Expert design thinking workshops to analyze users' perceived applicability of NUTRI-ONCOCARE algorithm to prevent and treat malnutrition in cancer patients under routine clinical practice conditions in Spain: the ALLIANCE study.

PURPOSE: NUTRI-ONCOCARE algorithm has been developed to identify and treat patients with solid tumors who are at risk of malnutrition. The present study is aimed at analyzing users' opinion about this new tool and at assessing whether it is perceived as useful to achieve the behavioral change required for a successful integration of nutritional assessment into routine cancer care. METHODS: Design thinking Double Diamond process was applied. A multidisciplinary team composed of ten potential end-users (four oncologists, three endocrinologists, one nutritionist, and two hospital pharmacists) participated in three different workshops aiming to analyze the different tasks included within the NUTRI-ONCOCARE algorithm. RESULTS: Users agreed on the need to perform nutritional assessment around cancer diagnosis and through the course of the disease using standardized tools included in hospital nutritional protocols and involving healthcare professionals with nutrition expertise. Nutritional evaluation and intervention should be individual and comprehensive, considering not only nutritional parameters but also patients' functional status. According to participants' opinion, the implementation of nutritional screening in routine clinical practice is limited by the lack of time and staff to conduct nutritional assessments, the low level of nutrition expert participation, and the poor support provided by hospital managers, which are often unaware of nutrition's impact in cancer care. CONCLUSIONS: Experts recognized the importance of considering nutritional status in cancer patients and identified the opportunity provided by the NUTRI-ONCOCARE algorithm for this purpose, as it meets main requirements for being used routinely in clinical practice.

NUTRI-ONCOCARE: Nuevo modelo integralde atención nutricional para prevenir y tratar la desnutrición en pacientes con cáncer / NUTRI-ONCOCARE: New integral nutrition care model to prevent and treat malnutrition in cancer patients

Objetivo: La máxima expresión de la desnutrición en los pacientesoncológicos es la caquexia cancerosa, siempre vinculada a un pronósticodesfavorable. Dado su carácter evolutivo se recomienda detectar y actuarprecozmente en aquellos pacientes con riesgo nutricional. El objetivo esdefinir un algoritmo de actuación para el abordaje nutricional de pacientes con tumores sólidos.Método: Mediante la técnica de grupo nominal se reunió a especialistas en farmacia hospitalaria, nutrición y oncología que establecieron unapriorización de temas relacionados con el estado nutricional y su abordaje en pacientes con tumores sólidos. Su discusión y análisis permitierondiseñar un algoritmo de actuación.Resultados: El algoritmo diferencia dos grupos de pacientes según lalocalización del tumor y su impacto en el estado nutricional: los tumores dealto riesgo (grupo 1) incluyen cánceres de cabeza y cuello, del tracto digestivo superior y colorrectal, y los tumores de bajo riesgo (grupo 2) englobanel resto de neoplasias. Los pacientes del grupo 1 (a excepción de aquellos con cáncer colorrectal) son directamente valorados nutricionalmenteen los primeros 3-5 días tras su presentación en el comité de tumores, iniciando el soporte nutricional requerido en ese momento. Los pacientes delgrupo 2 y los diagnosticados de cáncer colorrectal son cribados (medianteNUTRISCORE) tras su presentación en el comité, derivándose a consulta nutricional a aquellos con riesgo positivo para realizar una evaluación completa y proponer opciones de tratamiento, y reevaluándose periódicamentelos pacientes sin riesgo nutricional. (AU)

Objective: The maximum expression of malnutrition in cancer patientsis cancerous cachexia, always linked to an unfavorable prognosis. Givenits evolutionary nature it is recommended to detect and act early in thosepatients with nutritional risk. The objective is to propose an action algorithm for the nutritional approach of patients with solid tumors.Method: Through the nominal group technique, specialists in hospitalpharmacy, nutrition and oncology who established a prioritization ofissues related to nutritional status and its approach in patients with solidtumors were brought together. Their discussion and analysis allowed us todesign a performance algorithm.Results: The algorithm differentiates two groups of patients accordingto the location of the tumor and its impact on nutritional status: high-risktumors (group 1) include cancers of the head and neck, upper digestivetract and colorectal and low-risk tumors (group 2) include the rest of theneoplasms. Group 1 patients (with the exception of those with colorectalcancer) are directly assessed nutritionally in the first 3-5 days after theirpresentation in the Tumor Committee, starting the nutritional support required at that time. Patients in group 2 and those diagnosed with colorectalcancer are screened (through NUTRISCORE) after their presentation in theCommittee, those with positive risk being referred to nutritional consultationto perform a complete evaluation and propose treatment options. Patients without nutritional risk are periodically re-evaluated. Follow-up is plannedaccording to cancer therapy, with continuous monitoring in each treatmentcycle or during the perioperative period. (AU)

NUTRI-ONCOCARE: New integral nutrition care model to prevent and treat malnutrition in cancer patients.

OBJECTIVE: The maximum expression of malnutrition in cancer patients is  cancerous cachexia, always linked to an unfavorable prognosis. Given its  evolutionary nature it is recommended to detect and act early in those patients with nutritional risk. The objective is to propose an action  algorithm for the nutritional approach of patients with solid tumors. METHOD: Through the nominal group technique, specialists in hospital pharmacy, nutrition and oncology who established a prioritization  of issues related to nutritional status and its approach in patients with  solid tumors were brought together. Their discussion and analysis allowed  us to design a performance algorithm. RESULTS: The algorithm differentiates two groups of patients according to  the location of the tumor and its impact on nutritional status: high-risk tumors (group 1) include cancers of the head and neck, upper  digestive tract and colorectal and low-risk tumors (group 2) include the  rest of the neoplasms. Group 1 patients (with the exception of those with  colorectal cancer) are directly assessed nutritionally in the first 3-5 days  after their presentation in the Tumor Committee, starting the nutritional  support required at that time. Patients in group 2 and those diagnosed  with colorectal cancer are screened (through NUTRISCORE) after their  presentation in the Committee, those with positive risk being referred to  nutritional consultation to perform a complete evaluation and propose  treatment options. Patients without nutritional risk are periodically re- evaluated. Follow-up is planned according to cancer therapy, with  continuous monitoring in each treatment cycle or during the perioperative  period. CONCLUSIONS: From the nominal group technique, agreements were reached to propose an algorithm of nutritional approach of the cancer patient. The adoption of the proposed algorithm could reduce  variability in institutional clinical practice, promoting a timely and adequate nutritional approach in cancer patients.

Objetivo: La máxima expresión de la desnutrición en los pacientes oncológicos es la caquexia cancerosa, siempre vinculada a un  pronóstico desfavorable. Dado su carácter evolutivo se recomienda  detectar y actuar precozmente en aquellos pacientes con riesgo  nutricional. El objetivo es definir un algoritmo de actuación para el  abordaje nutricional de pacientes con tumores sólidos.Método: Mediante la técnica de grupo nominal se reunió a especialistas en farmacia hospitalaria, nutrición y oncología que establecieron una priorización de temas relacionados con el estado nutricional y su  abordaje en pacientes con tumores sólidos. Su discusión y análisis  permitieron diseñar un algoritmo de actuación.Resultados: El algoritmo diferencia dos grupos de pacientes según la localización del tumor y su impacto en el estado nutricional: los tumores  de alto riesgo (grupo 1) incluyen cánceres de cabeza y cuello, del tracto  digestivo superior y colorrectal, y los tumores de bajo riesgo (grupo 2)  engloban el resto de neoplasias. Los pacientes del grupo 1 (a excepción de aquellos con cáncer colorrectal) son directamente valorados  nutricionalmente en los primeros 3-5 días tras su presentación en el  comité de tumores, iniciando el soporte nutricional requerido en ese  momento. Los pacientes del grupo 2 y los diagnosticados de cáncer  colorrectal son cribados (mediante NUTRISCORE) tras su presentación en  el comité, derivándose a consulta nutricional a aquellos con riesgo positivo para realizar una evaluación completa y proponer opciones de tratamiento, y reevaluándose periódicamente los pacientes sin riesgo nutricional. El  seguimiento se planifica según la terapia oncológica, con una  monitorización continua en cada ciclo de tratamiento o durante el periodo  perioperatorio.Conclusiones: A partir de la técnica de grupo nominal, se alcanzaron acuerdos para proponer un algoritmo de abordaje nutricional  precoz del paciente con cáncer. La adopción del algoritmo propuesto podría reducir la variabilidad en la práctica clínica institucional, promoviendo un  enfoque nutricional oportuno y adecuado en pacientes con cáncer.

Impact of weight loss on cancer patients' quality of life at the beginning of the chemotherapy.

PURPOSE: Among the prognostic factors relevant to the condition of oncological patients, nutritional status (NS) has the greatest single impact on quality of life (QL). The goals of our study were to evaluate the influence of NS, weight loss (WL), and the presence of cachexia, prior to the initiation of chemotherapy, on the patient's QL. METHODS: Adult patients (aged ≥ 18 years) diagnosed with solid tumours for whom chemotherapy was started between April 2016 and June 2017 were eligible for inclusion in the study. They were asked to complete a QL questionnaire (Functional Assessment of Cancer Treatment (FACT-G)) at the beginning. The presence or absence of cachexia was evaluated at the outset, following the definition proposed by Fearon and nutritional assessment by the Patient-Generated Subjective Global Assessment (PG-SGA) scale. RESULTS: A total of 177 patients completed the FACT-G, the 60% receiving curative therapy. At the start of the treatment, 58.2% of patients had experienced WL, with an average of 4.4 ± 7.4%, and 19% were at risk of malnutrition. Patient who presented cachexia at diagnosis, were treated with palliative intention, had a Nutriscore ≥ 5 points or presented malnutrition in accordance with PG-SGA had a poorer QL (p < 0.05). Greater WL was associated with a worsened QL (p = 0.001). Breast cancer patients presented an inverse correlation between the %WL and the initial score in the FACT-G (r = - 0.304, p = 0.023), whereas no such correlation was observed for the other types of tumour (r = - 0.012, p = 0.892). CONCLUSIONS: These results underline the relation of NS before starting chemotherapy and QL. Greater WL was associated with a worsened QL, especially in women with breast cancer.

Estudio observacional de la toxicidad con diferentes formulaciones de docetaxel en pacientes con cáncer de mama / Observational study of clinical toxicity with different formulations of docetaxel in breast cancer patients

OBJETIVO: Estudiar los excipientes e impurezas de los diferentes medicamentos comercializados de docetaxel y conocer la incidencia de los diversos eventos adversos derivados del uso de docetaxel y su repercusión clínica en pacientes con cáncer de mama en el contexto de adyuvancia o neoadyuvancia. MÉTODO: Estudio observacional, longitudinal, prospectivo y multicéntrico en 26 hospitales de Madrid, Cataluña, Andalucía y Comunidad Valenciana. Se caracterizaron las distintas formulaciones de docetaxel en cuanto a pH, cantidad de docetaxel e impurezas. Se evaluó la incidencia acumulada de eventos adversos de cualquier grado estratificados por tipo de medicamento, analizando las diferencias mediante el test de χ2.RESULTADOS: Se detectaron diferencias estadísticamente significativas entre las distintas formulaciones de docetaxel en cuanto a la incidencia acumulada por ciclo de: modificación de dosis, anemia, reacciones de hipersensibilidad y anafilaxia, neuropatía, toxicidad palmo-plantar y dermatológica, toxicidad ungueal y edema facial. La formulación con un menor contenido en impurezas presentó mejores resultados en modificación de dosis, visitas a urgencias, e incidencia de anemia y edema facial, pero peores en hospitalización, neutropenia febril, neuropatía motora y toxicidad palmo-plantar. CONCLUSIONES: Los resultados muestran diferencias en la incidencia de los eventos adversos de los distintos medicamentos con docetaxel comercializados en nuestro país, con diferencias significativas entre ellos en algunas de las variables estudiadas. No se ha podido identificar un medicamento con un mejor perfil de toxicidad. Tampoco se ha podido establecer su relación con respecto a la composición de excipientes e impurezas

OBJECTIVE: To analyze the excipients and impurities contained in the various docetaxel products available on the market and find out whether they may be responsible for any of the different adverse events associated with the use of docetaxel in patients with breast cancer receiving adjuvant or neoadjuvant treatment. METHOD: This is a prospective, multicenter, longitudinal observational, study carried in 26 hospitals in Madrid, Catalonia, Andalusia, and the Valencia Region. The different docetaxel formulations were characterized in terms of their pH, amount of the active ingredient and impurities. The cumulative incidence of adverse events of any grade was evaluated. Adverse events were stratified by drug type and differences were analyzed by means of a chi-square test. RESULTS: Statistically significant differences were found between the different docetaxel formulations in the cumulative per-cycle incidence of: dosage change, anemia, hypersensitivity reactions and anaphylaxis, neuropathy, palmoplantar and dermal toxicity, ungual toxicity and facia edema. The formulation with the lowest content of impurities showed better results in terms of change of dosage, visits to the emergency room and incidence of anemia and facial edema. However, it was associated with poorer results regarding hospitalization, febrile neutropenia, motor neuropathy and palmoplantar toxicity. CONCLUSIONS: The results of the study showed differences in the incidence of adverse events of the different docetaxel products available in Spain. Such differences were statistically significant for some of the variables analyzed. The study was not able to determine which of the products offered the best toxicity profile. Nor was it possible to establish a correlation with respect to the composition of excipients or the content of impurities

Observational study of clinical toxicity with different formulations of docetaxel in breast cancer patients.

OBJECTIVE: To analyze the excipients and impurities contained in the various docetaxel products available on the market and find out  whether they may be responsible for any of the different adverse events  associated with the use of docetaxel in patients with breast cancer  receiving adjuvant or neoadjuvant treatment. METHOD: This is a prospective, multicenter, longitudinal observational, study carried in 26 hospitals in Madrid, Catalonia, Andalusia, and the Valencia Region. The different docetaxel formulations were  characterized in terms of their pH, amount of the active ingredient and  impurities. The cumulative incidence of adverse events of any grade was  evaluated. Adverse events were stratified by drug type and differences  were analyzed by means of a chi-square test. RESULTS: Statistically significant differences were found between the different docetaxel formulations in the cumulative per-cycle incidence of: dosage change, anemia, hypersensitivity reactions and  anaphylaxis, neuropathy, palmoplantar and dermal toxicity, ungual toxicity  and facial edema. The formulation with the lowest content of impurities  showed better results in terms of change of dosage, visits to the  emergency room and incidence of anemia and facial edema. However, it  was associated with poorer results regarding hospitalization, febrile  neutropenia, motor neuropathy and palmoplantar toxicity. CONCLUSIONS: The results of the study showed differences in the incidence of adverse events of the different docetaxel products available in  Spain. Such differences were statistically significant for some of the  variables analyzed. The study was not able to determine which of the  products offered the best toxicity profile. Nor was it possible to establish a  correlation with respect to the composition of excipients or the content of  impurities.

Objetivo: Estudiar los excipientes e impurezas de los diferentes  medicamentos comercializados de docetaxel y conocer la incidencia de  los diversos eventos adversos derivados del uso de docetaxel y su  repercusión clínica en pacientes con cáncer de mama en el contexto de  adyuvancia o neoadyuvancia.Método: Estudio observacional, longitudinal, prospectivo y multicéntrico en 26 hospitales de Madrid, Cataluña, Andalucía y  Comunidad Valenciana. Se caracterizaron las distintas formulaciones de  docetaxel en cuanto a pH, cantidad de docetaxel e impurezas. Se evaluó  la incidencia acumulada de eventos adversos de cualquier grado  estratificados por tipo de medicamento, analizando las diferencias  mediante el test de χ2.Resultados: Se detectaron diferencias estadísticamente significativas entre las distintas formulaciones de docetaxel en cuanto a  la incidencia acumulada por ciclo de: modificación de dosis, anemia,  reacciones de hipersensibilidad y anafilaxia, neuropatía, toxicidad palmo- plantar y dermatológica, toxicidad ungueal y edema facial. La  formulación con un menor contenido en impurezas presentó mejores  resultados en modificación de dosis, visitas a urgencias, e incidencia de  anemia y edema facial, pero peores en hospitalización, neutropenia  febril, neuropatía motora y toxicidad palmo-plantar.Conclusiones: Los resultados muestran diferencias en la incidencia de  los eventos adversos de los distintos medicamentos con docetaxel comercializados en nuestro país, con diferencias significativas  entre ellos en algunas de las variables estudiadas. No se ha podido  identificar un medicamento con un mejor perfil de toxicidad. Tampoco se  ha podido establecer su relación con respecto a la composición de  excipientes e impurezas.

A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice.

Background Immunotherapy has become a standard treatment for lung cancer; however, the high cost makes it necessary to assess health outcomes. Objective The aim of this study was to evaluate the effectiveness, safety and economic cost of nivolumab in real-world clinical practice. Setting Fifteen regional and academic hospitals from Spain participated in this study. Methods This study was a retrospective, multicentre and observational study involving patients who experienced progression after first-line therapy for non-small-cell lung cancer and were treated with nivolumab between January 2016 and July 2017. Effectiveness and safety were evaluated by the oncologist, and the data from the electronic clinical records of the patients were collected by the research team. Economic cost was calculated using the cost of acquiring nivolumab for the public health system. Main outcome measures Effectiveness variables were overall survival (OS) and progression-free survival (PFS). The safety variable was the incidence of adverse events (AEs), and the cost per life-year gained (LYG) was the economic variable. Results A total of 221 patients were enrolled (83.7% men). The mean age was 64.5 years, and 84.6% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1. Squamous tumours accounted for 59.7% of the total, and 78.7% of the patients presented a time since platinum therapy (TPT) > 6 months. The mean nivolumab dose was 216 mg (SD 211), and the treatment duration was 7.0 months (95% CI 5.8-8.1). The median PFS was 5.3 months (95% CI 3.2-7.3), and OS was 9.7 months (95% CI 7.6-11.8). The median PFS and OS values were statistically significantly superior for patients with an ECOG score of 0-1 and for patients with a TPT > 6 months. The median OS was also statistically significantly superior for patients with non-squamous histology. Regarding safety, 71% of the patients presented AEs of any grade, and in 18.6%, the nivolumab treatment had to be delayed or discontinued. The cost of nivolumab per patient was €19,910.00 (SD 19,369), and the cost per LYG was €110,026.00 (€77,557.00-€231,171.00). Conclusions This study confirms that the efficacy and safety of nivolumab treatment in a real population are comparable to the results obtained in clinical trials. A greater clinical benefit of nivolumab therapy was observed in patients with an ECOG score of 0-1, a TPT > 6 months or non-squamous histology. Despite the benefit observed, the cost per LYG is above the threshold of efficiency established by public health institutes.

New cutaneous toxicities with generic docetaxel: are the excipients guilty?

PURPOSE: Docetaxel is one of the most widely used anticancer drugs and an ideal candidate for the development of generic formulations to reduce the economic cost. However, the use of generic drugs is an issue of debate because studies of their safety and efficacy in comparison with the original drug are not required for approval. The aim of this study is to determine whether the change in the formulation of the original drug is responsible for the toxicity changes observed. METHODS: A retrospective study contrasts the incidence of acute infusion reactions and skin reactions to four different presentations of docetaxel including the original drug. These drugs differ in the amounts of excipients. RESULTS: 1.031 doses of docetaxel were administered to 268 patients. A total of 26 grade 3/4 infusion reactions were detected. Compared to the original formulation, the relative risk of acute infusion reaction was 3.74 (1.52-9.18, p = 0.002), 0.57 (0.19-1.64, p = 0.288) and 0.37 (0.1-1.34, p = 0.117) for the patients treated with drugs 2, 3 and 4. For the dermal toxicity, 9 % of patients suffered a clinically significant skin reaction. The relative risks of clinically significant dermal toxicity for the different formulations of docetaxel versus the original formulation were as follows: 6.15 (2.78-13.58) and 7.13 (3.24-15.69) for drugs 3 and 4 (p < 0.001). CONCLUSIONS: Our study suggests that some toxic effects of docetaxel may be related to the excipients used in different formulations of the drug.

Role of clinical pharmacists to prevent drug interactions in cancer outpatients: a single-centre experience.

BACKGROUND: Cancer patients are especially vulnerable to drug interactions, which may alter the efficacy and toxicity of treatment, leading to severe clinical consequences. OBJECTIVE: Determine the incidence of such interactions in patients receiving chemotherapy, as well as to identify the drugs most frequently involved, investigate the influence of the pharmacist's interventions and verify the degree of acceptance of pharmacist's recommendations by the medical team. SETTING: The oncology department of a Spanish tertiary hospital. METHODS: During 3 months, all the drug interactions in the regular combined with treatment for cancer were analysed using two databases, and recommendations were made when clinically significant interactions (CSI) were identified. MAIN OUTCOME MEASURE: Incidence of CSI in oncology outpatients; drugs involved in CSI. RESULTS: Of the 75 patients included, 31 (41%) presented CSI. Most interactions were among drugs included in the patient's usual treatment. The principal drug groups involved in CSI were cytostatic agents, antiemetics and antidepressants. The hospital pharmacist intervened on 20 occasions (35% of the patients presenting drug interactions). These interventions mainly focused on recommendations to modify or discontinue drug prescriptions, and were followed in 94% of cases. CONCLUSION: The incidence of drug interactions in cancer patients is high, and they most often involve medications to treat comorbid conditions. The pharmacist, as a member of the multidisciplinary team, can contribute significantly by checking the treatment prescribed and detecting interactions, to reduce medication-related problems and to optimise drug therapy for these patients.