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1.
Am J Gastroenterol ; 118(10): 1821-1828, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37439519

ABSTRACT

INTRODUCTION: Liver biopsy (LB) remains essential for the diagnosis and staging of parenchymal liver diseases. Endoscopic ultrasound-guided LB (EUS-LB) has emerged as an attractive alternative to percutaneous and transjugular routes. We aimed at comparing the adequacy of samples obtained by EUS-LB with percutaneous LB. METHODS: A single-center, randomized, controlled clinical trial was designed. Patients undergoing LB were randomly assigned to EUS-LB or percutaneous LB groups. EUS-LB was performed with a 19-gauge Franseen core needle through a transduodenal and transgastric route. Percutaneous LB was performed with a 16-gauge Tru-Cut needle. The main outcome was the percentage of adequate samples obtained. Secondary outcomes were the percentage of accurate histologic diagnosis, number of complete portal tracts (CPT), total and longest specimen length (TSL and LSL), sample fragmentation, adverse events, and patients' satisfaction. An adequate specimen was defined as TSL ≥20 mm and including ≥11 CPT. RESULTS: Ninety patients were randomized (44 to EUS-LB and 46 to percutaneous LB) and included in the analysis. The percentage of adequate tissue samples was 32.6% and 70.4% for percutaneous LB and EUS-LB, respectively ( P < 0.001). A final histologic diagnosis was provided in all cases but one. TSL was longer after EUS-LB (23.5 vs 17.5 mm, P = 0.01), whereas the number of CPT was similar in both groups. Sample fragmentation occurred more often after EUS-LB ( P < 0.001). No differences in adverse events were found. Satisfaction reported with both procedures was high. DISCUSSION: EUS-LB is safe and accurate and may be considered an alternative to percutaneous LB for the evaluation of parenchymal liver diseases.


Subject(s)
Liver Diseases , Humans , Liver Diseases/diagnosis , Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Prospective Studies , Image-Guided Biopsy
2.
Hepatology ; 67(2): 612-622, 2018 02.
Article in English | MEDLINE | ID: mdl-28898447

ABSTRACT

The clinical benefit of sorafenib in patients with hepatocellular carcinoma (HCC) has been undervalued due to the absence of complete responses, even though patients who develop early dermatologic reactions have shown to have a positive outcome. In addition, sorafenib is described as an antiangiogenic drug, but it also acts on immunological cells. Thus, the goal of this study was to assess the complete response rate in a retrospective cohort of HCC patients treated with sorafenib and to describe the profile of the patients who achieve complete response for identifying factors related to this event and their connection with the immunological profile of sorafenib. Ten Spanish centers submitted cases of complete response under sorafenib. The baseline characteristics, development of early dermatologic reactions, and cause of treatment discontinuation were annotated. Radiological images taken before starting sorafenib, at first control, after starting sorafenib, at the time of complete response, and at least 1 month after treatment were centrally reviewed. Of the 1119 patients studied, 20 had been classified as complete responders by the centers, but eight of these patients were excluded after central review. Ten patients had complete disappearance of all tumor sites, and two had just a small residual fibrotic scar. Thus, 12 patients were classified as complete responders (58% HCV, median age 59.7 years, 83.4% Child-Pugh class A, Eastern Cooperative Oncology Group performance status 0 91.7%, and Barcelona Clinic Liver Cancer stage C 83.3%). The median overall survival and treatment duration were 85.8 and 40.1 months, respectively. All but one patient developed early dermatologic reactions, and seven patients discontinued sorafenib after achieving complete response due to adverse events, patient decision, or liver decompensation. Conclusion: Complete response affects 1% of patients with HCC who are treated with sorafenib. The association of complete response with early dermatologic reactions supports the role of a specific immune/inflammatory patient profile in the improved response to sorafenib. (Hepatology 2018;67:612-622).


Subject(s)
Antineoplastic Agents/therapeutic use , Carcinoma, Hepatocellular/drug therapy , Liver Neoplasms/drug therapy , Skin/drug effects , Sorafenib/therapeutic use , Aged , Carcinoma, Hepatocellular/diagnostic imaging , Carcinoma, Hepatocellular/mortality , Female , Humans , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/mortality , Male , Middle Aged , Retrospective Studies , Sorafenib/adverse effects , alpha-Fetoproteins/analysis
3.
Gastroenterol. hepatol. (Ed. impr.) ; 40(9): 629-640, nov. 2017. graf, tab
Article in Spanish | IBECS | ID: ibc-168193

ABSTRACT

Los fármacos inhibidores de la mTOR, everolimus (EVL) y sirolimus, son inmunosupresores con muy poco efecto nefrotóxico, limitado al desarrollo de proteinuria en algunos casos. En la prevención del rechazo agudo EVL combinado con tacrolimus a dosis reducidas tiene una eficacia y seguridad comparables a la inmunosupresión estándar con tacrolimus. La aplicación temprana de una inmunosupresión basada en EVL con minimización de la exposición al inmunosupresor calcineurínico en trasplantados hepáticos permite mejorar los resultados de la función renal, con tasas similares de eficacia y seguridad, tanto en el período de novo como de mantenimiento. En pacientes con disfunción renal establecida la introducción de EVL permite minimizar la exposición al inmunosupresor calcineurínico, con la consiguiente mejoría en la función renal. Aunque no hay evidencia suficiente para recomendar su uso para prevenir la recurrencia del hepatocarcinoma y la progresión de tumores de novo, es práctica clínica habitual utilizarlos en este contexto (AU)


Mammalian target of rapamycin (mTOR) inhibitors, everolimus (EVL) and sirolimus are immunosuppressive agents with a minor nephrotoxic effect, limited to the development of proteinuria in some cases. The combination of EVL and low-dose tacrolimus has proven to be as safe and effective as standard therapy with tacrolimus for the prevention of acute cellular rejection. Early initiation of EVL-based immunosuppressive regimens with reduced exposure to calcineurin inhibitors has been shown to significantly improve renal function of LT recipients during induction and maintenance phases, with comparable efficacy and safety profiles. In patients with established kidney failure, initiating EVL may enable clinicians to reduce calcineurin inhibitors exposure, thereby contributing to the improved renal function of these patients. Although there is not sufficient evidence to recommend their use to prevent the recurrence of hepatocellular carcinoma and the progression of de novo tumours, they are used in this context in routine clinical practice (AU)


Subject(s)
Humans , Liver Transplantation/methods , Everolimus/therapeutic use , Immunosuppression Therapy/methods , Immunosuppressive Agents/therapeutic use , Graft Rejection/drug therapy , Graft Rejection/prevention & control , Renal Insufficiency/complications , Carcinoma, Hepatocellular/complications , Carcinoma, Hepatocellular/immunology , Prospective Studies
4.
Gastroenterol. hepatol. (Ed. impr.) ; 40(8): 515-524, oct. 2017. tab, graf
Article in English | IBECS | ID: ibc-167371

ABSTRACT

Introduction: The appropriate selection of hepatocellular carcinoma (HCC) patients who are eligible for transarterial chemoembolization (TACE) remains a challenge. The ART score has recently been proposed as a method of identifying patients who are eligible or not for a second TACE procedure. Objective: To assess the validity of the Assessment for Retreatment with TACE (ART) score in a cohort of patients treated with drug-eluting bead TACE (DEB-TACE). Secondary objective: to identify clinical determinants associated with overall survival (OS). Method: A retrospective, multicentre study conducted in Spain in patients with HCC having undergone two or more DEB-TACE procedures between January 2009 and December 2014. The clinical characteristics and OS from the day before the second DEB-TACE of patients with a high ART score (ART≥2.5) and a low ART score (ART 0-1) were compared. Risk factors for mortality were identified using Cox's proportional hazards model. Results: Of the 102 patients included, 51 scored 0-1.5 and 51 scored ≥2.5. Hepatitis C was more frequent in patients scoring ≥2.5. Median OS from the day before the second DEB-TACE was 21 months (95% CI, 15-28) in the group scoring 0-1.5, and 17 months (95% CI, 10-25) in the group scoring ≥2.5 (P=0.3562). Platelet count and tumour size, but not the ART score, were independent baseline predictors of OS. Conclusions: The ART score is not suitable for guiding DEB-TACE retreatment according to Spanish clinical practice standards (AU)


Introducción: La selección de los candidatos ideales con carcinoma hepatocelular (CHC) que más se benefician de realizar quimioembolización transarterial (TACE) sigue siendo un reto. Recientemente se ha propuesto el índice ART para seleccionar a aquellos pacientes tributarios o no de realizar un segundo procedimiento de TACE. Objetivo: Evaluar la validez del índice ART en una cohorte tratada con TACE con partículas cargadas (DEB-TACE). Objetivo secundario: identificar los factores clínicos asociados con la supervivencia global. Método: Estudio retrospectivo multicéntrico español en pacientes con CHC tratados con≥2 DEB-TACE entre enero del 2009 y diciembre del 2014. Se compararon las características clínicas y la supervivencia global desde el día previo a la segunda DEB-TACE entre los pacientes con ART alto (ART≥2,5) y bajo (ART 0-1). Los factores de riesgo de mortalidad se identificaron usando el modelo de riesgos proporcionales de Cox. Resultados: De los 102 pacientes incluidos, 51 obtuvieron puntuación de 0-1,5 y 51 ≥ 2,5. La hepatitis C fue más frecuente en pacientes con puntuación ≥ 2,5. La supervivencia global mediana desde el día previo a DEB-TACE-2 fue de 21 meses (IC del 95%, 15-28) y de 17 meses (IC del 95%, 10-25) en los pacientes con ART 0-1,5 y ≥ 2,5, respectivamente (p=0,3562). Los factores basales predictores independientes de supervivencia fueron el recuento de plaquetas y el tamaño del tumor, pero no el índice ART. Conclusiones: El índice ART no es adecuado para guiar el retratamiento con DEB-TACE según los estándares de práctica clínica español (AU)


Subject(s)
Humans , Carcinoma, Hepatocellular/therapy , Liver Neoplasms/therapy , Chemoembolization, Therapeutic , Risk Adjustment/methods , Patient Selection , Reproducibility of Results , Risk Factors , Survival Analysis , Retrospective Studies , Neoplasm Staging
5.
Gastroenterol Hepatol ; 40(9): 629-640, 2017 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-28743539

ABSTRACT

Mammalian target of rapamycin (mTOR) inhibitors, everolimus (EVL) and sirolimus are immunosuppressive agents with a minor nephrotoxic effect, limited to the development of proteinuria in some cases. The combination of EVL and low-dose tacrolimus has proven to be as safe and effective as standard therapy with tacrolimus for the prevention of acute cellular rejection. Early initiation of EVL-based immunosuppressive regimens with reduced exposure to calcineurin inhibitors has been shown to significantly improve renal function of LT recipients during induction and maintenance phases, with comparable efficacy and safety profiles. In patients with established kidney failure, initiating EVL may enable clinicians to reduce calcineurin inhibitors exposure, thereby contributing to the improved renal function of these patients. Although there is not sufficient evidence to recommend their use to prevent the recurrence of hepatocellular carcinoma and the progression of de novo tumours, they are used in this context in routine clinical practice.


Subject(s)
Everolimus/therapeutic use , Immunosuppressive Agents/therapeutic use , Liver Transplantation , Everolimus/adverse effects , Graft Rejection/prevention & control , Humans , Immunosuppressive Agents/adverse effects , Kidney Diseases/chemically induced , Kidney Diseases/prevention & control , Postoperative Complications/chemically induced , Postoperative Complications/prevention & control , Practice Guidelines as Topic
6.
Gastroenterol Hepatol ; 40(8): 515-524, 2017 Oct.
Article in English, Spanish | MEDLINE | ID: mdl-28676199

ABSTRACT

INTRODUCTION: The appropriate selection of hepatocellular carcinoma (HCC) patients who are eligible for transarterial chemoembolization (TACE) remains a challenge. The ART score has recently been proposed as a method of identifying patients who are eligible or not for a second TACE procedure. OBJECTIVE: To assess the validity of the Assessment for Retreatment with TACE (ART) score in a cohort of patients treated with drug-eluting bead TACE (DEB-TACE). SECONDARY OBJECTIVE: to identify clinical determinants associated with overall survival (OS). METHOD: A retrospective, multicentre study conducted in Spain in patients with HCC having undergone two or more DEB-TACE procedures between January 2009 and December 2014. The clinical characteristics and OS from the day before the second DEB-TACE of patients with a high ART score (ART≥2.5) and a low ART score (ART 0-1) were compared. Risk factors for mortality were identified using Cox's proportional hazards model. RESULTS: Of the 102 patients included, 51 scored 0-1.5 and 51 scored ≥2.5. Hepatitis C was more frequent in patients scoring ≥2.5. Median OS from the day before the second DEB-TACE was 21 months (95% CI, 15-28) in the group scoring 0-1.5, and 17 months (95% CI, 10-25) in the group scoring ≥2.5 (P=0.3562). Platelet count and tumour size, but not the ART score, were independent baseline predictors of OS. CONCLUSIONS: The ART score is not suitable for guiding DEB-TACE retreatment according to Spanish clinical practice standards.


Subject(s)
Carcinoma, Hepatocellular/therapy , Chemoembolization, Therapeutic/methods , Liver Neoplasms/therapy , Patient Selection , Severity of Illness Index , Aged , Carcinoma, Hepatocellular/epidemiology , Carcinoma, Hepatocellular/mortality , Chemoembolization, Therapeutic/adverse effects , Comorbidity , Drug Implants , Female , Hepatic Artery , Hepatitis C, Chronic/epidemiology , Humans , Kaplan-Meier Estimate , Liver Cirrhosis, Alcoholic/epidemiology , Liver Function Tests , Liver Neoplasms/epidemiology , Liver Neoplasms/mortality , Male , Microspheres , Middle Aged , Prognosis , Proportional Hazards Models , Retrospective Studies , Treatment Outcome
7.
Med. clín (Ed. impr.) ; 149(2): 61-71, jul. 2017. tab, graf
Article in Spanish | IBECS | ID: ibc-164729

ABSTRACT

Antecedentes y objetivo: En 2010 publicamos que en España el 53% de los carcinomas hepatocelulares (CHC) se diagnostican fuera de programas de cribado, lo que conlleva una menor supervivencia. El objetivo del presente estudio es evaluar la situación actual y las causas del diagnóstico fuera de cribado. Material y métodos: Registro prospectivo entre el 1 de octubre de 2014 y el 31 de enero de 2015 en 73 centros asistenciales españoles de segundo/tercer nivel. Se registraron las características basales y el primer tratamiento de los tumores primarios hepáticos incidentales de ese período. Resultados: Se incluyeron 720 pacientes: CHC (n=686), colangiocarcinoma intrahepático (n=29), hepatocolangiocarcinoma (n=2), otros (n=3). Los pacientes con CHC fueron varones en el 82% de los casos; media de 67 años; cirrosis en el 87%; etiología: alcohol 35%, VHC 30%, alcohol y VHC 15%, enfermedad hepática por depósito de grasa 6%; estadio tumoral: BCLC-0 11%, A 43%, B 19%, C 16% y D 11%; tratamiento inicial: quimioembolización transarterial (23%), ablación percutánea (22%), tratamiento sintomático (20%), resección (11%), sorafenib (11%). Se diagnosticaron fuera de cribado 356 pacientes (53%). Los motivos principales fueron la ausencia de diagnóstico previo de hepatopatía (76%) y la mala adherencia al cribado (18%). Estos pacientes eran predominantemente varones (p<0,001), de etiología alcohólica (p<0,001), con consumo activo de alcohol (p<0,001) y se diagnosticaron en estadios más avanzados (p<0,001), recibiendo menos tratamientos radicales (p<0,001). Conclusiones: En España, la principal causa del diagnóstico de CHC fuera del cribado es la ausencia de diagnóstico previo de enfermedad hepática, principalmente en varones con consumo de alcohol. La detección de hepatopatía en población asintomática y la mejora de la adherencia al cribado son los principales aspectos para mejorar la detección precoz (AU)


Background and objective: In 2010 we published that 53% of cases of hepatocellular carcinoma (HCC) detected in Spain were diagnosed outside the context of standard screening programs, which consequently leads to lower survival rates. The aim of this study was to analyze the current situation and the causes of diagnosis out of screening programs. Material and methods: Prospective registry of 73 second- and third-level Spanish healthcare centers carried out between October 1, 2014 and January 31, 2015. The baseline characteristics of the disease and the first treatment administered for the incidental primary liver tumors during such period were recorded. Results: A total of 720 patients were included in the study: HCC (n=686), intrahepatic cholangiocarcinoma (n=29), hepatic cholangiocarcinoma (n=2), other (n=3). HCC characteristics: male 82%; mean age 67 years; cirrhosis 87%; main etiologies: alcohol 35%, HCV 30%, alcohol and HCV 15%, non-alcoholic fatty liver disease 6%; tumor stage: BCLC-0 11%, A 43%, B 19%, C 16% and D 11%; first treatment: transarterial chemoembolization (23%), percutaneous ablation (22%), symptomatic treatment (20%), resection (11%), sorafenib (11%). Three hundred and fifty-six patients (53%) were diagnosed outside of screening programs, mainly owing to the fact that they suffered from an undiagnosed liver disease (76%) and to the poor adherence to the screening program (18%). These patients were mainly male (P<.001), with an alcoholic etiology (P<.001) and active alcohol consumption (P<.001). Moreover, the disease was predominantly diagnosed at more advanced stages (P<.001) and was addressed with less radical treatments (P<.001). Conclusions: In Spain, the main cause of diagnosis of a HCC outside the context of a screening program is the absence of a prior diagnosis of a liver disease, particularly in alcohol-consuming men. Detecting a liver disease in asymptomatic populations and improving adherence to screening programs are the main areas that must be subject to improvement in order to improve the early detection of HCC (AU)


Subject(s)
Humans , Carcinoma, Hepatocellular/epidemiology , Liver Neoplasms/epidemiology , Cholangiocarcinoma/epidemiology , Early Detection of Cancer/statistics & numerical data , Prospective Studies , Mass Screening/statistics & numerical data , Incidence , Neoplasm Staging/statistics & numerical data , Practice Patterns, Physicians'
8.
Med Clin (Barc) ; 149(2): 61-71, 2017 Jul 21.
Article in English, Spanish | MEDLINE | ID: mdl-28279536

ABSTRACT

BACKGROUND AND OBJECTIVE: In 2010 we published that 53% of cases of hepatocellular carcinoma (HCC) detected in Spain were diagnosed outside the context of standard screening programs, which consequently leads to lower survival rates. The aim of this study was to analyze the current situation and the causes of diagnosis out of screening programs. MATERIAL AND METHODS: Prospective registry of 73 second- and third-level Spanish healthcare centers carried out between October 1, 2014 and January 31, 2015. The baseline characteristics of the disease and the first treatment administered for the incidental primary liver tumors during such period were recorded. RESULTS: A total of 720 patients were included in the study: HCC (n=686), intrahepatic cholangiocarcinoma (n=29), hepatic cholangiocarcinoma (n=2), other (n=3). HCC characteristics: male 82%; mean age 67 years; cirrhosis 87%; main etiologies: alcohol 35%, HCV 30%, alcohol and HCV 15%, non-alcoholic fatty liver disease 6%; tumor stage: BCLC-0 11%, A 43%, B 19%, C 16% and D 11%; first treatment: transarterial chemoembolization (23%), percutaneous ablation (22%), symptomatic treatment (20%), resection (11%), sorafenib (11%). Three hundred and fifty-six patients (53%) were diagnosed outside of screening programs, mainly owing to the fact that they suffered from an undiagnosed liver disease (76%) and to the poor adherence to the screening program (18%). These patients were mainly male (P<.001), with an alcoholic etiology (P<.001) and active alcohol consumption (P<.001). Moreover, the disease was predominantly diagnosed at more advanced stages (P<.001) and was addressed with less radical treatments (P<.001). CONCLUSIONS: In Spain, the main cause of diagnosis of a HCC outside the context of a screening program is the absence of a prior diagnosis of a liver disease, particularly in alcohol-consuming men. Detecting a liver disease in asymptomatic populations and improving adherence to screening programs are the main areas that must be subject to improvement in order to improve the early detection of HCC.


Subject(s)
Carcinoma, Hepatocellular/diagnosis , Early Detection of Cancer , Liver Neoplasms/diagnosis , Adult , Aged , Aged, 80 and over , Carcinoma, Hepatocellular/etiology , Carcinoma, Hepatocellular/therapy , Female , Guideline Adherence/statistics & numerical data , Humans , Liver Neoplasms/etiology , Liver Neoplasms/therapy , Male , Middle Aged , Practice Guidelines as Topic , Practice Patterns, Physicians'/statistics & numerical data , Prospective Studies , Spain
9.
Liver Transpl ; 21(8): 1056-65, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25990257

ABSTRACT

A national, multicenter, retrospective study was conducted to assess the results obtained for liver transplant recipients with conversion to everolimus in daily practice. The study included 477 recipients (481 transplantations). Indications for conversion to everolimus were renal dysfunction (32.6% of cases), hepatocellular carcinoma (HCC; 30.2%; prophylactic treatment for 68.9%), and de novo malignancy (29.7%). The median time from transplantation to conversion to everolimus was 68.7 months for de novo malignancy, 23.8 months for renal dysfunction, and 7.1 months for HCC and other indications. During the first year of treatment, mean everolimus trough levels were 5.4 (standard deviation [SD], 2.7) ng/mL and doses remained stable (1.5 mg/day) from the first month after conversion. An everolimus monotherapy regimen was followed by 28.5% of patients at 12 months. Patients with renal dysfunction showed a glomerular filtration rate (4-variable Modification of Diet in Renal Disease) increase of 10.9 mL (baseline mean, 45.8 [SD, 25.3] versus 57.6 [SD, 27.6] mL/minute/1.73 m(2) ) at 3 months after everolimus initiation (P < 0.001), and 6.8 mL at 12 months. Improvement in renal function was higher in patients with early conversion (<1 year). Adverse events were the primary reason for discontinuation in 11.2% of cases. The probability of survival at 3 years after conversion to everolimus was 83.0%, 71.1%, and 59.5% for the renal dysfunction, de novo malignancy, and HCC groups, respectively. Everolimus is a viable option for the treatment of renal dysfunction, and earlier conversion is associated with better recovery of renal function. Prospective studies are needed to confirm advantages in patients with malignancy.


Subject(s)
Drug Substitution , Everolimus/administration & dosage , Graft Rejection/prevention & control , Immunosuppressive Agents/administration & dosage , Kidney/drug effects , Liver Transplantation , Adolescent , Adult , Aged , Child , Drug Monitoring , Everolimus/adverse effects , Everolimus/blood , Female , Glomerular Filtration Rate/drug effects , Graft Rejection/immunology , Graft Survival/drug effects , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/blood , Kidney/physiopathology , Liver Transplantation/adverse effects , Liver Transplantation/mortality , Male , Middle Aged , Recovery of Function , Retrospective Studies , Risk Factors , Spain , Time Factors , Treatment Outcome , Young Adult
10.
Gastroenterol. hepatol. (Ed. impr.) ; 38(4): 263-273, abr. 2015. ilus, tab
Article in Spanish | IBECS | ID: ibc-135140

ABSTRACT

INTRODUCCIÓN: GIDEON es un estudio internacional prospectivo, no intervencionista, que evaluó la seguridad de sorafenib en pacientes con carcinoma hepatocelular (CHC) no resecable en la práctica clínica diaria, incluidos pacientes Child-Pugh B. OBJETIVOS: Análisis de datos recogidos en España sobre seguridad y efectividad de sorafenib y los patrones de tratamiento. Métodos Se recogieron los datos demográficos y de la enfermedad, la dosis inicial usada, los acontecimientos adversos emergentes del tratamiento (AA) y las modificaciones de dosis a lo largo del seguimiento. Se valoraron la supervivencia global y el tiempo hasta la progresión de la enfermedad. La eficacia y la seguridad se analizaron en función de la clasificación Child-Pugh y la dosis inicial. RESULTADOS: Se incluyó a 143 pacientes de 19 hospitales españoles. El 24,5% eran pacientes Child-Pugh B. El 90,9% de los pacientes recibió una dosis inicial de 400 mg/12 h. En pacientes Child-Pugh A se modificó más frecuentemente la dosis y la duración del tratamiento fue más larga. La incidencia de AA y de aquellos relacionados con el fármaco fue similar en los pacientes Child-Pugh A y B, aunque los AA graves fueron más frecuentes en los pacientes Child-Pugh B. Los más frecuentes fueron diarrea, fatiga y eritrodisestesia palmo-plantar. La mediana de supervivencia global fue de 384 días, y superior en pacientes Child-Pugh A (593 vs. 211 días en Child-Pugh B); la mediana hasta la progresión de la enfermedad fue de 177 días, similar en ambos subgrupos. CONCLUSIÓN: El perfil de seguridad de sorafenib en pacientes españoles con CHC no resecable es independiente de la función hepática. El estado Child-Pugh no parece influir en el enfoque de dosificación de sorafenib ni en el tiempo hasta la progresión, pero sí parece ser un fuerte predictor de la supervivencia


INTRODUCTION: GIDEON is a non-interventional, prospective, international study that evaluated the safety of sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in daily clinical practice, including Child-Pugh B patients. OBJECTIVES: To analyze data collected in Spain on the safety and efficacy of sorafenib and treatment patterns. Methods Data were collected during follow-up on demographic and disease characteristics, the initial dose used, treatment-emergent adverse events (AEs) and dose modifications. Overall survival was evaluated, as well as time to disease progression. Efficacy and safety were analyzed according to the Child-Pugh classification and the initial dose. RESULTS: We included 143 patients from 19 Spanish hospitals. A total of 24.5% of the patients were Child-Pugh B. An initial dose of 400 mg/12 h was used in 90.9% of patients. In Child-Pugh A patients, dose modifications occurred more frequently and the treatment duration was longer. The incidence of AEs and drug-related AEs were similar in Child-Pugh A and B patients, although serious AEs were more frequent in Child-Pugh B patients. The most common AEs were diarrhea, fatigue and hand-foot skin reactions. The median overall survival was 384 days and was higher in Child-Pugh A patients (593 vs 211 days in Child-Pugh B). The median time to disease progression was 177 days, similar in both subgroups. CONCLUSION: The safety profile of sorafenib in Spanish patients with unresectable HCC is independent of liver function. Child-Pugh status does not seem to influence the approach to sorafenib dosage or time to progression but does seem to be a strong prognostic factor for survival


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Carcinoma, Hepatocellular/drug therapy , Liver Neoplasms/drug therapy , /administration & dosage , Patient Safety , Antineoplastic Agents/therapeutic use , Prospective Studies , Disease Progression
11.
Gastroenterol Hepatol ; 38(4): 263-73, 2015 Apr.
Article in Spanish | MEDLINE | ID: mdl-25583146

ABSTRACT

INTRODUCTION: GIDEON is a non-interventional, prospective, international study that evaluated the safety of sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in daily clinical practice, including Child-Pugh B patients. OBJECTIVES: To analyze data collected in Spain on the safety and efficacy of sorafenib and treatment patterns. METHODS: Data were collected during follow-up on demographic and disease characteristics, the initial dose used, treatment-emergent adverse events (AEs) and dose modifications. Overall survival was evaluated, as well as time to disease progression. Efficacy and safety were analyzed according to the Child-Pugh classification and the initial dose. RESULTS: We included 143 patients from 19 Spanish hospitals. A total of 24.5% of the patients were Child-Pugh B. An initial dose of 400 mg/12 h was used in 90.9% of patients. In Child-Pugh A patients, dose modifications occurred more frequently and the treatment duration was longer. The incidence of AEs and drug-related AEs were similar in Child-Pugh A and B patients, although serious AEs were more frequent in Child-Pugh B patients. The most common AEs were diarrhea, fatigue and hand-foot skin reactions. The median overall survival was 384 days and was higher in Child-Pugh A patients (593 vs. 211 days in Child-Pugh B). The median time to disease progression was 177 days, similar in both subgroups. CONCLUSION: The safety profile of sorafenib in Spanish patients with unresectable HCC is independent of liver function. Child-Pugh status does not seem to influence the approach to sorafenib dosage or time to progression but does seem to be a strong prognostic factor for survival.


Subject(s)
Antineoplastic Agents/therapeutic use , Carcinoma, Hepatocellular/drug therapy , Liver Neoplasms/drug therapy , Niacinamide/analogs & derivatives , Phenylurea Compounds/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Carcinoma, Hepatocellular/therapy , Combined Modality Therapy , Diarrhea/chemically induced , Disease Progression , Disease-Free Survival , Dose-Response Relationship, Drug , Fatigue/chemically induced , Female , Hand-Foot Syndrome/etiology , Humans , Liver Neoplasms/therapy , Male , Middle Aged , Niacinamide/adverse effects , Niacinamide/therapeutic use , Phenylurea Compounds/adverse effects , Prospective Studies , Protein Kinase Inhibitors/adverse effects , Salvage Therapy , Severity of Illness Index , Sorafenib , Spain , Treatment Outcome
13.
Gastroenterol Hepatol ; 37 Suppl 2: 51-4, 2014 Jul.
Article in Spanish | MEDLINE | ID: mdl-25087712

ABSTRACT

Although active immunization against the hepatitis B virus (HBV) through vaccination constitutes a fundamental strategy in the prevention of infection by this virus, it is not effective in isolation for preventing de novo HBV infections in recipients of liver grafts from core antigen antibody (anti-HBc) positive donors. In this situation, the risk of developing de novo hepatitis B depends on the recipient's serological status. It has been shown that, for vaccinated patients and in the absence of prophylaxis with nucleoside/nucleotide analogues and/or hyperimmune gamma globulin, the prevalence and cumulative incidence of HBV infection after transplantation is an intermediate risk. The absence of a surface antigen antibody (anti-HBs) titer cutoff considered protective, the gradual reduction of these titers after vaccination, the presence of false positives for anti-HBs in patients undergoing infusion of blood products and escape mutations of the hepatitis B surface antigen (HBsAg) could explain this lack of efficacy. For this reason, it is recommended that vaccination protocols be implemented universally, along with the follow-up of the level of protection in patients with cirrhosis, adding prophylaxis with analogues when receiving a graft from an anti-HBc-positive donor. Clinical and serological surveillance alone can be considered for patients with anti-HBs levels greater than 200 mUI/mL after vaccination.


Subject(s)
Hepatitis B, Chronic/etiology , Hepatitis B, Chronic/prevention & control , Liver Transplantation/adverse effects , Hepatitis B Core Antigens/blood , Hepatitis B Vaccines , Humans , Practice Guidelines as Topic , Tissue Donors
14.
Gastroenterol. hepatol. (Ed. impr.) ; 37(supl.2): 51-54, jul. 2014. graf
Article in Spanish | IBECS | ID: ibc-137582

ABSTRACT

Aunque la inmunización activa frente al virus de la hepatitis B (VHB) mediante la vacunación constituye una estrategia fundamental en la prevención de la infección por este virus, no resulta eficaz, de forma aislada, para la prevención de la infección por VHB de novo en receptores de un injerto hepático proveniente de un donante con positividad para el anticuerpo contra el antígeno del core (anti-HBc). En esta situación, el riesgo de desarrollar hepatitis B de novo depende del estatus serológico del receptor, y se ha comprobado que en vacunados, y en ausencia de profilaxis con análogos de nucleót(s) idos y/o gammaglobulina hiperinmune, la prevalencia y la incidencia acumuladas de la infección por VHB postrasplante los sitúan en una posición de riesgo intermedio. La ausencia de un punto de corte de títulos de anticuerpos contra el antígeno de superficie (anti-HBs) considerado protector, la disminución paulatina de estos títulos tras la vacunación, la presencia de falsos positivos para anti-HBs en sujetos sometidos a infusión de hemoderivados y mutaciones de escape del antígeno de superficie de la hepatitis B (HBsAg) podrían explicar esta ausencia de eficacia. Por este motivo, se recomienda la aplicación universal de los protocolos de vacunación y seguimiento del nivel de protección en los pacientes cirróticos, añadiendo profilaxis con análogos en caso de recibir un injerto proveniente de un donante anti-HBc positivo, y pudiendo considerarse únicamente vigilancia clínica y serológica en aquellos sujetos con niveles de anti-HBs superiores a 200 mUI/ml tras la vacunación


Although active immunization against the hepatitis B virus (HBV) through vaccination constitutes a fundamental strategy in the prevention of infection by this virus, it is not effective in isolation for preventing de novo HBV infections in recipients of liver grafts from core antigen antibody (anti-HBc) positive donors. In this situation, the risk of developing de novo hepatitis B depends on the recipient’s serological status. It has been shown that, for vaccinated patients and in the absence of prophylaxis with nucleoside/nucleotide analogues and/or hyperimmune gamma globulin, the prevalence and cumulative incidence of HBV infection after transplantation is an intermediate risk. The absence of a surface antigen antibody (anti-HBs) titer cutoff considered protective, the gradual reduction of these titers after vaccination, the presence of false positives for anti-HBs in patients undergoing infusion of blood products and escape mutations of the hepatitis B surface antigen (HBsAg) could explain this lack of efficacy. For this reason, it is recommended that vaccination protocols be implemented universally, along with the follow-up of the level of protection in patients with cirrhosis, adding prophylaxis with analogues when receiving a graft from an anti-HBc-positive donor. Clinical and serological surveillance alone can be considered for patients with anti-HBs levels greater than 200 mUI/mL after vaccination


Subject(s)
Adult , Female , Humans , Male , Hepatitis B/diagnosis , Hepatitis B/drug therapy , Hepatitis B/therapy , Hepatitis B , Hepatitis B/immunology
16.
Rev Esp Enferm Dig ; 105(2): 110-2, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23659512

ABSTRACT

Percutaneous ablation procedures are minimally invasive treatments for unresectable early stage hepatocellular carcinoma (HCC). These techniques are usually safe, but rare and even fatal complications have been described. We present a fatal result after percutaneous ethanol injection (PEI) for the treatment of a recurrent HCC in a non-cirrhotic liver, with subsequent development of diffuse cholangitis and multiple liver abscesses. Although percutaneous drainage and intensive antibiotic treatment were employed, the patient finally died. We discuss about the etiology and the physiopathology of this rare complication in which the therapeutic options are limited and usually unsuccessful.


Subject(s)
Ablation Techniques/adverse effects , Carcinoma, Hepatocellular/therapy , Cholangitis/etiology , Ethanol/administration & dosage , Liver Abscess/etiology , Liver Neoplasms/therapy , Neoplasm Recurrence, Local/therapy , Ablation Techniques/methods , Aged , Fatal Outcome , Humans , Injections, Intralesional , Liver Abscess/pathology , Male
17.
Rev. esp. enferm. dig ; 105(2): 110-112, feb. 2013. ilus
Article in English | IBECS | ID: ibc-112771

ABSTRACT

Percutaneous ablation procedures are minimally invasive treatments for unresectable early stage hepatocellular carcinoma (HCC). These techniques are usually safe, but rare and even fatal complications have been described. We present a fatal result after percutaneous ethanol injection (PEI) for the treatment of a recurrent HCC in a non-cirrhotic liver, with subsequent development of diffuse cholangitis and multiple liver abscesses. Although percutaneous drainage and intensive antibiotic treatment were employed, the patient finally died. We discuss about the etiology and the physiopathology of this rare complication in which the therapeutic options are limited and usually unsuccessful(AU)


Subject(s)
Humans , Female , Middle Aged , Cholangitis/chemically induced , Cholangitis/complications , Cholangitis/diagnosis , Ethanol/therapeutic use , Carcinoma, Hepatocellular/complications , Carcinoma, Hepatocellular/diagnosis , Antibiotic Prophylaxis/methods , Antibiotic Prophylaxis , Cholangitis/surgery , Cholangitis , Carcinoma, Hepatocellular , Hepatectomy , Abscess/physiopathology , Abscess , Magnetic Resonance Imaging/methods , Magnetic Resonance Imaging/trends , Magnetic Resonance Imaging
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