[18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study.

PURPOSE: Primary objective was to compare the per-patient detection rates (DR) of [18F]DCFPyL versus [18F]fluoromethylcholine positron emission tomography/computed tomography (PET/CT), in patients with first prostate cancer (PCa) biochemical recurrence (BCR). Secondary endpoints included safety and impact on patient management (PM). METHODS: This was a prospective, open label, cross-over, comparative study with randomized treatment administration of [18F]DCFPyL (investigational medicinal product) or [18F]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [18F]DCFPyL and [18F]fluoromethylcholine PET/CTs were performed within a maximum time interval of 12 days. DR was defined as the percentage of positive PET/CT scans identified by 3 central imaging readers. PM was assessed by comparing the proposed pre-PET/CT treatment with the local treatment", defined after considering both PET/CTs. RESULTS: A total of 205 patients with first BCR after radical prostatectomy (73%; median PSA = 0.46 ng/ml [CI 0.16;27.0]) or radiation therapy (27%; median PSA = 4.23 ng/ml [CI 1.4;98.6]) underwent [18F]DCFPyL- and/or [18F]fluoromethylcholine -PET/CTs, between July and December 2020, at 22 European sites. 201 patients completed the study. The per-patient DR was significantly higher for [18F]DCFPyL- compared to [18F]fluoromethylcholine -PET/CTs (58% (117/201 patients) vs. 40% (81/201 patients), p < 0.0001). DR increased with higher PSA values for both tracers (PSA ≤ 0.5 ng/ml: 26/74 (35%) vs. 22/74 (30%); PSA 0.5 to ≤ 1.0 ng/ml: 17/31 (55%) vs. 10/31 (32%); PSA 1.01 to < 2.0 ng/ml: 13/19 (68%) vs. 6/19 (32%);PSA > 2.0: 50/57 (88%) vs. 39/57 (68%) for [18F]DCFPyL- and [18F]fluoromethylcholine -PET/CT, respectively). [18F]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [18F]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed. CONCLUSIONS: The primary endpoint of this study was achieved, confirming a significantly higher detection rate for [18F]DCFPyL compared to [18F]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [18F]DCFPyL was safe and well tolerated.

Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study.

BACKGROUND: Peptide receptor radionuclide therapy (PRRT) is one of the most promising therapeutic strategies in neuroendocrine neoplasms (NENs). Nevertheless, its role in certain tumor sites remains unclear. This study sought to elucidate the efficacy and safety of [177Lu]Lu-DOTATATE in NENs with different locations and evaluate the effect of the tumor origin, bearing in mind other prognostic variables. Advanced NENs overexpressing somatostatin receptors (SSTRs) on functional imaging, of any grade or location, treated at 24 centers were enrolled. The protocol consisted of four cycles of 177Lu-DOTATATE 7.4 GBq iv every 8 weeks (NCT04949282). RESULTS: The sample comprised 522 subjects with pancreatic (35%), midgut (28%), bronchopulmonary (11%), pheochromocytoma/ paraganglioma (PPGL) (6%), other gastroenteropancreatic (GEP) (11%), and other non-gastroenteropancreatic (NGEP) (9%) NENs. The best RECIST 1.1 responses were complete response, 0.7%; partial response, 33.2%; stable disease, 52.1%; and tumor progression, 14%, with activity conditioned by the tumor subtype, but with benefit in all strata. Median progression-free survival (PFS) was 31.3 months (95% CI, 25.7-not reached [NR]) in midgut, 30.6 months (14.4-NR) in PPGL, 24.3 months (18.0-NR) in other GEP, 20.5 months (11.8-NR) in other NGEP, 19.8 months (16.8-28.1) in pancreatic, and 17.6 months (14.4-33.1) in bronchopulmonary NENs. [177Lu]Lu-DOTATATE exhibited scant severe toxicity. CONCLUSION: This study confirms the efficacy and safety of [177Lu]Lu-DOTATATE in a wide range of SSTR-expressing NENs, regardless of location, with clinical benefit and superimposable survival outcomes between pNENs and other GEP and NGEP tumor subtypes different from midgut NENs.

Efficacy and safety of 177Lu­DOTATATE in patients with advanced pancreatic neuroendocrine tumours: data from the NETTER-R international, retrospective study.

PURPOSE: NETTER-R aimed to determine the efficacy, safety and tolerability of 177Lu-DOTATATE in patients with progressive, advanced pancreatic neuroendocrine tumours (panNETs) using retrospective real-world data from multiple sites. METHODS: This international study retrospectively included patients with panNETs treated with 177Lu-DOTATATE. The primary endpoint was progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included overall survival (OS), safety and tumour response. RESULTS: In total, 110 patients with panNETs were studied; 65.5% received a cumulative dose of 177Lu-DOTATATE 29.6 GBq ± 10% (median: 7.4 GBq). In 62 patients with available RECIST v1.1 tumour response, the median PFS was 24.8 months (95% confidence interval [CI]: 17.5-34.5), and the objective response rate was 40.3% (95% CI: 28.1-53.6); all responses were partial. With a median follow up of 24.5 months (range: 2.0-123.4 months) after the first cycle of 177Lu-DOTATATE, the median OS in the full analysis set (n = 110) was 41.4 months (95% CI: 28.6-50.2). PFS (hazard ratio [HR]: 3.672; p = 0.0009) and OS (HR: 3.360; p < 0.0001) were longer in patients who received no chemotherapy prior to 177Lu-DOTATATE than those who did. No treatment-emergent adverse events (TEAEs) led to treatment discontinuation. Grade 3 anaemia, lymphopenia and thrombocytopenia occurred in 0.9%, 5.4% and 0.9% of patients, respectively. No acute leukaemia or myelodysplastic syndrome was reported. Six patients (5.5%) had renal TEAEs. All renal grade ≥ 3 events were transient and did not lead to treatment modification. CONCLUSIONS: These results reinforce the role of 177Lu-DOTATATE for the treatment of patients with advanced, somatostatin receptor-positive panNETs.

Multimodal therapy in aggressive pituitary tumors / Tratamiento multimodal de los tumores hipofisarios agresivos

The concept of aggressive pituitary tumor (APT) has been precisely defined in recent years. These tumors are characterized by morphological (radiological or histopathological) data of invasion, proliferative activity superior to that of typical adenomas and a clinical behavior characterized by resistance to standard therapies and frequent recurrences. The absence of cerebrospinal or distant metastases differentiates them from the pituitary carcinoma. APTs account for about 10% of all pituitary neoplasm. Proper diagnostic implies participation not only of radiological and hormonal investigation but also a thorough pathological assessment including proliferation markers and immunohistochemistry for hormones and transcription factors. Surgical resection, aiming gross total resection or tumor debulking, is the mainstay initial therapy in most patients. Most patients with APTs need more than one surgical intervention, pituitary radiation, sometimes on more than one occasion, and multiple sequential or combined medical treatments, to finally be doomed to unusual treatments, such as alkylating agents (temozolomide alone or in combination), molecular targeted therapies, or peptide receptor radionuclide therapy. Multimodal therapy, implemented by experts, preferably in specialized centers with high volume caseload, is the only way to improve the prognosis of patients with these uncommon tumors. The research needs in this area are multiple and include a greater knowledge of the molecular biology of these tumors, establishment of protocols for monitoring and sequencing of treatments, development of multicenter studies and international registries

El concepto de tumor hipofisario agresivo (THA) se ha definido con más precisión en los últimos años. Son tumores caracterizados por signos morfológicos (radiológicos o histopatológicos) de invasión, actividad proliferativa superior a la de los adenomas típicos y un comportamiento clínico caracterizado por resistencia a los tratamientos habituales y recidivas frecuentes. La ausencia de metástasis cefalorraquídeas o a distancia los diferencia del carcinoma hipofisario. Los THA suponen alrededor del 10% de todas las neoplasias hipofisarias. Un diagnóstico apropiado exige no solo investigación radiológica y hormonal, sino también una valoración histopatológica detenida que incluya marcadores de proliferación e inmunohistoquímica para hormonas y factores de transcripción. La resección quirúrgica encaminada a la resección total o la reducción del volumen tumoral es el tratamiento inicial clave en la mayoría de los pacientes. La mayoría de los pacientes con THA necesitan más de una intervención quirúrgica, irradiación hipofisaria, a veces en más de una ocasión, y diversos tratamientos médicos consecutivos o combinados, y están predestinados a terminar recibiendo tratamiento inhabituales como fármacos alquilantes (temozolomida sola o en combinación), tratamientos multidiana o tratamientos con péptidos radiomarcados. El tratamiento multimodal aplicado por expertos, preferiblemente en centros especializados con gran volume de pacientes, es el único modo de mejorar el pronóstico de los pacientes con estos tumores poco frecuentes. Las necesidades de investigación en este campo son enormes, e incluyen la de un mayor conocimiento de la biología molecular de estos tumores, el establecimiento de protocolos de vigilancia y secuenciación de los tratamientos, el desarrollo de estudios multicéntricos y registros internacionales

Multimodal therapy in aggressive pituitary tumors.

The concept of aggressive pituitary tumor (APT) has been precisely defined in recent years. These tumors are characterized by morphological (radiological or histopathological) data of invasion, proliferative activity superior to that of typical adenomas and a clinical behavior characterized by resistance to standard therapies and frequent recurrences. The absence of cerebrospinal or distant metastases differentiates them from the pituitary carcinoma. APTs account for about 10% of all pituitary neoplasm. Proper diagnostic implies participation not only of radiological and hormonal investigation but also a thorough pathological assessment including proliferation markers and immunohistochemistry for hormones and transcription factors. Surgical resection, aiming gross total resection or tumor debulking, is the mainstay initial therapy in most patients. Most patients with APTs need more than one surgical intervention, pituitary radiation, sometimes on more than one occasion, and multiple sequential or combined medical treatments, to finally be doomed to unusual treatments, such as alkylating agents (temozolomide alone or in combination), molecular targeted therapies, or peptide receptor radionuclide therapy. Multimodal therapy, implemented by experts, preferably in specialized centers with high volume caseload, is the only way to improve the prognosis of patients with these uncommon tumors. The research needs in this area are multiple and include a greater knowledge of the molecular biology of these tumors, establishment of protocols for monitoring and sequencing of treatments, development of multicenter studies and international registries.

Réplica: Sobre la profesionalidad en el manejo de los tumores del tiroides y los grupos de trabajo multidisciplinares / Reply letter: On professionalism in the management of thyroid tumors and multidisciplinary working groups

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Noncirrhotic portal hypertension: An under-reported late adverse event of SIRT in metastatic colorectal cancer patients.

INTRODUCTION: Selective internal radiation therapy (SIRT) is increasingly used in different scenarios. Although portal hypertension (PHT) has been described as a nonclinically relevant finding after SIRT, its real incidence could have been neglected due to the nature of the diseases for which SIRT is indicated. CASE REPORTS: Here we report three cases with clinically relevant late PHT after treatments including SIRT and oxaliplatin among others. DISCUSSION: The sequential use of oxaliplatin and SIRT in patients with colorectal cancer metastases could have additive effects on the liver.

Características de profesionalidad de los especialistas y ventajas de los equipos multidisciplinares en cáncer de tiroides: resultados de una encuesta de opinión nacional / Characteristics of professionalism of specialists and advantages of multidisciplinary teams in thyroid cancer: results of a national opinion survey

Introducción: En nuestro país no se ha estudiado la opinión de los profesionales sobre los equipos multidisciplinares en cáncer de tiroides. El objetivo de este estudio ha sido conocer la opinión de los especialistas sobre las características de los profesionales y las ventajas que aportan estos estos equipos. Métodos: Se diseñó una encuesta para valorar la opinión sobre las características de profesionalidad y las ventajas de los equipos multidisciplinares para pacientes, profesionales y sistema sanitario. La encuesta se mantuvo activa online del 15 de noviembre de 2017 al 15 de febrero de 2018. Resultados: Se recibieron 226 encuestas. La capacidad para trabajar en equipo fue considerada la característica más importante que deben cumplir los profesionales por el 37,2% de los encuestados, mientras que la competencia científica fue el indicador de profesionalidad más importante para el 37,6%. Más de 2/3 de los especialistas opinan que los equipos multidisciplinares mejoran la elección de tratamientos y procedimientos diagnósticos, reducen la variabilidad clínica, facilitan la implementación de las guías clínicas, mejoran la formación continuada y aumentan la satisfacción de los pacientes, así como el prestigio del hospital. El grado de acuerdo con las ventajas de los EMD fue significativamente superior entre los especialistas que contaban con un EMD en su hospital. Conclusiones: Estos resultados muestran una opinión globalmente muy favorable de los profesionales hacia el modelo de trabajo multidisciplinar. Los responsables de los hospitales y las autoridades sanitarias deberían tener en cuenta estos hechos para favorecer y apoyar la implantación de estos equipos

Introduction: The opinion of professionals about multidisciplinary teams (MDT) in thyroid cancer has not been studied in Spain. This study was intended to ascertain the opinion of specialists about the characteristics of the professionals and the advantages provided by these teams. Methods: A survey was designed to assess the opinion about the characteristics of professionalism and the advantages of MDT for patients, professionals, and the health care system. The survey was posted online from November 15, 2017 to February 15, 2018. Results: A total of 226 surveys were evaluated. The ability for teamwork was considered the most important characteristic to be met by professionals by 37.2% of respondents, while scientific competence was the most important indicator of professionalism for 37.6%. More than two thirds of specialists felt that MDTs improve the choice of treatments and diagnostic procedures, decrease clinical variability, facilitate implementation of clinical guidelines, improve ongoing training, and increase patient satisfaction and hospital prestige. The degree of agreement with the advantages of MDTs was significantly higher among specialists who had a MDT at their hospitals. Conclusions: The overall opinion of professionals on the MDT model is highly favorable. Hospital managers and health care authorities should take these facts into account in order to encourage and support implementation of these teams

Characteristics of professionalism of specialists and advantages of multidisciplinary teams in thyroid cancer: results of a national opinion survey. / Características de profesionalidad de los especialistas y ventajas de los equipos multidisciplinares en cáncer de tiroides: resultados de una encuesta de opinión nacional.

INTRODUCTION: The opinion of professionals about multidisciplinary teams (MDT) in thyroid cancer has not been studied in Spain. This study was intended to ascertain the opinion of specialists about the characteristics of the professionals and the advantages provided by these teams. METHODS: A survey was designed to assess the opinion about the characteristics of professionalism and the advantages of MDT for patients, professionals, and the health care system. The survey was posted online from November 15, 2017 to February 15, 2018. RESULTS: A total of 226 surveys were evaluated. The ability for teamwork was considered the most important characteristic to be met by professionals by 37.2% of respondents, while scientific competence was the most important indicator of professionalism for 37.6%. More than two thirds of specialists felt that MDTs improve the choice of treatments and diagnostic procedures, decrease clinical variability, facilitate implementation of clinical guidelines, improve ongoing training, and increase patient satisfaction and hospital prestige. The degree of agreement with the advantages of MDTs was significantly higher among specialists who had a MDT at their hospitals. CONCLUSIONS: The overall opinion of professionals on the MDT model is highly favorable. Hospital managers and health care authorities should take these facts into account in order to encourage and support implementation of these teams.

Declaración de consenso para la acreditación de unidades multidisciplinares en cáncer de tiroides / Consensus statement for accreditation of multidisciplinary thyroid cancer units

El cáncer de tiroides supone la primera causa de neoplasias del sistema endocrino. Recientemente hemos asistido a grandes avances en el conocimiento de sus causas y de la biología molecular que los hace crecer y proliferar, así como al perfeccionamiento de las técnicas diagnósticas y a una mayor disponibilidad de tratamientos eficaces, locales y sistémicos. Todo ello convierte a este tumor en un paradigma de cómo diversas especialidades deben trabajar de manera conjunta para conseguir el mayor beneficio para el paciente. La coordinación de los procedimientos y flujos que el paciente debe seguir a lo largo de su diagnóstico, tratamiento y seguimiento es fundamental para una optimización de recursos y tiempos. El presente artículo se ha redactado, a propuesta del Grupo de Trabajo de Cáncer de Tiroides de la Sociedad Española de Endocrinología y Nutrición, con la intención de presentar un documento de consenso sobre definición, composición, requisitos, estructura y funcionamiento de un equipo multidisciplinar para la atención integral de pacientes con cáncer de tiroides. Para ello se ha contado con las aportaciones de varios profesionales de distintas especialidades con experiencia en el tratamiento del cáncer de tiroides en centros donde los equipos multidisciplinares llevan años implantados con la voluntad de elaborar un consenso práctico y aplicable a la práctica médica asistencial (AU)

Thyroid cancer is the leading endocrine system tumor. Great advances have recently been made in understanding of the origin of these tumors and the molecular biology that makes them grow and proliferate, which have been associated to improvements in diagnostic procedures and increased availability of effective local and systemic treatments. All of the above makes thyroid cancer a paradigm of how different specialties should work together to achieve the greatest benefit for the patients. Coordination of all the procedures and patient flows should continue throughout diagnosis, treatment, and follow-up, and is essential for further optimization of resources and time. This manuscript was prepared at the request of the Working Group on Thyroid Cancer of the Spanish Society of Endocrinology and Nutrition, and is aimed to provide a consensus document on the definition, composition, requirements, structure, and operation of a multidisciplinary team for the comprehensive care of patients with thyroid cancer. For this purpose, we have included contributions by several professionals from different specialties with experience in thyroid cancer treatment at centers where multidisciplinary teams have been working for years, with the aim of developing a practical consensus applicable in clinical practice (AU)

[Consensus statement for accreditation of multidisciplinary thyroid cancer units]. / Declaración de consenso para la acreditación de unidades multidisciplinares en cáncer de tiroides.

Thyroid cancer is the leading endocrine system tumor. Great advances have recently been made in understanding of the origin of these tumors and the molecular biology that makes them grow and proliferate, which have been associated to improvements in diagnostic procedures and increased availability of effective local and systemic treatments. All of the above makes thyroid cancer a paradigm of how different specialties should work together to achieve the greatest benefit for the patients. Coordination of all the procedures and patient flows should continue throughout diagnosis, treatment, and follow-up, and is essential for further optimization of resources and time. This manuscript was prepared at the request of the Working Group on Thyroid Cancer of the Spanish Society of Endocrinology and Nutrition, and is aimed to provide a consensus document on the definition, composition, requirements, structure, and operation of a multidisciplinary team for the comprehensive care of patients with thyroid cancer. For this purpose, we have included contributions by several professionals from different specialties with experience in thyroid cancer treatment at centers where multidisciplinary teams have been working for years, with the aim of developing a practical consensus applicable in clinical practice.

Biliobronchial fistula after liver surgery for giant hydatid cyst.

Background. Biliobronchial fistula (BBF) is a rare complication in the natural history of liver hydatid disease by Echinococcus granulosus. We present a case of BBF after resection of a giant liver hydatid cyst in a 72-year-old woman. Case Report. A total cystpericystectomy was done, leaving the left lateral section of the liver that was fixed to the diaphragm. Postoperatively, the patient developed obstructive jaundice. An ERCP showed an obstruction at the junction of the left biliary duct and the main biliary duct and contrast leak. At reoperation, the main duct was ischemic, likely due to torsion along its longitudinal axis. A hepatotomy was done at the hilar plate, and the biliary duct was dissected and anastomosed to a Roux-en-Y jejunal loop. She was discharged without complications. Five months later, the patient developed cholangitis and was successfully treated with antibiotics. However, she suffered repeated respiratory infections, and four months later she was admitted to the hospital with fever, cough, bilioptysis, and right lower lobe pneumonia. The diagnosis of BBF was confirmed with (99m)Tc Mebrofenin scintigraphy. At transhepatic cholangiography, bile duct dilation was seen, with a biliothoracic leak. She underwent dilatation of cholangiojejunostomy stricture with placement of an external-internal catheter. The catheter was removed 3.5 months later, and two years later the patient remains in very good condition. Conclusion. An indirect treatment of the BBF by percutaneous transhepatic dilation of the biliary stenosis avoided a more invasive treatment, with satisfactory outcome.

Reflexión a mitad de camino / Reflections half way down the road

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Continuamos con la formación continuada / We continue with continuing education

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