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BACKGROUND: Different combination therapies using anti - PD-1 / PD-L1 or CTLA-4 immune checkpoint inhibition (ICI) are widely used in patients with metastatic renal cell carcinoma (mRCC). In the absents of established biomarkers, immune-related adverse events (irAEs) have been discussed as potential predictors of response. METHODS: In this retrospective cohort study, data of 134 patients with mRCC undergoing ICI treatment (Nivolumab, Ipilimumab and Nivolumab, Pembrolizumab and Axitinib or Avelumab and Axitinib) between 2015 and 2021 were analyzed. To examine the utility of irAEs as predictors of overall survival (OS) and progression-free survival (PFS), separate Kaplan-Meier analyses and Cox proportional regression analyses were applied. Landmark analysis was conducted after 12 weeks to reduce immortal time bias. RESULT: irAEs were observed in 85 patients (63.4%). Cutaneous (n = 52, 38.8%), endocrine (n = 33, 24.6%) and hepatic (n = 19, 14.2%) irAEs were most commonly observed. In Kaplan-Meier analysis, patients experiencing irAEs showed favorable median PFS (15 months, 95% CI, 9.91-20.09) compared to the non-irAE group (5 months, 95% CI, 3.56-6.44, P < .001). The median OS was 25 months (95% CI, 16.79-33.21) in the non-irAE group, while it was not reached in the irAE group (P = .002). In multivariable analysis, the presence of any irAE was associated with favorable PFS (HR 0.46 [95% CI, 0.26-0.82] P = .008) and OS (HR: 0.28 [95% CI, 0.12-0.63] P = .002), respectively. Landmark analysis after 12 weeks showed mixed results depending on the classification of the irAE group at the landmark time. CONCLUSION: The presence of irAEs under ICI therapy in patients with mRCC is associated with better PFS and OS. Thus, manageable irAEs should not be cause for premature discontinuation of ICI therapy, as they seem to indicate favorable outcomes. Considering the time-dependent nature of irAEs is crucial estimating their value as predictive markers.
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PURPOSE: To identify independent predictors of urinary continence and report early complications after radical prostatectomy (RP) in a large, contemporary German cohort. METHODS: Urinary incontinence data of patients undergoing 3-week inpatient rehabilitation (IR) after RP were prospectively assessed by 24-hr pad test and uroflowmetry at the beginning and the end of IR, respectively. Lymphoceles were assessed prospectively by ultrasound. Tumor and patient characteristics, and information on urinary leakage on initial cystography were retrospectively extracted from discharge letters and surgical reports. Regression analyses were performed to identify predictors of urinary continence at the beginning of IR. RESULTS: Overall, 2,141 patients were included in the final analyses. Anastomotic leakage on the initial cystography and lymphoceles were found in 11.4% and 30.8% of patients, respectively. Intervention for a symptomatic lymphocele was required in 4.2% of patients. At the end of IR, 54.2% of patients were continent, while the median urine loss decreased to 73 g (interquartile range 15-321). Multivariable logistic regression analysis identified age and diabetes mellitus as independent negative predictors, but nerve-sparing surgery as an independent positive predictor of urinary continence (each p < 0.001). Multivariable linear regression analysis showed that 24-hr urine loss increased by 7 g with each year of life (p < 0.001), was 79 g higher in patients with diabetes mellitus (p = 0.007), and 175 g lower in patients with NS (p < 0.001). CONCLUSION: Age, diabetes mellitus, and NS are significantly associated with continence outcomes in the early period after RP. Our analyses may help clinicians to pre-operatively counsel patients on potential surgical outcomes.
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Margens de Excisão , Complicações Pós-Operatórias , Prostatectomia , Neoplasias da Próstata , Incontinência Urinária , Humanos , Masculino , Prostatectomia/métodos , Prostatectomia/efeitos adversos , Pessoa de Meia-Idade , Incontinência Urinária/etiologia , Incontinência Urinária/epidemiologia , Alemanha/epidemiologia , Idoso , Neoplasias da Próstata/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Estudos Retrospectivos , Hospitais com Alto Volume de Atendimentos , Centros de ReabilitaçãoRESUMO
AIM: To evaluate and identify predictors of psychosocial distress (PD) in patients after surgical treatment for prostate cancer (PC), bladder cancer (BC), or kidney cancer (KC) during the COVID-19 pandemic in a large, multi-institutional cohort. MATERIAL AND METHODS: Patients undergoing inpatient rehabilitation (IR) after radical prostatectomy (RP), radical cystectomy (RC), or (partial) nephrectomy in one IR center in 2021 were included. PD was evaluated by the Questionnaire on Stress in Cancer Patients (QSC-R23) at the beginning (T1) and the end (T2) of IR. Regression analyses were performed to identify disease-specific predictors for high PD. RESULTS: A total of 4,290 patients (3,413 after RP, 563 after RC, 314 after (partial) nephrectomy) were included in this study. Median PD decreased significantly during IR across all tumor entities (each p < 0.001). The number of PC and BC patients suffering from high PD decreased significantly (each p < 0.001), but not in KC patients (p = 0.310). Younger age independently predicts high PD in all three malignancies, while additionally positive surgical margins (p = 0.016), ileal conduit (IC; p < 0.001), and nephrectomy (p = 0.032) independently predict high PD in PC, BC, and KC patients, respectively. During the Covid-19 pandemic the demand for individual psycho-oncologic counseling increased significantly in PC (p = 0.03) and KC (p = 0.001) patients. CONCLUSION: Younger age independently predicts high PD in the three main urological malignancies. Positive surgical margins in PCa, IC in BCa, and nephrectomy in KC are disease-specific independent predictors for high PD in the early period after surgical treatment. IMPLICATIONS FOR CANCER SURVIVORS: Disease-specific predictors for high PD may help clinicians identify patients at risk and may guide timely referrals to psycho-oncologic counseling in the early period after uro-oncologic surgery.
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OBJECTIVES: To assess the risk of venous thromboembolic events (VTEs) and bleeding with or without thromboprophylaxis during neoadjuvant chemotherapy in bladder cancer patients scheduled for radical cystectomy. MATERIALS AND METHODS: We conducted a retrospective cohort study in 4886 patients with non-metastatic bladder cancer undergoing cystectomy across 28 centres in 13 countries between 1990 and 2021. Inverse probability weighting analyses were performed to estimate the effect of thromboprophylaxis on VTE and bleeding. RESULTS: In 147 patients (3%) VTEs were recorded within the first year. These occurred a median (interquartile range [IQR]) of 127 (82-198) days after bladder cancer diagnosis. Bleeding events occurred in 131 patients (3%) within the first year. These occurred a median (IQR) of 101 (83-171) days after cancer diagnosis. In inverse probability weighting analyses, compared to patients without thromboprophylaxis during chemotherapy, patients with thromboprophylaxis had not only a lower risk of VTE (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.12-0.81; P = 0.016) but also a lower bleeding risk (HR 0.03, 95% CI 0.09-0.12; P <0.0001). The retrospective nature of the study was its main limitation. CONCLUSIONS: In this retrospective analysis, the benefit of thromboprophylaxis during neoadjuvant chemotherapy before cystectomy is in line with data from randomised trials in other malignancies. Our data suggest thromboprophylaxis is protective against VTEs and should be the standard of care during neoadjuvant chemotherapy.
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In non-muscle invasive bladder cancer, Bacillus Calmette-Guérin (BCG) responders benefit from strong Th1-type inflammatory and T cell responses mediating tumor rejection. However, the corresponding lack of anti-inflammatory Th2-type immunity impairs tissue repair in the bladder wall and facilitates the development of cystitis, causing urinary pain, urgency, incontinence, and frequency. Mechanistically, the leakage of the glycosaminoglycan (GAG) layer enables an influx of potassium ions, bacteria, and urine solutes towards the underlying bladder tissue, promoting chronic inflammation. Treatments directed towards re-establishing this mucopolysaccharide-based protective barrier are urgently needed. We discuss the pathomechanisms, as well as the therapeutic rationale of how chondroitin and hyaluronic acid instillations can reduce or prevent BCG-induced irritative bladder symptoms. Moreover, we present a case series of five patients with refractory BCG-induced cystitis successfully treated with combined chondroitin and hyaluronic acid instillations.
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OBJECTIVE: Antibody-drug conjugates (ADC), enfortumab-vedotin (EV) and sacituzumab-govitecan are new drugs in the treatment of urologic tumors, whose safety profile has not been fully investigated. Therefore, the aim of our study was to evaluate adverse events related to both agents reported to VigiBase, the World Health Organization's global pharmacovigilance database. METHODS: We employed Bayesian disproportionality analysis based on the information component (IC) to explore the safety profile associated with both therapies. Additionally, we used the proportional reporting ratio approach to examine the safety profile further. RESULTS: We identified 41,752 reports connected to ADC therapy (EV: n=5359; SG: n=36,393). In the EV subgroup, most reports were associated with dermatologic (38.6%), neurologic adverse events (16.5%), or adverse laboratory assessments (19.4%). In contrast, reports in the SG subgroup were mainly associated with gastrointestinal adverse events (24.2%) and adverse laboratory assessments (39.0%). Adverse laboratory assessments in both cohorts were often based on haematotoxic adverse events. CONCLUSION: We could provide a comprehensive real-world safety profile of EV and SG using a global pharmacovigilance database. Based on the safety signals explored in this study, further research regarding the impact of these side effects on patient outcomes is justified.
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Anticorpos Monoclonais Humanizados , Imunoconjugados , Farmacovigilância , Humanos , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/administração & dosagem , Imunoconjugados/efeitos adversos , Imunoconjugados/administração & dosagem , Masculino , Feminino , Camptotecina/análogos & derivados , Camptotecina/efeitos adversos , Camptotecina/administração & dosagem , Pessoa de Meia-Idade , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Teorema de Bayes , Idoso , Neoplasias/tratamento farmacológico , Terapia de Alvo Molecular/efeitos adversos , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/administração & dosagem , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , AdultoRESUMO
OBJECTIVE: To investigate the optimal number of induction chemotherapy cycles needed to achieve a pathological response in patients with clinically lymph node-positive (cN+) bladder cancer (BCa) who received three or four cycles of induction chemotherapy followed by consolidative radical cystectomy (RC) with pelvic lymph node dissection. PATIENTS AND METHODS: We included 388 patients who received three or four cycles of cisplatin/gemcitabine or (dose-dense) methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), followed by consolidative RC for cTanyN1-3M0 BCa. We compared pathological complete (pCR = ypT0N0) and objective response (pOR = yp ≤T1N0) between treatment groups. Predictors of pCR and/or pOR were assessed using uni- and multivariable logistic regression analysis. The secondary endpoints were overall (OS) and cancer-specific survival (CSS). We evaluated the association between the number of induction chemotherapy cycles administered and survival outcomes on multivariable Cox regression. RESULTS: Overall, 101 and 287 patients received three or four cycles of induction chemotherapy, respectively. Of these, 72 (19%) and 128 (33%) achieved pCR and pOR response, respectively. The pCR (20%, 18%) and pOR (40%, 31%) rates did not differ significantly between patients receiving three or four cycles (P > 0.05). The number of cycles was not associated with pCR or pOR on multivariable logistic regression analyses. The 2-year OS estimates were 63% (95% confidence interval [CI] 0.53-0.74) and 63% (95% CI 0.58-0.7) for patients receiving three or four cycles, respectively. Receiving three vs four cycles was not associated with OS and CSS on uni- or multivariable Cox regression analyses. CONCLUSION: Pathological response and survival outcomes did not differ between administering three or four induction chemotherapy cycles in patients with cN+ BCa. A fewer cycles (minimum three) may be oncologically sufficient in patients with cN+ BCa, while decreasing the wait for definitive local therapy in those patients who end up without a response to chemotherapy. This warrants further validation.
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Protocolos de Quimioterapia Combinada Antineoplásica , Cistectomia , Quimioterapia de Indução , Metástase Linfática , Neoplasias da Bexiga Urinária , Humanos , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/patologia , Neoplasias da Bexiga Urinária/mortalidade , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cistectomia/métodos , Estudos Retrospectivos , Resultado do Tratamento , Gencitabina , Cisplatino/administração & dosagem , Excisão de Linfonodo , Metotrexato/administração & dosagem , Linfonodos/patologia , Desoxicitidina/análogos & derivados , Desoxicitidina/administração & dosagemRESUMO
BACKGROUND: The European Association of Urology (EAU) recommends discussing upfront radical cystectomy for all patients with very high risk (VHR) non-muscle-invasive bladder carcinoma (NMIBC), but the role of bacillus Calmette-Guérin (BCG) treatment remains controversial. OBJECTIVE: To analyze oncological outcomes in VHR NMIBC patients (EAU risk groups) treated with adequate BCG. DESIGN, SETTING, AND PARTICIPANTS: A multi-institutional retrospective study involving patients with VHR NMIBC who received adequate BCG therapy from 2007 to 2020 was conducted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A survival analysis estimated recurrence-free survival (RFS), progression-free survival (PFS), and the cumulative incidence of cancer-specific mortality (CSM) after accounting for other causes of mortality as competing risk events and of the overall mortality (OM). Conditional survival probabilities for 0-4 yr without events were computed. Cox regression assessed the predictors of oncological outcomes. RESULTS AND LIMITATION: A total of 640 patients, with a median 47 (32-67) mo follow-up for event-free individuals, were analyzed. High-grade RFS and PFS at 5 yr were 53% (49-57%) and 78% (74-82%), respectively. The cumulative incidence of CSM and OM at 5 yr was 13% (10-16%) and 16% (13-19%), respectively. Conditional RFS, PFS, overall survival, and cancer-specific survival at 4 yr were 91%, 96%, 87%, and 94%, respectively. Cox regression identified tumor grade (hazard ratio [HR]: 1.54; 1.1-2) and size (HR: 1.3; 1.1-1.7) as RFS predictors. Tumor multiplicity predicted RFS (HR: 1.6; 1.3-2), PFS (HR: 2; 1.2-3.3), and CSM (HR: 2; 1.2-3.2), while age predicted OM (HR: 1.48; 1.1-2). CONCLUSIONS: Patients with VHR NMIBC who receive adequate BCG therapy have a more favorable prognosis than predicted by EAU risk groups, especially among those with a sustained response, in whom continuing maintenance therapy emerges as a viable alternative to radical cystectomy. PATIENT SUMMARY: Our research shows that a sustained response to bacillus Calmette-Guérin in patients can lead to favorable outcomes, serving as a viable alternative to cystectomy for select cases.
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PURPOSE: This study aims to investigate urinary symptoms (continence and stoma care), health-related quality of life (HRQoL) and psychosocial distress (PD) in the early postoperative period after radical cystectomy (RC) and urinary diversion for ileal conduit (IC) and ileal neobladder (INB) to obtain a better basis for patient counseling. METHODS: Data for 842 bladder cancer patients, who underwent 3 weeks of inpatient rehabilitation (IR) after RC and urinary diversion (447 IC, 395 INB) between April 2018 and December 2019 were prospectively collected. HRQoL, PD, and urinary symptoms were evaluated by validated questionnaires at the beginning (T1) and the end of IR (T2). In addition, continence status and micturition volume were objectively evaluated in INB patients by 24-h pad test and uroflowmetry, respectively. RESULTS: Global HRQoL was severely impaired at T1, without significant difference between the two types of urinary diversion. All functioning and symptom scales of HRQoL improved significantly from T1 to T2. In INB patients, all continence parameters improved significantly during IR, while patients with an IC reported fewer problems concerning urostomy management. The proportion of patients suffering from high PD decreased significantly from 50.7 to 34.9%. Age ≤ 59 years was the only independent predictor of high PD. Female patients and patients ≤ 59 years were more likely to use individual psycho-oncological counseling. CONCLUSION: HRQoL, PD and urinary symptoms improved significantly in the early recovery period after RC. Patients with urinary continence reported higher HRQoL and less PD. Psychosocial support should be offered especially to younger patients.
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Neoplasias da Bexiga Urinária , Derivação Urinária , Humanos , Feminino , Pessoa de Meia-Idade , Cistectomia , Qualidade de Vida , Neoplasias da Bexiga Urinária/cirurgia , PacientesRESUMO
INTRODUCTION: The aim of the study was to determine the adaption of neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC) in Germany, Austria, and Switzerland and especially underlying reasons for potential low adherence to guidelines. METHODS: We conducted a non-validated survey among 336 urologic departments in Germany, Austria, and Switzerland. RedCap questionnaires were electronically distributed and included 23 items concerning the general NAC administration standards and guideline compliance in patient counseling regarding the actual treatment. RESULTS: The return rate of the questionnaire was 19.1% (63/336). Although 45 departments (71.4%) claim to perform NAC as the standard of care, only 49% of eligible patients actually receive NAC. An advanced disease stage (≥cT3) and a high tumor volume were mentioned to support the application of NAC, whereas 35% of responders worry about deterioration of patients' preoperative status due to NAC. Furthermore, 26.7% of respondents are concerned about the low extent of survival benefit. CONCLUSION: Application of NAC in eligible MIBC patients in Germany, Austria, and Switzerland remains low. Although the majority of urologic departments discuss NAC and acknowledge the need for intensified treatment in advanced disease stages, not all eligible patients will actually receive NAC before radical cystectomy.
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Terapia Neoadjuvante , Neoplasias da Bexiga Urinária , Humanos , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/patologia , Quimioterapia Adjuvante , Suíça , Alemanha , Áustria , Fidelidade a Diretrizes , Inquéritos e Questionários , Cistectomia , Padrões de Prática Médica , Pesquisas sobre Atenção à SaúdeRESUMO
PURPOSE: This study aims to evaluate survival, health-related quality of life (HRQoL), psychosocial distress, and functional outcomes after radical cystectomy (RC) and urinary diversion for ileal neobladder (INB) or ileal conduit (IC) in a contemporary German cohort of bladder cancer patients. METHODS: Patients undergoing inpatient rehabilitation after RC between April 2018 and December 2019 in one high-volume rehabilitation center were surveyed regarding HRQoL, psychosocial distress, and functional outcomes until two years after RC. RESULTS: Eight-hundred forty-two patients (683 male, 159 female; 395 INB, 447 IC) were included. Patients with an IC suffered more often from locally advanced disease (≥ pT3; 41.4% vs. 24.1%, p < 0.001) and lymph node metastases (19.9% vs. 11.8%, p = 0.002), resulting in worse probability of survival (p < 0.001). Global HRQoL improved steadily during follow-up, but significant differences in subscales persisted between cohorts. Multivariable regression analysis identified IC, male sex, and patient age ≤ 59 years as independent predictors for persistent high psychosocial distress. Almost 42% of female patients reported severe urinary incontinence two years after RC. Most men reported severely diminished erectile function, even after nerve-sparing surgery. CONCLUSION: Global HRQoL two years after RC is comparable to the general German population. Female patients should be informed about worse continence rates. Conversely, men should be educated about erectile dysfunction. Aftercare should include psycho-oncologic counseling, especially for patients at risk. IMPLICATIONS FOR CANCER SURVIVORS: Patients should be counseled on long-term functional outcomes and persistent psychosocial distress after RC. Closer cooperation between urologists and psycho-oncologists is needed.
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OBJECTIVE: To determine the oncological impact of extended pelvic lymph node dissection (ePLND) vs standard PLND (sPLND) during radical cystectomy (RC) in clinically lymph node-positive (cN+) bladder cancer (BCa). PATIENTS AND METHODS: In this retrospective, multicentre study we included 969 patients who underwent RC with sPLND (internal/external iliac and obturator lymph nodes) or ePLND (sPLND plus common iliac and presacral nodes) with or without platin-based peri-operative chemotherapy for cTany N1-3 M0 BCa between 1991 and 2022. We assessed the impact of ePLND on recurrence-free survival (RFS) and the distribution of recurrences (locoregional and distant recurrences). The secondary endpoint was overall survival (OS). We performed propensity-score matching using covariates associated with the extent of PLND in univariable logistic regression analysis. The association of the extent of PLND with RFS and OS was investigated using Cox regression models. RESULTS: Of 969 cN+ patients, 510 were 1:1 matched on propensity scores. The median (interquartile range [IQR]) time to recurrence was 8 (4-16) months, and median (IQR) follow-up of alive patients was 30 (13-51) months. Disease recurrence was observed in 104 patients in the ePLND and 107 in the sPLND group. Of these, 136 (27%), 47 (9.2%) and 19 patients (3.7%) experienced distant, locoregional, or both distant and locoregional disease recurrence, respectively. When stratified by the extent of PLND, we did not find a difference in recurrence patterns (P > 0.05). ePLND improved neither RFS (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.70-1.19; P = 0.5) nor OS (HR 0.78, 95% CI 0.60-1.01; P = 0.06) compared to sPLND. Stratification by induction chemotherapy did not change outcomes. CONCLUSION: Performing an ePLND at the time of RC in cN+ patients improved neither RFS nor OS compared to sPLND, regardless of induction chemotherapy status. Pretreatment risk stratification is paramount to identify ideal candidates for RC with ePLND as part of a multimodal treatment approach.
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Recidiva Local de Neoplasia , Neoplasias da Bexiga Urinária , Humanos , Estudos Retrospectivos , Recidiva Local de Neoplasia/patologia , Excisão de Linfonodo , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/cirurgia , Linfonodos/cirurgia , Linfonodos/patologia , CistectomiaRESUMO
PURPOSE: To evaluate return to work (RTW), health-related quality of life (HRQoL) and psychosocial distress (PD) after radical cystectomy (RC) and creation of an ileal conduit (IC) or an orthotopic ileal neobladder (NB) for bladder cancer. METHODS: The study relied on prospectively collected data for 842 patients, who underwent 3 weeks of inpatient rehabilitation (IR) after surgery between April 2018 and December 2019. HRQoL (EORTC QLQ-C30) and PD (Questionnaire on Stress in Cancer Patients [QSC-R10]) were evaluated at the beginning (T1) and end (T2) of IR as well as both 6 (T3) and 12 months after surgery (T4). Regression analyses were performed to identify predictors of HRQoL and RTW, respectively. RESULTS: Two hundred thirty patients (IC n = 51, NB n = 179) were employed before surgery (27.3%). HRQoL improved steadily, while high PD was present in 51.0% of patients at T4. RTW rate was 86.8 and 80.6% at T3 and T4, respectively. Linear regression analysis identified RTW as the only predictor for better HRQoL at T4 (OR [odds ratio] 12.823, 95% CI [confidence interval] 2.927-22.720, p = 0.012). Multivariate regression analysis identified age ≤ 59 years (OR 7.842; 95% CI 2.495-24.645; p < 0.001) as an independent positive predictor and lymph node metastasis (OR 0.220; 95% CI 0.054-0.893; p = 0.034) as an independent negative predictor of RTW at T4. CONCLUSION: Global HRQoL improved steadily during the follow-up and RTW rates are high. However, patients often reported high PD, reflecting a need for additional psychosocial support within aftercare.
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Neoplasias da Bexiga Urinária , Derivação Urinária , Coletores de Urina , Humanos , Pessoa de Meia-Idade , Cistectomia , Qualidade de Vida/psicologia , Seguimentos , Retorno ao Trabalho , Neoplasias da Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/patologia , Derivação Urinária/psicologiaRESUMO
PURPOSE: This study aims to report on functional outcomes in a large cohort of patients who underwent inpatient rehabilitation (IR) in a highly specialized, high-volume German urologic rehabilitation center after radical cystectomy (RC) and creation of an ileal neobladder (INB). METHODS: Data for 842 patients, who underwent three weeks of IR after RC and urinary diversion between April 2018 and December 2019 were prospectively collected. INB patients were surveyed on continence and sexual function. Data were collected at 4 weeks (T1), 6 months (T2), and 12 months (T3) after RC. Multivariate logistic regressions were performed to identify predictors of better functional outcomes. RESULTS: INB was chosen as urinary diversion in 395 patients (357 male, 38 female). Social continence (maximum of one safety pad/24 h) was reported by 78.3% of men and 64.0% of women at T3. Severe incontinence was reported by 27.3% of men and 44.0% of women. Male sex was identified as an independent predictor for the use of no pads at T3 (OR 4.110; 95% CI 1.153-14.655; p = 0.029). Nerve-sparing surgery was identified as an independent predictor both for the use of only a safety pad (OR 1.918; 95% CI 1.031-3.569; p = 0.040) and good erectile function at T3 (OR 4.377; 95% CI 1.582-12.110; p = 0.004). CONCLUSION: Urologists should aspire for nerve-sparing surgery. When advising patients before RC, functional outcomes (continence, sexual function) should be given special attention. Women should be counseled on potentially prolonged urinary incontinence.
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Neoplasias da Bexiga Urinária , Derivação Urinária , Incontinência Urinária , Coletores de Urina , Humanos , Feminino , Masculino , Cistectomia/efeitos adversos , Neoplasias da Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/etiologia , Resultado do Tratamento , Bexiga Urinária/cirurgia , Incontinência Urinária/etiologia , Derivação Urinária/efeitos adversosRESUMO
OBJECTIVES: To assess the impact of urinary continence and erectile function on the quality of life in men undergoing radical prostatectomy (RP) for prostate cancer (PC), we analyzed the preoperative and 1-year postoperative outcomes of five functional domains and their influencing factors. PATIENTS AND METHODS: In this prospective study, all patients undergoing open or robot-assisted RP between Febuary 2017 and March 2020 in a single academic center were included. Patient-reported outcomes were assessed pre- and 12 months postoperatively using the Expanded Prostate Index Composite (EPIC-26) survey, evaluating continence, irritative/obstructive micturition, gastrointestinal symptoms, sexuality, and overall vitality. We examined the impact of RP on sexual function and urinary continence using multivariable logistic regression models, accounting for patient and tumor characteristics. RESULTS: Overall, 1313 consecutive patients gave consent for study participation and completed both surveys. The median age was 66 years (IQR: 60-70). The majority of patients (n = 601, 46%) had an intermediate risk PC. Robotic RP was performed in 71.6% and nerve-sparing technique in 81% of the cases. The median pre- versus postoperative scores were the following: urinary continence 100 (IQR: 91.8-100) versus 85.5 (64.8-100), irritative micturition 87.5 (IQR: 75-100) versus 93.8 (IQR: 87.5-100), gastrointestinal symptoms the same with 100 (IQR: 95.8-100), vitality 95 (IQR: 80-100) versus 90 (IQR: 75-100), and erectile function 65.3 (IQR: 38.8-87.5) versus 22.2 (IQR: 12.5-48.7), respectively. Age (p < 0.001), risk classification (p = 0.002), and nerve-sparing surgery (p = 0.016) were associated with good sexual function (EPIC-26 score ≥60), while only age (p = 0.001) was statistically significantly associated with good urinary continence (EPIC-26 score ≥80). CONCLUSION: Non-modifiable factors such as age and PC risk classification impact urinary continence and sexual function after RP. Nevertheless, urologic surgeons should further focus on improving nerve-sparing techniques, the only modifiable variable, to reduce the surgery's negative impact on urinary continence and sexual function.
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Disfunção Erétil , Neoplasias da Próstata , Incontinência Urinária , Masculino , Humanos , Idoso , Próstata/cirurgia , Disfunção Erétil/epidemiologia , Disfunção Erétil/etiologia , Qualidade de Vida , Estudos Prospectivos , Incontinência Urinária/epidemiologia , Incontinência Urinária/etiologia , Incontinência Urinária/diagnóstico , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Resultado do TratamentoRESUMO
PURPOSE: This study aims to evaluate health-related quality of life (HRQoL), psychosocial distress, and return to work (RTW) 2 years after radical cystectomy (RC) and inpatient rehabilitation (IR). MATERIAL AND METHODS: The study relied on prospectively collected data for 842 patients, who underwent 3 weeks of IR after RC and creation of an ileal conduit (IC) or ileal neobladder (INB). Validated questionnaires surveyed patients on HRQoL and psychosocial distress (EORTC QLQ-C30, QSC-R10). Furthermore, employment status was evaluated. Regression was performed to identify predictors for HRQol, psychosocial distress, and RTW. RESULTS: Two-hundred and thirty patients were employed pre-surgery (77.8% INB, 22.2% IC). Patients with an IC suffered significantly more often from locally advanced disease (≥ pT3: 43.1% vs 22.9%; p = 0.004). Two years after surgery, 16.1% of patients had died (median days of survival 302 (IQR 204-482). Global HRQoL improved steadily, while high psychosocial distress was present in 46.5% of patients 2 years after surgery. Employment was reported by 68.2% of patients, of which 90.3% worked full-time. Retirement was reported by 18.5%. Multivariate logistic regression analysis identified age ≤ 59 years as the only positive predictor for RTW 2 years after surgery (OR 7.730; 95% CI 3.369-17.736; p < 0.001). Gender, surgical technique, tumor stage, and socioeconomic status did not influence RTW in this model. In multivariate linear regression analysis, RTW was identified as an independent predictor of better global HRQoL (p = 0.018) and lower psychosocial distress (p < 0.001), whereas younger patient age was identified as an independent predictor for higher psychosocial distress (p = 0.002). CONCLUSION: Global HRQoL and RTW are high among patients two years after RC. However, role and emotional, cognitive, and social functioning were significantly impaired, while high psychosocial distress persists in a material number of patients. IMPLICATIONS FOR CANCER SURVIVORS: Our study highlights how a successful RTW decreases psychosocial distress and increases QoL in patients after RC for urothelial cancer. Nonetheless, additional efforts by employers and healthcare providers are needed in aftercare after creation of an INB or IC.
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PURPOSE: This study aims to report on psychosocial distress and QoL in bladder cancer patients after radical cystectomy (RC) and urinary diversion to obtain a better basis for patient counseling and postoperative care. METHODS: The study relied on prospectively collected data for 842 patients, who underwent three weeks of inpatient rehabilitation after RC and creation of an ileal conduit (IC) or ileal neobladder (INB). Data on QoL and psychosocial distress were collected by validated questionnaires. Multivariate logistic regression was performed to identify predictors for high psychosocial distress. RESULTS: Four-hundred and forty-seven patients (326 male, 121 female) received an IC, while 395 patients (357 male, 38 female) received an INB. Health-related QoL improved steadily in the whole cohort during follow-up. Patients with an INB reported better physical function but suffered more from diarrhea and financial worries. Patients with an IC reported reduced satisfaction with their body image, increased worries about the future, and suffered more from constipation. Psychosocial distress increased significantly during follow-up. One year after surgery, 43.1% of patients suffered from high psychosocial distress. Multivariate regression analysis identified age ≤ 59 years (OR 1.731; CI 1.056-2.838; p = 0.030) and lymph node metastases (OR 2.073; CI 1.133-3.793; p = 0.018) as independent predictors for high psychosocial distress. CONCLUSION: QoL improves significantly in all patients one year after RC. However, psychosocial distress remains high in a substantial number of patients. IMPLICATIONS FOR CANCER SURVIVORS: To prevent chronic psychological disorders, easily accessible opportunities for psycho-oncological counseling are needed for patients following RC.
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INTRODUCTION AND OBJECTIVES: Decision-making to perform prostate biopsy should include individual risk assessment. Patients classified as low risk by the Rotterdam Prostate Cancer Risk Calculator are advised to forego biopsy (PBx). There is concern about missing clinically significant prostate cancer (csPCa). A clear pathway for follow-up is needed. MATERIAL AND METHODS: Data for 111 consecutive patients were collected. Patients were encouraged to adhere to a PSA-density-based safety net after PBx was omitted. Cut off values indicating a re-evaluation were PSA density >0.15 ng/mL/ccm in PBx-naïve patients and >0.2 ng/mL/ccm in men with past-PBx. Primary endpoint was whether men had their PSA taken regularly. Secondary endpoint was whether a new multiparametric MRI was performed when PSA-density increased. Tertiary endpoint was whether biopsy was performed when risk stratification revealed an increased risk. RESULTS: Median follow-up was 12 months (IQR 9-15 months). The primary endpoint was reached by 97.2% (n = 106). The secondary endpoint was reached by 30% (n = 3). The tertiary endpoint was reached by 50% (n = 2). Histopathologic analyses revealed csPCa in none of these cases. Risk stratification did not change (p = 0.187) with the majority of patients (89.2%, n = 99). CONCLUSION: The concern of missing csPCa when omitting PBx in the risk-stratified pathway may be negated. Changes in risk stratification during follow-up should lead to subsequent PBx. We suggest implementing a safety net based on PSA density and digital rectal examination (DRE).
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Próstata , Neoplasias da Próstata , Masculino , Humanos , Próstata/patologia , Antígeno Prostático Específico , Estudos Retrospectivos , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Biópsia , Imageamento por Ressonância MagnéticaRESUMO
BACKGROUND: In an era of Bacillus of Calmette-Guérin (BCG) shortages, the comparative efficacy from different adjuvant intravesical BCG strains in non-muscle invasive bladder cancer (NMIBC) has not been clearly elucidated. We aim to compare, through a systematic review and meta-analysis, the cumulative BC recurrence rates and the best efficacy profile of worldwide available BCG strains over the last forty years. METHODS: PubMed, Scopus, Web of Science, Embase, and Cochrane databases were searched from 1982 up to 2022. A meta-analysis of pooled BC recurrence rates was stratified for studies with ≤3-y vs. >3-y recurrence-free survival (RFS) endpoints and the strain of BCG. Sensitivity analysis, sub-group analysis, and meta-regression were implemented to investigate the contribution of moderators to heterogeneity. A random-effect network meta-analysis was performed to compare BCG strains on a multi-treatment level. RESULTS: In total, n = 62 series with n = 15,412 patients in n = 100 study arms and n = 10 different BCG strains were reviewed. BCG Tokyo 172 exhibited the lowest pooled BC recurrence rate among studies with ≤3-y RFS (0.22 (95%CI 0.16-0.28). No clinically relevant difference was noted among strains at >3-y RFS outcomes. Sub-group and meta-regression analyses highlighted the influence of NMIBC risk-group classification and previous intravesical treated categories. Out of the n = 11 studies with n = 7 BCG strains included in the network, BCG RIVM, Tice, and Tokyo 172 presented with the best-predicted probability for efficacy, yet no single strain was significantly superior to another in preventing BC recurrence risk. CONCLUSION: We did not identify a BCG stain providing a clinically significant lower BC recurrence rate. While these findings might discourage investment in future head-to-head randomized comparison, we were, however, able to highlight some potential enhanced benefits from the genetically different BCG RIVM, Tice, and Tokyo 172. This evidence would support the use of such strains for future BCG trials in NMIBCs.
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INTRODUCTION: Evidence of transperineal (TP) superiority over transrectal (TR) biopsy is growing due to lower infectious complication rates. However, TR biopsy is the most common procedure, and it seems that a cross-over to TP is delayed by logistical challenges such as costs, complexity, and lack of experience. We investigate whether well-selected patients without any risk factors may further undergo TR biopsy if all precautions to avoid infections are warranted. MATERIALS AND METHODS: Data were collected in our academic institution between August 2021 and March 2022 and after clinical implementation of the currently updated European Association of Urology guideline recommendations on the performance of prostate biopsy. Patients underwent either TP or TR biopsy according to a riskstratification based on risk factors of infectious complications. Follow-up asked for post-biopsy complications. Inverse Probability of Treatment Weighting (IPTW) propensity score was used to balance baseline characteristics. Complications were subdivided into infectious and non-infectious complications. RESULTS: In total, 294 patients were included with 161 patients undergoing TR vs. 133 patients undergoing TP biopsy. Complication rates were 2.2% for TP vs. 5.5% for TR biopsy concerning all complications. Infectious complication rates only were 0.7% for TP vs. 1.8% for TR biopsy. After IPTW adjustment, differences were statistically significant different (p = 0.01). CONCLUSION: Our study revealed that even in a well-selected patient cohort with presumably lower risk of infectious complications, TR biopsy leads to more post-biopsy complications than TP biopsy. This conclusion should motivate the urological community to switch to TP biopsy.