RESUMO
Purpose Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related QoL. Methods The NETTER-1 trial is an international phase III study in patients with midgut NETs. Patients were randomly assigned to treatment with 177Lu-Dotatate versus high-dose octreotide. European Organisation for Research and Treatment of Cancer quality-of-life questionnaires QLQ C-30 and G.I.NET-21 were assessed during the trial to determine the impact of treatment on health-related QoL. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. QoL scores were converted to a 100-point scale according to European Organisation for Research and Treatment of Cancer instructions, and individual changes from baseline scores were assessed. Time to QoL deterioration (TTD) was defined as the time from random assignment to the first QoL deterioration ≥ 10 points for each patient in the corresponding domain scale. All analyses were conducted on the intention-to-treat population. Patients with no deterioration were censored at the last QoL assessment date. Results TTD was significantly longer in the 177Lu-Dotatate arm (n = 117) versus the control arm (n = 114) for the following domains: global health status (hazard ratio [HR], 0.406), physical functioning (HR, 0.518), role functioning (HR, 0.580), fatigue (HR, 0.621), pain (HR, 0.566), diarrhea (HR, 0.473), disease-related worries (HR, 0.572), and body image (HR, 0.425). Differences in median TTD were clinically significant in several domains: 28.8 months versus 6.1 months for global health status, and 25.2 months versus 11.5 months for physical functioning. Conclusion This analysis from the NETTER-1 phase III study demonstrates that, in addition to improving progression-free survival, 177Lu-Dotatate provides a significant QoL benefit for patients with progressive midgut NETs compared with high-dose octreotide.
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Tumores Neuroendócrinos/tratamento farmacológico , Octreotida/análogos & derivados , Compostos Organometálicos/uso terapêutico , Qualidade de Vida , Humanos , Octreotida/uso terapêutico , Inquéritos e QuestionáriosRESUMO
BACKGROUND AND OBJECTIVE: Abdominal hyperpressure developed during laparoscopic cholecystectomy by the effect of pneumoperitoneum represents an obstacle to the venous return that may facilitate thromboembolic complications. The aim of this study was to establish the effect of pneumoperitoneum in venous hemodynamics during laparoscopy. PATIENTS AND METHOD: Prospective study of 31 consecutive patients who underwent laparoscopic cholecystectomy. Venous occlusion plethysmography was performed preoperatively, after anaesthetic induction, after insufflation, before pneumoperitoneum release and at the end of surgery. Changes of plethysmography were compared with preoperative values and according to age, obesity, presence of varicose veins and pneumoperitoneum time. Bilateral lower limb venous Duplex scanning was performed at days 1, 7 and 30 to detect deep venous thrombosis (DVT). RESULTS: Average age was 56 years, 66.6% females, 40% obese, 16% with varicose veins and the pneumoperitoneum time was < 45 min in 22.5% patients. Capacitance decreased progressively during surgery and was significantly reduced with pneumoperitoneum. The maximum venous outflow in the first second was reduced significantly at the end of pneumoperitoneum. These reductions were more evident in older patients. CONCLUSIONS: Pneumoperitoneum produces plethysmographic changes on venous hemodynamics with a diminished venous return in lower limbs. Older patients have higher risk of thromboembolic complications, while obesity can also increase this risk. However, no DVT was demonstrated in this study.
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Colecistectomia Laparoscópica , Hemodinâmica , Pneumoperitônio Artificial , Complicações Pós-Operatórias/epidemiologia , Tromboembolia/epidemiologia , Fatores Etários , Colecistectomia Laparoscópica/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade , Pletismografia , Pneumoperitônio Artificial/efeitos adversos , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Trombose Venosa/epidemiologiaRESUMO
FUNDAMENTO Y OBJETIVO: La hiperpresión abdominal creada durante la cirugía por vía laparoscópica por el efecto del neumoperitoneo produce un obstáculo al retorno venoso que podría ser causa de complicaciones tromboembólicas. El objetivo de este estudio es establecer el efecto del neumoperitoneo en la hemodinámica venosa durante las colecistectomías laparoscópicas y su variación en relación con la edad, obesidad, presencia de venas varicosas y duración del neumoperitoneo.PACIENTES Y MÉTODO: Estudio prospectivo de 31 pacientes consecutivos operados electivamente de colecistectomía laparoscópica. Se realizó pletismografía venosa de oclusión preoperatoriamente (control), después de la inducción anestésica, después de la realización del neumoperitoneo, antes de retirar el neumoperitoneo y al final de la cirugía. Los cambios en la pletismografía fueron comparados con el control y relacionados con la edad, presencia de obesidad, varices y tiempo de neumoperitoneo. Se practicó una ecografía venosa dúplex bilateral en los miembros inferiores en los días postoperatorios 1, 7 y 30 para detectar trombosis venosa profunda (TVP).RESULTADOS: La edad media fue de 56 años, un 66,6 por ciento eran mujeres y el 33 por ciento, varones. Un 40 por ciento eran obesos, el 16 por ciento tenían varices y el tiempo de peritoneo fue de 45 min o inferior en el 22,5 por ciento. La capacitancia presenta una disminución progresiva durante la cirugía y se reduce significativamente con el neumoperitoneo. El flujo venoso máximo en el primer segundo (MVO1) se reduce significativamente antes de retirar el neumoperitoneo y al final de la cirugía.Estas reducciones son significativamente más evidentes en pacientes de más edad.CONCLUSIONES: El neumoperitoneo produce cambios hemodinámicos similares a aquellos relacionados con la TVP. Los pacientes de más edad son los que presentan más alteraciones y podrían tener más complicaciones tromboembólicas. La obesidad puede incrementar el riesgo de esta complicación. Sin embargo, no se ha demostrado ninguna TVP. (AU)
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Pessoa de Meia-Idade , Masculino , Feminino , Humanos , Colecistectomia Laparoscópica , Pneumoperitônio Artificial , Hemodinâmica , Fatores de Risco , Fatores de Tempo , Tromboembolia , Pletismografia , Complicações Pós-Operatórias , Obesidade , Estudos Prospectivos , Trombose Venosa , Fatores EtáriosRESUMO
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