Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial.

BACKGROUND: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. METHODS: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. RESULTS: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. CONCLUSION: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs.

La mastectomía como medida de reducción de riesgo de cáncer de mama / Risk-reducing mastectomy in breast cancer

Objetivos: Evaluar las mastectomías reductoras de riesgo realizadas y analizar las indicaciones y resultados según las características individuales, oncológicas y quirúrgicas de nuestras pacientes.MétodosEstudio observacional retrospectivo de todas las mastectomías con reconstrucción inmediata en mamas sanas realizadas desde 2013 a 2019. Se dividieron las pacientes en tres grupos: I) riesgo genético de cáncer de mama, II) cáncer de mama diagnosticado y III) antecedente de cáncer de mama.ResultadosSe realizaron 56 mastectomías reductoras de riesgo a 46 pacientes, 15% grupo I, 50% grupo II y 35% grupo III, pero tras estudios diferidos, 20 pacientes (43%) presentaban mutación genética. La media de edad en este subgrupo fue de 40 años y con predominio de tumores HER2+ (40% frente al 12%, p=0,164). En el grupo III observamos más complicaciones inmediatas (31%, p=0,014) y tardías (69%, p=0,027) relacionadas con la reconstrucción protésica, y más evidente en mamas que tuvieron enfermedad (73% frente al 39% sanas, p=0,002). Se encontró relación entre contractura capsular y la radioterapia postoperatoria (p=0,008) y entre necrosis y radioterapia preoperatoria (p=0,001). Se reintervino al 7% por complicaciones en mastectomías profilácticas. No hemos tenido recidivas locales.ConclusionesConsideramos justificada la mastectomía reductora de riesgo realizada a mujeres jóvenes con mutación genética y a pacientes con cáncer precoz, HER2+ y riesgo familiar. En pacientes ya tratadas por cáncer, el riesgo de complicaciones supera el valor profiláctico de la técnica. La reconstrucción mamaria es la principal responsable de complicaciones postoperatorias y las pacientes deben ser plenamente conscientes de ello. (AU)

Objectives: To evaluate the risk-reducing mastectomies performed and to analyse the indications and results according to the individual, oncological and surgical characteristics of our patients.MethodsRetrospective observational study of all mastectomies with immediate reconstruction in healthy breasts performed from 2013 to 2019. The patients were divided into three groups: I) genetic risk of breast cancer, II) diagnosed breast cancer and III) history of cancer breast.ResultsA total of 56 risk-reducing mastectomies were performed in 46 patients, 15% in group I, 50% in group II and 35% in group III. After deferred studies, 20 (43%) patients had a genetic mutation. This subgroup had an average age of 40 years and a predominance of HER2+ tumours (40% versus 12%, p=0.164). In group III, we observed more immediate (31%, p=0.014) and late (69%, p=0.027) complications related to prosthetic reconstruction, which were more evident in breasts with disease (73% versus 39% healthy, p=0.002). A relationship was found between capsular contracture and postoperative radiotherapy (p=0.008) and between necrosis and preoperative radiotherapy (p=0.001). Reoperation was required in 7% for complications of prophylactic mastectomies. There were no local relapses.ConclusionsWe consider risk-reducing mastectomy to be justified in young women with a genetic mutation and in patients with early cancer, HER2+ and family risk. In patients already treated for cancer, the risk of complications exceeds the prophylactic value of the technique. Breast reconstruction is primarily responsible for postoperative complications and patients should be fully aware of this. (AU)

Gigantomastia extrema / Extreme gigantomastia

No disponible

Cirugía oncológica de la mama y reconstrucción inmediata con prótesis directa / Oncologic breast surgery and immediate breast reconstruction with direct prosthesis

Objetivo. La reconstrucción mamaria con prótesis directa responde al deseo de las pacientes de no perder su imagen corporal tras la mastectomía y a evitar reoperaciones. Intentamos comprobar si esta técnica es segura y si ofrece similares resultados a la reconstrucción con expansores. Pacientes y métodos. Análisis retrospectivo de 98 pacientes intervenidas consecutivamente entre 2007 y 2015 con mastectomía y reconstrucción inmediata. Se comparan los datos clínicos, las complicaciones, las reintervenciones, los ingresos y los días de estancia entre las pacientes reconstruidas con prótesis directas (61) y reconstruidas con expansores (37). Resultados. No hubo diferencias en el tipo de pacientes incluidas en ambos grupos, salvo el mayor peso de las mamas extirpadas en el grupo de los expansores (277,64 g/462,75 g, p=0,011). Este grupo tuvo mayor número de ingresos (1,46/1,92, p=0,029), pero no hubo diferencias significativas en los días de estancia global, complicaciones, asimetrías secundarias, capsulitis o reoperaciones. No hubo complicaciones oncológicas. Recibieron radioterapia 37 pacientes, y de ellas el 29,7% presentó capsulitis frente al 16,3% de pacientes no radiadas (p=0,089). Conclusiones. La reconstrucción mamaria inmediata con prótesis directa es oncológicamente segura y no incrementa las tasas de complicaciones ni la estancia hospitalaria. La radioterapia aumenta el riesgo de capsulitis, pero no contraindica la técnica (AU)

Objective. Immediate breast reconstruction with direct prosthesis attempts to fulfil patients’ wishes to retain their body image after mastectomy and to avoid reoperations. The aim of this study was to determine the safety of this technique and whether it provides similar results to those of reconstruction with expanders. Patients and methods. A retrospective analysis was conducted of 98 patients who underwent surgery consecutively between 2007 and 2015 with mastectomy and immediate reconstruction. Clinical data, complications, reoperation rates, admissions and days of stay were compared between patients who underwent immediate reconstruction (n=61) and those who underwent reconstruction with expanders (n=37). Results. There were no differences in the type of patients included in the two groups, except the greater weight of the breast removed in the expanders group (277.64 g/462.75 g, P=.011). This group had a higher number of admissions (1.46 1.92, P=.029), but there was no significant difference in overall days of hospital stay, complications, secondary asymmetries, capsulitis, or reoperations. There were no oncological complications. Thirty-seven patients received radiotherapy and 29.7% had capsulitis compared with 16.3% of patients not receiving radiotherapy (P=.089). Conclusions. Immediate breast reconstruction with direct prosthesis is safe and does not increase complication rates or length of hospital stay. Radiotherapy increases the risk of capsulitis, but does not contraindicate the technique (AU)