Nomogram based on baseline clinicopathological characteristics for predicting bladder cancer-specific survival to neoadjuvant chemotherapy in muscle-invasive bladder cancer.

PURPOSE: To develop a risk score based on a prognostic model and a nomogram integrating baseline clinicopathological variables to predict bladder cancer-specific survival (BCSS) to neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC) patients. METHODS: We retrospectively identified a consecutive sample of 247 MIBC patients treated with cisplatin-based NAC-plus-cystectomy in two Spanish hospitals between 2000 and 2019. Age at MIBC diagnosis, sex, histology, lymphovascular invasion, previous non-MIBC, hydronephrosis, and clinical TNM were included in the initial Cox regression model. A risk score was computed based on the final prognostic model and a nomogram was used to estimate BCSS at 2 and 5 years. RESULTS: Median age was 66 years; 89% were males; 83% had pure urothelial carcinoma; 16.2% had previous non-MIBC. Clinical stage was T2N0, T3-4aN0, and Tx-4N + in 24%, 57%, and 19% of patients, respectively. Complete pathological response was seen in 29.4% and downstaging to non-MIBC (ypT1, ypTa, ypTis) in 12.5% of patients. Overall 5-year BCSS was 59%. Four prognostic factors were identified: variant histology, previous non-MIBC, female sex and hydronephrosis. By adding the points attributed to each of these factors, we categorized patients in three groups: low-risk (0 points); intermediate-risk (1-9 points); high-risk (≥ 10 points). Five-year BCSS was 72%, 53%, and 15%, respectively (p < 0.0001). CONCLUSION: We developed a nomogram and risk score based on four baseline clinicopathological characteristics to predict BCSS to NAC-plus-cystectomy in MIBC patients. If validated in prospective studies, this nomogram can be useful for selecting patients likely to benefit from NAC.

Role of Inflammation in the Perioperative Management of Urothelial Bladder Cancer With Squamous-Cell Features: Impact of Neutrophil-to-Lymphocyte Ratio on Outcomes and Response to Neoadjuvant Chemotherapy.

BACKGROUND: Neutrophil-to-lymphocyte ratio (NLR) might reflect an increased neutrophilic inflammatory response, and urothelial tumors with squamous-cell features (SqD) have been linked to inflammation. We hypothesized that NLR could be prognostic in these patients. PATIENTS AND METHODS: In patients with SqD muscle-invasive bladder cancer treated with curative intent, NLR and relationships with outcomes were analyzed by Cox regression, log-rank, and Kaplan-Meier analysis. RESULTS: Fifty patients presented SqD (median follow-up, 29 months). The ideal NLR cutoff (by receiver operating characteristic curves) was 5. Thirty-seven patients had NLR < 5 and 13 had NLR ≥ 5. The 5-year progression-free survival, cancer-specific survival (CSS), and overall survival were 46.8%, 48.4%, and 45% for NLR < 5 cases, and 10.3%, 10.3%, and 11.7% for NLR ≥ 5 cases (all P < .05). On multivariate analysis, NLR was prognostic (hazard ratio = 4.26, 6.21, and 4.08 for progression-free survival, CSS, and overall survival). Neoadjuvant chemotherapy (NAC) was of significant benefit in NLR < 5 patients, with a CSS of 91.2 months (n = 3) versus 38.1 months (n = 24) for those treated with up-front radical cystectomy (P = .009); Kaplan-Meier curves were also significantly different. These differences did not reach statistical significance for patients with NLR ≥ 5. For the 19 patients treated with NAC, NLR was also predictive of response to NAC. CONCLUSION: Inflammation, measured by NLR, is potentially prognostic in the perioperative management of SqD. NLR identifies 2 risk groups. Patients displaying low NLR had a 4-fold survival improvement and were highly responsive to NAC. NLR might be a good prognostic tool. Its role as a predictor of response to NAC deserves future study, along with its role as a selection criterion for therapies other than chemotherapy.

Low Pretreatment Neutrophil-to-Lymphocyte Ratio Predicts for Good Outcomes in Patients Receiving Neoadjuvant Chemotherapy Before Radical Cystectomy for Muscle Invasive Bladder Cancer.

PURPOSE: The pretreatment neutrophil-to-lymphocyte ratio (NLR) has been associated with cancer prognosis, influencing progression and chemosensitivity. We aimed to define the role of the NLR in predicting the outcomes to neoadjuvant chemotherapy (NAC) in patients with muscle invasive bladder cancer (MIBC). PATIENTS AND METHODS: The data from patients treated with NAC and radical cystectomy for MIBC from 2007 to 2015 at a tertiary care center were reviewed. The clinicopathologic pretreatment, including the NLR, and post-treatment predictors were documented. The NLR was evaluated as a continuous variable on uni- and multivariate analysis and dichotomized in Kaplan-Meier curves. The relationships with outcomes (progression-free survival [PFS], cancer-specific survival [CSS], and overall survival [OS]) were analyzed using Cox regression analysis and log-rank tests. The pathologic response (PR) included any downstaging from the baseline clinical stage to the final pathologic stage. RESULTS: Of 205 patients with MIBC, 75 underwent NAC (median follow-up, 31 months) with a 5-year PFS, CSS, and OS rate of 56%, 60%, and 52%, respectively, and a PR of 38.6%. On multivariate analysis, the PR, PFS, CSS, and OS were predicted by the NLR (hazard ratio > 0.8, 1.25, 1.27, and 1.12, respectively; P < .05 for all). The NLR with age and clinical stage predicted the PR. A NLR threshold of 2.26 better predicted CSS (P < .05) and OS (P = .055). The limitations included the retrospective design and modest number of cases. CONCLUSION: We have provided initial evidence that a low NLR helps understand the value of the underlying immune system in predicting a good outcome to NAC. The NLR is a simple and accessible biomarker that is easy to implement in clinical practice. In addition to established prognosticators and newer genomic predictors, the NLR could improve therapeutic algorithms and help in decision-making regarding the need for NAC, which is currently underused, in MIBC patients.

Versión española de la Satisfaction With Decision scale: adaptación transcultural, validez y fiabilidad / Spanish version of the Satisfaction With Decision scale: cross-cultural adaptation, validity and reliability

OBJETIVO: Desarrollar la versión española de la SWDs (Escala de Satisfacción con la Decisión, ESD) y analizar sus propiedades psicométricas de validez y fiabilidad en nuestro contexto. DISEÑO: Estudio observacional, descriptivo, de validación de un instrumento de medida de satisfacción con la decisión tomada. Emplazamiento: Consultas del Servicio de Urología, Oncología radioterápica y Oncología médica del Hospital Universitari Germans Trias I Pujol, del Institut Català d'Oncologia y en la sede del Institut Oncològic del Vallès del Hospital General de Catalunya. PARTICIPANTES: Se obtuvo un total de 170 participantes diagnosticados de cáncer de próstata, que sabían leer y escribir en castellano y dieron su consentimiento informado. MEDICIONES PRINCIPALES: Se ha realizado una traducción, retrotraducción y adaptación transcultural de la SWDs. Se analizó la validez de contenido, validez de criterio, validez de constructo, la fiabilidad y la estabilidad temporal. RESULTADOS: La ESD consta de 6 ítems con respuesta Likert-5 opciones. Se obtuvo una versión española lingüística y conceptualmente equivalente a la escala original. La validez de criterio, con la correlación entre la ESD con el grado de satisfacción con la decisión tomada marcada en una escala analógica lineal, resultó significativa (r = 0,63; p < 0,01). El análisis factorial extrajo una única dimensión para explicar el 82,08% de la varianza. La ESD mostró excelentes resultados de fiabilidad: consistencia interna (alfa de Cronbach = 0,95) y estabilidad temporal test-retest (CCI = 0,711). CONCLUSIONES: La ESD es un instrumento válido y fiable para evaluar la satisfacción de la decisión tomada en salud en nuestro contexto

OBJECTIVE: The aim of this study is to develop a Spanish version of the Satisfaction With Decision scale (SWDs) and analyse the psychometric properties of validity and reliability. DESIGN: An observational, descriptive study and validation of a tool to measure satisfaction with the decision. SETTING: Urology, Radiation oncology, and Medical oncology Departments of the Hospital Universitari Germans Trias I Pujol, Institut Català d'Oncologia and the Institut Oncològic del Vallès - Hospital General de Catalunya. PARTICIPANTS: A total of 170 participants diagnosed with prostate cancer, and who could read and write in Spanish and gave their informed consent. MAIN MEASUREMENTS: A translation, back-translation and cross-cultural adaptation to Spanish was performed on the SWDs. The content validity, criterion validity, construct validity and reliability (internal consistency and stability) of the Spanish version were evaluated. RESULTS: The SWDs contains 6 items with 5-item Likert scales. A Spanish version (ESD) was obtained that was linguistically and conceptually equivalent to the original version. Criterion validity, the ESD correlated with "satisfaction with the decision" using a linear analogue scale, was significant (r = 0.63, P<.01) for all items. The factorial analysis showed a unique dimension to explain 82.08% of the variance. The ESD showed excellent results in terms of internal consistency (Cronbach alpha = 0.95) and good test-retest reliability with intraclass correlation coefficient of 0.711. CONCLUSIONS: The ESD is a validated Spanish scale to measure the satisfaction with the decisions taken in health, and demonstrates a correct validity and reliability

[Spanish version of the Satisfaction With Decision scale: cross-cultural adaptation, validity and reliability]. / Versión española de la Satisfaction With Decision scale: adaptación transcultural, validez y fiabilidad.

OBJECTIVE: The aim of this study is to develop a Spanish version of the Satisfaction With Decision scale (SWDs) and analyse the psychometric properties of validity and reliability. DESIGN: An observational, descriptive study and validation of a tool to measure satisfaction with the decision. SETTING: Urology, Radiation oncology, and Medical oncology Departments of the Hospital Universitari Germans Trias i Pujol, Institut Català d'Oncologia and the Institut Oncològic del Vallès - Hospital General de Catalunya. PARTICIPANTS: A total of 170 participants diagnosed with prostate cancer, and who could read and write in Spanish and gave their informed consent. MAIN MEASUREMENTS: A translation, back-translation and cross-cultural adaptation to Spanish was performed on the SWDs. The content validity, criterion validity, construct validity and reliability (internal consistency and stability) of the Spanish version were evaluated. RESULTS: The SWDs contains 6 items with 5-item Likert scales. A Spanish version (ESD) was obtained that was linguistically and conceptually equivalent to the original version. Criterion validity, the ESD correlated with "satisfaction with the decision" using a linear analogue scale, was significant (r=0.63, P<.01) for all items. The factorial analysis showed a unique dimension to explain 82.08% of the variance. The ESD showed excellent results in terms of internal consistency (Cronbach alpha=0.95) and good test-retest reliability with intraclass correlation coefficient of 0.711. CONCLUSIONS: The ESD is a validated Spanish scale to measure the satisfaction with the decisions taken in health, and demonstrates a correct validity and reliability.

A Decision Aid to Support Informed Choices for Patients Recently Diagnosed With Prostate Cancer: A Randomized Controlled Trial.

BACKGROUND: Decision aids provide balanced information about the benefits and risks of treatment options and improve the match between patient preferences and the treatment received. OBJECTIVE: To assess the impact of a decision aid regarding the treatment options for patients with localized prostate cancer. METHODS: A 2-arm randomized controlled trial was used to compare booklet patient decision aid (intervention group n = 61) with standard information for localized prostate cancer (control group n = 61). The study was conducted at 3 hospitals between 2011 and 2013. The main outcome measures were knowledge, decisional conflict, satisfaction with the decision-making process, and coping. RESULTS: The respective mean Decisional Conflict Scale scores before and after the intervention were 53.0 ± 16.9 and 31.2 ± 10.2 in the intervention group and 49.1 ± 13.7 and 51.7 ± 13.3 in the control group (P < .001). Mean Knowledge scores were 38.6 ± 16.5 and 75.7 ± 19.0 in the intervention group and 42.0 ± 17.6 and 49.9 ± 16.0 in the control group (P < .001). Mean Satisfaction With Decision Scale scores were 81.1 ± 8.92 and 95.7 ± 6.89 in the intervention group and 82.5 ± 12.0 and 79.3 ± 10.3 in the control group (P < .001). CONCLUSIONS: Decision aid not only improved patient knowledge about localized prostate cancer and its treatment and their satisfaction with decision making but also decreased their decisional conflict. IMPLICATIONS FOR PRACTICE: Decision aid represents a rather innovative approach for a health insurance fund to develop and offer this format of information and decision support. This opens a new field of study for nurses to empower patients in the decision-making process and develop new roles in this area.

Developing a decision aid to support informed choices for newly diagnosed patients with localized prostate cancer.

BACKGROUND: Decision aids (DAs) have been developed in several health disciplines to support decision making informed by evidence, such as the benefits and risks of different treatment options. Decision aids can improve the decision-making process by reducing decisional conflict and helping patients to participate in decision making. OBJECTIVE: The aim of this study was to design and develop a DA for treatment decision making in localized prostate cancer in Spain with regard to surgery, radiotherapy, or watchful waiting. INTERVENTIONS/METHODS: We developed a DA based on the principles of the International Patient Decision Aid Standards Collaboration and according to the Ottawa Decision Support Framework. The structural development process involved DA developers, expert feedback, use of the Delphi method, and patient feedback. We conducted a pilot test on 34 men with localized prostate cancer. RESULTS: The DA is a structured booklet. According to the International Patient Decision Aid Standards checklist, the DA scored 22 of 27 points (81.48%). The development process section scored 22 of 24 points (91.6%), and the effectiveness of the decision-making process section scored 6 of 6 (100%). The clinical pilot test yielded positive feedback regarding the design, images, understandability, usability, explanations, and amount of information in the DA. CONCLUSIONS: We developed a Spanish DA with a strong quality score to help patients make an informed choice regarding their prostate cancer treatment. Future research will assess the impact of the DA and its association with improved decision making. IMPLICATIONS FOR PRACTICE: This tool provides information about the risks and benefits of different treatment options and helps patients to understand the importance of their own values for informing treatment choices.

Susceptibility of human lymphoid tissue cultured ex vivo to xenotropic murine leukemia virus-related virus (XMRV) infection.

BACKGROUND: Xenotropic murine leukemia virus-related virus (XMRV) was generated after a recombination event between two endogenous murine leukemia viruses during the production of a prostate cancer cell line. Although the associations of the XMRV infection with human diseases appear unlikely, the XMRV is a retrovirus of undefined pathogenic potential, able to replicate in human cells in vitro. Since recent studies using animal models for infection have yielded conflicting results, we set out an ex vivo model for XMRV infection of human tonsillar tissue to determine whether XMRV produced by 22Rv1 cells is able to replicate in human lymphoid organs. Tonsil blocks were infected and infection kinetics and its pathogenic effects were monitored RESULTS: XMRV, though restricted by APOBEC, enters and integrates into the tissue cells. The infection did not result in changes of T or B-cells, immune activation, nor inflammatory chemokines. Infectious viruses could be recovered from supernatants of infected tonsils by reinfecting DERSE XMRV indicator cell line, although these supernatants could not establish a new infection in fresh tonsil culture, indicating that in our model, the viral replication is controlled by innate antiviral restriction factors. CONCLUSIONS: Overall, the replication-competent retrovirus XMRV, present in a high number of laboratories, is able to infect human lymphoid tissue and produce infectious viruses, even though they were unable to establish a new infection in fresh tonsillar tissue. Hereby, laboratories working with cell lines producing XMRV should have knowledge and understanding of the potential biological biohazardous risks of this virus.

Peripheral zone prostate cancer in patients with elevated PSA levels and low free-to-total PSA ratio: detection with MR imaging and MR spectroscopy.

PURPOSE: To retrospectively assess the value of endorectal magnetic resonance (MR) imaging and MR spectroscopy combined with the free-to-total prostate-specific antigen (PSA) ratio for detecting prostate cancer in men with elevated PSA levels. MATERIALS AND METHODS: The institutional review board approved the study, and all patients provided informed written consent. Endorectal MR imaging and MR spectroscopy were performed in 54 patients with PSA levels greater than 3 ng/mL but less than 15 ng/mL and free-to-total PSA ratio of less than 20%, followed by sextant biopsy in the peripheral zone. For each patient, MR imaging and MR spectroscopic findings, PSA level, and free-to-total PSA ratio were analyzed and compared with biopsy results and/or histopathologic tumor maps with regard to a sextant-modified distribution. The likelihood of cancer in each sextant according to MR and MR spectroscopic findings was graded independently on a scale of 1 (benign) to 5 (malignant). Detection accuracy and a multivariate logistic regression analysis were used to determine the most accurate combination of imaging, and clinical tests were used to detect prostate cancer according to the area under the receiver operating characteristic curve (AUC). RESULTS: The model incorporating MR imaging, MR spectroscopy, and free-to-total PSA ratio (AUC = 97.5%) was significantly more accurate in predicting prostate cancer than models using MR imaging alone (AUC = 85.1%; P = .007), MR spectroscopy alone (AUC = 87.2%; P = .041), or MR imaging and free-to-total PSA ratio combined (AUC = 90.8%; P = .038). CONCLUSION: MR and MR spectroscopy combined with free-to-total PSA ratio improves the predictive value for prostate cancer detection.