RESUMEN
BACKGROUND: Bladder drainage is systematically used in rectal cancer surgery; however, the optimal type of drainage, transurethral catheterization (TUC) or suprapubic catheterization (SPC), is still controversial. The aim was to compare the rates of urinary tract infection on the fourth postoperative day (POD4) between TUC and SPC, after rectal cancer surgery regardless of the day of removal of the urinary drain. METHODS: This randomized clinical trial in 19 expert colorectal surgery centers in France and Belgium was performed between October 2016 and October 2019 and included 240 men (with normal or subnormal voiding function) undergoing mesorectal excision with low anastomosis for rectal cancer. Patients were followed at postoperative days 4, 30, and 180. RESULTS: In 208 patients (median age 66 years [IQR 58-71]) randomized to TUC (n = 99) or SPC (n = 109), the rate of urinary infection at POD4 was not significantly different whatever the type of drainage (11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35). There was significantly more pyuria in the TUC group (79/99 (79.0%) vs. (60/109 (60.9%), 95% CI, 5.7-30.0%; p = 0.004). No difference in bacteriuria was observed between the groups. Patients in the TUC group had a shorter duration of catheterization (median 4 [2-5] vs. 4 [3-5] days; p = 0.002). Drainage complications were more frequent in the SPC group at all followup visits. CONCLUSIONS: TUC should be preferred over SPC in male patients undergoing surgery for mid and/or lower rectal cancers, owing to the lower rate of complications and shorter duration of catheterization. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02922647.
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Drenaje , Complicaciones Posoperatorias , Neoplasias del Recto , Cateterismo Urinario , Infecciones Urinarias , Humanos , Masculino , Neoplasias del Recto/cirugía , Persona de Mediana Edad , Anciano , Cateterismo Urinario/métodos , Cateterismo Urinario/efectos adversos , Drenaje/métodos , Infecciones Urinarias/etiología , Infecciones Urinarias/prevención & control , Infecciones Urinarias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Vejiga Urinaria/cirugía , BélgicaRESUMEN
AIM: Robotic-assisted surgery (RAS) is becoming increasingly important in colorectal surgery. Recognition of the short, safe learning curve (LC) could potentially improve implementation. We evaluated the extent and safety of the LC in robotic resection for rectal cancer. METHOD: Consecutive rectal cancer resections (January 2018 to February 2021) were prospectively included from three French centres, involving nine surgeons. LC analyses only included surgeons who had performed more than 25 robotic rectal cancer surgeries. The primary endpoint was operating time LC and the secondary endpoint conversion rate LC. Interphase comparisons included demographic and intraoperative data, operating time, conversion rate, pathological specimen features and postoperative morbidity. RESULTS: In 174 patients (69% men; mean age 62.6 years) the mean operating time was 334.5 ± 92.1 min. Operative procedures included low anterior resection (n = 143) and intersphincteric resection (n = 31). For operating time, there were two or three (centre-dependent) LC phases. After 12-21 cases (learning phase), there was a significant decrease in total operating time (all centres) and an increase in the number of harvested lymph nodes (two centres). For conversion rate, there were two or four LC phases. After 9-14 cases (learning phase), the conversion rate decreased significantly in two centres; in one centre, there was a nonsignificant decrease despite the treatment of significantly more obese patients and patients with previous abdominal surgery. There were no significant differences in interphase comparisons. CONCLUSION: The LC for RAS in rectal cancer was achieved after 12-21 cases for the operating time and 9-14 cases for the conversion rate. RAS for rectal cancer was safe during this time, with no interphase differences in postoperative complications and circumferential resection margin.
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Neoplasias del Recto , Procedimientos Quirúrgicos Robotizados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Curva de Aprendizaje , Estudios Prospectivos , Neoplasias del Recto/patología , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Resultado del TratamientoRESUMEN
Twenty-seven experts under the aegis of the French Association of Surgery (AFC) offer this reference system with formalized recommendations concerning the performance of right colectomy by robotic approach (RRC). For RRC, experts suggest patient installation in the so-called "classic" or "suprapubic" setup. For patients undergoing right colectomy for a benign pathology or cancer, RRC provides no significant benefit in terms of intra-operative blood loss, intra-operative complications or conversion rate to laparotomy compared to laparoscopy. At the same time, RRC is associated with significantly longer operating times. Data from the literature are insufficient to define whether the robot facilitates the performance of an intra-abdominal anastomosis, but the robotic approach is more frequently associated with an intra-abdominal anastomosis than the laparoscopic approach. Experts also suggest that RRC offers a benefit in terms of post-operative morbidity compared to right colectomy by laparotomy. No benefit is retained in terms of mortality, duration of hospital stay, histological results, overall survival or disease-free survival in RRC performed for cancer. In addition, RRC should not be performed based on the cost/benefit ratio, since RRC is associated with significantly higher costs than laparoscopy and laparotomy. Future research in the field of RRC should consider the evaluation of patient-targeted parameters such as pain or quality of life and the technical advantages of the robot for complex procedural steps, as well as surgical and oncological results.
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Neoplasias del Colon , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Colectomía/métodos , Neoplasias del Colon/cirugía , Humanos , Laparoscopía/métodos , Tiempo de Internación , Tempo Operativo , Calidad de Vida , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Radiomics may be useful in rectal cancer management. The aim of this study was to assess and compare different radiomics approaches over qualitative evaluation to predict disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant therapy. METHODS: Patients from a phase II, multicentre, randomized study (GRECCAR4; NCT01333709) were included retrospectively as a training set. An independent cohort of patients comprised the independent test set. For both time points and both sets, radiomic features were extracted from two-dimensional manual segmentation (MS), three-dimensional (3D) MS, and from bounding boxes. Radiomics predictive models of DFS were built using a hyperparameters-tuned random forests classifier. Additionally, radiomics models were compared with qualitative parameters, including sphincter invasion, extramural vascular invasion as determined by MRI (mrEMVI) at baseline, and tumour regression grade evaluated by MRI (mrTRG) after chemoradiotherapy (CRT). RESULTS: In the training cohort of 98 patients, all three models showed good performance with mean(s.d.) area under the curve (AUC) values ranging from 0.77(0.09) to 0.89(0.09) for prediction of DFS. The 3D radiomics model outperformed qualitative analysis based on mrEMVI and sphincter invasion at baseline (P = 0.038 and P = 0.027 respectively), and mrTRG after CRT (P = 0.017). In the independent test cohort of 48 patients, at baseline and after CRT the AUC ranged from 0.67(0.09) to 0.76(0.06). All three models showed no difference compared with qualitative analysis in the independent set. CONCLUSION: Radiomics models can predict DFS in patients with locally advanced rectal cancer.
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Imagen por Resonancia Magnética/métodos , Modelos Estadísticos , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/terapia , Adulto , Anciano , Anciano de 80 o más Años , Quimioradioterapia , Supervivencia sin Enfermedad , Femenino , Humanos , Procesamiento de Imagen Asistido por Computador , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante , Neoplasias del Recto/mortalidad , Estudios Retrospectivos , Adulto JovenRESUMEN
BACKGROUND: Local excision (LE) after chemoradiotherapy is a new option in low rectal cancer, but morbidity has never been compared prospectively with total mesorectal excision (TME). Early and late morbidity were compared in patients treated either by LE or TME after neoadjuvant chemoradiotherapy for rectal cancer. METHOD: This was a post-hoc analysis from a randomized trial. Patients with clinical T2/T3 low rectal cancer with good response to the chemoradiotherapy and having either LE, LE with eventual completion TME, or TME were considered. Early (1 month) and late (2 years) morbidities were compared between the three groups. RESULTS: There were no deaths following surgery in any of the three groups. Early surgical morbidity (20 per cent LE versus 36 per cent TME versus 43 per cent completion TME, P = 0.025) and late surgical morbidity (4 per cent versus 33 per cent versus 57 per cent, P < 0.001) were significantly lower in the LE group than in the TME or the completion TME group. of LE, was associated with the lowest rate of early (10 versus 18 versus 21 per cent, P = 0.217) and late medical morbidities (0 versus 7 versus 7 per cent, P = 0.154), although this did not represent a significant difference between the groups. The severity of overall morbidity was significantly lower at 2 years after LE compared with TME or completion TME (4 versus 28 versus 43 per cent grade 3-5, P < 0.001). CONCLUSION: The rate of surgical complications after neoadjuvant chemoradiotherapy in the LE group was half that of TME group at 1 month and 10 times lower at 2 years. LE is a safe approach for organ preservation and should be considered as an alternative to watch-and-wait in complete clinical responders and to TME in subcomplete responders.
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Neoplasias del Recto , Quimioradioterapia/efectos adversos , Humanos , Morbilidad , Estadificación de Neoplasias , Neoplasias del Recto/patología , Neoplasias del Recto/terapia , Resultado del TratamientoAsunto(s)
Fuga Anastomótica/diagnóstico , Neoplasias del Recto/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Fuga Anastomótica/sangre , Fuga Anastomótica/terapia , Biomarcadores/sangre , Proteína C-Reactiva/análisis , Supervivencia sin Enfermedad , Diagnóstico Precoz , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias del Recto/mortalidad , Recto/cirugía , Análisis de SupervivenciaAsunto(s)
Adenocarcinoma/cirugía , Canal Anal/cirugía , Neoplasias del Recto/cirugía , Adenocarcinoma/mortalidad , Adenocarcinoma/radioterapia , Supervivencia sin Enfermedad , Humanos , Estimación de Kaplan-Meier , Márgenes de Escisión , Terapia Neoadyuvante/métodos , Neoplasias del Recto/mortalidad , Neoplasias del Recto/radioterapia , Análisis de SupervivenciaRESUMEN
BACKGROUND: Tumour extension beyond the mesorectal plane (ymrT4) occurs in 5-10 per cent of patients with rectal cancer and 10 per cent of patients develop locally recurrent rectal cancer (LRRC) after primary surgery. There is global variation in healthcare delivery for these conditions. METHODS: An international benchmark trial of the management of ymrT4 tumours and LRRC was undertaken in France and Australia between 2015 and 2017. Heterogeneity in management and operative decision-making were analysed by comparison of surgical resection rates, blinded intercountry reading of pelvic MRI, quality-of-life assessment and qualitative evaluations. RESULTS: Among 154 patients (97 in France and 57 in Australia), 31·8 per cent had ymrT4 disease and 68·2 per cent LRRC. The surgical resection rates were 88 and 79 per cent in France and Australia respectively (P = 0·112). The concordance in operative planning was low (κ = 0·314); the rate of pelvic exenteration was lower in France than Australia both in clinical practice (36 of 78 versus 34 of 40; P < 0·001) and in theoretical conditions (10 of 25 versus 50 of 57; P = 0·002). The R0 resection rate was lower in France than Australia for LRRC (25 of 49 versus 18 of 21; P = 0·007) but not for ymrT4 tumours (21 of 26 versus 15 of 15; P = 0·139). Morbidity rates were similar. Patients who underwent non-exenterative procedures had higher scores on the mental functioning subscale at 12 months (P = 0·047), and a lower level of distress at 6 months (P = 0·049). Qualitative analysis highlighted five categories of psychosocial factors influencing treatment decisions: patient, strategy, specialist, organization and culture. CONCLUSION: This international benchmark trial has highlighted the differences in worldwide treatment of locally advanced and LRRC. Standardized care should improve outcomes for these patients.
ANTECEDENTES: La extensión del tumor más allá del plano del meso-rrecto (ymrT4) ocurre en el 5-10% de los pacientes con cáncer de recto y el 10% de los pacientes desarrollan recidiva local del cáncer de recto (locally recurrent rectal cáncer, LRRC) después de una cirugía primaria. Existe una variación global en la prestación de la asistencia sanitaria para esta pato-logía. MÉTODOS: Se realizó un ensayo de referencia internacional sobre el manejo de ymrT4 y LRRC en Francia y Australia entre 2015 y 2017. La heterogeneidad en el manejo y la toma de decisiones quirúrgicas se analizaron mediante la comparación de las tasas de resección quirúrgica, la lectura a ciegas de la resonancia magnética (RM) pélvica entre países, la evaluación de la calidad de vida y las evaluaciones cualitativas. RESULTADOS: De 154 pacientes (97 en Francia versus 57 en Australia), el 32% tenía ymrT4 y el 68% tenía cáncer de recto con recidiva local. Las tasas de resección quirúrgica fueron del 87,6% versus 77,8% (P = 0,112). La tasa de concordancia en la decisión quirúrgica fue baja (coeficiente kappa = 0,314) con una tasa más baja de exenteración pélvica en Francia, tanto en la práctica clínica (46% versus 85%; P < 0,0001) como en condiciones teóricas (40% versus 88%; P = 0,002). La tasa de resección R0 fue menor en Francia para la LRRC (51% versus 86%, P = 0,007) pero no para el ymrT4 (81% versus 100%, P = 0,139). Las tasas de morbilidad fueron similares. Los pacientes que se sometieron a procedimientos no exenterativos tuvieron una subescala de funcionamiento mental más alta a los 12 meses (P = 0,04) y un nivel de angustia más bajo a los 6 meses (P = 0,04). El análisis cualitativo destacó 5 categorías de factores psicosociales que afectaron a la decisión del tratamiento: paciente, estrategia, especialista, organización y cultura. CONCLUSIÓN: Este ensayo de referencia internacional destaca las diferencias en el tratamiento mundial del cáncer de recto localmente avanzado y de la LRR. La aten-ción estandarizada debería mejorar los resultados para estos pacientes.
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Benchmarking , Toma de Decisiones Clínicas/métodos , Disparidades en Atención de Salud/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/cirugía , Adulto , Anciano , Australia , Femenino , Francia , Disparidades en Atención de Salud/normas , Humanos , Imagen por Resonancia Magnética/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico por imagen , Recurrencia Local de Neoplasia/psicología , Recurrencia Local de Neoplasia/cirugía , Estadificación de Neoplasias , Pautas de la Práctica en Medicina/normas , Proctectomía/estadística & datos numéricos , Estudios Prospectivos , Investigación Cualitativa , Calidad de Vida , Neoplasias del Recto/patología , Neoplasias del Recto/psicologíaRESUMEN
BACKGROUND: Enhanced recovery after surgery (ERAS) pathways are beneficial in proctocolectomy, but their impact on robotic low rectal proctectomy is not fully investigated. This study assessed the impact of an ERAS pathway on the outcomes and cost of robotic (RTME) versus laparoscopic (LTME) total mesorectal excision. METHODS: A retrospective review was performed of patients with rectal cancer in a single French tertiary centre for three yearly periods: 2011, LTME; 2015, RTME; and 2018, RTME with ERAS. Patient characteristics, operative and postoperative data, and costs were compared among the groups. RESULTS: A total of 220 consecutive proctectomies were analysed (71 LTME, 58 RTME and 91 RTME with ERAS). A prevalence of lower and locally advanced tumours was observed with RTME. The median duration of surgery increased with the introduction of RTME, but became shorter than that for LTME with greater robotic experience (226, 233 and 180 min for 2011, 2015 and 2018 respectively; P < 0·001). The median duration of hospital stay decreased significantly for RTME with ERAS (11, 10 and 8 days respectively; P = 0·011), as did the overall morbidity rate (39, 38 and 16 per cent; P = 0·002). Pathology results, conversion and defunctioning stoma rates remained stable. RTME alone increased the total cost by 2348 compared with LTME. The introduction of ERAS and improved robotic experience decreased costs by 1960, compared with RTME performed in 2015 without ERAS implementation. In patients with no co-morbidity, costs decreased by 596 for RTME with ERAS versus LTME alone. CONCLUSION: ERAS is associated with cost reductions in patients undergoing robotic proctectomy.
ANTECEDENTES: Las vías clínicas ERAS son beneficiosas en la proctocolectomía, pero su impacto en la proctectomía rectal baja robótica no se ha investigado exhaustivamente. El objetivo de este estudio fue evaluar el impacto de la vía clínica ERAS sobre los resultados y el coste de la proctectomía robótica (resección total del mesorrecto robótica, robotic total mesorectal excision, RTME) versus procedimientos laparoscópicos de resección total del mesorrecto (laparoscopic total mesorectal excision, LTME). MÉTODOS: Revisión retrospectiva de pacientes con cáncer de recto tratados en un único centro terciario francés durante un periodo de tres años: 1) 2011: resección total del mesorrecto laparoscópica (LTME); 2) 2015: TME robótica y 3) 2018: TME robótica plus ERAS. Se compararon las características de los pacientes, los datos operatorios y postoperatorios, y los costes entre subgrupos utilizando análisis estadísticos. RESULTADOS: Se analizaron 220 proctectomías consecutivas que incluían 71 LTME, 58 RTME y 91 RTME plus ERAS. Se observó un predominio de tumores inferiores y localmente avanzados en la RTME. La mediana del tiempo operatorio aumentó con la introducción de RTME, pero llegó a ser inferior que en la LTME con una mayor experiencia robótica (226, 233 y 180 minutos para los periodos 1, 2 y 3, respectivamente; P = 0,0001). La mediana de la estancia hospitalaria disminuyó significativamente con la RTME plus ERAS (11, 10 y 8 días; P = 0,01), así como la morbilidad global (40%, 38% y 16%; P = 0,002). Los resultados de la anatomía patológica, las tasas de conversión y de estomas de protección permanecieron estables. La RTME sola aumentó el coste total en 2.348 comparado con la LTME. La introducción de ERAS y una mejora en la experiencia robótica disminuyeron los costes en 1.960 versus RTME realizada en 2015 sin la implementación de ERAS. En pacientes sin comorbilidades, los costes disminuyeron en 1.196 con RTME plus ERAS versus LTME sola. CONCLUSIÓN: ERAS se asocia con reducciones de coste en la proctectomía robótica.
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Recuperación Mejorada Después de la Cirugía , Laparoscopía/economía , Neoplasias del Recto/cirugía , Robótica/economía , Adulto , Anciano , Anciano de 80 o más Años , Costos y Análisis de Costo , Femenino , Francia , Humanos , Tiempo de Internación/economía , Masculino , Persona de Mediana Edad , Proctectomía , Neoplasias del Recto/economía , Estudios Retrospectivos , Centros de Atención TerciariaRESUMEN
BACKGROUND: In early breast cancer (BC), there has been a trend to escalate endocrine therapy (ET) and to de-escalate chemotherapy (CT). However, the impact of ET versus CT on the quality of life (QoL) of early BC patients is unknown. Here, we characterize the independent contribution of ET and CT on patient-reported outcomes (PROs) at 2 years after diagnosis. PATIENTS AND METHODS: We prospectively collected PROs in 4262 eligible patients using the European Organization for Research and Treatment of Cancer QLQ-C30/BR23 questionnaires inside CANTO trial (NCT01993498). The primary outcome was the C30 summary score (C30-SumSc) at 2 years after diagnosis. RESULTS: From eligible patients, 37.2% were premenopausal and 62.8% postmenopausal; 81.9% received ET and 52.8% CT. In the overall cohort, QoL worsened by 2 years after diagnosis in multiple functions and symptoms; exceptions included emotional function and future perspective, which improved over time. ET (Pint = 0.004), but not CT (Pint = 0.924), had a persistent negative impact on the C30-SumSc. In addition, ET negatively impacted role and social function, pain, insomnia, systemic therapy side-effects, breast symptoms and further limited emotional function and future perspective recovery. Although CT had no impact on the C30-SumSc at 2-years it was associated with deteriorated physical and cognitive function, dyspnea, financial difficulties, body image and breast symptoms. We found a differential effect of treatment by menopausal status; in premenopausal patients, CT, despite only a non-significant trend for deteriorated C30-SumSc (Pint = 0.100), was more frequently associated with QoL domains deterioration than ET, whereas in postmenopausal patients, ET was more frequently associated with QoL deterioration, namely using the C30-SumSc (Pint = 0.004). CONCLUSION(S): QoL deterioration persisted at 2 years after diagnosis with different trajectories by treatment received. ET, but not CT, had a major detrimental impact on C30-SumSc, especially in postmenopausal women. These findings highlight the need to properly select patients for adjuvant ET escalation.
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Antibióticos Antineoplásicos/efectos adversos , Antineoplásicos Hormonales/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/terapia , Supervivientes de Cáncer/estadística & datos numéricos , Calidad de Vida , Adulto , Anciano , Mama/patología , Mama/cirugía , Neoplasias de la Mama/patología , Quimioterapia Adyuvante/efectos adversos , Quimioterapia Adyuvante/métodos , Femenino , Humanos , Estudios Longitudinales , Persona de Mediana Edad , Medición de Resultados Informados por el Paciente , Selección de Paciente , Estudios Prospectivos , Encuestas y Cuestionarios/estadística & datos numéricosRESUMEN
BACKGROUND: Tailored neoadjuvant treatment of locally advanced rectal cancer (LARC) may improve outcomes. The aim of this study was to determine early MRI prognostic parameters with which to stratify neoadjuvant treatment in patients with LARC. METHODS: All patients from a prospective, phase II, multicentre randomized study (GRECCAR4; NCT01333709) were included, and underwent rectal MRI before treatment, 4 weeks after induction chemotherapy and after completion of chemoradiotherapy (CRT). Tumour volumetry, MRI tumour regression grade (mrTRG), T and N categories, circumferential resection margin (CRM) status and extramural vascular invasion identified by MRI (mrEMVI) were evaluated. RESULTS: A total of 133 randomized patients were analysed. Median follow-up was 41·4 (95 per cent c.i. 36·6 to 45·2) months. Thirty-one patients (23·3 per cent) developed tumour recurrence. In univariable analysis, mrEMVI at baseline was the only prognostic factor associated with poorer outcome (P = 0·015). After induction chemotherapy, a larger tumour volume on MRI (P = 0·019), tumour volume regression of 60 per cent or less (P = 0·002), involvement of the CRM (P = 0·037), mrEMVI (P = 0·026) and a poor mrTRG (P = 0·023) were associated with poor outcome. After completion of CRT, the absence of complete response on MRI (P = 0·004), mrEMVI (P = 0·038) and a poor mrTRG (P = 0·005) were associated with shorter disease-free survival. A final multivariable model including all significant variables (baseline, after induction, after CRT) revealed that Eastern Cooperative Oncology Group performance status (P = 0·011), sphincter involvement (P = 0·009), mrEMVI at baseline (P = 0·002) and early tumour volume regression of 60 per cent or less after induction (P = 0·007) were associated with relapse. CONCLUSION: Baseline and early post-treatment MRI parameters are associated with prognosis in LARC. Future preoperative treatment should stratify treatment according to baseline mrEMVI status and early tumour volume regression.
ANTECEDENTES: El tratamiento neoadyuvante personalizado del cáncer de recto localmente avanzado (locally advanced rectal cancer, LARC) puede mejorar los resultados. El objetivo de este estudio fue determinar factores pronósticos precoces mediante RMN para estratificar el tratamiento neoadyuvante en pacientes con LARC. MÉTODOS: Todos los pacientes de un eensayo prospectivo de fase II, multicéntrico y aleatorizado (GRECCAR4-NCT01333709) se incluyeron en este estudio y se les realizó una RMN antes del tratamiento, 4 semanas después de la quimioterapia de inducción y después de completar la quimiorradioterapia (chemoradiation, CRT). Se evaluó la volumetría tumoral, el grado de regresión tumoral mediante RMN (MRI Tumor Regression Grade, mrTRG), la estadificación T, la estadificación N, el estado del margen de resección circunferencial (circumferential resection margin, CRM) y la presencia de invasión extramural vascular en la RMN (extramural vascular invasion, mrEMVI). RESULTADOS: Se analizaron 133 pacientes aleatorizados. La mediana de seguimiento fue de 41,4 meses (i.c. del 95%: 36,6-45,2). En 31 pacientes (23%) se diagnosticó una recidiva. En el análisis univariado de la situación basal, mrEMVI fue el único factor pronóstico asociado con un peor resultado (P = 0,0152). Después de la quimioterapia de inducción, un volumen tumoral más alto en la RMN (P = 0,019), una regresión del volumen tumoral ≤ 60% (P = 0,002), la afectación del CRM (P = 0,037), mrEMVI (P = 0,026) y un grado escaso mrTRG (P = 0,023) se asociaron con un mal resultado. Después de completar la CRT, la ausencia de respuesta completa en la RMN (P = 0,004), la presencia de mrEMVI (P = 0,04) y una insuficiente mrTRG (P = 0,005) se asociaron con una supervivencia libre de enfermedad más corta. En el modelo multivariable final en el que se incluyeron todas las variables significativas (basales, postinducción, post-CRT), el estado de ECOG (P = 0,011), la afectación esfinteriana (P = 0,009), la presencia de EMVI al inicio (P = 0,002) y una regresión precoz del volumen tumoral ≤ 60% después de la inducción (P = 0,007) se asociaron con una recidiva. CONCLUSIÓN: Los parámetros basales y post-tratamiento precoces de la RMN se asocian con el pronóstico en el LARC. La estrategia terapéutica preoperatoria futura deberá estratificar el tratamiento de acuerdo con la presencia de EMVI al inicio y la regresión precoz del volumen tumoral.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias del Recto/mortalidad , Adolescente , Adulto , Anciano , Quimioradioterapia Adyuvante/métodos , Supervivencia sin Enfermedad , Esquema de Medicación , Fluorouracilo/administración & dosificación , Humanos , Infusiones Intravenosas , Irinotecán/administración & dosificación , Laparoscopía/estadística & datos numéricos , Leucovorina/administración & dosificación , Imagen por Resonancia Magnética , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Oxaliplatino/administración & dosificación , Medicina de Precisión/métodos , Estudios Prospectivos , Neoplasias del Recto/patología , Neoplasias del Recto/terapia , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Carga Tumoral , Adulto JovenRESUMEN
AIM: Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgery technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery and transanal surgery. Comparative data for these techniques are required to provide clinical data on the surgical management of rectal cancers. METHODS: The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicentre trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery or transanal surgery in high-surgical-risk patients with mid-to-low non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in at least one of the techniques. Oncological, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥ 1 mm, TME Grade III and minimal postoperative morbidity (absence of Clavien-Dindo Grade III-IV complications within 30 days after surgery). Secondary end-points will include the co-primary end-points over the long term (2 years), quality of surgery, quality of life, length of hospital stay, operative time and rate of unplanned conversions. DISCUSSION: This will be the first trial to study all four surgical techniques currently used for TME with LAR in a specific group of high-risk patients. The knowledge obtained will contribute towards helping physicians determine the advantages of each technique and which may be the most appropriate for their patients.
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Proctectomía/métodos , Neoplasias del Recto/cirugía , Recto/cirugía , Adulto , Anciano , Investigación sobre la Eficacia Comparativa , Femenino , Humanos , Laparoscopía/métodos , Laparotomía/métodos , Tiempo de Internación , Masculino , Márgenes de Escisión , Persona de Mediana Edad , Estudios Observacionales como Asunto , Tempo Operativo , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Calidad de Vida , Procedimientos Quirúrgicos Robotizados/métodos , Cirugía Endoscópica Transanal/métodos , Resultado del TratamientoRESUMEN
This review discusses the clinical applications of magnetic resonance imaging (MRI) for the assessment of neo-adjuvant chemotherapy (NAC) indication, axillary lymph node status, preNAC cancer prognosis, early and intermediate response to NAC, and post-NAC residual disease in patients with breast cancer. Contrast-enhanced MRI with analysis of the tumor morphological features and qualitative enhancement kinetics must be considered as the standard method for pre-NAC breast cancer staging and post-NAC residual disease assessment. Diffusion-weighted imaging (DWI) is easy to perform and may increase the specificity of breast MRI for tumor staging, and also for the assessment of tumor multifocality and multicentricity and lymph node status. It also provides an ancillary added value in the early and post-NAC response evaluation. Changes in the functional tumor volume are the main criterion for the early response analysis. Other MRI methods, such as quantitative perfusion analysis, MR spectroscopy and texture analysis, are still under study.
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Neoplasias de la Mama/patología , Ganglios Linfáticos/patología , Imagen por Resonancia Magnética/métodos , Terapia Neoadyuvante , Neoplasias de la Mama/tratamiento farmacológico , Quimioterapia Adyuvante , Manejo de la Enfermedad , Femenino , Humanos , Estadificación de NeoplasiasRESUMEN
BACKGROUND: Rectal cancer surgery is technically challenging and depends on many factors. This study evaluated the ability of clinical and anatomical factors to predict surgical difficulty in total mesorectal excision. METHODS: Consecutive patients who underwent total mesorectal excision for locally advanced rectal cancer in a laparoscopic, robotic or open procedure after neoadjuvant treatment, between 2005 and 2014, were included in this retrospective study. Preoperative clinical and MRI data were studied to develop a surgical difficulty grade. RESULTS: In total, 164 patients with a median age of 61 (range 26-86) years were considered to be at low risk (143, 87·2 per cent) or high risk (21, 12·8 per cent) of surgical difficulty. In multivariable analysis, BMI at least 30 kg/m2 (P = 0·021), coloanal anastomosis (versus colorectal) (P = 0·034), intertuberous distance less than 10·1 cm (P = 0·041) and mesorectal fat area exceeding 20·7 cm2 (P = 0·051) were associated with greater surgical difficulty. A four-item score (ranging from 0 to 4), with each item (BMI, type of surgery, intertuberous distance and mesorectal fat area) scored 0 (absence) or 1 (presence), is proposed. Patients can be considered at high risk of a difficult or challenging operation if they have a score of 3 or more. CONCLUSION: This simple morphometric score may assist surgical decision-making and comparative study by defining operative difficulty before surgery.
Asunto(s)
Toma de Decisiones Clínicas/métodos , Técnicas de Apoyo para la Decisión , Imagen por Resonancia Magnética , Neoplasias del Recto/cirugía , Recto/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Neoplasias del Recto/diagnóstico por imagen , Recto/diagnóstico por imagen , Estudios RetrospectivosRESUMEN
BACKGROUND: Pelvic exenteration remains one of the most mutilating procedures, with important postoperative morbidity, an altered body image, and long-term physical and psychosocial concerns. This study aimed to assess quality of life (QOL) during the first year after pelvic exenteration for gynecologic malignancy performed with curative intent. METHODS: A French multicentric prospective study was performed by including patients who underwent pelvic exenteration. Quality of life by measurement of functional and symptom scales was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3.0) and the EORTC QLQ-OV28 questionnaires before surgery, at baseline, and 1, 3, 6, and 12 months after the procedure. RESULTS: The study enrolled 97 patients. Quality of life including physical, personal, fatigue, and anorexia reported in the QLQ-C30 was significantly reduced 1 month postoperatively and improved at least to baseline level 1 year after the procedure. Body image also was significantly reduced 1 month postoperatively. Global health, emotional, dyspnea, and anorexia items were significantly improved 1 year after surgery compared with baseline values. Unlike younger patients, elderly patients did not regain physical and social activities after pelvic exenteration. CONCLUSIONS: Therapeutic decision on performing a pelvic exenteration can have a severe and permanent impact on all aspects of patients' QOL. Deterioration of QOL was most significant during the first 3 months after surgery. Elderly patients were the only group of patients with permanent decreased physical and social function. Preoperative evaluation and postoperative follow-up evaluation should include health-related QOL instruments, counseling by a multidisciplinary team to cover all aspects concerning stoma care, sexual function, and long-term concerns after surgery.
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Imagen Corporal , Neoplasias de los Genitales Femeninos/cirugía , Exenteración Pélvica/psicología , Exenteración Pélvica/rehabilitación , Calidad de Vida , Adulto , Anciano , Femenino , Estudios de Seguimiento , Neoplasias de los Genitales Femeninos/patología , Neoplasias de los Genitales Femeninos/psicología , Humanos , Persona de Mediana Edad , Periodo Posoperatorio , Pronóstico , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
Dramatic progress has deeply moved rectal cancer management. Tailoring of treatment allow to select participants according to initial prognostic factors (radiotherapist) or tumoral response (surgeon). Today, this management must keep in mind tumoral initial staging, prognostic at the time of diagnosis, tumoral response and characteristic, and patient's motivation. The result of this patient care is more than oncologic, it is also functional.
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Selección de Paciente , Neoplasias del Recto/terapia , Toma de Decisiones Clínicas , HumanosRESUMEN
BACKGROUND: Mastectomy with immediate breast reconstruction (IBR) is a surgical strategy in breast cancer when breast-conserving surgery is not an option. There is a lack of evidence showing an advantage of mastectomy plus IBR over mastectomy alone on health-related quality of life (QoL). METHODS: A large prospective multicentre survey, STIC-RMI (support of innovative and expensive techniques - immediate breast reconstruction), was undertaken to study the changes in QoL in patients treated by mastectomy with or without IBR. Patients were recruited between 2007 and 2009. European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 instruments were used to assess QoL before operation, and at 6 and 12 months after surgery. A propensity score was used to compare QoL between mastectomy alone and mastectomy plus IBR, with limited bias. RESULTS: A total of 595 patients were included from 22 French academic hospitals, of whom 407 (68·4 per cent) underwent IBR. One-year data were available for 71·1 per cent of patients. Factors associated with IBR were age, histological tumour type, palpable nodes and an attempt at breast-conserving surgery. At inclusion, QoL was significantly better in the IBR group (P < 0·001) and there was no significant change in either group during 1 year compared with baseline. Results for the QLQ-BR23 functional dimension varied according to propensity score quartiles; IBR had no influence in the lowest quartile. In the upper quartiles, QoL increased slightly over the year among patients who had IBR, whereas it decreased among those who had mastectomy alone (P = 0·037). Satisfaction with the cosmetic outcome strongly influenced QoL, especially in upper quartiles (P < 0·001). However, an unsatisfactory outcome after IBR was still considered a better condition than simple mastectomy. CONCLUSION: The QoL benefit provided by IBR depends on patients' life status at inclusion; young active women with an in situ tumour are more likely to preserve their QoL after IBR.