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INTRODUCTION: Abiraterone and enzalutamide are two androgen receptor pathway inhibitors approved, among others, for the treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based regimen. Although hematological effects, especially neutropenia, are one of the main complications of other oral antineoplastic drugs, these adverse effects are infrequent in the case of androgen receptor pathway inhibitors. CASE REPORT: We report the case of a patient diagnosed with metastatic castration-resistant prostate cancer who discontinued an androgen receptor pathway inhibitor due to drug-related grade 4 neutropenia. His control blood counts before enzalutamide starting were normal. After one month of treatment, he developed a grade 4 neutropenia, with complete neutrophil count recovery four weeks later. He underwent a bone marrow aspiration, which revealed normocelullar results, and enzalutamide was restarted. Three weeks later, the treatment was eventually discontinued due to neutropenia reappearance. Neutrophil count recovery was achieved one month later. Then, he started treatment with abiraterone, but two weeks later neutropenia reappeared. Abiraterone was withdrawn, and the patient recovered from neutropenia 2 weeks later. MANAGEMENT AND OUTCOMES: This case exposes not only the occurrence of rare toxicity of two individual drugs but also the description of a probable drug-class adverse event not reported before. The patient recovered from neutropenia after the androgen receptor pathway inhibitor was withdrawn, thereby supporting the diagnosis of probable drug-induced neutropenia. DISCUSSION: There is scarce evidence in the literature concerning androgen receptor pathway inhibitor-related neutropenia. However, its life-threatening potential cannot be ignored, so healthcare professionals should be warned of the possibility of the occurrence of such adverse reactions.
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BACKGROUND: There are scarce data of the costs of non-small cell lung cancer (NSCLC) recurrence in Spain. The objective of this study is to assess the economic burden of disease recurrence, for both locoregional and/or metastatic relapses, after appropriate early-stage NSCLC treatment in Spain. MATERIALS AND METHODS: A two-round consensus panel of Spanish oncologists and hospital pharmacists was conducted to collect information on patient's flow, treatments, use of healthcare resources and sick leaves in patients with relapsed NSCLC. A decision-tree model was developed to calculate the economic burden of disease recurrence after appropriate early-stage NSCLC. Both direct and indirect costs were considered. Direct costs included drug acquisition and healthcare resources costs. Indirect costs were estimated using the human-capital approach. Unit costs were obtained from national databases (euros of 2022). A multi-way sensitivity analysis was performed to provide a range to the mean values. RESULTS: Among a cohort of 100 patients with relapsed NSCLC, 45 patients would have locoregional relapse (36.3 would eventually progress to metastasis and 8.7 would be considered in remission) and 55 patients would have metastatic relapse. Over time, 91.3 patients would experience a metastatic relapse (55 as first relapse and 36.6 after previous locoregional relapse). The overall cost incurred by the 100-patients cohort is 10,095,846 (9,336,782 direct costs, 795,064 indirect costs). The average cost of a locoregional relapse is 25,194 (19,658 direct costs, 5536 indirect costs), while the average cost a patient with metastasis who receives up to 4 lines of treatment is 127,167 (117,328 direct, 9839 indirect). CONCLUSIONS: To our knowledge, this is the first study that specifically quantifies the cost of relapse in NSCLC in Spain. Our findings shown that the overall cost of a relapse after appropriate treatment of early-stage NSCLC patients is substantial, and it increases considerably in the metastatic relapse setting, mainly due to the high cost and long duration of first-line treatments.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Humanos , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/patologia , Espanha , Custos de Cuidados de Saúde , Estresse Financeiro , Efeitos Psicossociais da Doença , Recidiva Local de NeoplasiaRESUMO
INTRODUCTION: Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) indicated for the treatment of epidermal growth factor receptor mutated non-small cell lung cancer (NSCLC). It has demonstrated better results concerning effectiveness than other TKIs for the same indication. However, despite a good safety profile, it could produce some cardiotoxicity that does not occur with other drugs of the same group. CASE REPORT: We report the evolution and management of a female patient diagnosed with NSCLC who developed a grade 3 cardiotoxicity due to treatment with osimertinib. This patient suffered from a left bundle branch block, dyslipidemia, and hypertension as cardiovascular risk factors. After a long period of treatment with osimertinib, she developed a severe heart failure (HF) with an important decrease in left ventricular ejection fraction (LVEF), which triggered an admission to the oncology unit for eight days. MANAGEMENT AND OUTCOMES: Treatment with osimertinib was first suspended and then resumed after stabilization of the HF. She also developed atrial fibrillation during admission and has required narrow cardiac monitoring and management since the debut of the HF. After evaluating the benefit-risk balance, osimertinib was reintroduced and the patient continues in treatment at the moment, although the baseline LVEF is not recovered. DISCUSSION: There is scarce evidence in the literature concerning HF and important LVEF decrease due to osimertinib. However, its severity and repercussion for the patient justify the thorough screening of cardiovascular risk factors before starting the therapy.
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Carcinoma Pulmonar de Células não Pequenas , Insuficiência Cardíaca , Neoplasias Pulmonares , Feminino , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Volume Sistólico , Cardiotoxicidade , Mutação , Função Ventricular Esquerda , Insuficiência Cardíaca/induzido quimicamenteRESUMO
INTRODUCTION: Spironolactone when combined with abiraterone in metastatic castration-resistant prostate cancer (mCRPC) may theoretically exert androgenic properties, thereby compromising the therapeutic effectiveness of abiraterone. CASE REPORT: Two patients with a medical history of cardiovascular disease and mCRPC combined spironolactone within the course of abiraterone regimen. The abiraterone-spironolactone interaction was identified using the Lexicomp® interaction tool (classified as risk C). MANAGEMENT & OUTCOME: Spironolactone treatment was maintained as it was considered beneficial due to the cardiac condition. The prostate-specific antigen (PSA) levels started to rise when these two drugs were used together. Eventually, tumour progression was observed. DISCUSSION: There is increasing evidence that spironolactone behaves as a selective androgen receptor modulator. Strategies to overcome abiraterone-spironolactone interaction could involve the use of eplerenone, although this drug is also controversial. The best strategy should imply a multidisciplinary evaluation by cardiologists and oncologists.
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Neoplasias de Próstata Resistentes à Castração , Espironolactona , Masculino , Humanos , Espironolactona/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/patologia , Acetato de Abiraterona/uso terapêutico , Resultado do Tratamento , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
WHAT IS KNOWN AND OBJECTIVE: Rosai-Dorfman disease (RDD) is an infrequent entity of unknown aetiology. Currently, there is no clear consensus on the treatment, and nothing has shown definitive safety and efficacy. We describe the case of a woman diagnosed with pulmonary RDD, who responded to thalidomide treatment after failure of four previous lines of systemic chemotherapy. CASE DESCRIPTION: We present the case of a 74-year-old woman diagnosed with pulmonary RDD and autoimmune complications. We decided to use thalidomide as a rescue treatment after the failure of corticosteroids and several chemotherapies. Our patient achieved remission of the disease and remained stable for years. WHAT IS NEW AND CONCLUSION: To the authors' knowledge, this is the first reported case in which thalidomide treatment induced remission in refractory pulmonary RDD. Thalidomide showed a rapid onset of action, with lasting responses, which could make it an exciting option for treating this life-threatening.
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Histiocitose Sinusal , Talidomida , Idoso , Feminino , Histiocitose Sinusal/complicações , Histiocitose Sinusal/diagnóstico , Histiocitose Sinusal/tratamento farmacológico , Humanos , Talidomida/uso terapêuticoRESUMO
PURPOSE: End-of-life cancer care varies widely, and very few centers evaluate it systematically. Our objective was to assess indicators of the aggressiveness of end-of-life cancer care in clinical practice. METHODS: An observational, longitudinal, and retrospective cohort study was conducted at a tertiary hospital. Eligible patients were at least 18 years old, had a solid tumor, were followed up by the Oncology Department, and had died because of cancer or associated complications during 2017. We used the criteria of Earle et al. (J Clin Oncol 21(6):1133-1138, 2003) to assess the aggressiveness of care. Multivariate logistic regression analyses were performed to characterize factors associated with aggressiveness of therapy. RESULTS: The study population comprised 684 patients. Eighty-eight patients (12.9%) received anti-cancer treatment during the last 14 days of their lives, and 62 patients (9.1%) started a new treatment line in the last 30 days. During the last month of life, 102 patients (14.9%) visited the ER, 80 patients (11.7%) were hospitalized more than once, and 26 (3.8%) were admitted to the ICU. A total of 326 patients (47.7%) died in the acute care unit. A total of 417 patients (61.0%) were followed by the Palliative Care Unit, and in 54 cases (13.0%), this care started during the last 3 days of life. CONCLUSIONS: The use of anti-cancer therapies and health care services in our clinical practice, except for the ICU, did not meet the Earle criteria for high-quality care. Concerning hospice care, more than half of the patients received hospice services before death, although in some cases, this care started close to the time of death.
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Cuidados Paliativos na Terminalidade da Vida/métodos , Neoplasias/terapia , Assistência Terminal/métodos , Idoso , Estudos de Coortes , Feminino , Humanos , Estudos Longitudinais , Masculino , Estudos RetrospectivosRESUMO
BACKGROUND: Diarrhea is one of the most frequent class adverse events associated with targeted oral antineoplastic agents (OAAs). Our objective was to analyze the incidence, characteristics, and severity of diarrhea in cancer patients in clinical practice. METHODS: An observational, longitudinal, and prospective study of cancer outpatients treated with targeted OAAs was carried out in a tertiary hospital. Targed OAAs analyzed were anaplastic lymphoma kinase inhibitors, BCR-ABL inhibitors, cyclin-dependent kinase inhibitors, epidermal growth factor receptor inhibitors, mTOR inhibitors, poly (ADP-ribose) polymerase inhibitors, and vascular endothelial growth factor receptor inhibitors. Patients were given a data collection form to record daily the number, severity (CTCAE version 5.0), and characteristics of stools during the first 30 days of treatment with OAAs. Multivariate analysis was performed to identify risk factors associated with the incidence of diarrhea. RESULTS: We analyzed 240 patients, of whom 28.7% experienced diarrhea (25.4% grades 1-2 and 3.3% grades 3-4). Patients treated with EGFR and VEGFR inhibitors had a higher incidence of diarrhea. The multivariate analysis revealed that taking the OAA with food was associated with a lower risk of diarrhea (OR = 0.404 [0.205-0.956], p = 0.038). CONCLUSIONS: More than a third of patients in treatment with OAAs presented diarrhea (any grade), and 22.1% of stools were semi-liquid/liquid. In multivariate analysis, taking the OAA on an empty stomach was associated with a statistically significant increase in the incidence of diarrhea.
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Antineoplásicos/efeitos adversos , Diarreia/induzido quimicamente , Feminino , Humanos , Incidência , Estudos Longitudinais , Masculino , Estudos Prospectivos , Fatores de RiscoRESUMO
INTRODUCTION: Use of oral antineoplastic agents (OAAs) has increased significantly in recent years. OAAs currently represent 30-50% of all cancer treatments. Drug interactions are the most frequent drug-related problem affecting OAAs. We describe the case of a patient who presented acute pancreatitis, possibly induced by the concomitant use of imatinib and gefitinib. CASE REPORT: A female patient received imatinib and gefitinib for the treatment of chronic myeloid leukemia and lung adenocarcinoma, respectively. Liver function and pancreatic enzyme values gradually worsened after initiation of imatinib, and the patient was diagnosed with acute pancreatitis. MANAGEMENT AND OUTCOMES: Imatinib was discontinued owing to pancreatic toxicity. Gefitinib was subsequently discontinued owing to tumor progression. The patient received supportive measures for pancreatitis, although she eventually died 3 months after the onset of symptoms. DISCUSSION: To our knowledge, this is the first case in the medical literature of acute pancreatitis possibly induced by an interaction between imatinib and gefitinib. The interaction most likely arose because imatinib is a CYP2D6 inhibitor and could therefore impair the metabolism of gefitinib (a CYP2D6 substrate) and increase its serum concentration. This interaction is extremely rare. However, due to its severity, hepatic and pancreatic function should be carefully monitored in patients treated with imatinib and/or gefitinib and other inhibitors or inducers of CYP2D6 and CYP3A4.
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Antineoplásicos/efeitos adversos , Gefitinibe/efeitos adversos , Mesilato de Imatinib/efeitos adversos , Pancreatite/induzido quimicamente , Pancreatite/diagnóstico , Inibidores de Proteínas Quinases/efeitos adversos , Antineoplásicos/administração & dosagem , Interações Medicamentosas/fisiologia , Feminino , Gefitinibe/administração & dosagem , Humanos , Mesilato de Imatinib/administração & dosagem , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/metabolismo , Pessoa de Meia-Idade , Pancreatite/metabolismo , Inibidores de Proteínas Quinases/administração & dosagemRESUMO
INTRODUCTION: Acute graft-versus-host disease GVHD (aGVHD) is the main complication during the first months after bone transplantation. Steroid therapy is clearly the upfront established treatment for aGVHD. However, there are patients with partial response to steroid treatment and steroid-refractory cases. For those patients, a vast number of therapeutic options have emerged, although the evidence is scarce. CASE REPORT: We report the use of tocilizumab as salvage treatment in a patient with corticosteroid refractory pulmonary aGVHD that was admitted to the critical care unit for respiratory support measures. MANAGEMENT & OUTCOME: We decided to use tocilizumab as rescue treatment, after failure of corticosteroid treatment, standard treatment with broad-spectrum antibiotics and etanercept. The patient showed a remarkable clinical improvement two days after first infusion and a total resolution of the symptomatology with normalization of the spirometry tests after 4 weeks of the administration of tocilizumab. DISCUSSION: To the authors' knowledge, this is the first case that describes the effective and safe use of tocilizumab as a rescue treatment in a patient with steroid-refractory pulmonary aGVHD. It showed a rapid onset of action and a favorable safety profile, which could make it an interesting option for the treatment of this potentially fatal complication.
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Anticorpos Monoclonais Humanizados/administração & dosagem , Doença Enxerto-Hospedeiro/tratamento farmacológico , Pneumopatias/tratamento farmacológico , Terapia de Salvação/métodos , Corticosteroides/administração & dosagem , Doença Enxerto-Hospedeiro/diagnóstico por imagem , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Humanos , Pneumopatias/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Terapia de Salvação/efeitos adversosRESUMO
OBJECTIVE: To design a mobile app based on the needs of the onco-hematological patient receiving oral antineoplastic agents. METHODS: A multidisciplinary working group (pharmacy-oncology-hematology) was created to design the app. The study was developed in three phases: first, we analyzed the features of patients receiving oral antineoplastic agents. We then analyzed available apps for cancer patients. Finally, we designed the app's functionalities. RESULTS: We included 51 patients with middle-advanced age (68.7 years (SD=10.7)). They were polymedicated (mean: 5.3 (SD = 2.7), with numerous drug-drug interactions and adverse effects (all patients presented adverse effects). We then analyzed 166 apps. Most apps had more than one use, the most frequent being information (39.8%) and diagnosis (38.6%). Ten apps (6%) were for registering and monitoring treatment and adverse effects. Almost half of the apps (48.8%) were developed by healthcare organizations. Finally, we designed an app (e-OncoSalud®) with the following functionalities: (a) agenda; (b) treatment and drug interactions checker; (c) continuous recording of self-controls (weight, blood pressure, general condition) and adverse effects. The management of the adverse effects are based on an algorithm which provides different recommendations according to the adverse effects severity; (d) patient-pharmacist messaging in real-time; (e) education. CONCLUSIONS: After analysis of the main problems affecting these patients and the needs not covered by the existing apps, we designed e-OncoSalud®. It integrates relevant information about their treatment, focused on drug interactions identification and the prevention, and management of adverse effects.
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Antineoplásicos/administração & dosagem , Aplicativos Móveis , Neoplasias/tratamento farmacológico , Smartphone , Telemedicina/métodos , Administração Oral , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aplicativos Móveis/tendências , Neoplasias/diagnóstico , Smartphone/tendências , Telemedicina/tendênciasRESUMO
BACKGROUND: Knowledge of the quantity and quality of apps related to coronavirus disease (COVID-19) is lacking. In addition, no directory has been established listing all the apps developed to address the COVID-19 pandemic. OBJECTIVE: The aim of this study was to identify smartphone apps designed to address the COVID-19 pandemic and to analyze their characteristics. METHODS: We performed an observational, cross-sectional, descriptive study of all smartphone apps associated with COVID-19. Between April 27 and May 2, 2020, we searched the App Store (iOS) and Google Play Store (Android) for COVID-19 apps. The search terms used were coronavirus, COVID-19, and SARS-COV-2. The apps were downloaded and evaluated. The variables analyzed were name, platform, country, language, category, cost, update date, size, version, number of downloads, developer, and purpose. Purpose was further classified into the following categories: news, general information, self-diagnosis, contact tracing, notices to contacts, notification of close cases, awareness, helplines, monitoring of clinical parameters, recording of symptoms and treatment, and messaging with health care professionals. RESULTS: We identified 114 apps on the investigated platforms. Of these, 62/114 (54.4%) were on Android and 52/114 (45.6%) were on iOS. Of the 114 apps, 37 (32.5%) were developed in Europe, 32 (28.1%) in Asia, and 30 (26.3%) in North America. The most frequent languages were English (65/114, 57.0%), Spanish (34/114, 29.8%), and Chinese (14/114, 12.3%). The most common categories were health and well-being/fitness apps (41/114, 41.2%) and medicine apps (43/114, 37.7%). Of the 114 apps, 113 (99.1%) were free. The mean time between the date of the analysis and the date of the last update was 11.1 days (SD 11.0). Overall, 95 of the 114 apps (83.3%) were intended for the general population, 99 apps (7.9%) were intended for health professionals, and 3 apps (2.6%) were intended for both. Regarding the type of developer, 64/114 apps (56.1%) were developed by governments; 42/114 (64.1%) were developed by national governments, and 23/114 (35.9%) were developed by regional governments. The apps with the highest number of downloads (100,000+) were developed by governments (P=.13), except for the World Health Organization app (500,000+). The purposes of the apps available in Western languages (107/114, 93.9%) were determined; the most common purposes were general information about COVID-19 (66, 64.0%), COVID-19 news (53, 51.0%), recording of symptoms (53, 51.0%), and contact tracing (51, 47.7%). More than one purpose was identified for 99/107 apps (92.5%). CONCLUSIONS: This paper offers a comprehensive and unique review of all available COVID-19 apps. Governments have adopted these tools during the pandemic, and more than half of the apps were developed by government agencies. The most common purposes of the apps are providing information on the numbers of infected, recovered, and deceased patients, recording of symptoms, and contact tracing.
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Betacoronavirus , Infecções por Coronavirus , Aplicativos Móveis , Pandemias , Pneumonia Viral , Smartphone , COVID-19 , Estudos Transversais , Humanos , SARS-CoV-2RESUMO
BACKGROUND: Information and communication technologies (ICTs) in oncology can revolutionize the medical care of cancer patients. ICTs can promote patients' empowerment and real-time disease monitoring. There is limited information about the impact of ICTs in cancer patients or their level of interest in using these tools for greater management of their condition. OBJECTIVE: This study aimed to understand the ICT usage profile in hematology-oncology patients to identify their needs and determine their level of interest in these technologies as a means of managing their disease. METHODS: A 28-item questionnaire was drawn up by a multidisciplinary team including pharmacists and oncologists. The questions were organized into 3 blocks, which were as follows: block A-sociodemographic characteristics; block B-use of ICTs when searching for health-related information; and block C-usage preferences for health apps. Hematology-oncology patients receiving treatment between May and July 2017 were included. A paper copy of the questionnaire was handed over to patients in either the day hospital or the pharmaceutical care consultancy in pharmacy services. RESULTS: A total of 650 questionnaires were handed out, with a participation of 94.0% (611/650). Patient sociodemographic characteristics were as follows: mean age was 57.8 years (age range: 19-91). Of 611 participants, 40.7% (249/611) had a university education, and 45.1% (276/611) of participants reported their overall state of health to be good. Results from use of ICTs when searching for health-related information were as follows: 87.1% (532/611) of participants were interested in being informed about health-related matters. Of all participants, 75.5% (532/611) sought information from health professionals and 61.3% (375/611) on the internet. Before going to their doctor's appointment, 21.8% (133/611) of patients looked up information about their disease or treatment on the internet. This access to the internet rose to 50.9% (311/611) after their first medical appointment with their oncologist. Usage preferences for health apps were as follows: 82.7% (505/611) had a smartphone, whereas 20.3% (124/611) had a health app installed. Overall, 81.5% (498/611) would use an app if their health professional recommended it to them, but 39.6% (242/611) were not willing to pay for it. CONCLUSIONS: The hematology-oncology patients showed a great deal of interest in searching for health-related information by means of ICTs, especially using smartphones and apps. The issues that drew the most interest in terms of apps were appointment management, advice on disease management, and communication with health professionals. Free access to these features and the recommendation by a health professional are important factors when it comes to their use. Therefore, the health care provider is a key element in the recommendation of ICTs, providing their knowledge and experience concerning their correct usage.
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Internet/normas , Neoplasias/terapia , Smartphone/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Tecnologia da Informação , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: No previous studies exist examining the effectiveness and safety in real clinical practice of the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice of the combination of OBV/PTV/r+DSV with or without ribavirin for 12 weeks in treatment-naïve and previously treated adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. METHODS: This was an observational study of a prospective cohort of treatment-naïve and pretreated adult patients who received 12 weeks of OBV/PTV/r (25/150/100 mg once daily) and DSV (250 mg twice daily) with or without ribavirin. The primary effectiveness outcome was sustained virological response 12 weeks after the end of treatment (SVR12). Safety outcomes were presented by the incidence of adverse events. RESULTS: A total of 116 of 121 patients achieved a SVR12 (95.9%, 95% CI = 90.6-98.6). The SVR12 rate was 93.8% (95% CI = 86.0-97.9) in cirrhotic patients and 100% (95% CI = 91.4-100.0) in noncirrhotic patients. Adverse events occurred in 91.7% of patients, of which 81.8% were grade 1/2, and none led to premature discontinuation. Grade 3 adverse events were reported in 9.9% of patients. The most frequent adverse event was anemia (52.1%), although only 1.6% had a hemoglobin level below 8 g/dL. The incidence of any adverse event was higher in the group of patients who received ribavirin (96.5% vs 80.0%, P = 0.002). CONCLUSIONS: The combination of OBV/PTV/r+DSV with or without ribavirin for 12-week settings achieved a high rate of SVR12, with an acceptable safety profile in routine clinical care.
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Antivirais/administração & dosagem , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/tratamento farmacológico , 2-Naftilamina , Idoso , Anilidas/administração & dosagem , Antivirais/efeitos adversos , Antivirais/uso terapêutico , Carbamatos/administração & dosagem , Ciclopropanos , Quimioterapia Combinada , Feminino , Genótipo , Hepacivirus/genética , Humanos , Lactamas Macrocíclicas , Compostos Macrocíclicos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Prolina/análogos & derivados , Estudos Prospectivos , Ribavirina/administração & dosagem , Ribavirina/uso terapêutico , Ritonavir/administração & dosagem , Ritonavir/uso terapêutico , Sulfonamidas/administração & dosagem , Uracila/administração & dosagem , Uracila/análogos & derivados , ValinaRESUMO
AIMS: To assess the cost-effectiveness of adjuvant atezolizumab in the treatment of early-stage NSCLC patients (stage II-IIIA) with expression PD-L1 ≥ 50% without mutations in EGFR or ALK rearrangements in Spain. MATERIALS AND METHODS: A 5-states Markov model (DFS, locoregional recurrence, 1 L-metastatic recurrence, 2 L-metastatic recurrence, and death states) was adapted to the Spanish setting. Demographic characteristics of the hypothetical cohort, transition probabilities from the DFS state, and safety parameters were obtained from IMpower010 study (GO29527). Transition probabilities from locoregional and metastatic health states were obtained from the literature. The usual clinical practice in Spain (use of health resources, management of the disease, etc.) was obtained from a previous analysis carried out by the authors of this study. A societal perspective was considered so both direct and indirect costs were included (expressed in of 2021). A lifetime horizon was used, so costs and health outcomes were discounted at 3% per year. Sensitivity analyses were performed to evaluate uncertainty. RESULTS: Over a lifetime horizon, treatment with adjuvant atezolizumab provided greater effectiveness (+2.61 life years [LY] and +1.95 quality-adjusted life years [QALY]) and higher cost (+22,538) than BSC. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratios (ICUR) of the analysis were 8,625/LY gained and 11,583/QALY gained, respectively. Robustness of these base-case results was confirmed by the sensitivity analyses performed. In the probabilistic sensitivity analysis, 90% of the simulations performed showed that adjuvant atezolizumab is cost-effective versus BSC, considering a threshold of 30,000/QALY. CONCLUSIONS: Our results showed that adjuvant treatment with atezolizumab in patients with early-stage resected NSCLC with overexpression of PD-L1 and without EGFR and ALK mutations is cost-effective versus BSC as the ICERs and ICURs obtained are below the cost-effectiveness thresholds commonly considered in Spain, thus offering a new treatment alternative for these patients.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Análise Custo-Benefício , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genética , Antígeno B7-H1 , Recidiva Local de Neoplasia , Receptores ErbB , Receptores Proteína Tirosina Quinases , Anos de Vida Ajustados por Qualidade de VidaRESUMO
PURPOSE: Our objectives were to analyze the use of complementary and alternative medicine (CAM) in cancer patients and to describe the incidence and characteristics of interactions between CAM and antineoplastic agents. METHODS: We performed an observational study in cancer outpatients at a university hospital. Variables were collected through a 22-item questionnaire. Potential interactions between CAM and antineoplastic agents were analyzed using the Lexicomp®, the About Herbs®, and the summary of product characteristics. Mechanism of action, reliability, and the potential clinical effect of interactions were analyzed. RESULTS: The study population comprised 937 patients, of whom 65% used CAM (70.6% herbal products, 25.8% dietary supplements, and 3.6% homeopathy). Female sex, younger age, and breast cancer were associated with more frequent use of CAM. The primary source of information about CAM was friends and family (43.5%). A total of 335 (57.1%) patients did not tell their doctor that they took CAM. The five most common CAM were chamomile, green tea, pennyroyal mint, linden, and rooibos. At least one interaction between CAM and antineoplastic agents was reported by 65.0% of CAM users (33.9% of all patients). Depending on the mechanism of action, 80% of CAM diminished the metabolism of the antineoplastic agents. CONCLUSION: Our results reveal a high incidence of interactions between CAM and antineoplastic agents. The most frequent CAM were herbal products. Family and friends were the primary sources of information that led patients to start taking CAM, and more than half of the patients did not tell their doctor that they were taking CAM.
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Antineoplásicos , Neoplasias da Mama , Terapias Complementares , Humanos , Feminino , Reprodutibilidade dos Testes , Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Suplementos Nutricionais , Inquéritos e QuestionáriosRESUMO
Objective: The management of cardiotoxicity concerning the use of oral antineoplastic agents (OAAs) is a challenge for healthcare professionals. Our objective was to create a comprehensive medication management guide with dose adjustment recommendations on OAAs concerning cardiotoxic and lipid metabolic adverse events (AEs) to assist healthcare professionals when prescribing OAAs. Materials and methods: A review of the available information on all dose adjustments necessary to safely prescribe and dispense OAAs concerning cardiotoxicity was conducted. In January 2023, we identified all OAAs authorized by the European Medicines Agency (EMA). For each drug, the latest summary of product characteristics (SPC) approved by the EMA and the tertiary data source Lexicomp® were reviewed. Cardiotoxic AEs were recorded, namely, QT interval prolongation, decrease in left ventricular ejection fraction (LVEF), imbalances in blood pressure (hypertension and hypotension), alterations in heart rate (tachycardia and bradycardia), and thrombosis. Any available dose adjustment recommendations in case of an occurrence of these adverse events were collected. Results: In all, 93 different OAAs had been approved by the EMA and were reviewed. Among them, 51.6% have recognized cardiotoxic AEs and 10.8% can cause alterations in lipid metabolism. A total of 27 (29.0%) OAAs had specific recommendations regarding QT prolongation; 88.9% were listed in the SPC and 59.3% in Lexicomp®. Eight OAAs (9.68%) have reported a decrease in LVEF, and four of these drugs, namely, encorafenib, lorlatinib, ripretinib, and sunitinib, have specific management recommendations. Almost half (49.5%) of currently approved OAAs can potentially alter blood pressure; 34 (36.6%) of them have been reported to cause hypertension and 12 (12.9%) are related to hypotension. Tachycardia and/or bradycardia are associated with 22.6% and 8.6% of the evaluated drugs, respectively. Regarding thrombosis, 30 (32.3%) of the drugs analyzed included the appearance of a thrombus as a possible AE. Conclusions: More than half of the OAAs can produce cardiotoxic effects, with the most frequent being blood pressure alteration and QT interval prolongation with a non-depreciable incidence of LV dysfunction or thrombosis. Before starting the treatment, it is necessary to stratify baseline cardiovascular risk, plan a surveillance schedule, and consider referral to cardio-oncology units.
RESUMO
OBJECTIVE: To review the evidence of the mobile apps in collection patient- reported outcomes and their impact on health outcomes. Method: A review was conducted of the literature on apps aimed at collecting patient-reported outcomes. Selected articles were required to consider the apps' impact on patients' health outcomes. The search was carried out during April 2021 in Pubmed and Embase using the search terms "app", "mobile applications" , "patient-reported outcomes", "outcome assessment, health care", and "quality of life", To be included articles had to be written in English or Spanish and they were required to dwell on apps used by patients, family members and/or caregivers that measured at least one health outcome. No time restrictions were applied. RESULTS: Of the 26 articles reviewed, 19 (73.1%) were clinical trials, 4 (15.4%) were quasi-experimental studies, and 3 (11.5%) were observational studies. A pharmacy department was involved in 4 studies (15.4%), and 3 (11.5%), were carried out in Spain. The sample size ranged from 14 to 411. Depending on the study population, the most frequent studies included cancer patients (42.3%) and patients with cardiovascular diseases (26.9%). Most of the studies focused on measuring the impact of the app on the patients' quality of life (50.0%), control of clinical parameters (46.2%), adherence (38.5%), and management of symptoms and/or reduction of complications (26.9%). Overall efficacy in terms of the percentage of studies where apps were found to result in a significant improvement was 73.1%. The most heavily impacted patient-reported outcomes were adherence, health-related quality of life and satisfaction. CONCLUSIONS: There is emerging evidence that apps have a positive impact on patients' health outcomes. These tools have shown to lead to an improvement in the management of different conditions, with results showing a reduction in complications rates and in the consumption of resources as well as better adherence to medication and enhanced patient quality of life.
OBJETIVO: Realizar una revisión sobre la evidencia de las aplicaciones móviles en el registro de los patient-reported outcomes y su impacto en los resultados en salud.Método: Revisión de la literatura sobre los estudios de aplicaciones orientadas al registro de patient-reported outcomes y que analizaran su impacto en los resultados en salud de los pacientes. La búsqueda se realizó en abril de 2021 en Pubmed y Embase con los términos "App", "Mobile Applications"; "Patient Reported Outcomes"; "Outcome Assessment, Health Care"; "Quality of Life". Se incluyeron artículos publicados en inglés o español sin límite de tiempo y que incluyeran aplicaciones cuyos participantes fueran pacientes, familiares y/o cuidadores y que midieran algún tipo de resultado en salud. RESULTADOS: De los 26 artículos revisados, 19 (73,1%) fueron ensayos clínicos, 4 (15,4%) estudios cuasiexperimentales y 3 (11,5%) estudios observacionales. En 4 estudios (15,4%) estaba implicado un servicio de farmacia y en 3 (11,5%) el estudio fue realizado en España. El tamaño muestral varió de 14 a 411. En función de la población de estudio, los más frecuentes incluyeron pacientes oncológicos (11 [42,3%] estudios) y pacientes con patologías cardiovasculares (7 [26,9%] estudios). La mayoría de los estudios se centraron en la medición del impacto de las aplicaciones en términos de calidad de vida (50,0%), control de parámetros clínicos (46,2%), adherencia (38,5%) y manejo de los síntomas y/o reducción de complicaciones (26,9%). La eficacia global en términos del porcentaje en los que se observó una mejoría significativa con el uso de las aplicaciones fue del 73,1%. Los patient-reported outcomes en los que se observó un mayor impacto fueron la adherencia, la calidad de vida relacionada con la salud y la satisfacción. CONCLUSIONES: Existe evidencia emergente de que las aplicaciones tienen un impacto positivo en los resultados en salud de los pacientes. Estas herramientas están demostrando una mejora en el manejo de diferentes patologías, con resultados que muestran una reducción de complicaciones y consumo de recursos y mejoras en la adherencia y calidad de vida de los pacientes.
Assuntos
Aplicativos Móveis , Humanos , Avaliação de Resultados em Cuidados de Saúde , Medidas de Resultados Relatados pelo Paciente , EspanhaRESUMO
OBJECTIVE: The purpose of this article is to describe the PeOpLe study protocol, developed to assess patient-reported health outcomes in advanced or metastatic non-small-cell lung cancer in routine clinical practice using the methodology provided by the International Consortium for Health Outcomes Measurement tool. METHOD: The study envisaged will be multicenter, longitudinal, ambispective and observational. Two groups will be compared: a control group (followed up according to standard clinical practice) and an experimental group (followed up using the International Consortium for Health Outcomes Measurement methodology adapted to the Spanish setting for 6 months). The variables collected will be related to demography (age, sex, degree of family support), clinical factors (smoking, comorbidities, lung capacity), the neoplasm (histology, staging, mutations), pharmacotherapy (treatment schedule, modifications, and complications), health status (functional status, quality of life, satisfaction and overall survival) and resource consumption (emergency visits, hospital admissions and time spent by health providers). The PeOpLe study protocol has been approved by the Ethics Committee for Research into Medicinal Products of the Gregorio Marañón General University Hospital and will be conducted in compliance with prevailing ethical principles and standards. CONCLUSIONS: The PeOpLe study will explore how patient-reported outcomes collection can be developed and integrated with the clinical processes used in the management of patients with locally advanced or metastatic nonsmall cell lung cancer what patient-reported outcomes can be measured with systems that can conveniently be used both by patients and by healthcare providers. Systematic evaluation of patient-reported outcomes will help determine their impact in terms of effectiveness (survival), safety (complications of systemic therapy), and quality of life and patient satisfaction. The multidisciplinary and multicenter nature of the study will facilitate a comprehensive view of the subject analyzed and allow external reproducibility.
OBJETIVO: El objetivo es describir el protocolo del estudio PeOpLe, cuyo fin es evaluar los resultados en salud centrados en el paciente con cáncer de pulmón no microcítico avanzado o metastásico en la práctica clínica habitual mediante una metodología adaptada de la herramienta del International Consortium for Health Outcomes Measurement.Método: Estudio observacional, ambispectivo, longitudinal y multicéntrico. Se compararán dos grupos: grupo control (seguimiento según práctica clínica habitual) frente a un grupo intervención (seguimiento mediante la metodología del International Consortium for Health Outcomes Measurement adaptada al entorno español) durante un período de 6 meses. Las variables recogidas incluirán aspectos demográficos (edad, sexo, apoyo familiar), clínicos (hábito tabáquico, comorbilidades, capacidad pulmonar), del tumor (histología, estadiaje, mutaciones), farmacoterapéutico (esquema de tratamiento, modificaciones y complicaciones), grado de salud (estado funcional, calidad de vida, satisfacción y supervivencia global) y consumo de recursos (visitas a urgencias, ingresos hospitalarios y tiempo dedicado por los profesionales sanitarios). El protocolo del estudio PeOpLe ha sido aprobado por el Comité de Ética de la Investigación con medicamentos y se realizará respetando los principios y las normas éticas básicas. CONCLUSIONES: El estudio PeOpLe explorará cómo se pueden desarrollar e integrar los procesos de medición de resultados en salud centrados en los pacientes, especialmente los patient-reported outcomes, en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico en la práctica clínica. La evaluación sistemática de estos patient-reported outcomes permitirá conocer su impacto en términos de efectividad (supervivencia), seguridad (complicaciones de la terapia sistémica) y calidad de vida y satisfacción. El carácter multidisciplinar y multicéntrico facilitará una visión integral y su reproducibilidad externa.
Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Hematological conditions are prevalent disorders that are associated with significant comorbidities and have a major impact on patient care. Concerning new tools for the care of these patients, the number of health apps aimed at hematological patients is growing. Currently, there are no quality analyses or classifications of apps for patients diagnosed with hematological conditions. OBJECTIVE: The aim of this study is to analyze the characteristics and quality of apps designed for patients diagnosed with hematological conditions by using the Mobile App Rating Scale (MARS). METHODS: We performed an observational, cross-sectional descriptive study of all smartphone apps for patients diagnosed with hematological conditions. A search was conducted in March 2021 using the following terms: anemia, blood cancer, blood disorder, hematological cancer, hematological malignancy, hematological tumor, hematology, hemophilia, hemorrhage, lymphoma, leukemia, multiple myeloma, thalassemia, thrombocytopenia, and thrombosis. The apps identified were downloaded and evaluated by 2 independent researchers. General characteristics were registered, and quality was analyzed using MARS scores. Interrater reliability was measured by using the Cohen κ coefficient. RESULTS: We identified 2100 apps in the initial search, and 4.19% (88/2100) of apps met the inclusion criteria and were analyzed. Of the 88 apps, 61% (54/88) were available on Android, 30% (26/88) were available on iOS, and 9% (8/88) were available on both platforms. Moreover, 7% (6/88) required payment, and 49% (43/88) were updated in the last year. Only 26% (23/88) of the apps were developed with the participation of health professionals. Most apps were informative (60/88, 68%), followed by preventive (23/88, 26%) and diagnostic (5/88, 6%). Most of the apps were intended for patients with anemia (23/88, 26%). The mean MARS score for the overall quality of the 88 apps was 3.03 (SD 1.14), ranging from 1.19 (lowest-rated app) to 4.86 (highest-rated app). Only 47% (41/88) of the apps obtained a MARS score of over 3 points (acceptable quality). Functionality was the best-rated section, followed by aesthetics, engagement, information, and app subjective quality. The five apps with the highest MARS score were the following: Multiple Myeloma Manager, Hodgkin Lymphoma Manager, Focus On Lymphoma, ALL Manager, and CLL Manager. The analysis by operating system, developer, and cost revealed statistically significant differences in MARS scores (P<.001, P<.001, and P=.049, respectively). The interrater agreement between the 2 reviewers was substantial (k=0.78). CONCLUSIONS: There is great heterogeneity in the quality of apps for patients with hematological conditions. More than half of the apps do not meet acceptable criteria for quality and content. Most of them only provide information about the pathology, lacking interactivity and personalization options. The participation of health professionals in the development of these apps is low, although it is narrowly related to better quality.
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Aplicativos Móveis , Estudos Transversais , Pessoal de Saúde , Humanos , Reprodutibilidade dos TestesRESUMO
Objective: This study aims to analyze the impact of the eOncosalud app on the management and follow-up of adverse effects (AE) in patients receiving oral antineoplastic agents. Material and methods: We performed an observational, prospective study of cancer outpatients treated with oral antineoplastic agents (OAA), monitored by the eOncosalud app between August 2017 and October 2021. Safety variables were collected from eOncosalud: the number of AE; severity of the AE according to CTCAE, version 4.03; timelapse from app installation to first recorded AE; automatic recommendations issued; and the patient's acceptance of the recommendations made. To assess the impact of the recommendations generated by the algorithm, we calculated the positive predictive value (PPV) as the number of recommendations accepted out of the total number of recommendations generated. Safety-related patient messages were also analyzed (AE, drug-drug interactions, drug administration). Result: The app was downloaded and used by 186 patients (58.0% women), with a mean age of 59.0 years. A total of 1,368 AE were recorded, the most frequent being fatigue (19.37%), diarrhea (18.20%), and skin changes (9.21%). Regarding the recommendations issued by the app algorithm, 102 patients received 344 information brochures, 39 patients received 51 recommendations for supportive care to control AE, 60 patients received 240 recommendations to visit their primary care doctor, 14 patients received 16 recommendations to contact their specialist pharmacist or oncologist-hematologist, and 34 patients received 73 recommendations to go to the emergency room. The suggestion to go to the emergency room and contact the specialist pharmacist or oncologist-hematologist had a PPV of 0.51 and 0.35, respectively. Half of the patients (50.4%) used the messaging module. A total of 1,668 messages were sent. Of these, 47.8% were related to treatment safety: AE, 22.7%; drug-drug interactions, 20.6%; drug administration, 3.6%; and missing a dose, 1.0%. Conclusions: The eOncosalud app enables close, real-time monitoring of patients treated with OAA. The automatic recommendations through the app's algorithm have optimized available healthcare resources. The app facilitated early detection of AE, thus enabling patients themselves to improve the safety of their treatment.