Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas / Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to drug-drug interactions

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to DDIs / Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

[Translated article] Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to DDIs.

OBJECTIVE: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyse the clinical relevance of drug-drug interactions in the development of adverse events. METHODS: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. RESULTS: The study included 146 patients. 82 (56.16%) were women, whose median age was 65 years (22-95). the number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least 1 interaction being 62.33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11.84%). 11 AEs were potentially related to any TDDI. 7 patients required contact with hospital assistance for AE management. 8 patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. CONCLUSIONS: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.

[Translated article] Influence of augmented renal clearance in the lower incidence of linezolid-related haematological toxicity.

OBJECTIVES: Linezolid is an oxazolidin commonly related to the development of haematological toxicity, being renal clearance the major factor involved in the drug clearance. The aim of this study is to evaluate the influence of increased filtration rates in the incidence of linezolid-induced haematological toxicity by comparing augmented renal clearance (ARC) patients versus normal renal function patients. MATERIAL AND METHODS: A retrospective, observational study was conducted on hospitalized patients treated with linezolid for 5 days or more during 2014-2019 period. Patients with a filtration rate of ≥130 mL/min versus reference patients (60-90 mL/min) were compared. Haematological toxicity was defined as a decrease of 25% in platelets, of 25% in haemoglobin, and/or 50% in neutrophils from baseline. Toxicity relevance was classified according to Common Terminology Criteria for Adverse Events v5. Incidence of haematological toxicity between groups was studied by chi-square and Fisher test. Furthermore, percentage diminution of all 3 parameters was calculated and compared by Mann-Whitney test and treatment interruption and transfusion requirements were registered. RESULTS: 30 ARC patients and 38 reference patients were included. Haematological toxicity was observed in 16.66% of ARC patients vs 44.74% of reference patients (P=.014); thrombocytopenia in 13.33% vs 36.84% (P=.051), anaemia in 3.3% vs 10.52% (P=.374) and neutropenia in 10% vs 23.68% (P=.204). Median percentage of platelets decrease in ARC patients was -10.36 (-193.33-62.03) vs 2.68 (-163.16-82.71) in reference patients (P=.333), while haemoglobin decrease was 2.50 (-12.12-25.93) vs 9.09 (-17.72-30.63) (P=.047) and neutrophils decrease was 9.14 (-73.91-76.47) vs 27.33 (-86.66-90.90) (P=.093). 10.5% of normal renal function patients reported at least 1 adverse event grade 3 or superior while 2.6% of them interrupted treatment and 5.2% had transfusion requirements. No major events or interruptions were reported in ARC patients. CONCLUSION: Our findings suggest a lower incidence and clinical relevance of haematological toxicity in augmented renal clearance patients. Thrombocytopenia was the major event in both populations. This might be related to a lower exposure to the drug due to the higher clearance and likely lower therapeutic efficiency. These results suggest a potential benefit of therapeutic drug monitoring on high risk patients.

Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to drug-drug interactions. / Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas.

OBJECTIVE: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. METHODS: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. RESULTS: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. CONCLUSIONS: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.

Influencia de la hiperfiltración glomerular en la menor toxicidad hematológica inducida por linezolid / Influence of augmented renal clearance on the lower incidence of linezolid-related hematological toxicity

Objetivos linezolid es una oxazolidina frecuentemente implicada en el desarrollo de toxicidad hematológica, siendo el aclaramiento renal el mecanismo mayoritario en su eliminación. Se evaluó la influencia de la hiperfiltración glomerular en la toxicidad hematológica inducida por linezolid en pacientes con aclaramiento incrementado frente a pacientes con función renal normal. Material y métodos se diseñó un estudio observacional y retrospectivo en pacientes hospitalizados, tratados al menos 5 días con linezolid entre 2014 y 2019. Se compararon pacientes con aclaramiento de creatinina incrementado (≥130 mL/min) y normal (60–90 mL/min). Se definió la toxicidad hematológica como el descenso en plaquetas y hemoglobina del 25% y en neutrófilos del 50% frente a los valores basales. Se clasificó el grado de toxicidad según Common Terminology Criteria for Adverse Events v5 y se comparó la incidencia entre ambos grupos mediante Chi-cuadrado y Fisher. Así mismo, se calculó el porcentaje de disminución de los 3 parámetros y su asociación mediante el test de Mann–Whitney y se registraron las interrupciones y transfusiones asociadas.Resultados se evaluaron 30 pacientes hiperfiltradores y 38 normofiltradores. El 16,66% de hiperfiltradores presentó toxicidad hematológica frente al 44,74% (p = 0,014). La trombocitopenia fue del 13,33 vs. 36,84% (p = 0,051), la anemia del 3,3 vs. 10,52% (p = 0,374) y la neutropenia del 10 vs. 23,68% (p = 0,204). La mediana del porcentaje de descenso plaquetario en hiperfiltradores frente a normofiltradores fue del −10,36 (−193,33–62,03) vs. 2,68 (−163,16–82,71) (p = 0,333), de hemoglobina 2,50 (−12,12–25,93) vs. 9,09 (−17,72–30,63) (p = 0,047) y de neutrófilos 9,14 (−73,91–76,47) vs. 27,33 (−86,66–90,90) (p = 0,093). El 10,5% con filtrado normal presentó toxicidad grado 3 o superior, el 2,6% interrumpió el tratamiento y el 5,2% requirieron transfusiones... (AU)

Objectives Linezolid is an oxazolidin commonly related to the development of hematological toxicity, being renal clearance the major factor involved in the drug clearance. The aim of this study is to evaluate the influence of increased filtration rates in the incidence of linezolid-induced hematological toxicity by comparing augmented renal clearance (ARC) patients versus normal renal function patients. Material and methods A retrospective, observational study was conducted on hospitalized patients treated with linezolid for 5 days or more during 2014–2019 period. Patients with a filtration rate of ≥130 mL/min versus reference patients (60–90 mL/min) were compared. Hematological toxicity was defined as a decrease of 25% in platelets, of 25% in hemoglobin and/or 50% in neutrophils from baseline. Toxicity relevance was classified according to Common Terminology Criteria for Adverse Events v5. Incidence of hematological toxicity between groups was studied by chi-square and Fisher test. Furthermore, percentaje disminution of all three parameters was calculated and compared by Mann–Whitney test and treatment interruption and tranfusion requirements were registered. Results 30 ARC patients and 38 reference patients were included. Hematological toxicity was observed in 16.66% of ARC patients vs 44.74% of reference patients (p = 0.014); thrombocytopenia in 13.33% vs 36.84% (p = 0.051), anemia in 3.3% vs 10.52% (p = 0.374) and neutropenia in 10% vs 23.68% (p = 0.204). Median percentaje of platelets decrease in ARC patients was −10.36 (−193.33–62.03) vs 2.68 (−163.16–82.71) in reference patients (p = 0.333), while hemoglobin decrease was 2.50 (−12.12–25.93) vs 9.09 (−17.72–30.63) (p = 0.047) and neutrophils decrease was 9.14 (−73.91–76.47) vs 27.33 (−86.66–90.90) (p = 0.093). 10.5% of normal renal function patients reported at least one adverse event grade 3 or superior while 2.6% of them interrupted treatment and 5.2% had tranfusion requirements... (AU)

Influence of augmented renal clearance on the lower incidence of linezolid-related hematological toxicity. / Influencia de la hiperfiltración glomerular en la menor toxicidad hematológica inducida por linezolid.

OBJECTIVES: Linezolid is an oxazolidin commonly related to the development of hematological toxicity, being renal clearance the major factor involved in the drug clearance. The aim of this study is to evaluate the influence of increased filtration rates in the incidence of linezolid-induced hematological toxicity by comparing augmented renal clearance (ARC) patients versus normal renal function patients. MATERIAL AND METHODS: A retrospective, observational study was conducted on hospitalized patients treated with linezolid for 5 days or more during 2014-2019 period. Patients with a filtration rate of ≥130 mL/min versus reference patients (60-90 mL/min) were compared. Hematological toxicity was defined as a decrease of 25% in platelets, of 25% in hemoglobin and/or 50% in neutrophils from baseline. Toxicity relevance was classified according to Common Terminology Criteria for Adverse Events v5. Incidence of hematological toxicity between groups was studied by chi-square and Fisher test. Furthermore, percentaje disminution of all three parameters was calculated and compared by Mann-Whitney test and treatment interruption and tranfusion requirements were registered. RESULTS: 30 ARC patients and 38 reference patients were included. Hematological toxicity was observed in 16.66% of ARC patients vs 44.74% of reference patients (p = 0.014); thrombocytopenia in 13.33% vs 36.84% (p = 0.051), anemia in 3.3% vs 10.52% (p = 0.374) and neutropenia in 10% vs 23.68% (p = 0.204). Median percentaje of platelets decrease in ARC patients was -10.36 (-193.33-62.03) vs 2.68 (-163.16-82.71) in reference patients (p = 0.333), while hemoglobin decrease was 2.50 (-12.12-25.93) vs 9.09 (-17.72-30.63) (p = 0.047) and neutrophils decrease was 9.14 (-73.91-76.47) vs 27.33 (-86.66-90.90) (p = 0.093). 10.5% of normal renal function patients reported at least one adverse event grade 3 or superior while 2.6% of them interrupted treatment and 5.2% had tranfusion requirements. No major events or interruptions were reported in ARC patients. CONCLUSION: Our findings suggest a lower incidence and clinical relevance of hematological toxicity in augmented renal clearance patients. Thrombocytopenia was the major event in both populations. This might be related to a lower exposure to the drug due to the higher clearance and likely lower therapeutic efficiency. These results suggest a potential benefit of therapeutic drug monitoring on high risk patients.

Impact of a Pharmaceutical Care Program at Discharge on Patients at High Risk of Readmission According to the Hospital Score.

Background: A significant percentage of hospital readmissions within 30 days of discharge are a result of avoidable drug-related problems. Stratifying patients according to readmission risk is key to pharmaceutical intervention (PI) design strategies to improve treatment outcomes. Objective: To assess whether a pharmaceutical care (PC) program at discharge in polymedicated patients at high potentially avoidable readmission (PAR) risk, according to the HOSPITAL score, improves 30-day readmission rate (30-dRR). Methods: This prospective controlled, quasi-experimental, 11-month study included 163 chronic polymedicated patients (>5 medications) at high PAR risk according to the HOSPITAL score. We calculated the 30-dRR and number of medication variations and Medication Regimen Complexity Index-E (MRCI-E) after PI. Results were compared with a retrospective cohort of chronic patients at high PAR risk. Results: The 30-dRR was 18.4% in the intervention group and 25.6% in the control group (odds ratio [OR] = 0.66; 95% CI = 0.38 to 1.14). Total medication reduction (-1.28; 95% CI = -1.88 to -0.68), number of high-risk medications in chronic patients (-0.58; 95% CI = -0.9 to -0.26), and MRCI-E (-6.42; 95% CI = -8.07 to -4.76) were statistically significant (P < .001). The number of medications at discharge was associated with an increased readmission risk (OR = 1.07; 95% CI = 1.01 to 1.14). Conclusions: The degree of polypharmacy and patients' treatment complexity after hospital discharge significantly reduced as a result of the PC program compared with the control group. This highlights the need for patient selection and prioritization strategies for implementing PIs focused on reducing polypharmacy and preventing drug-related problems that may cause PAR.

Uso de antineoplásicos orales en situaciones especiales en un hospital de tercer nivel: resultados en la vida real / Use of oral antineoplastic in special situations in a third level hospital: real life results

Objetivo: Analizar la efectividad y seguridad de los antineoplásicos orales (ANEO) autorizados en situaciones especiales en un hospital de tercer nivel y comparar los resultados obtenidos con los de la evidencia disponible empleada para autorizar el uso de estos fármacos. Método: Estudio descriptivo observacional y retrospectivo. Se incluyeron todos los pacientes adultos que iniciaron tratamiento con ANEO en situaciones especiales durante el año 2016. Se recogieron variables demográficas, relacionadas con el tratamiento, y clínicas (supervivencia global (SG), supervivencia libre de progresión (SLP)). Se recogieron reacciones adversas e interacciones detectadas. Se realizó una comparación no ajustada entre los resultados de la evidencia disponible y los de los pacientes del estudio. Resultados: Treinta y cuatro pacientes recibieron tratamiento, el 50% eran hombres, la mediana de edad fue de 58 años (38-80), y presentaron ECOG 1 el 64,7%. La mayoría de los pacientes tratados presentaban diagnóstico de cáncer colorrectal avanzado, tratados con trifluridina-tipiracil, seguidos de palbociclib en cáncer de mama, obteniendo resultados similares a los de la evidencia. La mediana de SLP fue de 2,8 meses (IC 95% 0,8-4,8) y la SG de 8 meses (IC 95% 3,4-12,5) para todos los pacientes. El 26% de los pacientes requirieron una reducción de la dosis debido a la toxicidad del tratamiento. Se encontraron 13 interacciones, que afectaron a 15 pacientes; solo dos de categoría X. Conclusiones: La efectividad de los ANEO en situaciones especiales en nuestro centro es similar al de la evidencia disponible. El impacto en la supervivencia es bajo y los efectos adversos son comunes (AU)

Objective: To analyse the effectiveness and safety of oral antineoplastic drugs (ANEOs) that are authorized in special situations in a third-level hospital and to compare the results obtained with the clinical evidence used for this authorization. Method: Descriptive observational and retrospective study. We included all adult patients who started treatment with ANEO in special situations during the year 2016. We collected demographic, treatment-related and clinical variables (overall survival (OS), progression-free survival (PFS)). Adverse reactions and detected interactions were collected. An unadjusted comparison was made between the results of the available evidence and those of the study patients. Results: 34 patients were treated, 50% were men, the median age was 58 years (38-80) and they presented ECOG 1 in 64.7%. Most of the treated patients were diagnosed with advanced colorectal cancer, treated with trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8-4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients. 26% of patients required dose reduction because of treatment toxicity. We found 13 interactions, which affected 15 patients, only two of category X. Conclusions: The effectiveness of ANEO in special situations in our center is similar to that of available evidence. The impact on survival is low and adverse effects are common (AU)

Use of oral antineoplastic in special situations in a third level hospital: real life results.

OBJECTIVE: To analyse the effectiveness and safety of oral antineoplastic drugs  (ANEOs) that are authorized in special situations in a third-level hospital and to  compare the results obtained with the clinical evidence used for this  authorization. METHOD: Descriptive observational and retrospective study. We included all  adult patients who started treatment with ANEO in special situations during the  year 2016. We collected demographic, treatment-related and clinical variables  (overall survival (OS), progression-free survival (PFS)). Adverse reactions and  detected interactions were collected. An unadjusted comparison was made  between the results of the available evidence and those of the study patients. RESULTS: 34 patients were treated, 50% were men, the median age was 58  years (38-80) and they presented ECOG 1 in 64.7%. Most of the treated  patients were diagnosed with advanced colorectal cancer, treated with  trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results  similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8- 4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients. 26% of patients  required dose reduction because of treatment toxicity. We found 13 interactions,  which affected 15 patients, only two of category X. CONCLUSIONS: The effectiveness of ANEO in special situations in our center is  similar to that of available evidence. The impact on survival is low and adverse  effects are common.

Objetivo: Analizar la efectividad y seguridad de los antineoplásicos orales  (ANEO) autorizados en situaciones especiales en un hospital de tercer nivel y  comparar los resultados obtenidos con los de la evidencia disponible empleada  para autorizar el uso de estos fármacos.Método: Estudio descriptivo observacional y retrospectivo. Se incluyeron todos  los pacientes adultos que iniciaron tratamiento con ANEO en situaciones  especiales durante el año 2016. Se recogieron variables demográficas,  relacionadas con el tratamiento, y clínicas (supervivencia global (SG),  supervivencia libre de progresión (SLP)). Se recogieron reacciones adversas e  interacciones detectadas. Se realizó una comparación no ajustada entre los  resultados de la evidencia disponible y los de los pacientes del estudio.Resultados: Treinta y cuatro pacientes recibieron tratamiento, el 50% eran  hombres, la mediana de edad fue de 58 años (38-80), y presentaron ECOG 1 el  64,7%. La mayoría de los pacientes tratados presentaban diagnóstico de cáncer colorrectal avanzado, tratados con trifluridina-tipiracil, seguidos de  palbociclib en cáncer de mama, obteniendo resultados similares a los de la evidencia. La mediana de SLP fue de 2,8 meses (IC 95% 0,8-4,8) y la SG de 8  meses (IC 95% 3,4-12,5) para todos los pacientes. El 26% de los pacientes  requirieron una reducción de la dosis debido a la toxicidad del tratamiento. Se  encontraron 13 interacciones, que afectaron a 15 pacientes; solo dos de  categoría X.Conclusiones: La efectividad de los ANEO en situaciones especiales en nuestro  centro es similar al de la evidencia disponible. El impacto en la supervivencia es  bajo y los efectos adversos son comunes.