RESUMEN
BACKGROUND: High-intensity focused ultrasound (HIFU) emerged as a novel approach for the treatment of localized prostate cancer (PCa). However, prospective studies on HIFU-related outcomes and predictors of treatment failure (TF) remain scarce. MATERIALS AND METHODS: We conducted a multinational prospective cohort study among patients undergoing HIFU therapy for localized, low- to intermediate-risk PCa. Follow-up data on serial prostate specific antigen (PSA), multi-parametric magnetic resonance imaging (mpMRI), targeted/systematic biopsies, adverse events and functional outcomes were collected. The primary endpoint was TF, defined as histologically confirmed PCa requiring whole-gland salvage treatment. Uni- and multi-variable adjusted hazard ratios (HRs) were calculated using Cox proportional hazard regression models. RESULTS: At baseline, mean (standard deviation) age was 64.14 (7.19) years, with the majority of patients showing T-stage 1 (73.9%) and International Society of Urological Pathology grading system Grade 2 (58.8%). PSA nadir (median, 1.70 ng/mL) was reached after 6 months. Of all patients recruited, 16% had clinically significant PCa, as confirmed by biopsy, of which 13.4% had TF. Notably, T-stage and number of positive cores at initial biopsy were independent predictors of TF during follow-up (HR [95% CI] 1.27 [1.02-1.59] and 5.02 [1.80-14.03], respectively). Adverse events were minimal (17% and 8% early and late adverse events, respectively), with stable or improved functional outcomes in the majority of patients. CONCLUSIONS: This interim analysis of a multinational study on HIFU therapy for the management of low-to-intermediate-risk PCa reveals good functional outcomes, minimal adverse events and low incidence of TF over the short-term. Data on long-term outcomes, specifically as it relates to oncological outcomes, are awaited eagerly.
Asunto(s)
Antígeno Prostático Específico , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/terapia , Neoplasias de la Próstata/patología , Persona de Mediana Edad , Anciano , Antígeno Prostático Específico/metabolismo , Antígeno Prostático Específico/sangre , Estudios Prospectivos , Ultrasonido Enfocado Transrectal de Alta Intensidad , Insuficiencia del Tratamiento , Modelos de Riesgos Proporcionales , Terapia Recuperativa/métodos , Ultrasonido Enfocado de Alta Intensidad de Ablación/métodos , Imágenes de Resonancia Magnética Multiparamétrica , Clasificación del Tumor , Estudios de CohortesRESUMEN
AIM: This study aimed to evaluate the postoperative incidence of recurrent varicose veins (vv) and the possibility to differentiate the different types of recurrence. MATERIAL OF STUDY: Patients who underwent surgery for saphenofemoral junction (SFJ) incompetence, great saphenous vein (GSV) varicosity and at least one perforator incompetence and varicosity of tributaries between January 1998 and December 2003 were selected for the study. Surgery consisted in SFJ flush ligation, GSV stripping, perforator vein ligature, and phlebectomies. Patients were assessed by detailed interview, clinical examination, and color duplex imaging after 10 years. The differentiation in recurrent, residual and progressive vv was done by comparison of the pre-and intraoperative and the phlebographic documentation in particular with the findings on follow-up.. RESULTS: 353 patients (400 legs) were analyzed at 120 ± 21 months. At follow up the vv were classified as recurrent in 23,75%, residual in 23,25%, and progressive in 21% of cases. Nine patients (1.9%) were reoperated after 70 ± 33 months, and 17 (3.5%) underwent sclerotherapy during follow-up. CONCLUSIONS: Recurrent, residual, and progressive vv can be clearly differentiated with the presented methodology. The authors suggest a revised definition (NEVVAS- new vv after surgery) because the term recurrent and the known acronyms do not embrace exactly the three types of vv after surgery. Since residual and many recurrent vv are due to avoidable technical or tactical errors, it is important to classify them properly in order to avoid these complications. KEY WORDS: Neovarices, NEVVAS (New Varicose Veins After Surgery), Neovascularization, Recurrent varicose veins, Residual varicose veins, Progressive varicose veins.