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1.
Ann Surg Oncol ; 28(8): 4647-4654, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33389293

RESUMO

BACKGROUND: The PERISCOPE I study was designed to assess the safety and feasibility of (sub)total gastrectomy, cytoreductive surgery (CRS), and hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin and docetaxel for gastric cancer patients who have limited peritoneal dissemination. The current analysis investigated changes in perioperative management together with their impact on postoperative outcomes. METHODS: Patients with resectable gastric cancer and limited peritoneal dissemination were administered (sub)total gastrectomy, CRS, and HIPEC with oxaliplatin (460 mg/m2) and docetaxel (escalating scheme: 0, 50, 75 mg/m2). Of the 25 patients who completed the study protocol, 14 were treated in the dose-escalation cohort and 11 were treated in the expansion cohort (to optimize perioperative management). RESULTS: A significant proportion of the patients in the dose-escalation cohort (n = 7, 50%) had ileus-related complications. In this cohort, enteral nutrition was started immediately after surgery at 20 ml/h, which was increased on day 1 to meet nutritional needs. In the expansion cohort, enteral nutrition was administered at 10 ml/h until day 3, then restricted to 20 ml/h until day 6, supplemented with total parenteral nutrition to meet nutritional needs. Ileus-related complications occurred for two patients (18%) of the expansion cohort. The intensive care unit (ICU) readmission rate decreased from 50 (n = 7) to 9% (n = 1; p = 0.04). CONCLUSION: The implementation of a strict nutritional protocol during the PERISCOPE I study was associated with a decrease in postoperative complications. Based on these results, a perioperative care path was described for the gastric cancer HIPEC patients in the PERISCOPE II study.


Assuntos
Hipertermia Induzida , Neoplasias Peritoneais , Neoplasias Gástricas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia Combinada , Procedimentos Cirúrgicos de Citorredução , Gastrectomia , Humanos , Quimioterapia Intraperitoneal Hipertérmica , Neoplasias Peritoneais/cirurgia , Neoplasias Gástricas/terapia
2.
Br J Surg ; 107(11): 1520-1528, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32277764

RESUMO

BACKGROUND: The role of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in gastric cancer is unknown. This non-randomized dose-finding phase I-II study was designed to assess the safety and feasibility of HIPEC, following systemic chemotherapy, in patients with gastric cancer and limited peritoneal dissemination. The maximum tolerated dose of normothermic intraperitoneal docetaxel in combination with a fixed dose of intraperitoneal oxaliplatin was also explored. METHODS: Patients with resectable cT3-cT4a gastric adenocarcinoma with limited peritoneal metastases and/or tumour-positive peritoneal cytology were included. An open HIPEC technique was used with 460 mg/m2 hyperthermic oxaliplatin for 30 min followed by normothermic docetaxel for 90 min in escalating doses (0, 50, 75 mg/m2 ). RESULTS: Between 2014 and 2017, 37 patients were included. Of 25 patients who completed the full study protocol, four were treated at dose level 1 (0 mg/m2 docetaxel), six at dose level 2 (50 mg/m2 ) and four at dose level 3 (75 mg/m2 ). At dose level 3, two dose-limiting toxicities occurred, both associated with postoperative ileus. Thereafter, another 11 patients were treated at dose level 2, with no more dose-limiting toxicities. Based on this, the maximum tolerated dose was 50 mg/m2 intraperitoneal docetaxel. Serious adverse events were scored in 17 of 25 patients. The reoperation rate was 16 per cent (4 of 25) and the treatment-related mortality rate was 8 per cent (2 patients, both in dose level 3). CONCLUSION: Gastrectomy combined with cytoreductive surgery and HIPEC was feasible using 460 mg/m2 oxaliplatin and 50 mg/m2 normothermic docetaxel.


ANTECEDENTES: El papel de la cirugía citorreductora (cytoreductive surgery, CRS) combinado con la quimioterapia intraperitoneal hipertérmica (hyperthermic intraperitoneal chemotherapy, HIPEC) en el cáncer gástrico no está definido. Este estudio fase I-II no aleatorizado de escalado de dosis fue diseñado para evaluar la seguridad y la viabilidad de HIPEC, después de la quimioterapia sistémica, en pacientes con cáncer gástrico con diseminación peritoneal limitada. Además, se exploró la máxima dosis tolerada (maximum tolerated dose, MTD) de docetaxel intraperitoneal normotérmico en combinación con una dosis fija de oxaliplatino intraperitoneal. MÉTODOS: Se incluyeron pacientes con adenocarcinoma gástrico cT3-cT4a resecable con metástasis peritoneales limitadas y/o citología peritoneal positiva. Se utilizó una técnica HIPEC abierta con 460 mg/m2 de oxaliplatino hipertérmico (30 minutos) seguido de docetaxel normotérmico (90 minutos) en dosis crecientes (0, 50, 75 mg/m2 ). RESULTADOS: Entre 2014 y 2017, se incluyeron 37 pacientes. De los 25 pacientes que completaron la totalidad del protocolo del estudio, 4 pacientes fueron tratados en el nivel de dosis 1 (0 mg/m2 de docetaxel), 6 pacientes en el nivel de dosis 2 (50 mg/m2 ) y 4 pacientes en el nivel de dosis 3 (75 mg/m2 ). En el nivel de dosis 3, se produjeron dos casos de toxicidad limitante de dosis (dose-limiting toxicities, DLTs), ambas asociadas con un íleo postoperatorio. Posteriormente, otros 11 pacientes fueron tratados con el nivel de dosis 2, y no se produjeron más DLTs. La MTD de docetaxel intraperitoneal fue de 50 mg/m2 . Se registraron efectos adversos graves en 17 de 25 pacientes. La tasa de reoperación fue del 16% (n = 4) y la mortalidad relacionada con el tratamiento fue del 8% (n = 2; ambos en el nivel de dosis 3).


Assuntos
Adenocarcinoma/secundário , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimioterapia do Câncer por Perfusão Regional/métodos , Procedimentos Cirúrgicos de Citorredução/métodos , Hipertermia Induzida/métodos , Neoplasias Peritoneais/secundário , Neoplasias Gástricas/patologia , Adenocarcinoma/mortalidade , Adenocarcinoma/terapia , Idoso , Antineoplásicos/uso terapêutico , Terapia Combinada , Docetaxel/uso terapêutico , Relação Dose-Resposta a Droga , Esquema de Medicação , Estudos de Viabilidade , Feminino , Gastrectomia , Humanos , Masculino , Pessoa de Meia-Idade , Oxaliplatina/uso terapêutico , Neoplasias Peritoneais/mortalidade , Neoplasias Peritoneais/terapia , Neoplasias Gástricas/mortalidade , Resultado do Tratamento
3.
BMC Cancer ; 19(1): 420, 2019 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-31060544

RESUMO

BACKGROUND: At present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients. The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy. METHODS: In this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4 cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index < 7) and/or tumour positive peritoneal cytology are confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy was given (prior to inclusion) without disease progression. DISCUSSION: The PERISCOPE II study will determine whether gastric cancer patients with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with systemic chemotherapy, gastrectomy, CRS and HIPEC have a survival benefit over patients treated with palliative systemic chemotherapy only. TRIAL REGISTRATION: clinicaltrials.gov NCT03348150 ; registration date November 2017; first enrolment November 2017; expected end date December 2022; trial status: Ongoing.


Assuntos
Procedimentos Cirúrgicos de Citorredução/métodos , Hipertermia Induzida/métodos , Cuidados Paliativos/métodos , Neoplasias Peritoneais/terapia , Neoplasias Gástricas/terapia , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/métodos , Ensaios Clínicos Fase III como Assunto , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Intervalo Livre de Doença , Feminino , Gastrectomia/economia , Gastrectomia/métodos , Humanos , Hipertermia Induzida/economia , Estimativa de Kaplan-Meier , Masculino , Estudos Multicêntricos como Assunto , Países Baixos/epidemiologia , Cuidados Paliativos/economia , Neoplasias Peritoneais/economia , Neoplasias Peritoneais/secundário , Peritônio/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Gástricas/economia , Neoplasias Gástricas/patologia
4.
Dig Surg ; 24(1): 54-7; discussion 57-8, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17369682

RESUMO

BACKGROUND: At the beginning of 2004, a large Dutch randomized study comparing mechanical bowel preparation with a single preoperative enema reported no differences in anastomotic leakage rates, septic complications, or mortality. On the basis of this study, this institution abandoned the routine practice of bowel preparation with polyethylene glycol and introduced a single preoperative enema. METHODS: A consecutive series of 78 patients undergoing elective colorectal surgery with mechanical bowel preparation using polyethylene glycol (PG group) was compared to a consecutive series of 71 patients with a single preoperative enema (SE group). The PG group was operated between June 2003 and December 2004, the SE group between January 2005 and January 2006. Mortality, anastomotic leakage, and infectious and noninfectious complications were compared. RESULTS: Mortality, anastomotic leakage, frequency of reoperations, and hospital stay were comparable for both groups. The overall postoperative morbidity was significantly higher in the SE group (26 vs. 9, p = 0.003). Specifically, the incidence of wound infections was significantly higher in the SE group (7 vs. 1, p = 0.041). Furthermore, a trend was observed in the incidence of intra-abdominal infections which was higher in the SE group (8 vs. 2, p = 0.070). Also a trend toward more extra-abdominal infectious complications was seen in the SE group (11 vs. 4, p = 0.086). CONCLUSIONS: Based on both the conflicting data currently available from different randomized studies and our results, the preoperative bowel preparation protocol in our institution has been changed. All left-sided colonic resections, in patients who can tolerate mechanical bowel preparation, are prepared with polyethylene glycol.


Assuntos
Cirurgia Colorretal , Enema , Polietilenoglicóis/administração & dosagem , Cuidados Pré-Operatórios/métodos , Adulto , Idoso , Distribuição de Qui-Quadrado , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estatísticas não Paramétricas , Resultado do Tratamento
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