ABSTRACT
Background: Metastatic hormone-sensitive prostate cancer (mHSPC) treatment has changed drastically during the last years with the emergence of androgen receptor-targeted agents (ARTAs). ARTA combined with androgen deprivation therapy has demonstrated better oncological and survival outcomes in these patients. However, the optimal choice among different ARTAs remains uncertain due to their analogous efficacy. Objectives: The objective of this study was to describe prostate-specific antigen (PSA) response and oncological outcomes of patients with mHSPC treated with apalutamide. Material and methods: Medical records from three different hospitals in Spain were used to conduct this study. Patients diagnosed with mHSPC and under apalutamide treatment were included between March 2021 and January 2023. Data regarding PSA response, overall survival (OS), and radiographic progression-free survival (rPFS) were collected and stratified by metastasis volume, timing, and stating. Results: 193 patients were included; 34.2% of patients were de novo mHSPC, and the majority was classified as m1b. The 18-month OS and rPFS were 92.5% and 88.9%, respectively. Patients with PSA levels ≤0.2 ng/ml showcased an 18-month OS rate of 98.7%, contrasting with 65.3% for those with PSA >0.2 ng/ml. Similar trends emerged for rPFS (97.4% and 53.7%, respectively). When differentiating between low-volume and high-volume metastasis, the OS rate stood at 98.4% and 80.7%, respectively, while the rPFS rates were 93% and 81.6%, respectively. No significant differences were found between groups stratified by metastasis timing. Conclusion: This real-world study on patients with mHSPC treated with apalutamide plus androgen deprivation therapy revealed robust oncological outcomes, aligning with the emerging evidence. The study's hallmark finding highlights the significance of rapid and deep PSA response as a predictor of improved oncological and survival outcomes.
ABSTRACT
OBJECTIVE: Describe the medium-term safety of the tension free vaginal tape obturator (TVT-O) procedure in terms of complications, cure and changes in quality of life (QoL) after the surgery. MATERIALS AND METHODS: Descriptive historical cohort that included women over 18 years of age who underwent TVT-O due to objectively proven stress urinary incontinence, urethral hypermobility or mixed urinary incontinence in which the stress component predominated, confirmed on urodynamic testing between July 2013-April 2017, in a reference hospital located in the city of Murcia Spain. Women with previous anti-incontinence surgery, concomitant vaginal surgery and planning pregnancy were excluded. Follow-up was determined for each patient based on the time elapsed between surgery and the time when the research protocol was applied. Complications were stratified according to the modified Clavien-Dindo classification; also we evaluated subjective cure rate, quality of life using the ICIQ-SF score, before and after surgery. RESULTS: The mean age was 52.6 (SD± 10.5) years and 80.1% of patients were at least overweight. The incidence of complications at 12 months was: 8.3% (12/144). We did not detect complications after this period in the followed patients at 24, 36 and 48 months. The subjective cure determined at 12, 24, 36 and 48 months was 62.5% (90/144), 59.09% (55/88), 50.81% (31/61) and 50% (7/14), respectively. There was a significant improvement in quality of life, as determined by the ICQ-SF mean score before and after surgery (13.76[6,34] vs 3.84[5.76]; p<0.05). CONCLUSIONS: The TVT-O surgery is a safe therapy associated with a low complication incidence at 12 months, an acceptable subjective cure rate in stress urinary incontinence, and quality-of-life improvement. Classifications of complications related to the insertion of the prosthesis and of those inherent to surgery, such as urinary tract infection, are required.
Objetivo: describir la seguridad a mediano plazo del procedimiento con el cabestrillo suburetral transobturador dentro-fuera (en inglés: tension free vaginal tape obturator TVT-O) en términos de: complicaciones, cura y cambios en la calidad de vida después de la cirugía. Materiales y métodos: cohorte histórica descriptiva que incluye mujeres mayores de 18 años intervenidas de TVT-O por incontinencia urinaria de esfuerzo (IUE) objetivamente comprobada, hipermovilidad uretral o incontinencia urinaria mixta en la que predominó el componente de esfuerzo, confirmada en prueba urodinámica entre julio del 2013 y abril del 2017 en un hospital de referencia ubicado en la ciudad de Murcia, España. Se excluyeron mujeres con cirugía previa de incontinencia, cirugía vaginal concomitante y planificación del embarazo. El seguimiento se determinó para cada paciente por el tiempo transcurrido desde la cirugía hasta el momento en que se aplicó el protocolo de investigación. Las complicaciones se estratificaron según la clasificación de Dindo-Clavien modificada, además, se evaluaron la tasa de curación subjetiva y la calidad de vida mediante el International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) antes y después de la cirugía. Resultados: la edad media de las pacientes fue de 52,59 (DE±10,46) años, el 80,1 % tenía al menos sobrepeso. La incidencia de complicaciones en los primeros 12 meses fue del 8,3%. No detectamos complicaciones después de este periodo en las pacientes seguidas a 24, 36 y 48 meses. La curación subjetiva determinada a los 12, 24, 36 y 48 meses fue del 62,5% (90/144), 59,09% (55/88), 50,81% (31/61) y 50% (7/14), respectivamente. Hubo una mejoría significativa en la calidad de vida, en términos de puntuación media ICQ-SF antes y después de la cirugía (13,76 [6,34] vs 3,84 [5,76]; p < 0,05). Conclusiones: el TVT-O es una terapia segura, con baja tasa de complicaciones a los 12 meses, aceptable tasa de curación subjetiva de la IUE y una mejora en la calidad de vida. Se necesitan clasificaciones de complicaciones relacionadas con la inserción de la prótesis y que incluyan complicaciones inherentes a la cirugía, como la infección del tracto urinario.
Subject(s)
Suburethral Slings , Urinary Incontinence, Stress , Adolescent , Adult , Female , Humans , Middle Aged , Prospective Studies , Quality of Life , Spain/epidemiology , Suburethral Slings/adverse effects , Treatment Outcome , Urinary Incontinence, Stress/surgeryABSTRACT
ABSTRACT Objective: Describe the medium-term safety of the tension free vaginal tape obturator (TVT-O) procedure in terms of complications, cure and changes in quality of life (QoL) after the surgery. Materials and methods: Descriptive historical cohort that included women over 18 years of age who underwent TVT-O due to objectively proven stress urinary incontinence, urethral hypermobility or mixed urinary incontinence in which the stress component predominated, confirmed on urodynamic testing between July 2013-April 2017, in a reference hospital located in the city of Murcia Spain. Women with previous anti-incontinence surgery, concomitant vaginal surgery and planning pregnancy were excluded. Follow-up was determined for each patient based on the time elapsed between surgery and the time when the research protocol was applied. Complications were stratified according to the modified Clavien-Dindo classification; also we evaluated subjective cure rate, quality of life using the ICIQ-SF score, before and after surgery. Results: The mean age was 52.6 (SD± 10.5) years and 80.1% of patients were at least overweight. The incidence of complications at 12 months was: 8.3% (12/144). We did not detect complications after this period in the followed patients at 24, 36 and 48 months. The subjective cure determined at 12, 24, 36 and 48 months was 62.5% (90/144), 59.09% (55/88), 50.81% (31/61) and 50% (7/14), respectively. There was a significant improvement in quality of life, as determined by the ICQ-SF mean score before and after surgery (13.76[6,34] vs 3.84[5.76]; p<0.05). Conclusions: The TVT-O surgery is a safe therapy associated with a low complication incidence at 12 months, an acceptable subjective cure rate in stress urinary incontinence, and quality-of-life improvement. Classifications of complications related to the insertion of the prosthesis and of those inherent to surgery, such as urinary tract infection, are required.
RESUMEN Objetivo: describir la seguridad a mediano plazo del procedimiento con el cabestrillo suburetral transobturador dentro-fuera (en inglés: tension free vaginal tape obturator TVT-O) en términos de: complicaciones, cura y cambios en la calidad de vida después de la cirugía. Materiales y métodos: cohorte histórica descriptiva que incluye mujeres mayores de 18 años intervenidas de TVT-O por incontinencia urinaria de esfuerzo (IUE) objetivamente comprobada, hipermovilidad uretral o incontinencia urinaria mixta en la que predominó el componente de esfuerzo, confirmada en prueba urodinámica entre julio del 2013 y abril del 2017 en un hospital de referencia ubicado en la ciudad de Murcia, España. Se excluyeron mujeres con cirugía previa de incontinencia, cirugía vaginal concomitante y planificación del embarazo. El seguimiento se determinó para cada paciente por el tiempo transcurrido desde la cirugía hasta el momento en que se aplicó el protocolo de investigación. Las complicaciones se estratificaron según la clasificación de Dindo-Clavien modificada, además, se evaluaron la tasa de curación subjetiva y la calidad de vida mediante el International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) antes y después de la cirugía. Resultados: la edad media de las pacientes fue de 52,59 (DE±10,46) años, el 80,1 % tenía al menos sobrepeso. La incidencia de complicaciones en los primeros 12 meses fue del 8,3%. No detectamos complicaciones después de este periodo en las pacientes seguidas a 24, 36 y 48 meses. La curación subjetiva determinada a los 12, 24, 36 y 48 meses fue del 62,5% (90/144), 59,09% (55/88), 50,81% (31/61) y 50% (7/14), respectivamente. Hubo una mejoría significativa en la calidad de vida, en términos de puntuación media ICQ-SF antes y después de la cirugía (13,76 [6,34] vs 3,84 [5,76]; p < 0,05). Conclusiones: el TVT-O es una terapia segura, con baja tasa de complicaciones a los 12 meses, aceptable tasa de curación subjetiva de la IUE y una mejora en la calidad de vida. Se necesitan clasificaciones de complicaciones relacionadas con la inserción de la prótesis y que incluyan complicaciones inherentes a la cirugía, como la infección del tracto urinario.
