Economic burden of locoregional and metastatic relapses in resectable early-stage non-small cell lung cancer in Spain.

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.

Possible heart failure caused by osimertinib in a lung cancer patient.

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.

Potential negative pharmacodynamic interaction of spironolactone and abiraterone in two prostate cancer patients.

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.

Thalidomide as treatment of refractory thoracic Rosai-Dorfman disease.

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.

Evaluation of the hospital care quality perceived by patients with immune-mediated inflammatory diseases from the pharmacy service. SACVINFA study.

WHAT IS KNOWN AND OBJECTIVE: Immune-mediated inflammatory diseases (IMIDs) are a group of chronic and highly disabling diseases. The objective is to evaluate the satisfaction with the health care received by patients with the most prevalent IMIDs in Spain: inflammatory bowel disease (IBD), psoriasis (Ps) psoriatic arthritis (PsA), rheumatoid arthritis (RA) and spondyloarthropathies (SpAs), and to determine the factors that influence patient satisfaction. METHODS: This was an observational, cross-sectional, multicentre study in a real-world evidence context conducted in the Pharmacy Service in four hospital centres of the Community of Madrid that belong to the National Health System. The study included adult patients diagnosed with an IMID who had attended the Pharmacy Service at least three times. The patients were grouped according to the main IMID. Health care satisfaction was evaluated using the chronic patient experience assessment (IEXPAC) questionnaire. The responses to IEXPAC are grouped into three factors: productive interactions, new relational model and patient self-management, with a total score from 0 (worst) to 10 (best experience). Health-related quality of life (HRQoL) was also evaluated using the EQ-5D-5L questionnaire, and pharmacological adherence was evaluated through the Morisky-Green test. RESULTS AND DISCUSSION: A total of 578 patients were analysed (IBD = 25.3%; Ps = 19.7%; SpAs = 18.7%; RA = 18.5%; PsA = 17.8%). The mean age (SD) was 49.8 (12.3) years and 50.7% were male. The average score (SD) for the total IEXPAC sample was 6.6 (1.9). RA was the IMID with the lowest score, at 5.83 (2.0), significantly lower than the scores of Ps (SD) [7.01 (1.7); p = 0.003], IBD [6.83 (1, 9); p = 0.012] and SpAs [6.80 (1.6); p = 0.001]. Productive interactions (SD) [8.5 (1.8)] and patient self-management (SD) [7.3 (2.3)] were the factors with the highest scores, and the new relational model had the lowest score (SD) [3.2 (2.7)]. Male gender, a longer time interval between medication administrations and a higher HRQoL were correlated with better patient satisfaction. Current biological therapy (according to the Anatomical Chemical classification system) also had a significant influence; patients treated with tumour necrosis factor inhibitors and interleukin inhibitors showed greater satisfaction than those treated with selective immunosuppressants. WHAT IS NEW AND CONCLUSION: The IEXPAC results show high general satisfaction with care quality reported by patients with IMIDs treated in the Pharmacy Service. However, there are areas of improvement in care quality specially health professional-patient communication, such as increasing access to information, and promoting and facilitating relationships with patients in similar conditions.

The Characteristics and Functionalities of Mobile Apps Aimed at Patients Diagnosed With Immune-Mediated Inflammatory Diseases: Systematic App Search.

BACKGROUND: Immune-mediated inflammatory diseases (IMIDs) are systemic conditions associated with a high social and health impact. New treatments have changed the prognosis of IMIDs and have increased patient autonomy in disease management. Mobile apps have enormous potential to improve health outcomes in patients with IMIDs. Although a large number of IMID apps are available, the app market is not regulated, and functionality and reliability remain uncertain. OBJECTIVE: Our aims are to review available apps for patients with IMIDs or caregivers and to describe the main characteristics and functionalities of these apps. METHODS: We performed an observational, cross-sectional, descriptive study of all apps for patients with IMIDs. Between April 5 and 14, 2021, we conducted a search of the App Store (iOS) and Play Store (Android) platforms. We used the names of the different IMIDs as search terms. The inclusion criteria were as follows: content related to IMIDs, English or Spanish language, and user population consisting of patients and health care consumers, including family and caregivers. The variables analyzed were as follows: app name, type of IMID, platform (Android or iOS), country of origin, language, category of the app, cost, date of the last update, size, downloads, author affiliation, and functionalities. RESULTS: We identified 713 apps in the initial search, and 243 apps met the criteria and were analyzed. Of these, 37% (n=90) were on Android, 27.2% (n=66) on iOS, and 35.8% (n=87) on both platforms. The most frequent categories were health and well-being/fitness apps (n=188, 48.5%) and medicine (n=82, 37.9%). A total of 211 (82.3%) apps were free. The mean time between the date of the analysis and the date of the most recent update was 18.5 (SD 19.3) months. Health care professionals were involved in the development of 100 (41.1%) apps. We found differences between Android and iOS in the mean time since the last update (16.2, SD 14.7 months vs 30.3, SD 25.7 months) and free apps (85.6% vs 75.8%; respectively). The functionalities were as follows: general information about lifestyles, nutrition, or exercises (n=135, 55.6%); specific information about the disease or treatment (n=102, 42%); recording of symptoms or adverse events (n=51, 21%); agenda/calendar (n=44, 18.1%); reminder medication (n=41, 16.9%); and recording of patient-reported outcomes (n=41, 16.9%). A total of 147 (60.5%) apps had more than one functionality. CONCLUSIONS: IMID-related apps are heterogeneous in terms of functionality and reliability. Apps may be a useful complement to IMID care, especially inpatient education (their most frequent functionality). However, more than half of the IMID apps had not been developed by health care professionals or updated in the last year.

Information and Communication Technologies in Patients With Immune-Mediated Inflammatory Diseases: Cross-sectional Survey.

BACKGROUND: Information and communication technologies (ICTs) are changing the traditional health care model and redefining personalized health. ICTs offer effective communication and real-time monitoring of patients and provide additional data to support clinical decision-making, improve the quality of care, and contribute to the empowerment of patients. However, evidence on the use of ICTs and digital preferences of immune-mediated inflammatory disease (IMID) patients is scarce. OBJECTIVE: The aim of this study is to describe the degree of use of ICTs in patients with IMIDs (including rheumatic diseases, inflammatory bowel diseases, and psoriasis), identify their needs, and analyze their interest in the use of apps as tools for better management of their disease. METHODS: A questionnaire was created by a multidisciplinary team including pharmacists, rheumatologists, gastroenterologists, dermatologists, and nurses with experience in ICTs applied to the field of IMID. The survey included 27 questions organized into 3 blocks: (1) sociodemographic characteristics, (2) ICT use for health-related information, and (3) patient expectations about mobile health. RESULTS: A total of 472 questionnaires were analyzed. Overall, 52.9% (250/472) of patients were diagnosed with a rheumatologic disease, 39.4% (186/472) with inflammatory bowel disease, and 12.3% (58/472) with psoriasis. The state of health was considered good by 45.6% (215/472) of patients. Patients were interested in staying informed about health issues in 86.9% (410/427) of cases and sought health-related information mainly from the internet (334/472, 70.8%) and health care professionals (318/472, 67.4%). Overall, 13.6% (64/472) did not trust the health information they found in internet. Of the patients, 42.8% (202/472) had a health app, and 42.2% (199/472) had found it on their own. Patients would like a health app to help mainly to manage appointments (281/472, 59.5%), obtain information about their diseases and treatments (274/472, 58.1%), and get in contact with health professionals (250/472, 53.0%). Overall, 90.0% (425/472) of patients reported they would use an app to manage their IMID if their health professional recommended it, and 58.0% (274/472) would pay or probably be willing to pay for it. CONCLUSIONS: IMID patients were very interested in finding health-related information via ICTs, especially using smartphones and apps recommended by health professionals. Appointment management, advice on disease and treatment management, and personalized communication with health professionals were the most desired app features identified. Health professionals should play an essential role in recommending and validating these tools to ensure they are of high quality.

Assessment of diarrhea as side effect of oral targeted antineoplastic agents in clinical practice.

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.

Aggressiveness of end-of-life cancer care: what happens in clinical practice?

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.

Acute pancreatitis in a patient treated with imatinib and gefitinib.

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.

Tocilizumab as salvage treatment of refractory pulmonary acute graft-versus-host disease.

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.

Design of the functional requirements of a smartphone app for patients receiving oral antineoplastic agents: The e-OncoSalud® app.

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.

Features and Functionalities of Smartphone Apps Related to COVID-19: Systematic Search in App Stores and Content Analysis.

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.

Drug-to-drug interactions of tyrosine kinase inhibitors in chronic myeloid leukemia patients. Is it a real problem?

With tyrosine kinase inhibitors (TKI), chronic myeloid leukemia (CML) patients are achieving similar rates of survival to the general population and some treatment aspects such as adherence and drug-to-drug interactions (DDI) are becoming increasingly important. Our aim was to investigate the frequency and real clinical consequences of DDI between TKI and concurrent medications in CML. We performed a retrospective multicenter study including 105 patients receiving 134 TKI treatments. Sixty-three patients (60%) had at least one potential DDI. The mean number of concomitant medications was 4.8 (0-19). The mean number of DDI by TKI treatment was 1.2 (0-8); it increased with the number of concomitant medications and age in a significant manner. A total of 159 DDI were detected, involving 55 different drugs. The most common drug classes involved were proton pump inhibitors, statins, and antidepressants. A DDI-related clinical effect (toxicity and/or lack of efficacy) was suspected during the common course of patient follow-up in only five patients (4.7%). This number increased to 20% when data were centrally reviewed. Most of the adverse events (AE) attributed to DDIs were mild. The most common were diarrhea, vomiting, edema, cramps, and transaminitis. Nilotinib and dasatinib showed a tendency towards a higher risk of DDI compared with imatinib. There were no significant differences in AE frequency or in treatment response between patients with or without DDI. Due to their frequency, and their potential to cause clinically relevant effects, DDI are an important aspect of CML management.

Oncology Patient Interest in the Use of New Technologies to Manage Their Disease: Cross-Sectional Survey.

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.

Severe liver toxicity in a chronic myeloid leukemia patient probably induced by a drug interaction between imatinib and sertraline.

Our objective is to describe a chronic myeloid leukemia patient with a severe liver toxicity likely due to a drug-drug interaction between imatinib and sertraline. The patient started treatment with sertraline three months after starting imatinib. From the beginning of sertraline treatment, the patient developed vomiting, and five weeks later she developed a severe hepatic failure and was admitted to the hospital. The Naranjo nomogram showed a probable correlation between this adverse effect and the interaction between imatinib and sertraline. This interaction is extremely rare and the mechanism of action is not clear; it could be a mix of pharmacokinetic and pharmacodynamic processes. To our knowledge, this is the first case in medical literature of a severe liver toxicity due to an interaction between imatinib and sertraline. This interaction is also not described in the main secondary data sources, such as Lexicomp® and Micromedex®. However, due to the severity of this event, the hepatic function should be carefully monitored in patients treated with imatinib and sertraline.

Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice.

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.

Perceived quality of life by patients with immune-mediated inflammatory diseases treated with biological therapies. SACVINFA study.

OBJECTIVES: To evaluate health-related quality of life perceived by patients with the most prevalent immune-mediated inflammatory diseases in Spain: inflammatory bowel disease (IBD), psoriasis (Ps), psoriatic arthritis (AP), rheumatoid arthritis (RA), and spondyloarthropathies (SpAs), and to determine the factors that influence patient quality of life. METHODS: The SACVINFA study (SA=satisfaction, CV=quality of life, IN=immune-mediated, FA=pharmacy) consisted of an observational study conducted in 4 hospitals in the Community of Madrid. A cross-sectional analysis was made for adult patients diagnosed with an immune-mediated inflammatory disease who attended the Pharmacy Service. Quality of life was assessed using the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and specific questionnaires: SIBDQ-9, DLQI, PsAQoL, QoL-RA, and ASQoL. RESULTS: A total of 578 patients were analysed (inflammatory bowel disease=25.3%; psoriasis=19.7%; spondyloarthropathies=18.7%; rheumatoid arthritis=18.5%; psoriatic arthritis=17.8%). The mean age (standard deviation) was 49.8 (12.3) years and 50.7% were male. The average score (standard deviation) for the global EQ-5D-5L was 0.771 (0.2) and the mean (standard deviation) visual analogue scale score was 71.5 (20.0). Type of immune-mediated inflammatory diseases was associated with differences in quality of life showing psoriasis and inflammatory bowel disease higher values of EQ5D-5L than psoriatic arthritis, rheumatoid arthritis, and spondyloarthropathies, p<.05 in all comparisons. Patients with RA, IBD, and Ps achieved 70% of the maximum score, while patients with PsA and SpAs did not reach 50% of the maximum possible score. Female gender, a state of moderate/severe disease severity, an older age, and a higher number of previous treatments were correlated with worse quality of life. Conversely, persistence to current treatment correlated with better quality of life. CONCLUSIONS: Patients with immune-mediated inflammatory diseases have markedly affected quality of life, mainly in the pain/discomfort dimension, especially in those immune-mediated inflammatory diseases with a rheumatological component.

Efficiency of adalimumab, etanercept and infliximab in rheumatoid arthritis patients: dosing patterns and effectiveness in daily clinical practice.

OBJECTIVES: This retrospective, multicentre, observational study aimed to assess the mean annual doses and associated costs of three anti-tumour necrosis factor agents in daily clinical practice in rheumatoid arthritis patients, correlating these costs with disease activity. METHODS: Adult rheumatoid arthritis patients were treated and followed at the Rheumatology departments of two Spanish hospitals for at least 6 months, with adalimumab, etanercept or infliximab over a 4-year period. ANOVA and multivariate statistical analyses of dosing patterns, disease activity and annualised costs were carried out. RESULTS: A total of 198 patients, comprising 215 cases, met the inclusion criteria (73 on adalimumab, 81 etanercept and 61 infliximab). Compared to recommended doses, mean doses of adalimumab and etanercept decreased by 7% and 19%, respectively, while the mean dose of infliximab increased by 36%. There were no statistical differences between treatments in terms of clinical effectiveness. The hazard of dose escalation was significantly higher for either adalimumab (4.4-fold) or infliximab (11.8-fold) compared to etanercept (p<0.05). Clinical control was achieved and maintained in more than half of the patients treated with reduced doses of etanercept. Associated mean patient-year costs were significantly higher in adalimumab patients (€11.962.58) (etanercept €9.594.73; infliximab €10.094.53; [p<0.05]). CONCLUSIONS: In rheumatoid arthritis patients, it is possible to reduce doses and associated costs of biological therapies while controlling disease activity. Mean doses used in our clinical practice were significantly lower with etanercept than with the anti-TNF monoclonal antibodies, adalimumab and infliximab. Dose differences impact directly on associated patient-year costs, and thus on treatment efficiency.