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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.
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Analgésicos Opioides/efeitos adversos , Dor do Câncer/tratamento farmacológico , Morfinanos/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Constipação Induzida por Opioides/tratamento farmacológico , Polietilenoglicóis/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/efeitos adversos , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Inquéritos e QuestionáriosRESUMO
Purpose: We aimed to explore the characteristics, and real-life therapeutic management of patients with breakthrough cancer pain (BTcP) caused by bone metastases in Spain, and to evaluate physicians' opinion of and satisfaction with prescribed BTcP therapy. Participants and methods: For the purposes of this study, an ad-hoc questionnaire was developed consisting of two domains: a) organizational aspects and care standards; b) clinical and treatment variables of bone metastatic BTcP patients. In addition, physicians' satisfaction with their prescribed BTcP therapy was assessed. Specialists collected data from up to five patients receiving treatment for BTcP caused by bone metastasis, all patients gave their consent to participate prior to inclusion. Results: A total of 103 cancer pain specialists (radiation oncologists [38.8%], pain specialists [33.0%], and palliative care (PC) specialists [21.4%]) were polled, and data on 386 BTcP patients with bone metastatic disease were collected. Only 33% of the specialists had implemented specific protocols for BTcP management, and 19.4% had established referral protocols for this group of patients. Half of all participants (50.5%) address quality of life and quality of care in their patients; however, only 27.0% did so from the patient's perspective, as they should do. Most patients had multiple metastases and were prescribed rapid-onset fentanyl preparations (71.2%), followed by immediate-release morphine (9.3%) for the treatment of BTcP. Rapid-onset fentanyl was prescribed more often in PC units (79.0%) than in pain units (75.9%) and radiation oncology units (61.1%) (p<0.01). Furthermore, most physicians (71.8%) were satisfied with the BTcP therapy prescribed. Conclusions: Our results demonstrate the need for routine assessment of quality of life in patients with bone BTcP. These findings also underscore the necessity for a multidisciplinary therapeutic strategy for breakthrough pain in clinical practice in Spain.
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OBJECTIVES: We aimed to generate expert-based recommendations on the management of breakthrough cancer pain (BTcP) in older patients with cancer. MATERIAL AND METHODS: A two-round multidisciplinary Delphi study. Specialists rated their agreement with a set of statements using a nine-point Likert scale (oneâ¯=â¯totally disagree and nineâ¯=â¯totally agree). Statements were classified as appropriate (median ranged from seven to nine), irrelevant (median ranged from four to six) or inappropriate (median ranged from one to three). Consensus was established when at least two thirds of the panel scored within any of the ranges. RESULTS: A total of 64 specialists from pain units (44.4%), palliative care units (25.4%), medical oncology (19.1%), geriatric medicine (7.9%) and others (3.2%), participated in two consultation rounds. Specialists agreed that effective coordination between the different specialties and levels of care is essential for proper management of BTcP. Most participants (81.3%) supported the assessment of frailty and resolved (96.8%) that frailty status is a better indicator of patient needs than biological age. Participants agreed (75.8%) in the application of the Davies algorithm for diagnosis of BTcP in older patients. A strong consensus was achieved regarding which pharmacological treatment (transmucosal fentanyl) and dosing method (start low and go slow) are the most suitable for the older population. No agreement was reached on how interventionist techniques should be integrated into the therapeutic strategy for BTcP. CONCLUSIONS: The present Delphi has generated a set of recommendations that will help healthcare professionals in the management of BTcP in older patients.
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Analgésicos Opioides/uso terapêutico , Dor Irruptiva/tratamento farmacológico , Dor do Câncer/tratamento farmacológico , Administração através da Mucosa , Idoso , Depressores do Sistema Nervoso Central/efeitos adversos , Indutores das Enzimas do Citocromo P-450/efeitos adversos , Inibidores das Enzimas do Citocromo P-450/efeitos adversos , Tomada de Decisão Compartilhada , Técnica Delphi , Interações Medicamentosas , Fentanila/uso terapêutico , Fragilidade , Avaliação Geriátrica , Geriatria , Humanos , Oncologia , Morfina/uso terapêutico , Oxicodona/uso terapêutico , Manejo da Dor , Medição da Dor , Medicina Paliativa , Equipe de Assistência ao Paciente , Guias de Prática Clínica como AssuntoRESUMO
OBJECTIVE: The study objective was to assess the quality of life and satisfaction with treatment of patients with chronic neuropathic pain (CNP) who experience breakthrough pain (BTP) and to assess its economic impact. DESIGN: Cross-sectional observational study. SETTING: Fifteen pain units from Spanish hospitals completed the study. PARTICIPANTS: A total of 124 patients with adequately controlled CNP who experienced BTP were enrolled into the study. INTERVENTION: No interventions were required. MAIN OUTCOME MEASURES: Quality of life was assessed using the SF12 v2 questionnaire, the results of which were used to calculate the estimated costs per patient and month and the SF-6D Health Utility Index. Patient satisfaction with treatment received for CNP and for BTP was assessed using a 10-point visual analogue scale. Other associated symptoms were analyzed using the ESAS (Edmonton Symptom Assessment System). RESULTS: Patients had a mean age of 60.2 years (95% CI 58.4-63.3), and 46.8% (58) were males. 18.9% (23) experienced their first episode of BTP. A severe impairment of the physical component of SF12v2 was noted, with 94% of patients below the mean score of the population, while 88% had values lower than normal for the mental component. Mean cost per patient and month was $679 and was significantly greater in males ($763 versus $606), 4.96 times greater than in healthy population, and approximately double the cost of patients with CNP in Spain. CONCLUSIONS: Occurrence of BTP in patients with CNP causes a substantial increase in healthcare costs which is significantly greater in older males.
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INTRODUCTION: Breakthrough pain (BTP) has great repercussions on the quality of life, and on the use of health resources. The scope of BTP costs in cancer patients is unknown. The purpose of this study was to evaluate the economic cost of BTP in patients with cancer and the relationship with their quality of life. METHODS: A 1-month observational prospective cost-of-illness study was designed. The patients recorded the consumption of health resources and drugs related to BTP in a diary. The current symptoms in Edmonton Symptoms Assessment Scale (ESAS) and their quality of life (EORTC QLQ-C30, version 3) were assessed. The direct medical and non-medical costs fixed and variable and the indirect costs of the patient and the caregivers were evaluated. Factors related to cost and quality of life were identified using linear generalized models (LGM) type gamma and logistic link. Participants were oncologic patients with BTP, older than 18 years, with controlled basal pain. RESULTS: Eight Spanish pain units, eight palliative care units, and one oncology department included 152 patients. One hundred patients (65.8%) were male and the mean age was 66.8 years (95% CI 64.8-68.8). The total cost per patient was 2941.60 euros per month: 88% direct medical costs, 5% non-medical direct costs, and 7% indirect costs due to lost productivity. A better score in EORTC QLQ-30 quality of life was associated with a reduction in overall costs. CONCLUSIONS: The study showed the results of the first real-life prospective study evaluating the cost of illness of BTP in cancer patients demonstrating that the presence of breakthrough pain in a cancer patient causes a very significant increase in healthcare costs. FUNDING: Kyowa Kirin Farmacéutica, S.L.U.
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INTRODUCTION: Although breakthrough dyspnea is very frequent in cancer patients, there are no precise recommendations for treating it. The main objective of this study was to analyze what treatments are used in clinical practice for the management of breakthrough dyspnea in cancer patients in Spain and the secondary objectives were to describe the characteristics of cancer patients with breakthrough dyspnea and the attributes of the disorder. METHODS: Cancer patients over 18 years of age, with breakthrough dyspnea and a Karnofsky performance score of ≥30, who were treated at departments of oncology in institutes across Spain were included in this cross-sectional observational study. The characteristics of breakthrough dyspnea, history of treatment, anthropometric variables, Mahler dyspnea index, Borg scale, Edmonton Symptoms Assessment Scale, and patient satisfaction with current breakthrough dyspnea treatment were assessed. RESULTS: The mean age of the 149 included patients was 66 years (95% confidence interval: 64.3 to 67.9), and 53 were females (35.6%). The mean breakthrough dyspnea intensity was 5.85 (95% confidence interval 5.48 to 6.22, Borg scale). A total of 55.1% of the first-choice treatments consisted of opioids, followed by oxygen (17.3%). A total of 119 patients (79.9%) received monotherapy for breakthrough dyspnea. Patients presenting with basal dyspnea received oxygen in a greater proportion of cases (21.1% vs 7.4%; p = 0.07). Patients with predictable dyspnea received a greater proportion of opioids (70.9% vs 44.4%; p = 0.01). CONCLUSIONS: Opioids constitute first-line therapy for breakthrough dyspnea in routine clinical practice, though the scientific evidence supporting their use is scarce. Further information derived from controlled clinical trials is needed regarding the comparative efficacy of the different treatments in order to justify their use.
INTRODUCCIÓN: Siendo la disnea irruptiva un síntoma muy frecuente en los pacientes oncológicos, no existen recomendaciones precisas para su tratamiento. El objetivo principal del estudio fue analizar qué tratamientos se utilizan en la práctica clínica diaria para el manejo de la disnea irruptiva en pacientes con cáncer en España. Los objetivos secundarios fueron describir las características de los pacientes oncológicos con disnea irruptiva y los atributos de esta alteración. MÉTODOS: Pacientes oncológicos mayores de 18 años, con disnea irruptiva y estado funcional Karnofsky mayor o igual a 30, atendidos en servicios de oncología. Se recogió el historial de tratamientos para la disnea irruptiva y las características de esta patología, variables antropométricas, índice de disnea de Mahler, escala de Borg, escala Edmonton Symptoms Assessment Scale, satisfacción del paciente con el tratamiento actual de la disnea irruptiva. RESULTADOS: La edad media de los 149 pacientes incluidos fue de 66 años (intervalo de confianza 95%: 64,3 a 67,9), siendo mujeres el 35,6% (53). La intensidad media de la disnea irruptiva fue de 5,85 (intervalo de confianza 95%: 5,48 a 6,22 Borg). El 55,1% de los tratamientos de primera opción fueron los opioides, seguidos del oxígeno (17,3%). El 79,9% de los pacientes (119) fueron tratados en monoterapia. En los casos que presentaban disnea basal se administró oxígeno en mayor proporción 21,1% versus 7,4% (p = 0,07). Si la disnea era predecible se administró en mayor proporción opioides, 70,9% versus 44,4% (p = 0,01). CONCLUSIONES: Los opioides constituyen el tratamiento de primera línea de la disnea irruptiva en la práctica clínica habitual; sin embargo, el grado de evidencia científica que justifique su uso es escasa. Se necesita más información procedente de ensayos clínicos controlados en los que se evalúe la eficacia comparativa de diferentes tratamientos.