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Article ; Online: Implementation of a methodology to assess patient reported outcomes in lung cancer patients: The PeOpLe (Patient-reported Outcomes in Lung cancer ) study protocol.

Villanueva-Bueno, Cristina / Collado-Borrell, Roberto / Revuelta-Herrero, José Luis / Fernández-Román, Ana Beatriz / Casado-Abad, Gema / Escudero-Vilaplana, Vicente

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria

2022 Volume 46, Issue 4, Page(s) 265–269

Abstract: 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 ... ...

Title translation	Implantación de una metodología para evaluar patient‑reported outcomes en pacientes con cáncer de pulmón: Protocolo del estudio PeOpLe (Patient‑reported Outcomes in Lung cancer ).
Abstract	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.
MeSH term(s)	Carcinoma, Non-Small-Cell Lung/drug therapy ; Humans ; Lung Neoplasms/drug therapy ; Multicenter Studies as Topic ; Observational Studies as Topic ; Patient Reported Outcome Measures ; Quality of Life ; Reproducibility of Results
Language	English
Publishing date	2022-05-21
Publishing country	Spain
Document type	Journal Article
ZDB-ID	1122680-8
ISSN	2171-8695 ; 1130-6343
ISSN (online)	2171-8695
ISSN	1130-6343
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Article ; Online: Patient-reported outcomes and mobile applications. A review of their impact on patients' health outcomes.

Collado-Borrell, Roberto / Escudero-Vilaplana, Vicente / Narrillos-Moraza, Álvaro / Villanueva-Bueno, Cristina / Herranz-Alonso, Ana / Sanjurjo-Sáez, María

Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria

2022 Volume 46, Issue 3, Page(s) 173–181

Abstract: 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 ...

Title translation	Patient-reported outcomes y aplicaciones móviles. Revisión de su impacto en los resultados en salud de los pacientes.
Abstract	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.
MeSH term(s)	Humans ; Mobile Applications ; Outcome Assessment, Health Care ; Patient Reported Outcome Measures ; Spain
Language	English
Publishing date	2022-04-27
Publishing country	Spain
Document type	Journal Article ; Review
ZDB-ID	1122680-8
ISSN	2171-8695 ; 1130-6343
ISSN (online)	2171-8695
ISSN	1130-6343
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Article ; Online: Economic burden of locoregional and metastatic relapses in resectable early-stage non-small cell lung cancer in Spain.

De Castro, Javier / Insa, Amelia / Collado-Borrell, Roberto / Escudero-Vilaplana, Vicente / Martínez, Alex / Fernandez, Elena / Sullivan, Ivana / Arrabal, Natalia / Carcedo, David / Manzaneque, Alba

BMC pulmonary medicine

2023 Volume 23, Issue 1, Page(s) 69

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/pathology ; Lung Neoplasms/pathology ; Spain ; Health Care Costs ; Financial Stress ; Cost of Illness ; Neoplasm Recurrence, Local ; Small Cell Lung Carcinoma
Language	English
Publishing date	2023-02-21
Publishing country	England
Document type	Journal Article
ZDB-ID	2059871-3
ISSN	1471-2466 ; 1471-2466
ISSN (online)	1471-2466
ISSN	1471-2466
DOI	10.1186/s12890-023-02356-0
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Article ; Online: Cost-effectiveness of adjuvant atezolizumab versus best supportive care in the treatment of patients with resectable early-stage non-small cell lung cancer and overexpression of PD-L1.

Escudero-Vilaplana, Vicente / Collado-Borrell, Roberto / De Castro, Javier / Insa, Amelia / Martínez, Alex / Fernández, Elena / Sullivan, Ivana / Flores, Andrés / Arrabal, Natalia / Carcedo, David / Manzaneque, Alba

Journal of medical economics

2023 Volume 26, Issue 1, Page(s) 445–453

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/surgery ; Cost-Benefit Analysis ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; B7-H1 Antigen ; Neoplasm Recurrence, Local ; ErbB Receptors ; Receptor Protein-Tyrosine Kinases ; Quality-Adjusted Life Years
Chemical Substances	atezolizumab (52CMI0WC3Y) ; B7-H1 Antigen ; ErbB Receptors (EC 2.7.10.1) ; Receptor Protein-Tyrosine Kinases (EC 2.7.10.1)
Language	English
Publishing date	2023-03-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2270945-9
ISSN	1941-837X ; 1369-6998
ISSN (online)	1941-837X
ISSN	1369-6998
DOI	10.1080/13696998.2023.2188844
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Article ; Online: Thalidomide as treatment of refractory thoracic Rosai-Dorfman disease.

Hoyo-Muñoz, Angela / Collado-Borrell, Roberto / Escudero-Vilaplana, Vicente / Bastos-Oreiro, Mariana / Herranz-Alonso, Ana / Sanjurjo-Sáez, María

Journal of clinical pharmacy and therapeutics

2021 Volume 47, Issue 4, Page(s) 548–551

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Aged ; Female ; Histiocytosis, Sinus/complications ; Histiocytosis, Sinus/diagnosis ; Histiocytosis, Sinus/drug therapy ; Humans ; Thalidomide/therapeutic use
Chemical Substances	Thalidomide (4Z8R6ORS6L)
Language	English
Publishing date	2021-09-12
Publishing country	England
Document type	Case Reports
ZDB-ID	639006-7
ISSN	1365-2710 ; 0269-4727
ISSN (online)	1365-2710
ISSN	0269-4727
DOI	10.1111/jcpt.13513
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Article: Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective.

Marzal-Alfaro, María Belen / Escudero-Vilaplana, Vicente / Revuelta-Herrero, Jose Luis / Collado-Borrell, Roberto / Herranz-Alonso, Ana / Sanjurjo-Saez, Maria

Frontiers in oncology

2021 Volume 11, Page(s) 636068

Abstract: Purpose: The use process for chimeric antigen receptor T (CAR-T) cell drugs is complex and has been associated with a number of potentially severe complications, which requires management by a multidisciplinary team. Pharmacists are a key element in the ...

Abstract	Purpose: The use process for chimeric antigen receptor T (CAR-T) cell drugs is complex and has been associated with a number of potentially severe complications, which requires management by a multidisciplinary team. Pharmacists are a key element in the team and have roles and responsibilities. Our objective was to develop a structured and practical guide that supports hospital pharmacist responsibilities and defines specific activities in a CAR-T cell therapy program, specifically in Europe. Methods: A literature review was performed, and the recommendations related to pharmacy practice in CAR-T therapy programs were analyzed. A multidisciplinary team was assembled, and meetings were held to address the key tasks in the CAR-T cells' management process and to create the guide, based on national and international recommendations and in expert's opinions. Results: The multidisciplinary team defined the following key tasks and issued recommendations to improve patient safety, treatment efficacy, and quality: patient selection and evaluation, CAR-T cell drug order to manufacturer, apheresis and material shipment, reception of CAR-T cell drug and storing, CAR-T cell drug prescription and pharmacy verification, CAR-T cell drug thawing and dispensing, CAR-T cell drug administration, patient education, pharmacovigilance and monitoring and outcomes' record and evaluation. In each task the pharmacist's role and how it can improve patient care are defined. A checklist was created to guarantee the compliance of standard operating procedures approved in the institution to manage CAR-T cell therapy and as a tool to collect required data for outcomes' record and evaluation. Conclusion: This article provides a consensus set of safety recommendations regarding CAR-T therapy management in clinical practice, easily implementable by other institutions in the European setting. The guide identifies key steps where the involvement of hospital pharmacists would improve the safety and quality of the process and is a support guide to standardize hospital pharmacists' responsibilities within the multidisciplinary team.
Language	English
Publishing date	2021-03-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2021.636068
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Article: Medication guide for dose adjustment and management of cardiotoxicity and lipid metabolic adverse events of oral antineoplastic therapy.

Ramos-Ruperez, Elena / Escudero-Vilaplana, Vicente / Ruiz-Briones, Paula / Collado-Borrell, Roberto / Villanueva-Bueno, Cristina / Revuelta-Herrero, José Luis / González-Haba, Eva / Garcia-Gonzalez, Xandra / Ibañez-Garcia, Sara / Perez-Ramirez, Sara / Zatarain-Nicolás, Eduardo / Herranz, Ana / Sanjurjo, María

Frontiers in oncology

2023 Volume 13, Page(s) 1220305

Abstract: 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 ...

Abstract	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 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 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.
Language	English
Publishing date	2023-08-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2023.1220305
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Article: A New Methodology to Estimate Drug Cost Avoidance in Clinical Trials: Development and Application.

García-Sánchez, Sebastián / Collado-Borrell, Roberto / González-Haba, Eva / Revuelta-Herrero, José Luis / Escudero-Vilaplana, Vicente / Marzal-Alfaro, María Belén / Sánchez-Fresneda, María Norberta / Mur-Mur, Ana / Herranz, Ana / Martín, Miguel / Sanjurjo, María

Frontiers in oncology

2022 Volume 12, Page(s) 889575

Abstract: Background: Oncology clinical trials can lead to relevant financial savings in drug acquisition for healthcare providers. Considerable methodological heterogeneity is observed among previous studies estimating these savings.: Methods: We developed a ... ...

Abstract	Background: Oncology clinical trials can lead to relevant financial savings in drug acquisition for healthcare providers. Considerable methodological heterogeneity is observed among previous studies estimating these savings. Methods: We developed a methodology to estimate the economic benefit obtained from the enrollment of patients into clinical trials through the analysis of drug cost avoidance. We designed a decision algorithm to determine if a clinical trial is associated with drug cost avoidance. This algorithm is based on five scenarios according to the availability or not of standard treatment, the presence or absence of a control arm (placebo or active treatment), and the provider of the medication. We considered as reference the cost of the standard treatment that the patient would have received in routine clinical practice. We standardized drug doses and treatment durations according to the literature. Costs were considered from a National Health System perspective. We applied this methodology at a single, research-active University Hospital in 2019. A cost avoidance analysis per trial and patient was carried out on cancer patients. Results: We analyzed 140 trials in which 198 patients were recruited. Drug cost avoidance was found in 120 trials (85.7%). The estimated total drug cost avoidance amounted to over €3,200,000. Melanoma and genitourinary tumors were the tumor types associated with the highest cost avoidance. The average drug cost avoidance per patient was €16,245. Conclusion: We describe a standardized method to estimate drug cost avoidance in clinical trials. We have applied it to all ongoing oncology clinical trials in our center. This methodology could be valuable for other centers to analyze the potential saving of clinical trials.
Language	English
Publishing date	2022-06-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2022.889575
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Article ; Online: Potential negative pharmacodynamic interaction of spironolactone and abiraterone in two prostate cancer patients.

Vicente-Valor, Juan / Escudero-Vilaplana, Vicente / Collado-Borrell, Roberto / López-López, Cristina / Villanueva-Bueno, Cristina / Revuelta-Herrero, José Luis / Ruiz-Briones, Paula / Somoza-Fernández, Beatriz / Herranz, Ana / Sanjurjo, María

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

2022 Volume 28, Issue 5, Page(s) 1259–1263

Abstract: 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 ...

Abstract	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.
MeSH term(s)	Male ; Humans ; Spironolactone/therapeutic use ; Prostatic Neoplasms, Castration-Resistant/drug therapy ; Prostatic Neoplasms, Castration-Resistant/pathology ; Abiraterone Acetate/therapeutic use ; Treatment Outcome ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Chemical Substances	abiraterone (G819A456D0) ; Spironolactone (27O7W4T232) ; Abiraterone Acetate (EM5OCB9YJ6)
Language	English
Publishing date	2022-01-17
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	1330764-2
ISSN	1477-092X ; 1078-1552
ISSN (online)	1477-092X
ISSN	1078-1552
DOI	10.1177/10781552221074621
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Article ; Online: Possible heart failure caused by osimertinib in a lung cancer patient.

Ruiz-Briones, Paula / Escudero-Vilaplana, Vicente / Collado-Borrell, Roberto / Vicente-Valor, Juan / Alvarez, Rosa / Villanueva-Bueno, Cristina / Narrillos-Moraza, Álvaro / Herranz, Ana / Sanjurjo, Maria

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

2022 Volume 29, Issue 4, Page(s) 1015–1020

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Female ; Humans ; Lung Neoplasms/drug therapy ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Stroke Volume ; Cardiotoxicity ; Mutation ; Ventricular Function, Left ; Heart Failure/chemically induced
Chemical Substances	osimertinib (3C06JJ0Z2O)
Language	English
Publishing date	2022-12-08
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	1330764-2
ISSN	1477-092X ; 1078-1552
ISSN (online)	1477-092X
ISSN	1078-1552
DOI	10.1177/10781552221143787
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