended medications in the five most populous European countries; (2) conversion of the costs into international dollars to account for differences in purchasing power parity among countries; (3) evaluation of the cost trends over time; and (4) comparison of the medication costs to World Health Organization thresholds. Introduction of ICIs in European guidelines substantially increased the cost of medications for mUC. Intriguingly, important differences across European countries emerged: the annual cost of medications was twofold higher in Italy than in France and the UK. Despite limitations, our study sheds light on the escalating costs and economic challenges of mUC treatment, and highlights the need for assessments of sustainable and cost-effective management approaches. PATIENT SUMMARY: We looked at the costs of treatments for metastatic bladder cancer and found that costs have been rising over time, especially with the introduction of new immune therapies, with notable differences among European countries. While these new treatments improve patient outcomes, they also come with a high price tag, which could strain health care budgets. Our results suggest that cost-effectiveness studies will be essential in determining the best and most sustainable treatment strategies in the future.
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Use of artificial intelligence (AI) in social media (SoMe) in health care is increasing. Benefits include personalisation of SoMe content for individual patients and identification of trends to prompt timely generation of relevant content. Data security, ethical considerations, medical accuracy, patient engagement, and regulatory compliance are issues to address for this evolving AI use.
Subject(s)
Digital Health , Social Media , Humans , Artificial Intelligence , Patient Compliance , Patient ParticipationABSTRACT
Background and objective: The ability of health care professionals to communicate with patients compassionately and effectively is crucial for shared decision-making, but little research has investigated patient-clinician communication. As part of PIONEER-an international Big Data Consortium led by the European Association of Urology to answer key questions for men with prostate cancer (PCa), funded through the IMI2 Joint Undertaking under grant agreement 777492- we investigated communication between men diagnosed with PCa and the health care professional(s) treating them across Europe. Methods: We used the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Communication 26, which was shared via the PIONEER and patient organisations on March 11, 2022. We sought men who spoke French, Italian, Spanish, German, Dutch, or English who were diagnosed with PCa and were undergoing or had already received treatment for their PCa. Results and limitations: A total of 372 men reported that they communicated with their clinician during either the diagnostic or the treatment period. Overall, the majority of participants reported positive experiences. However, important opportunities to enhance communication were identified, particularly with regard to correcting misunderstandings, understanding the patient's preferred approach to information presentation, addressing challenging questions, supporting the patient's comprehension of information, attending to the patient's emotional needs, and assessing what information had already been given to patients about their disease and treatment, and how much of it was understood. Conclusions and clinical implications: These results help us to identify gaps and barriers to shared treatment decision making. This knowledge will help devise measures to improve patient-health care professional communication in the PCa setting. Patient summary: As part of the PIONEER initiative, we investigated the communication between men diagnosed with prostate cancer and their health care professionals across Europe. A total of 372 men from six different countries participated in the study. Most participants reported positive experiences, but areas where communication could be improved were identified. These included addressing misunderstandings, tailoring the presentation of information to the patient's preferences, handling difficult questions, supporting emotional needs, and assessing the patient's understanding of their diagnosis and treatment.
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Background and objective: The treatment landscape of metastatic prostate cancer (mPCa) has evolved significantly over the past two decades. Despite this, the optimal therapy for patients with mPCa has not been determined. This systematic review identifies available predictive models that assess mPCa patients' response to treatment. Methods: We critically reviewed MEDLINE and CENTRAL in December 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Only quantitative studies in English were included with no time restrictions. The quality of the included studies was assessed using the PROBAST tool. Data were extracted following the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews criteria. Key findings and limitations: The search identified 616 citations, of which 15 studies were included in our review. Nine of the included studies were validated internally or externally. Only one study had a low risk of bias and a low risk concerning applicability. Many studies failed to detail model performance adequately, resulting in a high risk of bias. Where reported, the models indicated good or excellent performance. Conclusions and clinical implications: Most of the identified predictive models require additional evaluation and validation in properly designed studies before these can be implemented in clinical practice to assist with treatment decision-making for men with mPCa. Patient summary: In this review, we evaluate studies that predict which treatments will work best for which metastatic prostate cancer patients. We found that existing studies need further improvement before these can be used by health care professionals.
ABSTRACT
BACKGROUND: Androgen deprivation therapy (ADT) with docetaxel (D) and/or antiandrogen receptor therapies (ARTs) are the standard therapies in metastatic hormone-sensitive prostate cancer (mHSPC). Alterations in the tumor suppressor genes (TSGs) RB1, PTEN, and TP53 are associated with an aggressive evolution and treatment resistance in castration-resistant prostate cancer (CRPC). OBJECTIVE: To study the clinical implications of TSG mRNA expression in mHSPC patients. DESIGN, SETTING, AND PARTICIPANTS: This is a multicenter retrospective biomarker study in mHSPC patients. TSGlow status was defined when two or more out of the three TSGs presented low RNA expression by nCounter in formalin-fixed paraffin-embedded samples and TSGwt for the remaining cases. The microarray data from the CHAARTED trial were analyzed as an independent validation cohort. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Molecular data were correlated with CRPC-free survival (CRPC-FS) and overall survival (OS) by the Kaplan-Meier method and multivariate Cox analysis. RESULTS AND LIMITATIONS: A total of 226 patients were included, of whom 218 were eligible: 93 were treated with ADT and 125 with ADT + D; 75.7% presented de novo stage IV and 67.9% high-volume disease. TSGlow (19.2%) was independently correlated with shorter CRPC-FS (hazard ratio [HR] 1.8, p = 0.002) and OS (HR 2, p = 0.002). In the CHAARTED trial, TSGlow was independently correlated with lower CRPC-FS (HR 2.2, p = 0.02); no differences in clinical outcomes according to treatment were observed in TSGlow patients, while a significant benefit was observed for ADT + D in the TSGwt group for CRPC-FS (HR 0.4, p < 0.001) and OS (HR 0.4, p = 0.001). However, no interaction was observed between TSG signature and treatment in either series. Study limitations are the retrospective design, small sample size, and lack of inclusion of patients treated with ADT + ART. CONCLUSIONS: TSGlow expression correlates with adverse outcomes in patients with mHSPC. The investigation of new therapeutic strategies in these patients is warranted. PATIENT SUMMARY: The low RNA expression of tumor suppressor genes in the tumors is correlated with adverse outcomes in patients with metastatic hormone-sensitive prostate cancer.
Subject(s)
PTEN Phosphohydrolase , Retinoblastoma Binding Proteins , Tumor Suppressor Protein p53 , Humans , Male , PTEN Phosphohydrolase/genetics , Retrospective Studies , Aged , Prognosis , Tumor Suppressor Protein p53/genetics , Tumor Suppressor Protein p53/metabolism , Retinoblastoma Binding Proteins/genetics , Ubiquitin-Protein Ligases/genetics , Prostatic Neoplasms, Castration-Resistant/drug therapy , Prostatic Neoplasms, Castration-Resistant/genetics , Prostatic Neoplasms, Castration-Resistant/pathology , Prostatic Neoplasms, Castration-Resistant/mortality , Middle Aged , Transcriptome , Neoplasm Metastasis , Androgen Antagonists/therapeutic use , Aged, 80 and over , Prostatic Neoplasms/genetics , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/pathologyABSTRACT
Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in "real-life" patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.
ABSTRACT
INTRODUCTION: Open surgery (ONU) is still considered to be the gold standard approach for nephroureterectomy (NU); however, with the introduction of laparoscopic surgery, minimally invasive techniques have been applied to surgical therapy of upper urinary tract tumours (UUT-UC) and they are gaining adepts. However, several concerns still exist about the safety of laparoscopic nephroureterectomy (LNU) in the treatment of UUT-UC, and different authors suggest that, although it could be equivalent to open surgery, this equivalence is not accomplished in all UUT-UC, suggesting that more advanced disease should undergo open surgery. More controversial still is the application of robotic surgery (RALNU) or really novel minimally invasive techniques, such as laparoendoscopic single-site surgery (LESSNU), for the treatment of UUT-UC. Although all these techniques seem feasible, their influence on oncologic results is still a matter of concern. METHODOLOGY: We present a review on the oncologic outcomes of minimally invasive laparoscopic techniques in the treatment of UUT-UC. We focus our analysis on oncologic outcomes and we also analyze the different techniques proposed for the treatment of the distal ureter during minimally invasive surgery for UUT-UC. In the absence of prospective randomized studies with large patient samples, we must base our conclusions on retrospective studies and longer follow-up. CONCLUSION: Given the evidence accumulated so far, LNU has proven to be equivalent or non-inferior, in terms of recurrence-free survival (RFS) and cancer-specific survival (CSS) to ONU. Nevertheless, comparative studies are needed with longer follow-up before determining the equivalence of LNU in advanced tumours.
Subject(s)
Carcinoma, Transitional Cell/surgery , Kidney Neoplasms/surgery , Laparoscopy/methods , Nephrectomy/methods , Robotics/methods , Ureter/surgery , Ureteral Neoplasms/surgery , Disease-Free Survival , Humans , Kidney Pelvis , Treatment OutcomeABSTRACT
BACKGROUND: Evidence-practice gaps exist in urology. We previously surveyed European Association of Urology (EAU) guidelines for strong recommendations underpinned by high-certainty evidence that impact patient experience for which practice variations were suspected. The recommendation "Do not offer neoadjuvant androgen deprivation therapy (ADT) before surgery for patients with prostate cancer" was prioritised for further investigation. ADT before surgery is neither clinically effective nor cost effective and has serious side effects. The first step in improving implementation problems is to understand their extent. A clear picture of practice regarding ADT before surgery across Europe is not available. OBJECTIVE: To assess current ADT use before prostate cancer surgery in Europe. DESIGN, SETTING, AND PARTICIPANTS: This was an observational cross-sectional study. We retrospectively audited recent ADT practices in a multicentre international setting. We used nonprobability purposive sampling, aiming for breadth in terms of low- versus high-volume, academic, versus community and public versus private centres. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Our primary outcome was adherence to the ADT recommendation. Descriptive statistics and a multilevel model were used to investigate differences between countries across different factors (volume, centre type, and funding type). Subgroup analyses were performed for patients with low, intermediate, and high risk, and for those with locally advanced prostate cancer. We also collected reasons for nonadherence. RESULTS AND LIMITATIONS: We included 6598 patients with prostate cancer from 187 hospitals in 31 countries from January 1, 2017 to May 1, 2020. Overall, nonadherence was 2%, (range 0-32%). Most of the variability was found in the high-risk subgroup, for which nonadherence was 4% (range 0-43%). Reasons for nonadherence included attempts to improve oncological outcomes or preoperative tumour parameters; attempts to control the cancer because of long waiting lists; and patient preference (changing one's mind from radiotherapy to surgery after neoadjuvant ADT had commenced or feeling that the side effects were intolerable). Although we purposively sampled for variety within countries (public/private, academic/community, high/low-volume), a selection bias toward centres with awareness of guidelines is possible, so adherence rates may be overestimated. CONCLUSIONS: EAU guidelines recommend against ADT use before prostate cancer surgery, yet some guideline-discordant ADT use remains at the cost of patient experience and an additional payer and provider burden. Strategies towards discontinuation of inappropriate preoperative ADT use should be pursued. PATIENT SUMMARY: Androgen deprivation therapy (ADT) is sometimes used in men with prostate cancer who will not benefit from it. ADT causes side effects such as weight gain and emotional changes and increases the risk of cardiovascular disease, diabetes, and osteoporosis. Guidelines strongly recommend that men opting for surgery should not receive ADT, but it is unclear how well the guidance is followed. We asked urologists across Europe how patients in their institutions were treated over the past few years. Most do not use ADT before surgery, but this still happens in some places. More research is needed to help doctors to stop using ADT in patients who will not benefit from it.
Subject(s)
Prostatic Neoplasms , Urology , Male , Humans , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/surgery , Androgen Antagonists/adverse effects , Androgens/therapeutic use , Cross-Sectional Studies , Retrospective Studies , Europe , HospitalsABSTRACT
Interactive interventions represent a new application of social media in urology that involves multidirectional communication within a group. Such interventions have the potential to influence health behaviours in patients and the public and result in a significant impact on urological diseases.
Subject(s)
Social Media , Urologic Diseases , Urology , Humans , CommunicationABSTRACT
PIONEER is a European network of excellence for big data in prostate cancer consisting of 37 private and public stakeholders from 9 countries across Europe. Many progresses have been done in prostate cancer management, but unanswered questions in the field still exist, and big data could help to answer these questions. The PIONEER consortium conducted a two-round modified Delphi survey aiming at building consensus between two stakeholder groups - health-care professionals and patients with prostate cancer - about the most important questions in the field of prostate cancer to be answered using big data. Respondents were asked to consider what would be the effect of answering the proposed questions on improving diagnosis and treatment outcomes for patients with prostate cancer and to score these questions on a scale of 1 (not important) to 9 (critically important). The mean percentage of participants who scored each of the proposed questions as critically important was calculated across the two stakeholder groups and used to rank the questions and identify the highest scoring questions in the critically important category. The identification of questions in prostate cancer that are important to various stakeholders will help the PIONEER consortium to provide answers to these questions to improve the clinical care of patients with prostate cancer.
Subject(s)
Prostatic Neoplasms , Male , Humans , Consensus , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/therapy , Treatment Outcome , EuropeABSTRACT
INTRODUCTION: Bladder cancer (BC) is a common malignancy in Spain. The aims of this study were: to identify the proportion of patients diagnosed with BC incidentally or after symptomatic presentation in a contemporary period in Spain; to compare demographic, clinical, and pathologic characteristics between these groups. METHODS: This was a retrospective analysis of a multi-centre observational study of 26 hospitals in the Spanish National Health System of all BCs newly diagnosed in 2011. The study represented 21.5% of the Spanish population and hospitals were selected in proportion to Spain's regions to ensure a representative sample. Patients were categorized by whether the cancer was diagnosed incidentally or after symptomatic presentation and baseline demographic, pathologic, and clinical characteristics were analyzed. RESULTS: 2472 were newly diagnosed with BC at the 26 participating Spanish hospitals with 308 (12.5%) of cases diagnosed incidentally and 2164 (87.5%) diagnosed after symptomatic presentation. No differences were observed between patients diagnosed incidentally vs. symptomatically in terms of demographics or measured co-morbidities. Compared to symptomatically diagnosed bladder tumours, those diagnosed incidentally were more likely to have a papillary appearance, to be significantly smaller, and less likely to have positive/suspicious cytology. Additionally, incidentally diagnosed bladder tumours were less likely to be muscle-invasive (11.7% vs. 25.0%, pâ¯<â¯0.01) nor aggressive at pathology, with 33.6% Grade 3 compared to 50.1%, (pâ¯<â¯0.01). CONCLUSIONS: We identified a significant percentage (12.5%) of new bladder cancer diagnosis made incidentally in a representative sample of the Spanish population. These tumours exhibited less aggressive pathologic characteristics than their symptomatic counterparts.