Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study.

AIMS: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+(®)) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag(®)) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication. METHODS: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. RESULTS: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. CONCLUSIONS: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM.

La linfogammagrafía prequirúrgica y el grado histológico del tumor se asocian a la detección quirúrgica del ganglio centinela / Preoperative lymphoscintigraphy and tumor histologic grade are associated with surgical detection of the sentinel lymph node

Objetivo. Estudiar qué variables implicadas en el proceso de la biopsia selectiva del ganglio centinela (BSGC) influyen en la detección intraoperatoria del ganglio centinela. Material y métodos. Estudio transversal prospectivo de 210 pacientes (edad media: 54 años) diagnosticadas de cáncer de mama a las que se les realizó BSGC. Se recogieron los datos clínicos y radiológicos, de la administración del radioisótopo, quirúrgicos, de anatomía patológica y de seguimiento, y se realizó un análisis descriptivo y asociativo mediante una regresión múltiple multivariante. Resultados. La vía de inyección del radioisótopo más utilizada fue la profunda aislada (72,7%). La mayoría de las lesiones fueron palpables (57,1%), se presentaron como nódulos (67,1%), fueron menores de 2 cm (64,8%), se localizaron en el cuadrante supero-externo (49,1%), se trataba de carcinomas ductales (85,7%), con infiltración (66,2%) y el grado de diferenciación histológica fue ii (44,8%). Con la gammagrafía prequirúrgica se detectó el ganglio centinela en el 97,6% de los casos, y en el quirófano el 95,7%. Se observó una recurrencia axilar. En el estudio asociativo, las variables «linfogammagrafía prequirúrgica» y «grado de diferenciación histológica del tumor» mostraron una asociación estadísticamente significativa con la detección del ganglio centinela en el quirófano. Conclusión. La probabilidad de no detectar el ganglio centinela durante la intervención quirúrgica es mayor en los pacientes con tumores de alto grado histológico o en las que no se ha conseguido verlo en la linfogammagrafía prequirúrgica (AI)

Objective. To study which variables involved in the process of selective sentinel node biopsy (SSNB) influence the intraoperative detection of the sentinel lymph node. Material and methods. This was a prospective cross-sectional study in 210 patients (mean age, 54 years) diagnosed with breast cancer who underwent SSNB. We recorded clinical, radiological, radioisotope administration, surgical, and histological data as well as follow-up data. We did a descriptive analysis of the data and an associative analysis using multivariable regression. Results. Deep injection alone was the most common route of radioisotope administration (72.7%). Most lesions were palpable (57.1%), presented as nodules (67.1%), measured less than 2 cm in diameter (64.8%), were located in the upper outer quadrant (49.1%), were ductal carcinomas (85.7%), were accompanied by infiltration (66.2%), and had a histologic grade of differentiation of ii (44.8%). Preoperative scintigraphy detected the sentinel node in 97.6% of cases and 95.7% were detected during the operation. One axillary relapse was observed. In the associative study, the variables «preoperative lymphoscintigraphy» and «histologic grade of differentiation of the tumor» were significantly associated with the detection of the sentinel lymph node during the operation. Conclusion. The probability of not detecting the sentinel lymph node during the surgical intervention is higher in patients with high histologic grade tumors or in patients in whom preoperative lymphoscintigraphy failed to detect the sentinel node (AU)

Preoperative lymphoscintigraphy and tumor histologic grade are associated with surgical detection of the sentinel lymph node.

OBJECTIVE: To study which variables involved in the process of selective sentinel node biopsy (SSNB) influence the intraoperative detection of the sentinel lymph node. MATERIAL AND METHODS: This was a prospective cross-sectional study in 210 patients (mean age, 54 years) diagnosed with breast cancer who underwent SSNB. We recorded clinical, radiological, radioisotope administration, surgical, and histological data as well as follow-up data. We did a descriptive analysis of the data and an associative analysis using multivariable regression. RESULTS: Deep injection alone was the most common route of radioisotope administration (72.7%). Most lesions were palpable (57.1%), presented as nodules (67.1%), measured less than 2 cm in diameter (64.8%), were located in the upper outer quadrant (49.1%), were ductal carcinomas (85.7%), were accompanied by infiltration (66.2%), and had a histologic grade of differentiation of ii (44.8%). Preoperative scintigraphy detected the sentinel node in 97.6% of cases and 95.7% were detected during the operation. One axillary relapse was observed. In the associative study, the variables "preoperative lymphoscintigraphy" and "histologic grade of differentiation of the tumor" were significantly associated with the detection of the sentinel lymph node during the operation. CONCLUSION: The probability of not detecting the sentinel lymph node during the surgical intervention is higher in patients with high histologic grade tumors or in patients in whom preoperative lymphoscintigraphy failed to detect the sentinel node.

Prevalencia de micrometástasis y células aisladas en el ganglio centinela en estadios iniciales del cáncer de mama / Prevalence of micrometastases and isolated tumor cells in the sentinel node at early stage breast cancer

Objetivo. Estudiar la prevalencia de células tumorales aisladas (CTA) y micrometástasis en el ganglio centinela del cáncer de mama en estadios iniciales. Material y métodos. Estudiamos 234 enfermas con cáncer de mama estadios T1 o T2, sin afectación axilar clínica ni con ecografía-PAAF. El ganglio centinela fue identificado mediante linfogammagrafía y extraído en el quirófano. Posteriormente se estudió mediante cortes seriados y tinciones inmunohistoquímicas, y catalogados como negativo (GC−), negativo con CTA (GC−CTA), positivo por micrometástasis (Mic) y positivo con macrometástasis (GC+mac). Se realizó linfadenectomía axilar completa cuando se hallaron micro o macrometástasis en el ganglio centinela, siendo catalogada en el primer caso como negativa (LAC−), positiva con micrometástasis (LAC+mic) y positivo con macrometástasis (LAC+mac) el resto. El período de seguimiento fue de entre 6 y 71 meses. Resultados. Se detectaron CTA en el ganglio centinela en 12 enfermas (5,1%), y micrometástasis en otras 24 (10,3%). Por tanto, un total de 36 pacientes se vieron afectadas por alguna de estas dos entidades (15,4%). Por su parte la LAC en el grupo con micrometástasis fue LAC− en 19/24 (79,1%), positivo LAC+mic en 2 (8,3%) y LAC+mac en 3 (12,5%). No existen recaídas axilares hasta la fecha. Conclusiones. La infiltración del ganglio centinela por CTA o micrometástasis en estadios iniciales del cáncer de mama afecta a un porcentaje significativo de enfermas. La escasa frecuencia de LAC+ en los GC+ mic invita a plantear la posibilidad de evitar la LAC en favor de otros tratamientos adyuvantes (quimioterapia, radioterapia)(AU)

Aim. To analyze the prevalence of isolated tumor cells (ITC) and micrometastases in the sentinel node of early stage breast cancer. Material and methods. A total of 234 patients diagnosed of breast cancer, stages T1 or T2, with no axillary involvement detected by palpation or ultrasound-FNA, were studied. The sentinel node (SN) was identified by lymphoscintigraphy and removed in the operating room. Serial sections and immunohistochemical staining were then performed, classifying them as negative (SN−), negative with ITC (SN-ITC), positive with micrometastases (SN+mic) and positive with macrometastases (SN+mac). A complete axillary lymphadenectomy (CAL) was carried out in those cases with micro- or macrometastases, the former being classified as negative (CAL−), positive with micrometatases (CAL+mic), and positive with macrometastases (CAL+mac). The follow-up ranged from 6-71 months. Results. ITC were found in 12 patients (5.1%) and micrometastases in 24 (10.3%). Thus, a total of 36 patients were affected by some of these conditions (15.4%). In the group with micrometastases, the result of CAL was CAL− in 19/24 (79.1%), CAL+mic in 2 (8.3%) and CAL+mac in 3 (12.5%). No axillary recurrences have occurred up to date. Conclusions. ITC and micrometastases were found in the sentinel node in a significant percentage of patients in the early stages of breast cancer. The low percentage of further axillary invasion in the group of micrometastases may open up the possibility of avoiding CAL in favor of other adjuvant treatments (chemotherapy, radiotherapy)(AU)

[Prevalence of micrometastases and isolated tumor cells in the sentinel node at early stage breast cancer]. / Prevalencia de micrometástasis y células aisladas en el ganglio centinela en estadios iniciales del cáncer de mama.

AIM: To analyze the prevalence of isolated tumor cells (ITC) and micrometastases in the sentinel node of early stage breast cancer. MATERIAL AND METHODS: A total of 234 patients diagnosed of breast cancer, stages T1 or T2, with no axillary involvement detected by palpation or ultrasound-FNA, were studied. The sentinel node (SN) was identified by lymphoscintigraphy and removed in the operating room. Serial sections and immunohistochemical staining were then performed, classifying them as negative (SN-), negative with ITC (SN-ITC), positive with micrometastases (SN+mic) and positive with macrometastases (SN+mac). A complete axillary lymphadenectomy (CAL) was carried out in those cases with micro- or macrometastases, the former being classified as negative (CAL-), positive with micrometatases (CAL+mic), and positive with macrometastases (CAL+mac). The follow-up ranged from 6-71 months. RESULTS: ITC were found in 12 patients (5.1%) and micrometastases in 24 (10.3%). Thus, a total of 36 patients were affected by some of these conditions (15.4%). In the group with micrometastases, the result of CAL was CAL- in 19/24 (79.1%), CAL+mic in 2 (8.3%) and CAL+mac in 3 (12.5%). No axillary recurrences have occurred up to date. CONCLUSIONS: ITC and micrometastases were found in the sentinel node in a significant percentage of patients in the early stages of breast cancer. The low percentage of further axillary invasion in the group of micrometastases may open up the possibility of avoiding CAL in favor of other adjuvant treatments (chemotherapy, radiotherapy).

Micrometástasis en el ganglio centinela y macrometástasis ganglionares axilares en el cáncer de mama / Micrometastasis in the sentinel node and axillary lymph node macrometastasis in breast cancer

ObjetivoEl estudio del ganglio centinela ha permitido tener un conocimiento más preciso del grado de afectación axilar en el cáncer de mama, disminuyendo a su vez la morbilidad quirúrgica asociada a la exploración de la axila. El uso sistemático de técnicas inmunohistoquímicas y de biología molecular permite detectar la presencia de micrometástasis o de células aisladas en un porcentaje relevante de casos, como único signo de extensión linfática de la enfermedad. Actualmente, se plantea la posibilidad de evitar la linfadenectomía axilar completa en aquellas enfermas que solo presentan micrometástasis, dada la baja incidencia de afectación en el resto de los ganglios axilares.Material y métodoSe incluyeron 159 enfermas con cáncer de mama en estadio T1 o T2, en las que se identificó mediante gammagrafía y se localizó intraoperatoriamente el ganglio centinela, practicándoseles una linfadenectomía axilar completa en el caso de observarse afectación por micro o macrometástasis, con el fin de determinar el grado de extensión axilar.ResultadosUn total de 40 enfermas (25%) mostraron afectación del ganglio centinela, siendo en 17 de ellas (10,7%) invasión sólo por micrometástasis. De entre estas 17 enfermas, solo 2 (11,8%) mostraron invasión por macrometástasis en la linfadenectomía, no modificándose en el resto la estadificación alcanzada tras el estudio del ganglio centinela.ConclusiónCabe conjeturar que en el futuro pueda evitarse la disección axilar en las enfermas con afectación por micrometástasis, a la espera de los resultados que arrojen los estudios multicéntricos actualmente en marcha(AU)

AimThe study of the sentinel node has made it possible to obtain more comprehensive knowledge about the extent of axillary involvement in breast cancer. It has also decreased the surgical morbidity associated to the surgical examination of the axilla. The systematic use of immunohistochemical staining and molecular biology techniques improves the ability to detect the presence of micrometastasis or isolated tumor cells in a significant number of cases when this is the only sign of the lymph node extension of the disease. The possibility of avoiding complete axillary lymphadenectomy in those patients who are only affected by micrometastasis is proposed because of the low incidence of further involvement of the remaining lymph nodes.Material and method159 patients diagnosed of stage T1 or T2 breast cancer, in which the sentinel node had been identified by scintigraphy and intraoperative localization, were included in the study. Complete axillary lymphadenectomy was performed when micro- or macrometastases were found in the sentinel node, in order to determine the degree of axillary involvement.ResultsA total of 40 patients (25%) showed infiltration of the sentinel node. This infiltration was only by micrometastasis in 17 of them (10.7%). Of these 17 patients, only 2 (11.8%) showed macrometastasis in the lymphadenectomy. In the remaining subjects, the final staging reached after the sentinel node study was not modified.ConclusionIt is possible to speculate that, in the future, axillary dissection can be avoided in those patients diagnosed of micrometastasis in the sentinel node, pending the conclusions of the on-going multicenter studies(AU)

[Micrometastasis in the sentinel node and axillary lymph node macro-metastasis in breast cancer]. / Micrometástasis en el ganglio centinela y macrometástasis ganglionares axilares en el cáncer de mama.

AIM: The study of the sentinel node has made it possible to obtain more comprehensive knowledge about the extent of axillary involvement in breast cancer. It has also decreased the surgical morbidity associated to the surgical examination of the axilla. The systematic use of immunohistochemical staining and molecular biology techniques improves the ability to detect the presence of micrometastasis or isolated tumor cells in a significant number of cases when this is the only sign of the lymph node extension of the disease. The possibility of avoiding complete axillary lymphadenectomy in those patients who are only affected by micrometastasis is proposed because of the low incidence of further involvement of the remaining lymph nodes. MATERIAL AND METHOD: 159 patients diagnosed of stage T1 or T2 breast cancer, in which the sentinel node had been identified by scintigraphy and intraoperative localization, were included in the study. Complete axillary lymphadenectomy was performed when micro- or macrometastases were found in the sentinel node, in order to determine the degree of axillary involvement. RESULTS: A total of 40 patients (25%) showed infiltration of the sentinel node. This infiltration was only by micrometastasis in 17 of them (10.7%). Of these 17 patients, only 2 (11.8%) showed macro-metastasis in the lymphadenectomy. In the remaining subjects, the final staging reached after the sentinel node study was not modified. CONCLUSION: It is possible to speculate that, in the future, axillary dissection can be avoided in those patients diagnosed of micrometastasis in the sentinel node, pending the conclusions of the on-going multicenter studies.

[Radioguided occult breast lesion location (ROLL)]. / Localización radioguiada de lesiones ocultas de mama (ROLL).

OBJECTIVE: To obtain correct location of occult breast lesions by radiopharmaceutical methods. MATERIAL AND METHODS: Sixty-one patients whose ages ranged from 32 to 83 years (average: 57), with non-palpable breast lesions detected by mammography were studied. Six of them had a background of previous breast cancer. Sixty-three lesions were found. The lesions were classified into 34 clusters of microcalcifications, 25 nodules and 4 others parenchymal distortions. All patients received one dose of 0.3-0.5 mCi (11.1-18.5 MBq) of macroaggregates of 99mTc-labelled human serum albumin (99mTc-MAA) into the lesion under stereotactic mammographic or ultrasonography guidance. Anterior and lateral scintigraphic images were acquired in order to verify the correct location of the radiopharmaceutical. Intraoperative location of the lesion was performed using a gammaprobe. In case of microcalcifications, the entire removal of the lesion was verified by X-ray of the specimen. RESULTS: Placement of the radiotracer was good in 60 of 63 (95.2%) cases. Sixty-one lesions were completely removed. Pathological examination revealed 29 (47.6%) breast cancers and 32 (52.4%) benign lesions. CONCLUSION: Radioguided occult breast lesion location by radiopharmaceutical methods is a simple, safe and well-tolerated method by patients.

Localización radioguiada de lesiones ocultas de mama (ROLL) / Radioguided occult breast lesion location (ROLL)

Objetivo: Obtener una correcta localización de lesiones ocultas de mama mediante técnicas radioisotópicas. Material y métodos: Se han estudiado 61 pacientes con edades comprendidas entre 32 y 83 años (media de 57 años), con lesiones no palpables de mama, detectadas por mamografía. Seis pacientes tenían antecedentes de cáncer de mama. Sesenta y tres lesiones fueron encontradas. Las lesiones se clasificaron en 34 grupos de microcalcificaciones, 25 nódulos y 4 otras distorsiones de parénquima. Todas las pacientes recibieron una dosis de 0,3-0,5 mCi (11,1-18,5 MBq) de macroagregados de albúmina humana marcados con 99mTc ( 99mTc-MAA) intralesionalmente mediante mamografía estereotáxica o ecografía. Se adquirieron imágenes gammagráficas en proyecciones anterior y lateral, para valorar la correcta colocación del radiotrazador. La localización quirúrgica se realizó mediante la ayuda de una sonda gammadetectora (SGD). En el caso de microcalcificaciones, se realizó comprobación mamográfica de la pieza quirúrgica para confirmar su correcta exéresis. Resultados: La colocación del radiotrazador fue correcta en 60 de 63 casos (95,2 %). Sesenta y una lesiones fueron extraídas totalmente. La anatomía patológica reveló 29 (47,6 %) lesiones malignas y las 32 (52,4 %) restantes fueron benignas. Conclusión: La localización radioguiada de lesiones ocultas de mama mediante técnica radioisotópica es un método sencillo, seguro y bien tolerado por las pacientes

Objective: To obtain correct location of occult breast lesions by radiopharmaceutical methods. Material and methods: Sixty-one patients whose ages ranged from 32 to 83 years (average: 57), with non-palpable breast lesions detected by mammography were studied. Six of them had a background of previous breast cancer. Sixty-three lesions were found. The lesions were classified into 34 clusters of microcalcifications, 25 nodules and 4 others parenchymal distortions. All patients received one dose of 0.3-0.5 mCi (11.1-18.5 MBq) of macroaggregates of 99mTc-labelled human serum albumin ( 99mTc-MAA) into the lesion under stereotactic mammographic or ultrasonography guidance. Anterior and lateral scintigraphic images were acquired in order to verify the correct location of the radiopharmaceutical. Intraoperative location of the lesion was performed using a gammaprobe. In case of microcalcifications, the entire removal of the lesion was verified by X-ray of the specimen. Results: Placement of the radiotracer was good in 60 of 63 (95.2 %) cases. Sixty-one lesions were completely removed. Pathological examination revealed 29 (47.6 %) breast cancers and 32 (52.4 %) benign lesions. Conclusion: Radioguided occult breast lesion location by radiopharmaceutical methods is a simple, safe and well-tolerated method by patients

Pseudomixoma peritoneal de origen desconocido / Pseudomixoma peritonei of unknown origin

No disponible

Paciente de 77 años de edad con derrame pleural recidivante / A 77 years old patient with relapsed pleural effusion

No disponible

Hematoma subcapsular hepático sintomático tras litotricia renal extracorpórea mediante ondas de choque / Symptomatic hepatic subcapsular hematoma following extracorporeal real shock wave lithotripsy

La presentación de un hematoma subcapsular hepático como complicación tras la realización de litotricia renal extracorpórea mediante ondas de choque es bastante infrecuente. Describimos el caso de un enfermo que presentó sintomatología abdominal intensa post-litotricia renal extracorpórea y en el que se descartó la presencia de patología hepática previa, alteraciones en el sistema de coagulación sanguínea así como anomalías en la ejecución de la litotricia extracorpórea como mecanismos etiológicos. Realizamos una revisión bibliográfica debido a la rareza del proceso descrito (AU)

[Symptomatic subcapsular hepatic hematoma after renal extracorporeal shock wave lithotripsy]. / Hematoma subcapsular hepático sintomático tras litotricia renal extracorpórea mediante ondas de choque.

The presentation of a hepatic subcapsular hematoma as a complication following the carrying out of an extracorporeal renal shock wave lithotripsy is fairly uncommon. We would like to describe the case of a patient who showed after extracorporeal renal post-lithotripsy intense abdominal symptoms and in which the presence of any prior hepatic pathology was ruled out, alterations in the blood coagulation system as well as anomalies in the execution of the extracorporeal lithotripsy as etiological mechanisms. We carried out a bibliographical review due to the rarity of the process described.

[Tumors originating in the muscularis mucosae of the recto-sigma]. / Tumores originados en la muscularis mucosae del recto-sigma.

Tumours arising from the muscular layer of the bowel are uncommon and extremely rare when localized in colon and rectum. Most of them arise from the external muscular layer or muscularis propria. Tumours originating in muscularis mucosae or in the vascular system are uncommon. Two hundred rectal leiomyomas and leiomyosarcomas have been described. Tumours originated in the muscularis mucosae are polypoid, pedunculated, benign and most of them will be treated by a polypectomy without recurrence. However leiomyomas arising from the muscularis propia have a 60% of recurrence after local treatment and in some cases the recurrence will be a metastatic leiomyosarcoma. Three tumours arising from muscularis mucosae of the rectum and sigma are presented. All three were diagnosed and removed by colonoscopy. Two were diagnosed as leiomyomas. The third was a low grade leiomyosarcoma and an anterior resection was performed as definitive treatment.