Adhesive capsaicin 8% patch for improved control of pain caused by chemotherapy-induced peripheral neuropathy in patients with multiple myeloma: A single-centre, seven-case series.

BACKGROUND: Capsaicin is a highly selective agonist of the transient receptor potential vanilloid 1. The adhesive capsaicin patch provides a high capsaicin concentration (8%) directly in the painful area - its efficacy in benign peripheral neuropathic pain (diabetic neuropathy or postherpetic neuralgia) has recently been described in the literature. However, there is scant evidence of its efficacy in chemotherapy-induced peripheral neuropathy (CIPN). This is a concern for patients with multiple myeloma, who suffer from peripheral neuropathic pain induced by first-line treatments (bortezomib or thalidomide). AIM: To describe improved control of CIPN in patients with multiple myeloma using adhesive capsaicin 8% patch. METHODS: We opted for a retrospective observational case series. Between October 2017 and October 2020, we collected clinical data from adult multiple myeloma patients affected by CIPN who were administered the capsaicin 8% patch in our palliative care outpatient clinic. We compiled Numerical Pain Rating Scale (NPRS) scores, patients' medication needs and performance status before and after patch application. RESULTS: Two women and five men with an average age of 62.85 years received bortezomib. Two patients (28.57% of the sample) also received thalidomide. The average NPRS score before patch application was 6.42/10. Five of the seven patients (71.42%) received a mean daily oral morphine dose of 52.85 mg/day, five (71.42%) received gabapentinoids and one (14.28%) received antidepressants. The average NPRS score decreased to 4/10 seven days after patch application, while the mean daily oral morphine dose remained stable. Performance status improved slightly in two patients (28.57%) and remained stable in the rest. One patient (14.28%) required an extra analgesic dose during patch application. CONCLUSIONS: Capsaicin 8% patch application appears to reduce pain intensity in patients with multiple myeloma suffering from CIPN.

Development of a Guide to Multidimensional Needs Assessment in the Palliative Care Initial Encounter (MAP).

CONTEXT: Ensuring patient-centered palliative care requires a comprehensive assessment of needs beginning in the initial encounter. However, there is no generally accepted guide for carrying out this multidimensional needs assessment as a first step in palliative intervention. OBJECTIVES: To develop an expert panel-endorsed interview guide that would enable proactive and systematic Multidimensional needs Assessment in the Palliative care initial encounter (MAP). METHODS: A preliminary version of the MAP guide was drafted based on a published literature review, published semistructured interviews with 20 patients, 20 family carers, and 20 palliative care professionals, and a nominal group process with palliative care professionals and a representative of the national patient's association. Consensus regarding its content was obtained through a modified Delphi process involving a panel of palliative care physicians from across Spain. RESULTS: The published systematic literature review and qualitative study resulted in the identification of 55 needs, which were sorted and grouped by the nominal group. Following the Delphi process, the list of needs was reduced to 47, linked to six domains: Clinical history and medical conditions (n = 8), Physical symptoms (n = 17), Functional and cognitive status (n = 4), Psycho-emotional symptoms (n = 5), Social issues (n = 8), and Spiritual and existential concerns (n = 5). CONCLUSION: MAP is an expert panel-endorsed semi-structured clinical interview guide for the comprehensive, systematic, and proactive initial assessment to efficiently assess multiple domains while adjusting to the needs of each patient. A future study will assess the feasibility of using the MAP guide within the timeframe of the palliative care initial encounter.

One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study.

OBJECTIVES: Naloxegol 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. METHODS: This 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). RESULTS: A 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 (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment. CONCLUSION: The 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.

Efficacy of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: a 3-month follow-up analysis.

OBJECTIVES: Opioid-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. METHODS: An 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. RESULTS: A 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 (p<0.0001) from 15 days of treatment. The number of days a week with complete spontaneous bowel movements increased significantly (p<0.0001) from 2.4 to 4.6 on day 15, 4.7 after 1 month and 5 after 3 months. Pain control significantly improved (p<0.0001) during follow-up. A total of 13.5% of the patients (17/126) presented some gastrointestinal adverse reaction, mostly of mild (62.5%) or moderate intensity (25%). CONCLUSIONS: Clinically 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.

Sedación paliativa: ¿ha cambiado algo durante la pandemia? / Palliative sedation: has anything changed during the pandemic?

La pandemia por COVID-19 ha provocado una crisis sanitaria sin precedentes en nuestra historia reciente, con unas peculiaridades clínicas y sociales que han generado un importante papel de los equipos de cuidados paliativos (CP), destacando su participación en la toma de decisiones al final de la vida y en la elaboración de protocolos de sedación paliativa (SP). Una proporción significativa de pacientes con mala evolución, sin mejoría con los tratamientos disponibles ni criterios de ingreso en Unidades de Cuidados Intensivos (UCI), presentaron una alta carga sintomática y elevados niveles de sufrimiento por la refractariedad de los síntomas; por ello, de igual manera que sucede en otras enfermedades terminales, se requirió frecuentemente de la SP. A pesar del elevado número de trabajos sobre la infección por SARS-CoV-2, existe escasez de publicaciones hasta la fecha sobre SP en pacientes COVID. En este artículo revisamos la bibliografía existente y presentamos nuestra experiencia en tres unidades de cuidados paliativos hospitalarias respecto a las indicaciones de SP, fármacos y dosis, considerando además los importantes aspectos éticos en este contexto, como son la información al paciente y a la familia y la toma de decisiones en una situación de confinamiento de la población y de duras medidas de aislamiento. La pandemia por COVID-19 ha supuesto un desafío 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 terapéuticas como la SP

The 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

Protocolo territorial de adecuación de la intensidad terapéutica. Área Metropolitana Sur de Barcelona / Regional protocol for adjusting the therapeutic intensity. Southern Metropolitan Area of Barcelona

La identificación de pacientes en situación de enfermedad crónica avanzada y complejidad, y la fragmentación de cuidados hacia el final de la vida aconsejan trazar un plan terapéutico a largo plazo, congruente con los valores y preferencias de los pacientes, a la vez que con un pronóstico vital y funcional razonables. Disponer de una herramienta de ajuste en la adecuación de la intensidad diagnóstica y terapéutica sería de ayuda en la continuidad de cuidados y podría ser facilitadora de la toma de decisiones en las transiciones y en los cambios dinámicos que presentan los pacientes a medida que se acercan al final del proceso vital

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

[Regional protocol for adjusting the therapeutic intensity. Southern Metropolitan Area of Barcelona]. / Protocolo territorial de adecuación de la intensidad terapéutica. Área Metropolitana Sur de Barcelona.

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.

Neoplasias hematológicas y cuidados paliativos: revisión sistemática de la literatura / Haematological malignancies and palliative care: a systematic literature review

Objetivo: Revisión sistemática de la literatura sobre la intervención de Cuidados Paliativos en el paciente con cáncer hematológico avanzado. Material y método: Realizamos una revisión sistemática sobre los artículos en PubMed y Cochrane, desde el 1 de enero de 2001 al 1 de mayo de 2009, publicados en español y en inglés, usando como palabras claves: «Haematology, Palliative Care, Dying, Death, Supporting Team, advanced Malignancies, Prognostic», así como literatura no indexada en páginas web y libros de Hematología y Cuidados Paliativos sobre temas relacionados. Se incluyeron artículos en cuyos abstracts incluyeran la información sobre la intervención de Cuidados Paliativos en el paciente con enfermedad hematológica maligna avanzada. Los artículos que solo trataban de tratamientos del tumor o de su pronóstico fueron excluidos. Resultados: Un total de 16 artículos fueron aceptados para su lectura y revisión. Se pueden diferenciar dos tipos de artículos: un grupo que hace referencia a las características clínicas 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 información obtenida de la revisión se constata una escasa y heterogénea información al respecto, surgiendo la necesidad de ampliar el estudio en pacientes y familiares en fases avanzadas de la enfermedad hematológica maligna (AU)

Objective: To conduct a systematic review of the literature on the palliative care intervention in the far-advanced patient with haematological malignancies. Material and method: We carried out a systematic search of articles in PubMed and Cochrane, from 1 January 2001 to 1t May 2009, published in Spanish or English, and using ‘‘Haematology, Palliative Care, Dying, Death, Supporting Team, advanced Malignancies, Prognosis’’. Websites and Palliative and Haematology journals and books were also searched. We included papers with an abstract providing information of palliative care intervention in patients with far advanced haematological malignancies. Papers dealing with tumour treatment or prognosis were excluded. Results: Sixteen papers were acceptable for full reading and assessment. Two categories of works could be differentiated; one regarding the clinical characteristics of the patients, and a second lot of papers devoted to the professional, and patient/families experiences with the disease at the end of life. Conclusions: Information provided by the review gave us little and heterogeneous information. Thus there is a great need for the patients and families living with the last stages of haematological malignancy. Further studies are needed (AU)

[Combined radiochemotherapy in localised small-cell lung cancer. Concurrent treatment protocols?]. / Radioquimioterapia de la enfermedad limitada del carcinoma pulmonar de célula pequeña. Tratamiento concomitante en protocolos asistenciales?

PURPOSE: 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). MATERIAL AND METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Patient appointment process, symptom control and prediction of follow-up compliance in a palliative care outpatient clinic.

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.

Radioquimioterapia de la enfermedad limitada del carcinoma pulmonar de célula pequeña. ¿Tratamiento concomitante en protocolos asistenciales? / Combined radiochemotherapy in localised small-cell lung cancer. Concurrent treatment protocols?

Purpose. 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). Material and methods. 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). Results. 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. Conclusions. 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

Purpose. 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). Material and methods. 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). Results. 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. Conclusions. 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

[Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases]. / Análisis coste-efectividad de samario-153 (Quadramet) en el tratamiento del dolor en pacientes con cáncer de próstata y metástasis óseas.

OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.

Análisis coste-efectividad de samario-153 (Quadramet®) en el tratamiento del dolor en pacientes con cáncer de próstata y metástasis óseas / Cost-effectiveness analysis of samario-153 (Quadramet®) for the treatment of patients with prostate cancer and bone metastases

Objetivo. Realizar un análisis coste-efectividad de samario [153Sm-EDTMP] (Quadramet®) respecto a la terapia convencional, para el tratamiento del dolor causado por metástasis óseas en pacientes con cáncer de próstata. Metodología. Se ha adaptado un modelo de árbol de decisión, que representa el tratamiento del dolor óseo metastásico, al contexto español. El modelo muestra las opciones terapéuticas habituales en el contexto sanitario español para la población del estudio. El horizonte temporal del modelo es de 4 meses y calcula el cociente coste-efectividad por paciente controlado. Los datos de eficacia del modelo provienen de un ensayo clínico aleatorizado. Las pautas de tratamiento habituales en España han sido indicadas por varios especialistas médicos. Resultados. El coste por paciente controlado para la terapia convencional es de 12.515,39 € y para la terapia con samario-153 (Quadramet®) es de 5.595,52 €. El análisis coste-efectividad incremental muestra que samario-153 (Quadramet®) es una terapia dominante, es decir, que presenta una mayor eficacia y un menor coste que la terapia convencional. Los resultados obtenidos han demostrado ser robustos en un extenso análisis de sensibilidad. Conclusiones. La terapia con samario-153 (Quadramet®) es eficiente en el tratamiento del dolor de pacientes con cáncer de próstata y metástasis óseas

Objective. 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. Method. 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. Results. The cost of pain control per patient is €12,515.39 for conventional therapy and € 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. Conclusion. Samarium-153 (Quadramet®) is cost-effective in treating pain in patients with prostate cancer and bone metastases