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ObjectivesOpioid-induced constipation (OIC) can affect up to 63% of all patients with cancer. The objectives of this study were to assess quality of life as well as efficacy and safety of naloxegol, in patients with cancer with OIC.MethodsAn observational study was made of a cohort of patients with cancer and with OIC exhibiting an inadequate response to laxatives and treated with naloxegol. The sample consisted of adult outpatients with a Karnofsky performance status score ≥50. The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and the Patient Assessment of Constipation Symptoms (PAC-SYM) were applied for 3 months.ResultsA total of 126 patients (58.2% males) with a mean age of 61.3 years (range 34–89) were included. Clinically relevant improvements (>0.5 points) were recorded in the PAC-QOL and PAC-SYM questionnaires (pConclusionsClinically relevant improvements in OIC-related quality of life, number of bowel movements and constipation-related symptoms were recorded as early as after 15 days of treatment with naloxegol in patients with cancer and OIC, with a good safety profile.

The identification of patients with advanced and complex chronic diseases, and the fragmentation of care towards the end of life, requires the drawing up a long-term therapeutic plan. This should take into account the values and preferences of the patients, as well as the vital and functional prognosis. Having an adjustment tool for determining the diagnostic and therapeutic effort is helpful in the continuity of care, as well as in decision-making in the transitions and dynamic changes of patients as they approach the end of life process.

espanolLa pandemia por COVID-19 ha provocado una crisis sanitaria sin precedentes en nuestra historia reciente, con unas peculiaridades clinicas y sociales que han generado un importante papel de los equipos de cuidados paliativos (CP), destacando su participacion en la toma de decisiones al final de la vida y en la elaboracion de protocolos de sedacion paliativa (SP). Una proporcion significativa de pacientes con mala evolucion, sin mejoria con los tratamientos disponibles ni criterios de ingreso en Unidades de Cuidados Intensivos (UCI), presentaron una alta carga sintomatica y elevados niveles de sufrimiento por la refractariedad de los sintomas; por ello, de igual manera que sucede en otras enfermedades terminales, se requirio frecuentemente de la SP. A pesar del elevado numero de trabajos sobre la infeccion por SARS-CoV-2, existe escasez de publicaciones hasta la fecha sobre SP en pacientes COVID. En este articulo revisamos la bibliografia existente y presentamos nuestra experiencia en tres unidades de cuidados paliativos hospitalarias respecto a las indicaciones de SP, farmacos y dosis, considerando ademas los importantes aspectos eticos en este contexto, como son la informacion al paciente y a la familia y la toma de decisiones en una situacion de confinamiento de la poblacion y de duras medidas de aislamiento. La pandemia por COVID-19 ha supuesto un desafio para todo el sistema sanitario, incluyendo los CP. Debemos aprovechar esta oportunidad para garantizar en el futuro el menor sufrimiento posible de nuestros pacientes, mediante el acceso a medidas terapeuticas como la SP. EnglishThe COVID-19 pandemic has provoked an unprecedented health crisis in our recent history, with clinical and social peculiarities that have created an important role for Palliative Care (PC) teams, highlighting their participation in decision-making at the end of life and in the development of Palliative Sedation (PS) protocols. A significant percentage of patients with a negative evolution, without improvement with available treatments, or meeting admission criteria in an Intensive Care Unit (ICU) present with a high symptom loads and high levels of suffering due to symptom refractoriness; therefore, as is also the case with other terminal diseases, PS is frequently required. Despite the abundance of literature about the SARS-CoV-2 infection, there is so far a shortage of publications about PS in COVID patients. In this article we review the existing literature and present our experience in three Hospital Palliative Care Units regarding PS indications, drugs, and doses, considering also important ethical aspects in this context such as patient and family information, and decision-making in a situation of population confinement and strict isolation measures. The COVID-19 pandemic has been a challenge for the whole health care system, including PC. We must seize this opportunity to ensure that our patients suffer as little as possible in the future through access to therapeutic measures such as PS.

ObjectivesNaloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.MethodsThis one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L).ResultsA total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (pConclusionThe results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.

e24155 Background: Naloxegol is a peripherally acting, µ-opioid receptor antagonist for treatment of opioid-induced constipation (OIC). The main objective of this study was to analyze the efficacy and safety of naloxegol in patients with cancer in a real-world 12-month follow-up study. Methods: An observational prospective study was conducted in 16 Spanish centers. Patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky ≥ 50 were selected. OIC with inadequate response to treatment with laxative (s) was the main diagnostic. All the patients received treatment with naloxegol according to clinical criteria. Efficacy was measured by the response rate and symptoms evolution measured by means of PAC-SYM questionnaire. Intensity of pain was measured by a 0-10-point visual analogue scale (VAS). Intent to treat last observation carried forward was applied. Results: A total of 126 patients were included in the study. About 58.7% were men, with a mean age of 61.5 years (34-89). Lung cancer was observed in 35.7%, breast cancer in 16.7%, 10.3% digestive cancer and 8.7% had prostate cancer. About 67.5% had metastases. Naloxegol at doses of 25 mg/day was administered to 88.1% and with concomitant laxatives in 48.4%. At 12 months, 77.8% of the patients were responders to naloxegol treatment: 78.6% at doses of 12.5 mg/day, and 78.4% with 25 mg/day. Furthermore, response was observed in 78.5% of patients without concomitant laxative treatment and 77% of patients with any concomitant laxative. PAC-SYM total score and all the dimensions improved from baseline (p < 0.0001). VAS pain intensity was reduced and controlled from baseline onwards (Baseline-12 months: 4.6 to 3.6, p < 0.001). A total of 28 adverse reactions mainly gastrointestinal were observed in 15.1% of the patients (19/126), 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) were observed the first 15 days of treatment with naloxegol. Conclusions: The results of this first real-world-data study in patients with cancer confirm the long-term efficacy of naloxegol for the treatment of OIC in this group of patients. Naloxegol is safe and well tolerated in patients with cancer while maintaining pain control.

The identification of patients with advanced and complex chronic diseases, and the fragmentation of care towards the end of life, requires the drawing up a long-term therapeutic plan. This should take into account the values and preferences of the patients, as well as the vital and functional prognosis. Having an adjustment tool for determining the diagnostic and therapeutic effort is helpful in the continuity of care, as well as in decision-making in the transitions and dynamic changes of patients as they approach the end of life process.

Resumen Objetivo Revision sistematica de la literatura sobre la intervencion de Cuidados Paliativos en el paciente con cancer hematologico avanzado. Material y metodo Realizamos una revision sistematica sobre los articulos en PubMed y Cochrane, desde el 1 de enero de 2001 al 1 de mayo de 2009, publicados en espanol y en ingles, usando como palabras claves: «Haematology, Palliative Care, Dying, Death, Supporting Team, advanced Malignancies, Prognostic», asi como literatura no indexada en paginas web y libros de Hematologia y Cuidados Paliativos sobre temas relacionados. Se incluyeron articulos en cuyos abstracts incluyeran la informacion sobre la intervencion de Cuidados Paliativos en el paciente con enfermedad hematologica maligna avanzada. Los articulos que solo trataban de tratamientos del tumor o de su pronostico fueron excluidos. Resultados Un total de 16 articulos fueron aceptados para su lectura y revision. Se pueden diferenciar dos tipos de articulos: un grupo que hace referencia a las caracteristicas clinicas de los pacientes y, un segundo grupo que hace referencia a las experiencias de profesionales, pacientes y familiares al final de la vida. Conclusiones De la informacion obtenida de la revision se constata una escasa y heterogenea informacion al respecto, surgiendo la necesidad de ampliar el estudio en pacientes y familiares en fases avanzadas de la enfermedad hematologica maligna.

We retrospectively reviewed our institution’s database to investigate the outcome and impact of combined radiochemotherapy (RT/CT; concomitant or in sequence) in localised small-cell lung cancer (L-SCLC). Between January 1995 to November 1999, 79 patients with L-SCLC received combined RT/CT at our Institution. RT was delivered concurrently or sequentially following the CT. Patients with treatment response received additional prophylactic cranial irradiation (PCI). Of the patients treated, 54% had received concurrent CT/RT compared to 46% receiving RT following the CT. PCI was administered to 80% of the patients. Complete response was observed in 66% of patients. With a median follow up of 30 months, median overall survival was 15.9 months; 14.3 months for patients who received RT following CT and 21.6 months for those receiving concurrent CT/RT. The type of schedule of combined radiochemotherapy was an independent prognostic factor for survival free of local recurrence, as was additional PCI for distant metastasis-free survival. Our results are similar to those reported previously in the literature. The main point of interest is that our patients were non-selected. We strongly support the use of concurrent CT/RT so as to achieve results comparable to the best in the literature.

Activities and outcomes in an outpatient palliative care clinic (PCC) have attracted little attention in the literature. We describe the results of our patient appointment scheduling process, our efficacy in relieving cancer-associated symptoms and an analysis of risk factors for patient non-compliance with the appointment schedule. Over a one-year study period, 730 first-time appointments were scheduled and 73.1% of them were kept. Only patients who had kept 3 consecutive visits (n = 203) were included in the symptom control analysis. All symptoms except constipation, physical weakness, and anxiety improved significantly with palliative care. History of alcohol abuse was not associated with poorer pain control. A low Karnofsky index and high anxiety levels were identified as risk factors for early withdrawal from the PCC scheduled appointment. These data indicate that the PCC is an effective place for symptom management, but specific organizational strategies are needed to encourage patients to comply with scheduled appointments.

Objetivo. Realizar un analisis coste-efectividad de samario [153Sm-EDTMP] (Quadramet®) respecto a la terapia convencional, para el tratamiento del dolor causado por metastasis oseas en pacientes con cancer de prostata.

Dentro de las neoplasias malignas en la mujer, el cancer de cervix uterino ocupa el cuarto lugar despues de la neoplasia de mama, colorrectal y endometrio. En la mujer es la tercera neoplasia genital mas frecuente. La radioterapia es el tratamiento de eleccion en los estadios avanzados y obtiene los mismos resultados que la cirugia en los estadios precoces. En el presente estudio describimos nuestra experiencia en los casos tratados con radioterapia radical e intentamos analizar la influencia de los factores pronosticos clasicos.

We retrospectively reviewed our Institution's database to investigate the outcome and impact of combined radiochemotherapy (RT/CT; concomitant or in sequence) in localised small-cell lung cancer (L-SCLC).Between January 1995 to November 1999, 79 patients with L-SCLC received combined RT/CT at our Institution. RT was delivered concurrently or sequentially following the CT. Patients with treatment response received additional prophylactic cranial irradiation (PCI).Of the patients treated, 54% had received concurrent CT/RT compared to 46% receiving RT following the CT. PCI was administered to 80% of the patients. Complete response was observed in 66% of patients. With a median follow up of 30 months, median overall survival was 15.9 months; 14.3 months for patients who received RT following CT and 21.6 months for those receiving concurrent CT/RT. The type of schedule of combined radiochemotherapy was an independent prognostic factor for survival free of local recurrence, as was additional PCI for distant metastasis-free survival.Our results are similar to those reported previously in the literature. The main point of interest is that our patients were non-selected. We strongly support the use of concurrent CT/RT so as to achieve results comparable to the best in the literature.

To evaluate the cost-effectiveness of samarium [153Sm-EDTMP] (Quadramet) compared to conventional therapy in the treatment of pain in patients with prostate cancer and bone metastases.A decision tree model for the treatment of bone pain due to metastases was adapted to the Spanish context. The model represents the standard treatment patterns in Spain for the study population. The time-course of the model is 4 months and it computes an estimate for the cost of pain control per patient. The effectiveness data for the model derive from a randomised trial. The current treatment patterns have been established according to the consensus opinions of a group of medical experts.The cost of pain control per patient is euro 12,515.39 for conventional therapy and euro 5,595.52 for samarium-153 (Quadramet) therapy. The incremental cost-effectiveness analysis shows that samarium-153 (Quadramet) is a dominant therapy. It presents lower costs and higher efficacy than the conventional strategy. The sensitivity analyses showed these results to be robust.Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.