Avelumab first-line maintenance treatment for advanced urothelial carcinoma: review of evidence to guide clinical practice.

The JAVELIN Bladder 100 phase III trial led to the incorporation of avelumab first-line (1L) maintenance treatment into international guidelines as a standard of care for patients with advanced urothelial carcinoma (UC) without progression after 1L platinum-based chemotherapy. JAVELIN Bladder 100 showed that avelumab 1L maintenance significantly prolonged overall survival (OS) and progression-free survival in this population compared with a 'watch-and-wait' approach. The aim of this manuscript is to review clinical studies of avelumab 1L maintenance in patients with advanced UC, including long-term efficacy and safety data from JAVELIN Bladder 100, subgroup analyses in clinically relevant subpopulations, and 'real-world' data obtained outside of clinical trials, providing a comprehensive resource to support patient management. Extended follow-up from JAVELIN Bladder 100 has shown that avelumab provides a long-term efficacy benefit, with a median OS of 23.8 months measured from start of maintenance treatment, and 29.7 months measured from start of 1L chemotherapy. Longer OS was observed across subgroups, including patients who received 1L cisplatin + gemcitabine, patients who received four or six cycles of 1L chemotherapy, and patients with complete response, partial response, or stable disease as best response to 1L induction chemotherapy. No new safety signals were seen in patients who received ≥1 year of avelumab treatment, and toxicity was similar in those who had received cisplatin or carboplatin with gemcitabine. Other clinical datasets, including noninterventional studies conducted in Europe, USA, and Asia, have confirmed the efficacy of avelumab 1L maintenance. Potential subsequent treatment options after avelumab maintenance include antibody-drug conjugates (enfortumab vedotin or sacituzumab govitecan), erdafitinib in biomarker-selected patients, platinum rechallenge in suitable patients, nonplatinum chemotherapy, and clinical trial participation; however, evidence to determine optimal treatment sequences is needed. Ongoing trials of avelumab-based combination regimens as maintenance treatment have the potential to evolve the treatment landscape for patients with advanced UC.

Optimización de la seguridad del paciente durante el servicio de dispensación de medicamentos con formas farmacéuticas tipo parche transdérmico / Optimising patient safety during the dispensing service of medicines with transdermal patch-type dosage forms

INTRODUCCIÓN: la frecuencia de los errores que se producen por una incorrecta administración de los medicamentos en el domicilio de los pacientes oscila entre el 19 y el 59 %, dependiendo del estudio. Hasta en un 26 % delos casos los pacientes sufren daños. Los tipos de errores más frecuentes en el domicilio de los pacientes son la toma del medicamento a una dosis incorrecta o con un intervalo incorrecto, confusiones entre los medicamentos por falta de información o debido a la similitud en la apariencia de los nombres o los envases, duplicidades terapéuticas, omisiones y falta de adherencia, así como en el manejo de dispositivos de preparación y o administración, situación que no se escapa a la administración de parches transdérmicos tal y como indican los resultados del Instituto para el Uso Seguro del Medicamento en España.OBJETIVOS: analizar, desde el punto de vista de la seguridad del paciente, la seguridad clínica del servicio de dispensación de aquellos medicamentos cuya forma farmacéutica es un parche transdérmico. Establecer una lista de verificación PRELIMINAR que debe de considerar el farmacéutico en su protocolo de dispensación para optimizar la gestión terapéutica del paciente usuario de parches transdérmicos.MÉTODOS: reunión de varios farmacéuticos comunitarios en plataforma ZOOM para valorar los riesgos asociados a la dispensación de formas farmacéuticas tales como parches transdérmicos, comprimidos bucodispersables y formas de liberación modificada. Creación de documento compartido en la plataforma Google Drive donde poder hacer una lluvia de ideas. Creación de un decálogo y un checklist que sirva para evitar potenciales errores de medicación asociados a la dispensación de medicamentos cuya forma farmacéutica sea un parche transdérmico. (AU)

Optimización de la seguridad del paciente durante el servicio de dispensación de medicamentos con formas farmacéuticas tipo comprimido bucodispersable / Optimising patient safety during the dispensing service of orodispersible tablet type medicines

INTRODUCCIÓN: la frecuencia de los errores que se producen por una incorrecta administración de los medicamentos en el domicilio de los pacientes oscila entre el 19 y el 59 %, dependiendo del estudio. Hasta en un 26 % delos casos los pacientes sufren daños. Los tipos de errores más frecuentes en el domicilio de los pacientes son la toma del medicamento a una dosis incorrecta o con un intervalo incorrecto, confusiones entre los medicamentos por falta de información o debido a la similitud en la apariencia de los nombres o los envases, duplicidades terapéuticas, omisiones y falta de adherencia, así como en el manejo de dispositivos de preparación y o administración, situación que no se escapa a la administración de comprimidos bucodispersables, tal y como indican los resultados del Instituto para el Uso Seguro del Medicamento en España.OBJETIVOS: analizar, desde el punto de vista de la seguridad del paciente, la seguridad clínica del servicio de dispensación de aquellos medicamentos cuya forma farmacéutica es un comprimido bucodispersable. Establecer una lista de verificación preliminar que debe de considerar el farmacéutico en su protocolo de dispensación para optimizar la gestión terapéutica del paciente usuario de comprimidos bucodispersables.MÉTODO: reunión de varios farmacéuticos comunitarios en plataforma ZOOM para valorar los riesgos asociados ala dispensación de formas farmacéuticas tales como parches transdérmicos, comprimidos bucodispersables y formas de liberación modificada. Creación de documento compartido en la plataforma Google Drive donde poder hacer una lluvia de ideas. Creación de un decálogo y un checklist que sirva para evitar potenciales errores de medicación asociados a la dispensación de medicamentos cuya forma farmacéutica sea un comprimido bucodispersable. (AU)

Optimización de la seguridad del paciente durante el servicio de dispensación de medicamentos con formas farmacéuticas de liberación modificada FLM / Optimisation of patient safety during the dispensing service of medicines with modified release dosage forms FLM

INTRODUCCIÓN: la frecuencia de los errores que se producen por una incorrecta administración de los medicamentos en el domicilio de los pacientes oscila entre el 19 y el 59 %, dependiendo del estudio. Hasta en un 26 % delos casos los pacientes sufren daños. Los tipos de errores más frecuentes en el domicilio de los pacientes son la toma del medicamento a una dosis incorrecta o con un intervalo incorrecto, confusiones entre los medicamentos por falta de información o debido a la similitud en la apariencia de los nombres o los envases, duplicidades terapéuticas, omisiones y falta de adherencia, así como en el manejo de dispositivos de preparación y o administración, situación que no se escapa a la administración deformas farmacéuticas de liberación modificada (FLM), tal y como indican los resultados del Instituto para el Uso Seguro del Medicamento en España.OBJETIVOS: analizar, desde el punto de vista de la seguridad del paciente, la seguridad clínica del servicio de dispensación de aquellos medicamentos cuya forma farmacéutica es una FLM. Establecer una lista de verificación preliminar que debe de considerar el farmacéutico en su protocolo de dispensación para optimizar la gestión terapéutica del paciente usuario de FLM.MÉTODOS: Reunión de varios farmacéuticos comunitarios en plataforma ZOOM para valorar los riesgos asociados a la dispensación de formas farmacéuticas tales como parches transdérmicos, comprimidos bucodispersables y formas de liberación modificada. Creación de documento compartido en la plataforma Google Drive donde poder hacer una lluvia de ideas. Creación de un decálogo y un checklist que sirva para evitar potenciales errores de medicación asociados a la dispensación de medicamentos cuya forma farmacéutica sea una FLM. (AU)

El farmacéutico es un profesional sanitario perfectamente preparado, desde un punto de vista académico, para ser un educador nutricional poblacional / The pharmacist is a health professional perfectly prepared, from an academic point of view, to be a population nutrition educator

INTRODUCCIÓN: la Organización Mundial de la Salud ha recomendado encarecidamente seguir una dieta saludable durante los períodos de confinamiento. Una dieta saludable como la Dieta Mediterránea consiste, en general, en consumir alimentos de todos los grupos para obtener todos los nutrientes necesarios.JUSTIFICACIÓN: como los hábitos alimentarios están cambiando de forma globalizada. Destaca el abandono de la dieta mediterránea. La literatura científica establece que por la COVID-19 se alteraron los comportamientos alimentarios.OBJETIVO: propiciar actividades de orientación alimentaria que conduzcan a la adopción y reforzamiento de hábitos de alimentación saludables con la finalidad de reducir la susceptibilidad de las complicaciones por SARS-CoV2 .Material /Métodos Durante la pandemia un grupo de 10 farmacias del distrito de Arganzuela de Madrid pensábamos en conocer las maneras de alimentarse de nuestros clientes con el uso de esta encuesta propia. 1. ¿Qué factor consideras más importante al elegir un alimento ?2. Lees las etiquetas: 3. ¿Evitas algún alimento?4. ¿Cómo preparas tus alimentos? 5. En casa, ¿quién cocina?6. ¿Te sacias?7. ¿Qué haces con la grasa visible de la carne?8. Masticas cada bocado 9. Frutas10. Verduras 11. Carnes y pollo12. Pescados y mariscos13. Lácteos14. Cereales15. Legumbres16. Dulces17. Huevo18. Frutos secos.19. Bebidas alcohólicas20. Alimentos empaquetados 21. ¿Comes entre horas?22. ¿Comes fuera de casa?23. ¿Comes alimentos en exceso?24. ¿Cuidas tu cuerpo y salud? 25. ¿Mejorarías tu alimentación?26. Tu dieta es: 27 ¿Consideras que el virus te afectó? Utilizábamos la educación nutricional para ofrecer consejos sobre seguridad, compra y preservación de alimentos para conseguir una alimentación saludable. Como el lavado de manos antes de preparar los alimentos y después de manipular alimentos Para no gastar compra alimentos de todos los grupos. Planifica recetas con tres ingredientes. (AU)

La seguridad del paciente es vital para realizar una correcta atención farmacéutica / Patient safety is vital to good pharmaceutical care

INTRODUCCIÓN: muestra farmacia ha tenido que trabajar en una situación estresante para dar servicio por otras cerradas debido a la pandemia. En el Día Mundial de la Seguridad del Paciente 2020 la Organización Mundial de la Salud planteó concienciar sobre la seguridad de los profesionales y la seguridad del paciente. El paciente es mayoritariamente receptor de los servicios asistenciales y no una parte activa del sistema sanitario. Se debe trabajar, ahora que la pandemia parece disiparse, por incorporar al paciente como un elemento más del equipo asistencial en materia de seguridad.OBJETIVOS: el sistema sanitario debe estar comprometido con la seguridad del paciente, y el paciente informado y formado.MATERIAL Y MÉTODOS: el reto mundial de seguridad del paciente, Medicamentos sin Daño, lanzado en 2017 por la OMS supuso el reducir problemas y errores. Nos supuso un desafío con el medicamento, riesgos con la medicación, con los centros de salud y la prescripción. La estrategia la basamos en cuatro retos: pacientes, profesionales, medicamentos y prescripción. Paciente pasa de ser activo a experto. Profesionales: debemos contar con historia farmacoterapéutica actualizada para evitar errores. Medicamentos: evitar errores de medicación que pueden ser por omisión, por similitud de medicamentos o por uso. Identificamos discrepancias en la medicación en más de un 70 % antes de la pandemia, en la pandemia estaba entorno al 85 % y después de “fabricar” pacientes individuales expertos. Con educación sanitaria y promoción de la salud. (AU)

Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy.

BACKGROUND: The INMUNOSUN trial had the objective of prospectively evaluating the efficacy and safety of sunitinib as a pure second-line treatment in patients with metastatic renal cell carcinoma (mRCC) who have progressed to first-line immune checkpoint inhibitor (ICI)-based therapies. PATIENTS AND METHODS: A multicenter, phase II, single-arm, open-label study was carried out in patients with a histologically confirmed diagnosis of mRCC with a clear-cell component who had progressed to a first-line regimen of ICI-based therapies. All patients received sunitinib 50 mg once daily orally for 4 weeks, followed by a 2-week rest period following package insert instructions. The primary outcome was the objective response rate. RESULTS: Twenty-one assessable patients were included in the efficacy and safety analyses. Four patients [19.0%, 95% confidence interval (CI) 2.3% to 35.8%] showed an objective response (OR), and all of them had partial responses. Additionally, 14 (67%) patients showed a stable response, leading to clinical benefit in 18 patients (85.7%, 95% CI 70.7% to 100%). Among the four assessable patients who showed an OR, the median duration of the response was 7.1 months (interquartile range 4.2-12.0 months). The median progression-free survival (PFS) was 5.6 months (95% CI 3.1-8.0 months). The median overall survival (OS) was 23.5 months (95% CI 6.3-40.7 months). Patients who had better antitumor response to first-line ICI-based treatment showed a longer PFS and OS with sunitinib. The most frequent treatment-emergent adverse events were diarrhea (n = 11, 52%), dysgeusia (n = 8, 38%), palmar-plantar erythrodysesthesia (n = 8, 38%), and hypertension (n = 8, 38%). There was 1 patient who exhibited grade 5 pancytopenia, and 11 patients experienced grade 3 adverse events. Eight (38%) patients had serious adverse events, four of which were considered to be related to sunitinib. CONCLUSION: Although the INMUNOSUN trial did not reach the pre-specified endpoint, it demonstrated that sunitinib is active and can be safely used as a second-line option in patients with mRCC who progress to new standard ICI-based regimens.

Different approaches to the analysis of causes of death during the COVID-19 epidemic.

OBJECTIVE: The aim of the study is to assess the impact of the COVID-19 pandemic on causes of mortality through multiple methodological approaches. MATERIALS AND METHODS: The causes of mortality in the Veneto region (Italy) during the first epidemic wave, March-April 2020, were compared with the corresponding months of the previous two years. Both the underlying cause of death (UCOD), and all diseases reported in the death certificate (multiple causes of death) were investigated; a further analysis was carried out through a simulation where the UCOD was selected after substituting ICD-10 codes for COVID with unspecified pneumonia. RESULTS: Overall 10,222 deaths were registered in March-April 2020, corresponding to a 24% increase compared to the previous two years. COVID-19 was mentioned in 1,444 certificates, and selected as the UCOD in 1,207 deaths. Based on the UCOD, the increases in mortality were observed for COVID and related respiratory conditions, diabetes mellitus, hypertensive heart diseases, cerebrovascular diseases, and ill-defined causes. Multiple causes of death and the simulation analysis demonstrated further increases in mortality related to dementia/Alzheimer and chronic lower respiratory diseases. CONCLUSIONS: This first report demonstrates an increase of several causes of death during the pandemic, underlying the need of a continuous surveillance of mortality records through different analytic strategies.

Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS).

BACKGROUND: ATLAS evaluated the efficacy and safety of the PARP inhibitor rucaparib in patients with previously treated locally advanced/unresectable or metastatic urothelial carcinoma (UC). METHODS: Patients with UC were enrolled independent of tumor homologous recombination deficiency (HRD) status and received rucaparib 600 mg BID. The primary endpoint was investigator-assessed objective response rate (RECIST v1.1) in the intent-to-treat and HRD-positive (loss of genome-wide heterozygosity ≥10%) populations. Key secondary endpoints were progression-free survival (PFS) and safety. Disease control rate (DCR) was defined post-hoc as the proportion of patients with a confirmed complete or partial response (PR), or stable disease lasting ≥16 weeks. RESULTS: Of 97 enrolled patients, 20 (20.6%) were HRD-positive, 30 (30.9%) HRD-negative, and 47 (48.5%) HRD-indeterminate. Among 95 evaluable patients, there were no confirmed responses. However, reductions in the sum of target lesions were observed, including 6 (6.3%) patients with unconfirmed PR. DCR was 11.6%; median PFS was 1.8 months (95% CI, 1.6-1.9). No relationship was observed between HRD status and efficacy endpoints. Median treatment duration was 1.8 months (range, 0.1-10.1). Most frequent any-grade treatment-emergent adverse events were asthenia/fatigue (57.7%), nausea (42.3%), and anemia (36.1%). Of 64 patients with data from tumor tissue samples, 10 (15.6%) had a deleterious alteration in a DNA damage repair pathway gene, including four with a deleterious BRCA1 or BRCA2 alteration. CONCLUSIONS: Rucaparib did not show significant activity in unselected patients with advanced UC regardless of HRD status. The safety profile was consistent with that observed in patients with ovarian or prostate cancer. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov (NCT03397394). Date of registration: 12 January 2018. This trial was registered in EudraCT (2017-004166-10).

ATLAS trial of adjuvant axitinib in patients with renal cell carcinoma: subgroup analyses with focus on axitinib dosing and racial groups.

BACKGROUND: The ATLAS trial, investigating adjuvant axitinib versus placebo in renal cell carcinoma (RCC), was stopped for futility at a preplanned interim analysis. We report subgroup outcome analyses by ethnicity, time on treatment, dose modification and toxicity. PATIENTS AND METHODS: Patient demographics, baseline characteristics, treatment duration and exposure and safety were analysed for Asian versus non-Asian patients treated with axitinib versus placebo. Disease-free survival (DFS) was analysed by ethnicity, treatment duration (≥1 versus <1 year), dose modification and adverse event (AE) grade. RESULTS: No DFS benefit was observed for Asian {hazard ratio (HR) 0.883 [95% confidence interval (CI) 0.638-1.220]} or non-Asian [HR 0.828 (95% CI 0.490-1.400)] patients treated with axitinib or placebo. Fewer Asian versus non-Asian patients were in the highest-risk group in axitinib (51.9% versus 72.3%) or placebo (51.5% versus 66.0%) arm. Highest-risk patients in both subgroups had no DFS benefit with either treatment. More axitinib-treated Asian versus non-Asian patients had dose reductions due to AEs (58.8% versus 46.0%; P = 0.028). Asian patients experienced more nasopharyngitis but less fatigue or asthenia than non-Asians. Among Asian patients, proteinuria, hypothyroidism, nasopharyngitis, and hypertension were more common in Japanese patients than Korean patients and more common in Korean patients than Chinese patients. Patients receiving axitinib >1 year versus ≤1 year did not have different DFS: HR 0.572 (95% CI 0.247-1.327); P = 0.1874. Compared with patients on stable axitinib dose, DFS was longer in patients with dose reduction [HR 0.458 (95% CI 0.305-0.687); P = 0.0001], whereas DFS was not different in those with dose escalation [HR 1.936 (95% CI 0.937-3.997); P = 0.0685]. DFS was not different in patients experiencing grade ≥2 versus <2 AEs within 6 months of initiating axitinib: HR 0.885 (95% CI 0.419-1.869); P = 0.7488. CONCLUSIONS: Asian versus non-Asian subgroup analysis revealed differences in AE experience and drug exposure. There were no DFS differences based on ethnicity or treatment duration, but axitinib dose reduction led to longer DFS.

Impacts of major health conditions affecting the Australian sheepmeat value chain: a review.

Major health conditions in sheep contribute to substantial economic losses throughout the sheepmeat supply chain in Australia. A systematic review was undertaken to explore the measurable impact of six conditions: arthritis, sheep measles, pleurisy, pneumonia, grass seeds and rib fractures, on the production of lamb and mutton across the meat value chain. Peer-reviewed scientific literature from three databases and non-peer-reviewed articles and reports from Australian government and non-government websites were searched between 11 and 17 November 2019. Original articles, including studies conducted in Australia and New Zealand, that had measurable impacts on conditions of interest were included. The search yielded 16 articles and reports and were classified as producer impact and/or processor impact studies. Mortalities were quantified for pneumonia and arthritis, with pneumonia having the highest impact for producers. Grass seed infestation resulted in the highest impact on carcase and liveweight losses compared to arthritis and pneumonia. Arthritis had the highest trim weight losses for both lamb and mutton and the highest rate of carcase condemnation. Grass seed was the only condition where other impacts on the processor (chain speed and staff relocation to the boning room) were quantified. Although quantifiable production and processing losses were available for some conditions, this review has highlighted that limited quantifiable data based on scientifically sound research were not available for other conditions. The evidence for some conditions found in this review can be used to target future research activities and to further assist producers in making informed management decisions on prevention and control.

Excess liver-related mortality among people with AIDS compared to the general population: an Italian nationwide cohort study using multiple causes of death.

OBJECTIVES: Liver diseases have become a leading cause of death among people with AIDS (PWA). This study aimed to investigate whether PWA experienced excess mortality related to liver diseases as compared to the general population (non-PWA), using a multiple cause of death (MCoD; i.e. all conditions reported on death certificates) approach. METHODS: A population-based, nationwide, retrospective cohort study was conducted among Italian people, aged 15-74 years, who had been diagnosed with AIDS since 2006. Date of death and MCoD data were retrieved, up to December 2015, by individual record linkage with national mortality data. Sex- and age-standardized mortality ratios (SMRs), with 95% confidence intervals (CIs), were estimated by dividing the observed number of deaths related to a specific condition among PWA to the expected number, based on non-PWA mortality rates. RESULTS: Among 7912 PWA (34 184 person-years), 2076 deaths occurred. The number of death certificates reporting liver diseases among MCoDs was 583 (28.1%), including 382 (18.4%) reporting viral hepatitis, 370 (17.8%) reporting nonviral liver diseases, and 41 (2.0%) reporting liver cancers. The corresponding SMRs were 40.4 (95% CI 37.2-43.8) for all liver diseases, 131.1 (95% CI 118.3-145.0) for viral hepatitis, 29.9 (95% CI 27.0-33.1) for nonviral liver diseases, and 11.2 (95% CI 8.1-15.3) for liver cancers. Particularly elevated SMRs emerged among PWA aged 15-49 years and those infected by injecting drug use. CONCLUSIONS: The high excess liver-related mortality observed among PWA warrants preventive actions to limit the burden of viral hepatitis coinfections, alcohol abuse, and metabolic disorders, especially among younger PWA and injecting drug users.

Facing treatment of non-urothelial bladder cancers in the immunotherapy era.

Non-urothelial Bladder Cancer (BC) and variants of urothelial carcinoma account for up to 25 % of all BCs. Given their heterogeneity, these entities are not well represented in clinical trials and treatment remains challenging. Checkpoint inhibitor therapy has shown a role in the treatment of urothelial BC. By contrast, robust evidence regarding its use in other histological types is lacking. We aimed to provide a comprehensive update of non-urothelial and variant urothelial BC, exploring the evidence for immune checkpoint inhibitor therapy. A detailed analysis of the literature was conducted regarding epidemiology, aetiology, diagnosis, prognosis, treatment and outcomes of these patients in the immunotherapy era. A growing body of evidence suggests that immune checkpoint inhibition might have a role to play in non-urothelial BC, similarly to what happened with urothelial carcinomas.

SEOM clinical guideline thyroid cancer (2019).

Thyroid carcinoma is the most frequent endocrine malignancy and accounts for around 3% of global cancer incidence. Different histologies and clinical scenarios make necessary a multidisciplinary approach that includes new diagnostic methods and surgical, radiopharmaceutical and systemic therapies. This guideline updates several aspects of management of thyroid cancer.

First-line single-agent regorafenib in frail patients with metastatic colorectal cancer: a pilot phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD).

BACKGROUND: Treatment of frail patients with advanced colorectal cancer (CRC) is controversial. This pilot phase II trial aimed to assess the efficacy and safety of regorafenib when administered in first-line to frail patients with advanced CRC. METHODS: Frail patients without prior advanced colorectal cancer treatment were included in the study. Definition of frailty was defined per protocol based on dependency criteria, presence of chronic comorbid pathologies and/or geriatric features. MAIN OBJECTIVE: to assess progression-free survival (PFS) rate at 6 months. Treatment consisted of 28-day cycles of orally administered regorafenib 160 mg/day (3 weeks followed by 1 week rest). RESULTS: Forty-seven patients were included in the study. Median age was 81 years (range 63-89). Frailty criteria: dependency was observed in 26 patients (55%), comorbidities in 27 (57%) and geriatric features in 18 (38%). PFS rate at 6 months was 45% (95% confidence interval [CI] 30-60]. Median PFS was 5.6 months (95%CI 2.7-8.4). Median overall survival (OS) was 16 months (95%CI 7.8-24). Complete response, partial response and stable disease were observed in one, two and 21 patients respectively (objective response rate 6.4%; disease control rate 51%). Thirty-nine patients (83%) experienced grade 3-4 adverse events (AEs). The most common grade 3-4 AEs were hypertension (15 patients; 32%), asthenia (14; 30%), hypophosphatemia (6; 13%); diarrhea (4; 8%), hand-foot-skin reaction (4; 8%). There were two toxic deaths (4.2%) (grade 5 rectal bleeding and death not further specified). Dose reduction was required in 26 patients (55%) and dose-delays in 13 patients (28%). CONCLUSIONS: The study did not meet the pre-specified boundary of 55% PFS rate at 6 months. Toxicity observed (83% patients experienced grade 3 and 4 AEs) preclude its current use in clinical practice on this setting. Disease control rate and overall survival results are interesting and might warrant further investigation to identify those who benefit from this approach. TRIAL REGISTRATION: This trial was prospectively registered at EudraCT ( 2013-000236-94 ). Date of trial registration: April 9th, 2013.

Results of a nationwide survey on multidisciplinary teams on thyroid cancer in Spain.

AIM: There is an important lack of knowledge as to the functioning of multidisciplinary teams on thyroid cancer in current clinical practice. We aimed to retrieve data on the composition, structure, and procedures developed by the multidisciplinary units of thyroid cancer in Spain. METHODS: A nationwide survey consisting of questions about composition, structure, and functioning of multidisciplinary teams was designed. It was available online from November 15, 2017 to February 15, 2018. RESULTS: Seventy-two multidisciplinary units responded to our survey. Of these, 15 (20.8%) focused only in thyroid cancer, while 57 (79.2%) included other endocrine disorders or non-endocrine tumors. The median (interquartile range) of members of the teams was 11 (9-14). The most frequent medical specialties in the units were endocrinology (100%), surgery (94.4%), pathology (80.6%), radiology (75.0%), nuclear medicine (73.6%), and medical oncology (55.6%). The annual number of patients reviewed by the teams was 40 (20-74). 56.9% of the multidisciplinary teams have elaborated clinical protocols for local use. Apart from clinical case discussions in the meetings, 45.8% of the units included educational activities and 36.1% research subjects. Quality indicators were developed by 22% of the teams. CONCLUSIONS: These results suggest that there are some hopeful signs that international recommendations of having multidisciplinary approach to patients with thyroid cancer are being followed in Spain. This gives us the opportunity to proceed with further studies to analyze the real impact of this high standard of care on patient outcomes.

Correction to: SEOM clinical guideline for treatment of kidney cancer (2017).

The conflict of interest declaration was published incorrectly in the original version.

Consensus document on the progression and treatment response criteria in gastroenteropancreatic neuroendocrine tumors

Purpose: Gastroenteropancreatic neuroendocrine tumors are a heterogeneous group of low incidence neoplasms characterized by a low proliferative activity and slow growth. Their response to targeted therapies is heterogeneous and often does not lead to tumor shrinkage. Thus, evaluation of the therapeutic response should differ from other kind of tumors. Methods: To answer relevant questions about which techniques are best in the assessment of progression or treatment response a RAND/UCLA-based consensus process was implemented. Relevant clinical questions were listed followed by a systematic search of the literature. The expert panel answered all questions with recommendations, combining available evidence and expert opinion. Recommendations were validated through a questionnaire and a participatory meeting. Results: Expert recommendations regarding imaging tools for tumor assessment and evaluation of progression were agreed upon. Available imaging techniques were reviewed and recommendations for best patient monitoring practice and the best way to evaluate treatment response were formulated

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Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial.

Background: The ATLAS trial compared axitinib versus placebo in patients with locoregional renal cell carcinoma (RCC) at risk of recurrence after nephrectomy. Patients and methods: In a phase III, randomized, double-blind trial, patients had >50% clear-cell RCC, had undergone nephrectomy, and had no evidence of macroscopic residual or metastatic disease [independent review committee (IRC) confirmed]. The intent-to-treat population included all randomized patients [≥pT2 and/or N+, any Fuhrman grade (FG), Eastern Cooperative Oncology Group status 0/1]. Patients (stratified by risk group/country) received (1 : 1) oral twice-daily axitinib 5 mg or placebo for ≤3 years, with a 1-year minimum unless recurrence, occurrence of second primary malignancy, significant toxicity, or consent withdrawal. The primary end point was disease-free survival (DFS) per IRC. A prespecified DFS analysis in the highest-risk subpopulation (pT3, FG ≥ 3 or pT4 and/or N+, any T, any FG) was conducted. Results: A total of 724 patients (363 versus 361, axitinib versus placebo) were randomized from 8 May 2012, to 1 July 2016. The trial was stopped due to futility at a preplanned interim analysis at 203 DFS events. There was no significant difference in DFS per IRC [hazard ratio (HR) = 0.870; 95% confidence interval (CI) : 0.660-1.147; P = 0.3211). In the highest-risk subpopulation, a 36% and 27% reduction in risk of a DFS event (HR; 95% CI) was observed per investigator (0.641; 0.468-0.879; P = 0.0051), and by IRC (0.735; 0.525-1.028; P = 0.0704), respectively. Overall survival data were not mature. Similar adverse events (AEs; 99% versus 92%) and serious AEs (19% versus 14%), but more grade 3/4 AEs (61% versus 30%) were reported for axitinib versus placebo. Conclusions: ATLAS did not meet its primary end point; however, improvement in DFS per investigator was seen in the highest-risk subpopulation. No new safety signals were reported. Trial registration number: NCT01599754.