RESUMEN
BACKGROUND: Early identification and management of metastases in prostate cancer (PC) patients is crucial. This study aimed to describe the nonpharmacological management and characteristics of patients with castration-resistant PC with unknown metastatic status (CRPC-MX) and estimate their prevalence in Spain. METHODS: Cross-sectional, multicenter, real-world study including adult (≥18 years) CRPC-MX patients from 46 Urology services. In a first phase, patients on continuous ADT for ≥6 months were screened and classified as hormone-sensitive PC (HSPC), castration-resistant PC (CRPC), and unknown hormonal status, with metastases (M1), without (M0) and unknown metastatic status (MX) using an ad hoc designed algorithm. In Phase 2, 15 months (m) after Phase 1, all patients on ADT were reviewed and reclassified again using the algorithm. RESULTS: Among 6169 eligible PC patients, 294 (4.8%) were classified as CRPC-MX, which decreased to 179 of 4050 (4.4%) 15 m after study initiation. We included 103 CRPC-MX patients with a median age at diagnosis of 75.4 years (IQR: 67.8, 80.4); 26 (25.2%) lacked a histological diagnosis, and only 25 (24.5%) received treatment with curative intent, despite ECOG being ≤1 at inclusion in 83.5%. In the 15 m before inclusion, most CRPC-MX patients had <5 prostate-specific antigen (PSA) determinations (80.6%) and no imaging (63.1%). After CRPC-MX identification (15 m after inclusion), metastatic status was assessed in 55.4%, with an increased number of patients with ≥5 PSA determinations (Pâ¯=â¯0.0357), visits per patient (P < 0.0001), patients with some imaging test (P < 0.0001), imaging tests/patient (P < 0.0001), and visits to onco-urology specialized consultation units (52.0% before and 79.2% after). CONCLUSION: A substantial proportion of PC patients on ADT in the real-world setting are not appropriately followed up. Identification of CRPC-MX patients raised awareness among physicians and improved their adherence to guidelines, resulting in improved care for these patients.
RESUMEN
BACKGROUND: Optimising therapeutic strategies of intermediate-risk non-muscle-invasive bladder cancer (IR-NMIBC) is needed. OBJECTIVE: To compare recurrence-free survival (RFS) with adjuvant intravesical mitomycin C (MMC) at normothermia or hyperthermia using the COMBAT bladder recirculation system at 43⯰C for 30 and 60 min. DESIGN, SETTING, AND PARTICIPANTS: A prospective open-label, phase 3 randomised controlled trial (HIVEC-1) accrued across 13 centres between 2014 and 2020 in Spain. After complete transurethral resection of the bladder and immediate postoperative MMC instillation, patients with IR-NMIBC were randomised (1:1:1) to four weekly followed by three monthly 40-mg MMC instillations at normothermia (control; nâ¯=â¯106), 43⯰C for 30 min (nâ¯=â¯107), or 43⯰C for 60 min (nâ¯=â¯106) were investigated. Therapeutic compliance was defined as four or more instillations. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was RFS at 24 mo in the intention-to-treat (ITT) and per-protocol (PP) populations. The secondary outcomes included progression-free survival at 24 mo, safety outcome measures, and changes in health-related quality of life. Log-rank, Fisher, χ2, and analysis of variance tests were used. RESULTS AND LIMITATIONS: The ITT 24-mo RFS was 77% for control, 82% for 43⯰C-30 min, and 80% for 43⯰C-60 min (pâ¯=â¯0.6). The PP 24-mo RFS was 77% for control, 83% for 43⯰C-30 min, and 80% for 43⯰C-60 min (pâ¯=â¯0.59). Six patients progressed to muscle-invasive disease in the ITT population (four in the control, 43⯰C-30 min, and 43⯰C-60 min groups each) and four in the PP population (all controls). Serious adverse events occurred in 26 patients (8.1%), and we were unable to demonstrate a difference between groups (pâ¯=â¯0.5). Adverse events, mainly dysuria and spasms, occurred in 124 patients (33% in control, 35% in 43⯰C-30 min, and 48% in 43⯰C-60 min; pâ¯=â¯0.05). The total International Prostate Symptom Score worsened by 1.2⯱â¯7.3 points, similarly across groups (pâ¯=â¯0.29). The Functional Assessment of Cancer Therapy-Bladder domains and indexes showed no significant change. CONCLUSIONS: Four-month adjuvant hyperthermic MMC using the COMBAT system for 30 and 60 min in IR-NMIBC is well tolerated, but we did not find it to be superior to normothermic MMC at 24 mo. PATIENT SUMMARY: We were unable to demonstrate the effectiveness of hyperthermia using the COMBAT system in intermediate-risk non-muscle-invasive bladder cancer. Further evaluation of long-term recurrence and progression, and maintenance regimens appears mandatory.
Asunto(s)
Neoplasias Vesicales sin Invasión Muscular , Neoplasias de la Vejiga Urinaria , Masculino , Humanos , Mitomicina/uso terapéutico , Calidad de Vida , Estudios Prospectivos , Administración Intravesical , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/cirugía , Adyuvantes Inmunológicos/uso terapéuticoRESUMEN
AIM: To evaluate effectiveness and safety of the adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI). MATERIAL AND METHODS: A retrospective multicenter study was conducted in nine Iberian institutions using a board-approved database for 215 patients intervened between 2012 and 2017, with no case excluded. Continence status, patient satisfaction, number, and grade of complications (Clavien-Dindo) and factors affecting dry rate at adjustment were evaluated. Multivariate analysis defined the population at best success rate. Incontinence recurrence due to device failure and/or explant was evaluated and Kaplan-Meier curve for durability performed. RESULTS: Adjustment was achieved at a mean 1.4 ± 1.9 fillings. Dry-rate after adjustment was 80.5% (96.2% mild and 75.3% moderate-severe), 121 (56.3%) used no pads, and 52 (24.2%) a security pad with urine loss under 10 mL. Mean basal daily pad-test and pad-count decreased from 484 ± 372.3 mL and 3.9 ± 2 pads to 63.5 ± 201.2 mL and 0.9 ± 1.5pads (both P < 0.0001). Satisfaction rate was 85.1% (94.3% mild and 82.1% moderate-severe). Factors associated to dryness were: lesser severity of SUI (P < .0001), absence of radiotherapy (P = 0.0002) and device generation (P = 0.05). Multivariate analysis revealed absence of radiation (OR = 3.12; 1.36-7.19), mild (OR = 19.61; 3.95-100), and moderate (OR = 2.48; 1.1-5.59) SUI were independent predictors. Complications presented in 33(15.35%); 66.7% grade 1, 9.1% grade 2, and 24.2% grade 3. At 24.3 ± 15 mo mean follow-up device was explanted in seven (3.25%) and SUI worsened after adjustment in nine (4.2%). Dry-rate at follow-up was 73% and durability of device in dry patients at adjustment was 89.8% (82.9-94) at 2-years. CONCLUSIONS: This study confirms ATOMS device is safe and achieves high treatment efficacy and patient satisfaction in a multicenter setting. Significantly better results are achieved in less severe and non-irradiated cases. Durability of the device is reassuring in the short-term.
Asunto(s)
Satisfacción del Paciente , Prostatectomía/efectos adversos , Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Recurrencia , Estudios Retrospectivos , España , Resultado del Tratamiento , Incontinencia Urinaria de Esfuerzo/etiologíaRESUMEN
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.
Asunto(s)
Antagonistas de Andrógenos/efectos adversos , Hormona Liberadora de Gonadotropina/agonistas , Síndrome Metabólico/inducido químicamente , Neoplasias de la Próstata/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Humanos , Masculino , Síndrome Metabólico/epidemiología , Persona de Mediana Edad , Prevalencia , Estudios ProspectivosRESUMEN
Altered microRNA (miRNA) expression may occur early in bladder cancer and may play a role in carcinogenesis and tumor behavior. We evaluated whether alterations in miRNA expression could improve disease stratification and outcome prognosis in bladder tumors and noninvasive diagnosis in urinary samples. miR-143, miR-222, and miR-452 expression levels were analyzed by quantitative RT-PCR (RT-qPCR) in paired urinary and matching tumors and in two independent prospective series of tumors and urinary specimens. Differential expression of miR-143, miR-222, and miR-452 in urine were verified by in situ hybridization in matching tumors. Tumor miRNA expression by RT-qPCR correlated with tumor grade, size, and presence of carcinoma in situ for miR-222, recurrence (miR-222 and miR-143), progression (miR-222 and miR-143), disease-specific survival (miR-222), and overall survival (miR-222). Protein expression patterns of potential miRNA targets, including vascular endothelial growth factor, BCL2, v-erb-b2 erythroblastic leukemia viral oncogene (ERBB) homolog 3, and ERBB4, were evaluated by IHC in tissue arrays containing tumors for which miRNAs were assessed by RT-qPCR. Target expression correlated with expression of their predicted regulatory miRNAs, recurrence (ERBB3), progression (ERBB4), disease-specific survival (ERBB3 and ERBB4), and overall survival (ERBB3 and ERBB4). Furthermore, RT-qPCR of miR-452 (area under the curve, 0.848) and miR-222 (area under the curve, 0.718) in urine provided high accuracies for bladder cancer diagnosis. Thus, bladder tumors were characterized by changes in miRNA expression that could aid in tumor stratification and clinical outcome prognosis, and miRNAs were detected in urinary specimens for noninvasive diagnosis.