Medication guide for the perioperative management of oral antineoplastic agents in cancer patients.

BACKGROUND: Oral antineoplastic agents (OAAs) are high-risk drugs that may increase the risk of bleeding, difficulty in wound healing, or produce alterations in coagulation and/or platelet aggregation. These aspects had to be highly considered throughout the entire perioperative process. Our aim was to create a comprehensive management medication guide based on reconciliation and dose adjustment recommendations for OAAs in patients undergoing a surgical intervention. RESEARCH DESIGN AND METHODS: We analyzed all OAAs approved by the EMA in November 2020. We assessed data related to dose adjustment, drug reconciliation, coagulation disturbances, or anticoagulant interactions from the FDA and EMA summary of product characteristics. RESULTS: We analyzed 67 OAAs. We identified that 51 (76.2%) OAAs can produce alteration in the platelet count, 12 (17.9%) affect the wound healing and recovery process, and 32 (47.8%) require control and monitoring in case of combination with anticoagulants. Only 13 (19.4%) OAAs, most of them antiangiogenics, have specific recommendations for temporary suspension before surgery. CONCLUSIONS: Most OAAs require perioperative monitoring. This review can serve as an easy (simple, effective) tool to help healthcare professionals involved in patient care to manage OAAs during the perioperative process.

Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study.

BACKGROUND: Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care. OBJECTIVE: The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app. METHODS: We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated. RESULTS: With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10. CONCLUSIONS: Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group.

Novel mobile application for direct communication between pharmacists and patients treated with oral antineoplastic agents.

PURPOSE: Initial experience with use of a smartphone application to enhance communication with and home monitoring of hematology/oncology patients under treatment with oral antineoplastic agents (OAAs) is described. SUMMARY: Broad use of OAAs is changing the landscape of hematology/oncology patient care, with this form of therapy giving patients greater autonomy but also raising concerns about correct OAA administration and management of adverse effects (AEs) or interactions. Information and communication technologies, specifically mobile health technologies, are ideal tools in this new environment. A multidisciplinary team at a large hospital in Spain developed a smartphone application for patients receiving OAA therapy that consists of 5 modules or functionalities: (1) a treatment agenda, or electronic journal of patient activity, including medication use; (2) a treatment record; (3) continuous recording of vital signs (blood pressure and temperature), health-related quality of life, and AEs, with management of AEs based on an algorithm that displays different recommendations according to AE severity; (4) 2-way messaging capability; and (5) information and links to websites of interest. From June through November 2017, 37 patients downloaded and used the application. About two-thirds (68%) of the patients sent a total of 182 messages to the pharmacist on duty; 58% of the patients registered at least 1 AE. The mean time of registration of the first AE after initiation of OAA therapy was 8 days. As a result of patient use of the application, 2 emergency room visits were avoided and 3 patients were referred to a general practitioner. CONCLUSION: The application has allowed real-time monitoring of patients treated with OAAs. This new patient-pharmacist communication channel has facilitated the early detection of AEs, contributing to the safety of treatment and patient satisfaction with healthcare.

Improving surgical antibiotic prophylaxis adherence and reducing hospital readmissions: a bundle of interventions including health information technologies.

OBJECTIVES: Infection following orthopaedic surgery is a feared complication and an indicator of the quality of the hospital. Surgical antibiotic prophylaxis (SAP) guidelines are not always properly followed. Our aim was to describe and evaluate the impact of a multidisciplinary intervention on antibiotic prophylaxis adherence to hospital guidelines and 30-day postoperative outcomes. METHODS: The study was carried out from January to May 2016 and consisted of creating a multidisciplinary team, updating institutional guidelines and embedding the recommendations in the computerised physician order entry system which is linked to dose and renal function alerts, educational activities and pharmaceutical bedside care of patients in the orthopaedic department. A prospective pre-post study was carried out in accordance with the Declaration of Helsinki. The following information was recorded: patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30 days after discharge. Statistical analyses were performed using SPSS 18.0. RESULTS: Eighty three orthopaedic patients of mean±SD age 68.2±17.0 years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included. Cefazolin was the recommended and most commonly administered antibiotic agent. In the intervention group, an improvement in global adherence to guidelines was achieved (76.7% vs 89.9%; p=0.039): antibiotic duration (75.0% vs 97.7%), correct dosage post-surgery (55.0% vs 76.7%), timing of administration (57.5% vs 72.1%), antibiotic pre-surgery prescription (92.5% vs 97.7%). Three surgical site infections were detected in the pre-intervention group and none in the intervention group (p>0.05). Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038). CONCLUSIONS: SAP is used in daily practice in most orthopaedic patients. The implementation of a multidisciplinary programme based on health technology improved the adherence to guidelines and appeared to reduce the readmission rate.

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.

Thromboprophylaxis Management in Surgical Patients: The Efficacy of a Protocol in the Electronic Prescription Program.

BACKGROUND AND OBJECTIVE: Venous thromboembolism (VTE) continues to be a problem in surgical patients, but thromboprophylactic measures are not always implemented. This study aimed to evaluate thromboprophylaxis practice in surgical patients at our institution by assessing appropriateness during admission and discharge; 60-day clinical outcomes are analyzed, and finally further interventions are discussed for continued improvement. METHODS: A cross-sectional, observational study was conducted in patients undergoing orthopedic and abdominal surgical procedures. Initially, the institution protocol was updated and embedded in the Computerized Physician Order Entry system. We then assessed prospective adequacy of thromboprophylaxis as per established in the protocol. The primary endpoint was thromboprophylaxis initiation and, secondarily, the quality of related prescriptions during hospitalization and at discharge. RESULTS: A total of 114 patients were included in the study. According to VTE risk, thromboprophylaxis was initiated in 85.1% of the patients as needed during hospitalization and 94.8% at discharge. The following inadequacies versus the protocol were found: no duration information in the discharge summary (32.5%), incorrect postsurgical administration time of pharmacological prophylaxis (15.8%), omission of mechanical prophylaxis (13.7%), misdosing (9.6%), and omission of pharmacological prophylaxis (2.6%). No VTE events occurred 60 days postdischarge. CONCLUSION: The electronic protocol was an effective tool, as evidenced by the fact that thromboprophylaxis was initiated in the majority of surgical patients in our institution during hospitalization and at discharge. Still, some aspects leave room for improvement (duration, dosing, and timing), and further measures such as implementation of Electronic Medication Administration Records and new functionalities in the Clinical Decision Support systems are proposed.

Evolución nutricional y de la supervivencia en un grupo de pacientes oncológicos en tratamiento con inhibidores de tirosina quinasa / Evolution of nutritional status and survival in patients with cancer on tyrosine kinase inhibitors treatment

Antecedentes y objetivo: El tratamiento con antineoplásicos orales tipo inhibidores de tirosina quinasa (ITK) es novedoso, y por ello se conoce poco sobre cómo afectan al estado nutricional (EN), la ingesta dietética, la calidad de vida, y su influencia sobre la supervivencia. Este estudio pretende aportar información sobre estos componentes, para dirigir las recomendaciones nutricionales futuras. Pacientes y método: Estudio prospectivo y observacional en adultos que inician ITK, donde se valoró el EN mediante el cuestionario de valoración subjetiva global generada por el paciente (VSG-GP), medidas antropométricas, parámetros bioquímicos e ingesta dietética (Recuerdo de 24 h). La calidad de vida se estudió con EORTC QLQ-C30. El análisis estadístico empleó pruebas no paramétricas y la supervivencia se analizó mediante curvas de Kaplan-Meier y log-rank. Resultados: El 21,7% de la muestra presentó desnutrición moderada según VSG-GP; el 74,2% mostró pérdida de peso moderada a los 6 meses, aunque ningún paciente tuvo un IMC < 18,5 kg/m2. Los pacientes moderadamente desnutridos presentaron menor supervivencia a los 4 años del diagnóstico (log-rank = 0,015). El 44,4% realizó una ingesta energética inferior a las recomendaciones ESPEN 2017 y ningún paciente cubrió requerimientos proteicos (1,5 g proteína/kg peso) durante el seguimiento. Una peor puntuación en la escala global de salud del EORTC QLQ-C30 se relacionó con peor EN. Conclusiones: El tratamiento con ITK no parece afectar de manera importante el EN y la calidad de vida a los 6 meses de seguimiento. Se debe prevenir la desnutrición, mediante un consejo nutricional individualizado, pues se relaciona con menor supervivencia

Background and objective: Treatment with oral antineoplastic agents known as tyrosine kinase inhibitors (TKIs) is new and, thus, little is known about their impact on nutritional status (NS), dietary intake, quality of life, and survival. The aim of this study was to provide information on these components in order to guide future nutritional recommendations. Patients and method: A prospective, observational study in adults who start treatment with TKIs, in whom NS was assessed using the Patient-Generated Subjective Global Assessment (PG-SGA), anthropometric measures, biochemical parameters, and dietary intake (24-hour dietary recall). The EORTC QLQ-C30 was used to assess quality of life. Nonparametric tests were used in statistical analysis, and survival was analyzed using Kaplan-Meier and log-rank curves. Results: Of the overall sample, 21.7% had moderate malnutrition according to PG-SGA, and 74.2% moderate weight loss at 6 months, but no patient had BMI < 18.5 kg/m2. Patients with moderate malnutrition had lower survival at four years of diagnosis (log-rank = 0.015). Energy intake was lower than recommended by the ESPEN 2017 congress, and no patient covered the protein requirements (1.5 g protein/kg weight) during follow-up. A worse score on the global health scale of the EORTC QLQ-C30 was related to worse NS. Conclusions: Treatment with TKIs does not appear to have a significant impact on NS and quality of life after 6 months of follow-up. Malnutrition should be prevented through individualized nutritional advice because it is related to shorter survival

Evolution of nutritional status and survival in patients with cancer on tyrosine kinase inhibitors treatment. / Evolución nutricional y de la supervivencia en un grupo de pacientes oncológicos en tratamiento con inhibidores de tirosina quinasa.

BACKGROUND AND OBJECTIVE: Treatment with oral antineoplastic agents known as tyrosine kinase inhibitors (TKIs) is new and, thus, little is known about their impact on nutritional status (NS), dietary intake, quality of life, and survival. The aim of this study was to provide information on these components in order to guide future nutritional recommendations. PATIENTS AND METHOD: A prospective, observational study in adults who start treatment with TKIs, in whom NS was assessed using the Patient-Generated Subjective Global Assessment (PG-SGA), anthropometric measures, biochemical parameters, and dietary intake (24-hour dietary recall). The EORTC QLQ-C30 was used to assess quality of life. Nonparametric tests were used in statistical analysis, and survival was analyzed using Kaplan-Meier and log-rank curves. RESULTS: Of the overall sample, 21.7% had moderate malnutrition according to PG-SGA, and 74.2% moderate weight loss at 6 months, but no patient had BMI<18.5kg/m2. Patients with moderate malnutrition had lower survival at four years of diagnosis (log-rank=0.015). Energy intake was lower than recommended by the ESPEN 2017 congress, and no patient covered the protein requirements (1.5g protein/kg weight) during follow-up. A worse score on the global health scale of the EORTC QLQ-C30 was related to worse NS. CONCLUSIONS: Treatment with TKIs does not appear to have a significant impact on NS and quality of life after 6 months of follow-up. Malnutrition should be prevented through individualized nutritional advice because it is related to shorter survival.

Cancellations of elective surgical procedures due to inadequate management of chronic medications.

WHAT IS KNOWN AND OBJECTIVES: Inadequate management of chronic medication puts patients at risk and causes unnecessary suspension of surgical procedures. The objective of the study was to calculate the rate of cancellation of elective surgical procedures due to inadequate management of chronic medications and to analyse the underlying causes of cancellation. METHODS: We designed an analytic, observational, retrospective study of all elective surgical procedures performed from July to October 2017 in a tertiary hospital. The main variable was the percentage of surgeries cancelled owing to inadequate management of chronic medications. Other variables recorded included demographic characteristics, time between the preanaesthesia evaluation and surgery, drug involved, and the reason for incorrect management of the medication. RESULTS: During the study period, 5415 surgical procedures were programmed, and 793 (14.6%) were cancelled. Cancellations due to inadequate patient preparation accounted for 5.3% (42 cases), and 19 were related to incorrect medication management (2.4% of the total number of cancellations). The 19 patients, who were mostly men (73.7%), had a median age of 76 years (IQR 68-81). The drugs involved were acenocoumarol (6), enoxaparin (4), clopidogrel (4), direct-acting oral anticoagulants (2), acetylsalicylic acid (1), tocilizumab (1) and leflunomide (1). The reasons for drug mishandling were poor understanding of the anaesthesiology recommendations (15) and lack of a preanaesthesia evaluation (4). WHAT IS NEW AND CONCLUSION: Inadequate management of chronic medications (2.4%) is not the most frequent reason for cancellation, although it is one of the easiest to avoid. Based on our results, starting in October 2017, the Pharmacy Department began to offer a pharmaceutical service to patients with doubts about the preoperative management of chronic medications.

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.

Guiding pharmacist clinical interviews: a safety tool to support the education of patients treated with oral antineoplastic agents.

OBJECTIVE: Oral antineoplastic agents (OAA) lead to new challenges in patient education, monitoring, medication errors, drug interactions, adverse events management, and adherence. The aim is to develop a structured guide supporting pharmacist interviews and onco-hematologic outpatients' education process and to identify the key points that a pharmacist should address in order to increase OAA safety and efficacy. METHODS: A literature review was performed and the recommended standards associated with OAA approved by ASCO and MASCC were analyzed. Additionally, a multidisciplinary team was formed to address the key points associated with OAA in clinical practice and to create a useful clinical guide. RESULTS: The multidisciplinary team defined the safety and efficacy key points during patient education and issued recommendations regarding the following items: dose, drug administration, interactions, adverse events, adherence, literacy, quality of life, storage, and handling. A guide was created as a check-list in support of the pharmacist clinical interview. Implications for clinical practice, including adverse events management, drug interactions management, and interventions on adherence were added. CONCLUSION: This article provides a consensus set of safety recommendations regarding OAA in clinical practice and a well-researched easily implementable support guide to standardize and guarantee quality pharmaceutical care of onco-hematologic outpatients.

Pharmaceutical care program for onco-hematologic outpatients: safety, efficiency and patient satisfaction.

BACKGROUND: Self-administration of oral chemotherapy regimens in the home setting leading to new challenges in the health system. OBJECTIVE: To develop and evaluate a comprehensive pharmaceutical care program for cancer outpatients treated with oral antineoplastic agents. SETTING: A Spanish tertiary hospital. METHODS: During 2012, a comprehensive pharmaceutical care program was elaborated following the standards recommended by ASCO. It comprised a standard procedure focusing on: drug indication, dosing regimen, required laboratory tests, route of administration, interactions with other current medications and adverse events; a checklist and informational brochures. A pharmaceutical follow up was defined and structured into three clinical interviews over 6 months which focused on safety and efficiency outcomes. Patients starting treatment with oral antineoplastic agents during 2011 (control group) without pharmacist monitoring were compared to patients beginning treatment at some point in 2013 who were prospectively monitored by a pharmacist (intervention group). Statistical analysis was performed by the statistical program SPSS, 21.0 and p < 0.05 was considered significant. MAIN OUTCOME MEASURES: Patient demographics and clinical data were recorded. The primary endpoint was safety outcomes: detection of drug related problems, drug interactions, and adverse events. Adherence, permanence and patient satisfaction were also collected. RESULTS: A total of 249 patients were enrolled in the study. Two hundred and seventy-five medication errors were recorded [106 in the control group and 169 in the intervention group (p = 0.008)]. The pharmacist intervened in 362 occasions being accepted 88.8 % of the time, mainly to reinforce patient education and literacy and giving information on co-administration with other drugs and herbal medicines. Adherent patients increased at the 6th month of treatment in the intervention group by 20 % (p < 0.001). High satisfaction was reported. CONCLUSION: The program has been implemented and evaluated successfully. It ensures a high quality and standard of pharmaceutical care with high patient satisfaction rate and the key points to prioritize for improvement in terms of safety (interactions and administration errors) and efficiency (adherence and permanence) of oral antineoplastic agents.

Ingesta dietética y estado nutricional de pacientes oncológicos que inician tratamiento con inhibidores tirosina quinasa / Dietary intake and nutritional status in oncology patients who start treatment with tyrosine kinase inhibitors

Introducción: la investigación sobre nuevos antineoplásicos orales sigue avanzando en los últimos años mientras que su repercusión sobre la ingesta dietética y el estado nutricional (EN) no progresa de la misma forma. Objetivos: evaluar la ingesta dietética y EN de pacientes que inician tratamiento con inhibidores tirosina quinasa (ITK) y valorar el impacto que tienen sobre ellos. Métodos: estudio observacional y prospectivo de seis meses en el que se incluyeron pacientes que iniciaban tratamiento con ITK. La ingesta se evaluó con: recuerdo 24 h y cuestionario de frecuencia de consumo. El EN se valoró con: medidas antropométricas y cuestionario de valoración subjetiva global generada por el paciente (VSGGP); los resultados se compararon con las referencias SENC-semFYC, 2007 y Moreiras O., 2013. Para el análisis estadístico se utilizaron: Test de Friedman, χ2, Wilcoxon, Kruskall-Wallis y Mann-Whitney. Significación p< 0,05. Resultados: se incluyeron 22 pacientes (54,5% hombres). Al inicio del tratamiento, el 73,9% tenía un EN adecuado según VSG-GP. No se produjeron pérdidas de peso significativas, pese a que un porcentaje elevado no cubrió los requerimientos energéticos y proteicos. El número de comidas se relacionó positivamente con la ingesta calórica. La ingesta y los patrones de frecuencia de consumo por grupos de alimentos tampoco variaron durante el tratamiento. Conclusión: la ingesta dietética al inicio del tratamiento no alcanza los requerimientos nutricionales. Los ITK no parecen afectar la ingesta ni el estado nutricional de los pacientes. El estudio de estos parámetros antes de comenzar el tratamiento evitaría futuras complicaciones y guiaría el consejo dietético (AU)

Background: in recent years, researching about new oral antineoplastics has progressed while its impact on dietary intake and nutritional status (NS) hasn’t developed enough yet. Objectives: dietary intake and NS assessment in patients who start treatment with tyrosine kinase inhibitors (TKI) and evaluate its impact on them. Methods: an observational, prospective-six-months study, in which were included patients starting treatment with TKI. The intake was evaluated by a 24 h dietary record and a food frequency questionnaire. The NS was evaluated by anthropometric measurements and the patient-generated Global Subjective Assessment (PG-GSA); the results were compared with the Spanish references (SENC-semFYC, 2007 and O. Moreiras, 2013). Friedman test, χ2, Wilcoxon, Kruskal-Wallis and Mann-Whitney were used in the statistical analysis. Significance p< 0.05. Results: 22 patients (54.5% male) were included. At baseline, NS was adequate in 73.9% of patients according PG-GSA. Weight loss was no significant, although a high percentage of the energy and protein requirements hadn´t been reached. The caloric intake was positively related with the number of meals. Dietary habits did not change during treatment. Conclusion: dietary intake did not reach nutritional requirements at baseline. The TKI don´t seem to affect the patient´s intake and nutritional status. The research about these parameters before starting treatment could prevent future complications and it would guide the dietary advice (AU)

[DIETARY INTAKE AND NUTRITIONAL STATUS IN ONCOLOGY PATIENTS WHO START TREATMENT WITH TYROSINE KINASE INHIBITORS]. / INGESTA DIETÉTICA Y ESTADO NUTRICIONAL DE PACIENTES ONCOLÓGICOS QUE INICIAN TRATAMIENTO CON INHIBIDORES TIROSINA QUINASA.

BACKGROUND: in recent years, researching about new oral antineoplastics has progressed while its impact on dietary intake and nutritional status (NS) hasn't developed enough yet. OBJECTIVES: dietary intake and NS assessment in patients who start treatment with tyrosine kinase inhibitors (TKI) and evaluate its impact on them. METHODS: an observational, prospective-six-months study, in which were included patients starting treatment with TKI. The intake was evaluated by a 24 h dietary record and a food frequency questionnaire. The NS was evaluated by anthropometric measurements and the patient-generated Global Subjective Assessment (PG-GSA); the results were compared with the Spanish references (SENC-semFYC, 2007 and O. Moreiras, 2013). Friedman test, χ2, Wilcoxon, Kruskal-Wallis and Mann-Whitney were used in the statistical analysis. Significance p < 0.05. RESULTS: 22 patients (54.5% male) were included. At baseline, NS was adequate in 73.9% of patients according PG-GSA. Weight loss was no significant, although a high percentage of the energy and protein requirements hadn't been reached. The caloric intake was positively related with the number of meals. Dietary habits did not change during treatment. CONCLUSION: dietary intake did not reach nutritional requirements at baseline. The TKI don't seem to affect the patient's intake and nutritional status. The research about these parameters before starting treatment could prevent future complications and it would guide the dietary advice.

Introducción: la investigación sobre nuevos antineoplásicos orales sigue avanzando en los últimos años mientras que su repercusión sobre la ingesta dietética y el estado nutricional (EN) no progresa de la misma forma. Objetivos: evaluar la ingesta dietética y EN de pacientes que inician tratamiento con inhibidores tirosina quinasa (ITK) y valorar el impacto que tienen sobre ellos. Métodos: estudio observacional y prospectivo de seis meses en el que se incluyeron pacientes que iniciaban tratamiento con ITK. La ingesta se evaluó con: recuerdo 24 h y cuestionario de frecuencia de consumo. El EN se valoró con: medidas antropométricas y cuestionario de valoración subjetiva global generada por el paciente (VSGGP); los resultados se compararon con las referencias SENC-semFYC, 2007 y Moreiras O., 2013. Para el análisis estadístico se utilizaron: Test de Friedman, 2, Wilcoxon, Kruskall-Wallis y Mann-Whitney. Significación p < 0,05. Resultados: se incluyeron 22 pacientes (54,5% hombres). Al inicio del tratamiento, el 73,9% tenía un EN adecuado según VSG-GP. No se produjeron pérdidas de peso significativas, pese a que un porcentaje elevado no cubrió los requerimientos energéticos y proteicos. El número de comidas se relacionó positivamente con la ingesta calórica. La ingesta y los patrones de frecuencia de consumo por grupos de alimentos tampoco variaron durante el tratamiento. Conclusión: la ingesta dietética al inicio del tratamiento no alcanza los requerimientos nutricionales. Los ITK no parecen afectar la ingesta ni el estado nutricional de los pacientes. El estudio de estos parámetros antes de comenzar el tratamiento evitaría futuras complicaciones y guiaría el consejo dietético.

Seguimiento del estado nutricional y calidad de vida de pacientes que inician tratamiento con inhibidores tirosin kinasa / Nutritional assessment and quality of life of oncology outpatientes initiating treatment with tyrosine-dinase inhibitors

Introducción y objetivo: El consumo de antineoplásicos orales y concretamente de inhibidores tirosin kinasa (ITK) se ha incrementado en los últimos años. Son terapias mejor toleradas y, sin embargo, las alteraciones nutricionales relativas a su uso clínico diario y crónico están aún en estudio. El presente estudio valora la repercusión de los ITK sobre la ingesta, estado nutricional y micronutrientes y valora la calidad de vida de estos pacientes. Métodos: Se realizó un estudio prospectivo y longitudinal en el que se incluyeron aquellos pacientes adultos que iniciaron tratamiento con algún ITK de julio 2012 a junio 2013 con un periodo de seguimiento de 6 meses. Se recogieron variables demográficas, farmacoterapéuticas, nutricionales, bioquímicas y el cuestionario EORTC-QLQ30 al inicio, primer, tercer y sexto mes de tratamiento. Resultados: Se incluyeron 31 pacientes. El porcentaje de pérdida de peso al inicio del tratamiento se relacionó estadísticamente con la clasificación de la Valoración Subjetiva Global-generada por el paciente. Tras un mes de tratamiento descendió el apetito, las calorías consumidas y un 62,1% de los pacientes perdió peso, 55,5% al tercer mes y 70,6% al sexto mes. Entre un 6-17% de los pacientes sufría algún grado de desnutrición durante el seguimiento y se detectó una disminución de los niveles plasmáticos de calcio, fosfato y magnesio. En el EORTC QLQ-30, la escala emocional fue la peor puntuada y los síntomas más comunes al inicio de tratamiento fueron la fatiga y pérdida de apetito, aumentando progresivamente las náuseas, vómitos y la diarrea. Discusión: Los pacientes tratados con ITK no presentaron una desnutrición importante. A la vista de los resultados es importante valorar la pérdida de peso al inicio de tratamiento, monitorizar los niveles de calcio y el fosfato durante el tratamiento, aconsejar y prevenir al paciente sobre los efectos gastrointestinales (náuhistoseas, vómitos y diarrea) y reforzar emocionalmente al paciente (AU)

Background and objective: The consumption of oral antineoplastics -and more particularly of tyrosine-kinase inhibitors (TKI)- has increased in recent years. These therapies show a better tolerance but still, the nutritional alterations related to their daily and chronic clinical use are under investigation. This study assesses the effects of TKI on the intake, nutritional status and micronutrients as well as the patients quality of life. Methods: A prospective longitudinal study was conducted including adult patients having started some TKI treatment from July 2012 to June 2013, and a 6 month follow-up period was established. Demographic pharmacotherapeutic, nutritional and biochemical variables were collected and also a EORTC-QLQ30 questionnaire at baseline, first, third and sixth month of treatment. Results: 31 patients were included in the study. The percentage of weight loss at treatment baseline was statistically matched to the results on the patient-generated Global Subjective Assessment. Appetite decreased after one month of treatment, and so did the calorie consumption; 62.1% of the patients lost weight, 55.5% on the third month and 70.6% on the sixth month. 6-17% of the patients suffered from malnutrition to some degree during the follow-up period and a decrease of calcium, phosphate and magnesium plasma levels was detected. The emotional scale was the one with a lowest score in EORTC QLQ-30, and fatigue and lack of appetite were the most common symptoms at treatment baseline, progressively increasing those of nausea, vomits and diarrhea. Discussion: Patients treated with TKI did not show relevant malnutrition. Considering the results, it is important to take into account weight loss at treatment baseline; it is also important to control calcium and phosphate levels during treatment, to advise and counsel the patient on the GI effects (nausea, vomits and diarrhea) and emotionally reinforce the patient (AU)