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Spanish to English: Sentinel node biopsy after neoadjuvant chemotherapy for breast cancer: prospective multicentre study for validation and analysis of subgroups (GEICAM 2005-07) General field: Medical Detailed field: Medical (general)
Source text - Spanish Biopsia selectiva del ganglio centinela tras quimioterapia neoadyuvante en el cáncer de mama: estudio prospectivo multicéntrico para la validación y análisis de subgrupos (GEICAM 2005-07)
Introducción
En el estudio de extensión del cáncer de mama, la biopsia selectiva del ganglio centinela (BSGC) es en la actualidad el método diagnóstico estándar. Mediante este procedimiento se logra demostrar la afectación ganglionar y, de este modo, evitar la morbilidad asociada a la linfadenectomía axilar que se realizaba sistemáticamente. En la actualidad, incluso, se considera la posibilidad de no realizar esta linfadenectomía en casos seleccionados con afectación ganglionar limitada.
No obstante, en todas estas series se considera contraindicada su realización cuando se administra terapia sistémica primaria (TSP). La quimioterapia se ha considerado como un factor que puede llegar a interferir en la detección y correcta identificación del ganglio centinela debido a las modificaciones que produce en la estructura del sistema de drenaje linfático, especialmente, cuando provoca una respuesta efectiva.
Un aspecto controvertido es, ahora, conocer si las pacientes que reciben TSP, cada vez más frecuente, se beneficiarían de la BSGC y cuál sería el momento más apropiado para aplicarla.
En este estudio se plantean 2 objetivos: 1) analizar la tasa de detección (TD) y falsos negativos (FN) de la BSGC realizada tras administrar quimioterapia neoadyuvante y 2) conocer si existen diferencias cuando se detecta enfermedad ganglionar inicial y cuando se aplican protocolos asistenciales.
Pacientes y métodos
Estudio clínico prospectivo observacional multicéntrico (GEICAM 2005-07) que incluyó a pacientes con cáncer invasivo de mama en las que se indicaron TSP y se realizó BSGC después de administrarla, con linfadenectomía axilar posterior.
Se excluyó a las pacientes con antecedentes de cirugía axilar previa, carcinoma inflamatorio o contraindicación para la BSGC. También se excluyó a aquellas pacientes en las que, por cualquier circunstancia, no se realizaba la BSGC de forma estandarizada siguiendo los protocolos asistenciales habituales. El estudio fue aprobado por el Comité de Ética de la Investigación de los centros participantes. Todas las pacientes fueron informadas y se obtuvo consentimiento informado específico para participar en el estudio.
Las características generales de la serie se muestran en la tabla 1, y la tabla 2 muestra los principales cambios pre- y post-TSP.
El estudio pre-TSP de las pacientes incluyó una valoración axilar clínico-ecográfica que, en caso de sugerirlo, se acompañó de punción aspiración con aguja fina (PAAF) para confirmar la presencia de enfermedad ganglionar y su clasificación como estadio N░+░pre-TSP. En caso de no obtenerse estos hallazgos, las pacientes se clasificaron como estadio N0 pre-TSP. Los centros hospitalarios fueron clasificados según el tipo de tratamiento realizado tras la TSP, teniendo en cuenta si fue aplicado un protocolo específico que incluía una nueva valoración con ecografía, y PAAF-BAG en caso de que fuera necesario, después de administrar la TSP y antes de realizar la BSGC.
La metodología para la realización de la BSGC se realizó siguiendo la de los protocolos de la Sociedad Española de Senología y Patología Mamaria. En todos los casos se realizó linfadenectomía axilar y se registró el número de ganglios aislados y el número de ganglios afectados.
La TD o identificación positiva fue considerada cuando se detectó al menos un ganglio centinela durante la intervención quirúrgica, ya fuera con el trazador isotópico o con un método mixto con isótopo y colorante. Si en la gammagrafía preoperatoria o durante la cirugía no se producía la detección, esta fue considerada negativa.
Se definió como verdadero positivo (VP) aquel caso con BSGC positiva y afectación de algún ganglio no centinela aislado en la linfadenectomía y como verdadero negativo (VN) aquel caso de ganglio centinela negativo sin afectación en ningún ganglio de los aislados en la linfadenectomía. Se definió como FN el caso en el que, siendo el ganglio centinela negativo, se identificaron ganglios no centinelas afectados en la linfadenectomía. La tasa de falsos negativos (TFN) se calculó dividiendo el número de falsos negativos entre la suma de falsos negativos y verdaderos positivos.
Se estudiaron la TD y la TFN global, así como en los casos según que se demostrara afectación ganglionar inicial (cN+) o no (cN0), y se compararon las TD y TFN entre ellas.
Se realizó un subanálisis, inicialmente no planificado, que evaluó los centros hospitalarios según sus protocolos aplicados antes de la realización de la BSGC. Se compararon aquellos centros en los que se realizaba de forma sistemática por radiólogos con dedicación exclusiva a la enfermedad mamaria el estudio axilar con ecografía tras acabar la quimioterapia neoadyuvante y antes de realizar la BSGC, que era excluido en caso de manifiesta afectación, con los centros hospitalarios en los que no se realizaba este estudio o el estudio radiológico era practicado por radiólogos sin dedicación exclusiva.
Análisis estadístico
Se realizó un estudio descriptivo de las variables demográficas, anatomopatológicas y de evolución clínico-radiológica tanto previas como tras TSP. Para las variables cualitativas se calculó su distribución de frecuencias, mientras que para las cuantitativas se utilizaron medidas de tendencia central, como la media y la mediana. Se han aportado tanto los estimadores puntuales de las TD, VPP, VPN, TFN como sus intervalos de confianza (IC) al 95%. En caso de tratarse de muestras pequeñas se ha calculado el IC de manera exacta utilizando la fórmula propuesta por Clopper y Pearson.
Se han comparado las diversas tasas (TD, PVp, PVn, TFN) entre los distintos subconjuntos de pacientes. Para ello se ha utilizado el test chi-cuadrado o el test exacto de Fisher si la frecuencia esperada era menor de 5.
Se evaluó la validez de la clasificación realizada por la técnica del ganglio centinela frente a la linfadenectomía (gold standard), utilizando la curva ROC. Para ello se calculó la sensibilidad, la especificidad y el área bajo la curva. Estos cálculos se realizaron tanto de forma global como separando los casos con afectación axilar inicial y los que no la tuvieron.
Los cálculos estadísticos se realizaron utilizando el software PASW v18. Se consideró significativo un nivel de p░
Translation - English Sentinel node biopsy after neoadjuvant chemotherapy for breast cancer: prospective multicentre study for validation and analysis of subgroups (GEICAM 2005-07)
Introduction
In the staging of breast cancer, sentinel lymph node biopsy (SLNB) is the current standard diagnostic technique used. Through this procedure, it is possible to demonstrate lymph node involvement and therefore avoid the morbidity associated with an axillary lymphadenectomy, which was previously performed systematically. Even now the possibility of not performing this type of lymphadenectomy in selected cases with limited lymph node involvement is being considered.
However, in all these studies, it is considered contraindicated to perform an SLNB when primary systemic therapy (PST) is being administered. Chemotherapy has been seen as a factor that can sometimes interfere with the detection and correct identification of the sentinel node due to the changes that it produces in the structure of the lymphatic drainage system, in particular when it generates an effective response.
Currently, one controversial aspect is whether the ever-growing number of patients who receive PST would benefit from an SLNB and when the best moment to perform it would be.
This study has a double objective: 1) to analyse the detection rate (DR) and false negatives (FN) of SLNB performed after administration of neoadjuvant chemotherapy and 2) to establish whether the results are affected by the detection of initial nodal disease and by the application of care protocols.
Patients and methods
Prospective observational multicentre clinical study (GEICAM 2005-07) that included patients with invasive breast cancer for whom PST was indicated and on whom an SLNB was performed after administering PST, with subsequent axillary lymphadenectomy.
Patients with a history of previous axillary surgery, an inflammatory carcinoma or for whom SLNB was contraindicated were omitted from the study. Patients on whom, for whatever reason, the SLNB was not performed in the standard manner according to normal care protocols were also omitted. The study was approved by the Research Ethics Committee of the participating centres. All patients were informed and specific informed consent was obtained in order to include the patient in the study.
The general characteristics of the study are shown in table 1, and table 2 details the principal changes pre- and post-PST.
The pre-PST evaluation of the patients included an axillary assessment using clinical ultrasonography that, where suggested, was accompanied by fine needle aspiration (FNA) in order to confirm the presence of nodal disease and its classification as N░+░pre-PST. Where these results were not found, patients were classified as N0 pre-PST. Health care centres were classified according to the type of treatment performed after PST, taking into account whether a specific protocol was applied that included a reassessment with ultrasonography, and with FNA or a core needle biopsy (CNB) where necessary, after delivering PST and before performing the SLNB.
The SLNB was performed in accordance with the methodology included in the protocols of the Spanish Society of Senology and Breast Pathology (Sociedad Española de Senología y Patología Mamaria). In all cases, an axillary lymphadenectomy was performed and both the number of isolated lymph nodes and the number of affected lymph nodes were recorded.
The DR or positive identification was considered when at least one sentinel node was detected during surgical intervention, either with an isotopic tracer or with a mixed method using an isotope and dye. If during the pre-operative scan or during surgery nothing was detected, it was considered to be a negative result.
Cases with positive SLNB and with involvement of non-sentinel nodes isolated during the lymphadenectomy were defined as true positives (TP), and cases with negative sentinel nodes without involvement of any of the nodes isolated during the lymphadenectomy were defined as true negatives (TN). Cases where the sentinel node was negative and yet involved non-sentinel nodes were identified during the lymphadenectomy were defined as false negatives (FN). The false negative rate (FNR) was calculated by dividing the number of false negatives by the sum of false negatives and true positives.
The global DR and FNR were studied, as well as those in cases that demonstrated initial lymph node involvement (cN+) and those that did not (cN0), and the DR and FNR of these groups were compared with one another.
An initially unplanned sub-analysis was carried out, which evaluated the health care centres according to the protocols that were applied before the SLNB was performed. A comparison was made between centres in which an axillary examination using ultrasonography was performed systematically by specialist radiologists dedicated exclusively to breast health after neoadjuvant chemotherapy was delivered and before the SLNB was performed, which was excluded in cases where there was manifest involvement, and health care centres in which this examination was not performed or the radiological examination was performed by non-specialist radiologists.
Statistical analysis
A descriptive study was carried out of the demographic and anatomopathological variables and of the variables related to clinical and radiological evolution, both before and after PST. For the qualitative variables, the distribution of frequencies was calculated, whereas for the quantitative variables, measures of central tendency were used, such as the median and the mean. Both the point estimators of the DR, PPV, NPV and FNR and their confidence intervals (CI) at 95% were used. When dealing with small sample sizes, the CI was calculated precisely using the formula proposed by Clopper and Pearson.
The various rates (DR, PPV, NPV, FNR) for the different subsets of patients were compared. To do so, either a chi-square test was used, or if the expected frequency was less than 5, Fisher’s exact test was used.
Using a ROC curve, an evaluation was carried out of the validity of classifications made using the sentinel node technique compared with those using a lymphadenectomy (the gold standard technique). To do so, the sensitivity, specificity and area under the curve were calculated. These calculations were carried out both globally as well as by separating cases with initial axillary involvement from those without.
The statistical calculations were made using PASW v18 software. A level of p░
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Master's degree - University of Leeds
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Years of experience: 11. Registered at ProZ.com: Jul 2014.
Freelance translator and proofreader with experience of CAT tools and project management, providing high-quality language services from French, Spanish and Arabic into English.
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I graduated from the University of Durham in 2012 with a BA in Modern Languages (First Class Honours). I studied French, Spanish, Arabic and specialised translation, and I gained distinctions in spoken Arabic and French during my final year. I decided to spend the following academic year in China, teaching English to secondary school students in Changsha, in order to learn basic Mandarin Chinese and to gain a better insight into the culture. In 2014, I graduated from the University of Leeds with an MA in Applied Translation Studies (Distinction). I subsequently completed a six-month traineeship in the English and Irish Translation Unit of the European Parliament, based in Luxembourg, during which I translated documents for publication from French and Spanish into English and I edited original English documents for use by Parliament Members and staff.
I have experience as a freelance translator both professionally and on a voluntary basis for a wide range on clients across various subject fields. I specialise in the fields of medicine/allied health professions. I have a growing glossary of medical terminology, resources for researching any problem terms/concepts and a network of medical professionals with whom I discuss any queries relating to terminology or medical knowledge, and I work continuously to update and develop my skills and knowledge in my specialist fields.
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