RESUMEN
OBJECTIVE: to report the final analysis of a phase 2 trial assessing the efficacy and safety of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with advanced epithelial ovarian cancer (EOC). METHODS: this was an open-label, multicenter, single-arm trial of HIPEC in patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT). HIPEC was performed as a concentration-based regimen of platinum-based chemotherapy for 30 minutes. Primary endpoint was the rate of disease progression occurring at nine months following iCRS plus HIPEC (PD9). Secondary endpoints were postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS). Analysis was by intention-to-treat with final database lock for survival outcomes on February 23, 2021. RESULTS: fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers. The intention to treat PD9 was 6.7%. With a median follow-up of 33 months (IQR, 24.3-46.5), the median PFS was 18.1 months and corresponding 2-year rates of PFS and OS was 33.3% and 93.3%, respectively. Three patients (20%) experienced graded III complications. Median length of hospital and ICU stay was 5 (IQR, 4-6.5) and 1 (IQR, 1-1) days, respectively. Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed. CONCLUSIONS: we demonstrate preliminary efficacy and safety of short-course HIPEC in patient with advanced EOC.
Asunto(s)
Procedimientos Quirúrgicos de Citorreducción , Neoplasias Ováricas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Humanos , Quimioterapia Intraperitoneal Hipertérmica , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Calidad de VidaRESUMEN
ABSTRACT Objective: to report the final analysis of a phase 2 trial assessing the efficacy and safety of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with advanced epithelial ovarian cancer (EOC). Methods: this was an open-label, multicenter, single-arm trial of HIPEC in patients with advanced EOC who underwent interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy (NACT). HIPEC was performed as a concentration-based regimen of platinum-based chemotherapy for 30 minutes. Primary endpoint was the rate of disease progression occurring at nine months following iCRS plus HIPEC (PD9). Secondary endpoints were postoperative complications, time to start adjuvant chemotherapy, length of hospital and ICU stay, quality of life (QoL) over treatment, and ultimately 2-year progression-free survival (PFS) and overall survival (OS). Analysis was by intention-to-treat with final database lock for survival outcomes on February 23, 2021. Results: fifteen patients with stage III EOC were enrolled between February 2015 and July 2019, in four centers. The intention to treat PD9 was 6.7%. With a median follow-up of 33 months (IQR, 24.3-46.5), the median PFS was 18.1 months and corresponding 2-year rates of PFS and OS was 33.3% and 93.3%, respectively. Three patients (20%) experienced graded III complications. Median length of hospital and ICU stay was 5 (IQR, 4-6.5) and 1 (IQR, 1-1) days, respectively. Time to restart systemic chemotherapy was 39 (IQR, 35-49.3) days and no significant difference over time in QoL was observed. Conclusions: we demonstrate preliminary efficacy and safety of short-course HIPEC in patient with advanced EOC.
RESUMO Objetivo: apresentar a análise final de ensaio clínico de fase 2 que avaliou a eficácia e a segurança da quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração em pacientes com câncer epitelial de ovário avançado (EOC). Métodos: estudo aberto, multicêntrico, de braço único avaliando a HIPEC em pacientes com EOC avançado submetidos a cirurgia citorredutora de intervalo (iCRS) após quimioterapia neoadjuvante (NACT). A HIPEC foi realizada como regime baseado na concentração de cisplatina, perfundida por 30 minutos. O desfecho primário foi a taxa de progressão da doença 9 meses após a iCRS com HIPEC (PD9). Os desfechos secundários foram complicações pós-operatórias, tempo para iniciar a quimioterapia adjuvante, tempo de internação e permanência em UTI, qualidade de vida (QoL) ao longo do tratamento e, finalmente, sobrevida cumulativa livre de progressão (PSF) e global (OS) em 2 anos. As análises foram em intenção de tratar (ITT) com fechamento dos dados para análise da sobrevida em 23 de fevereiro de 2021. Resultados: quinze pacientes com EOC em estágio III foram incluídos no estudo entre fevereiro de 2015 e julho de 2019 em quatro centros recrutadores. A PD9 por ITT foi de 6,7%. Com acompanhamento mediano de 33 meses (IQR, 24,3-46,5), a PFS mediana foi de 18,1 meses e as taxas correspondentes de PFS e OS em 2 anos foram 33,3% e 93,3%, respectivamente. Três pacientes (20%) apresentaram complicações grau III. O tempo mediano de internamento hospitalar e em UTI foi de 5 (IQR, 4-6,5) e 1 (IQR, 1-1) dias, respectivamente. O tempo para reinício da quimioterapia sistêmica foi de 39 dias (IQR, 35-49,3) e não foi observada diferença significativa na QoL ao longo do tratamento. Conclusões: demonstrou-se eficácia e segurança preliminares da HIPEC de curta duração em pacientes com EOC avançado.
Asunto(s)
Humanos , Neoplasias Ováricas/cirugía , Neoplasias Ováricas/tratamiento farmacológico , Procedimientos Quirúrgicos de Citorreducción , Calidad de Vida , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Quimioterapia Intraperitoneal HipertérmicaRESUMEN
OBJECTIVE: to suggest a script for surgical oncology assistance in COVID-19 pandemic in Brazil. METHOD: a narrative review and a "brainstorming" consensus were carried out after discussion with more than 350 Brazilian specialists and renowned surgeons from Portugal, France, Italy and United States of America. RESULTS: consensus on testing for COVID-19: 1- All patients to be operated should be tested between 24 and 48 before the procedure; 2- The team that has contact with sick or symptomatic patients should be tested; 3 - Chest tomography was suggested to investigate pulmonary changes. Consensus on protection of care teams: 1 - Use of surgical masks inside the hospitals. Use of N95 masks for all professionals in the operating room; 2 - Selection of cases for minimally invasive surgery and maximum pneumoperitoneal aspiration before removal of the surgical specimen; 2 - Optimization of the number of people in teams, with a minimum number of professionals, reducing their occupational exposure, the consumption of protective equipment and the circulation of people in the hospital environment; 3 - Isolation of contaminated patients. Priority consensus: 1- Construction of service priorities; 2 - Interdisciplinary discussion on minimally invasive or conventional pathways. CONCLUSION: the Brazilian Society of Surgical Oncology (BSSO) suggests a script for coping with oncological treatment, remembering that the impoundment in the assistance of these cases, can configure a new wave of overload in health systems.
Asunto(s)
Betacoronavirus , Consenso , Infecciones por Coronavirus/epidemiología , Neoplasias/cirugía , Neumonía Viral/epidemiología , Brasil/epidemiología , COVID-19 , Infecciones por Coronavirus/diagnóstico , Personal de Salud , Humanos , Cooperación Internacional , Italia , Pulmón/diagnóstico por imagen , Máscaras , Procedimientos Quirúrgicos Mínimamente Invasivos , Neoplasias/complicaciones , Exposición Profesional/prevención & control , Pandemias , Paris , Equipo de Protección Personal , Neumonía Viral/diagnóstico , Portugal , Cuidados Preoperatorios , SARS-CoV-2 , Manejo de Especímenes , WashingtónRESUMEN
ABSTRACT Objective: to suggest a script for surgical oncology assistance in COVID-19 pandemic in Brazil. Method: a narrative review and a "brainstorming" consensus were carried out after discussion with more than 350 Brazilian specialists and renowned surgeons from Portugal, France, Italy and United States of America. Results: consensus on testing for COVID-19: 1- All patients to be operated should be tested between 24 and 48 before the procedure; 2- The team that has contact with sick or symptomatic patients should be tested; 3 - Chest tomography was suggested to investigate pulmonary changes. Consensus on protection of care teams: 1 - Use of surgical masks inside the hospitals. Use of N95 masks for all professionals in the operating room; 2 - Selection of cases for minimally invasive surgery and maximum pneumoperitoneal aspiration before removal of the surgical specimen; 2 - Optimization of the number of people in teams, with a minimum number of professionals, reducing their occupational exposure, the consumption of protective equipment and the circulation of people in the hospital environment; 3 - Isolation of contaminated patients. Priority consensus: 1- Construction of service priorities; 2 - Interdisciplinary discussion on minimally invasive or conventional pathways. Conclusion: the Brazilian Society of Surgical Oncology (BSSO) suggests a script for coping with oncological treatment, remembering that the impoundment in the assistance of these cases, can configure a new wave of overload in health systems.
RESUMO Objetivo: sugerir roteiro de assistência oncológica cirúrgica em meio à pandemia COVID-19 no Brasil. Método: foi realizada revisão narrativa da literatura e consenso tipo "brainstorming" após discussão com mais de 350 especialistas brasileiros e cirurgiões renomados de Portugal, França, Itália e Estados Unidos da América. Resultados: consenso sobre testagem para COVID-19: 1-Todos os pacientes a serem operados devem ser testados entre 24 e 48 antes do procedimento; 2-Equipe que tenha contato com doentes ou sintomáticos deve ser testada; 3-Tomografia de tórax foi sugerida para pesquisa de alterações pulmonares. Consenso sobre proteção das equipes de assistência: 1-Uso de máscaras cirúrgicas dentro de hospitais. Uso de máscaras N95 para todos os profissionais na sala cirúrgica; 2-Seleção dos casos para cirurgia minimamente invasiva e aspiração máxima do pneumoperitônio antes da retirada da peça cirúrgica; 2-Otimização das equipes, com número mínimo de profissionais, reduzindo a exposição ocupacional, o consumo de equipamento de proteção e a circulação de pessoas no ambiente hospitalar; 3 -Isolamento de pacientes contaminados. Consenso sobre priorizações: 1-Construção de prioridades de atendimento; 2- Discussão interdisciplinar sobre via minimamente invasiva ou convencional. Conclusão: a Sociedade Brasileira de Cirurgia Oncológica (SBCO) sugere roteiro de enfrentamento para o tratamento oncológico, lembrando que o represamento na assistência desses casos, pode configurar uma nova onda de sobrecarga em sistemas de saúde.
Asunto(s)
Humanos , Neumonía Viral/epidemiología , Infecciones por Coronavirus/epidemiología , Consenso , Betacoronavirus , Neoplasias/cirugía , Paris , Neumonía Viral/diagnóstico , Portugal , Manejo de Especímenes , Brasil/epidemiología , Cuidados Preoperatorios , Washingtón , Exposición Profesional/prevención & control , Personal de Salud , Infecciones por Coronavirus/diagnóstico por imagen , Procedimientos Quirúrgicos Mínimamente Invasivos , Pandemias , Equipo de Protección Personal , SARS-CoV-2 , COVID-19 , Cooperación Internacional , Italia , Pulmón/diagnóstico por imagen , Máscaras , Neoplasias/complicacionesRESUMEN
Cytoreductive surgery plus hypertermic intraperitoneal chemotherapy has emerged as a major comprehensive treatment of peritoneal malignancies and is currently the standard of care for appendiceal epithelial neoplasms and pseudomyxoma peritonei syndrome as well as malignant peritoneal mesothelioma. Unfortunately, there are some worldwide variations of the cytoreductive surgery and hypertermic intraperitoneal chemotherapy techniques since no single technique has so far demonstrated its superiority over the others. Therefore, standardization of practices might enhance better comparisons between outcomes. In these settings, the Brazilian Society of Surgical Oncology considered it important to present a proposal for standardizing cytoreductive surgery plus hypertermic intraperitoneal chemotherapy procedures in Brazil, with a special focus on producing homogeneous data for the developing Brazilian register for peritoneal surface malignancies.
Asunto(s)
Neoplasias del Apéndice/terapia , Procedimientos Quirúrgicos de Citorreducción/normas , Hipertermia Inducida/normas , Neoplasias Pulmonares/terapia , Mesotelioma/terapia , Neoplasias Peritoneales/terapia , Humanos , Mesotelioma MalignoRESUMEN
ABSTRACT Cytoreductive surgery plus hypertermic intraperitoneal chemotherapy has emerged as a major comprehensive treatment of peritoneal malignancies and is currently the standard of care for appendiceal epithelial neoplasms and pseudomyxoma peritonei syndrome as well as malignant peritoneal mesothelioma. Unfortunately, there are some worldwide variations of the cytoreductive surgery and hypertermic intraperitoneal chemotherapy techniques since no single technique has so far demonstrated its superiority over the others. Therefore, standardization of practices might enhance better comparisons between outcomes. In these settings, the Brazilian Society of Surgical Oncology considered it important to present a proposal for standardizing cytoreductive surgery plus hypertermic intraperitoneal chemotherapy procedures in Brazil, with a special focus on producing homogeneous data for the developing Brazilian register for peritoneal surface malignancies.
RESUMO A cirurgia citorredutora com quimioterapia intraperitoneal hipertérmica emergiu como um importante tratamento das neoplasias peritoneais e é, atualmente, o padrão de atendimento para neoplasias epiteliais do apêndice associadas à síndrome de pseudomixoma peritoneal, bem como para o mesotelioma peritoneal maligno difuso. No mundo, existem algumas variações reconhecidas das técnicas de cirurgia citorredutora e quimioterapia intraperitoneal hipertérmica, entretanto nenhuma técnica até agora demonstrou sua superioridade sobre o outra. Portanto, a padronização destes procedimentos poderia melhorar a prática clínica e permitir a comparação adequada entre os resultados. Neste cenário, a Sociedade Brasileira de Cirurgia Oncológica considera importante a apresentação de uma proposta de padronização de procedimentos de cirurgia citorredutora com quimioterapia intraperitoneal hipertérmica no Brasil, com um foco especial na produção de dados homogêneos para o desenvolvimento do registro brasileiro das neoplasias peritoneais.
Asunto(s)
Humanos , Neoplasias del Apéndice/terapia , Neoplasias Peritoneales/terapia , Procedimientos Quirúrgicos de Citorreducción/normas , Hipertermia Inducida/normas , Neoplasias Pulmonares/terapia , Mesotelioma/terapiaRESUMEN
BACKGROUND: An important aspect dealing with gastric cancer is the role of lymphadenectomy in gastric cancer staging. AIM: To verify if lymphadenectomy with stations separation increases the number of dissected lymph nodes and establish comparison between TNM 2002 and JGCA 1998 evaluating lymph nodal status (N). METHODS: This is a retrospective analysis of the patients that underwent curative gastrectomy and D2 dissections for adenocarcinoma between 2004 and 2006. Between January of 2004 and June of 2005 (group 1), lymphadenectomy was performed en-bloc with gastrectomy and only TNM system was used. After June of 2005 (group 2), the surgeon himself dissected lymph nodal stations, allowing use of TNM and JGCA systems. Studied aspects were age, Borrmann classification, histological grade, venous or lymphatic invasion, depth of invasion, peritoneal cytology and type of gastrectomy. End points were number of dissected lymph nodes, number of positive lymph nodes and agreement between staging systems. Chi-square test and T-test were used for statistical analysis. RESULTS: One hundred forty-five gastrectomies were performed, 76 in group 1 and 69 in group 2. In group 1, mean age was of 61 years and 59 years in group 2 (P=0,12). Eighty per cent of tumors were advanced in both groups. Venous or lymphatic invasion and positive peritoneal cytology were more frequent in group 1, 65.6% vs 35,3% (P= 0,001) e 13.9% vs 3.1% (P=0,03), respectively. Borrmann classification, histological grade, Lauren classification and type of gastrectomy were not different between the groups. In group 1, mean number of lymph nodes was 32,7 and 37,35 in group 2 (P= 0,09). Rates of positive lymph nodes in groups 1 and 2 were 72.2% and 53%, respectively (P= 0,02). Migration analysis of lymph node status (N) realized only in group 2 (69 patients) showed agreement between TNM and JGCA in 50 patients (72,5%). Using JGCA system, modification in 19 patients occurred (27,5%), with upstaging in 13 (18,8%) and downstaging in six (8,7%). CONCLUSION: In this study, a tendency of increase in number of lymph nodes was verified when the surgeon himself dissected lymph nodal stations. JGCA system modified the lymph nodal staging in comparison to TNM system in 30% of all cases.
RACIONAL: O papel da linfadenectomia no estadiamento de câncer gástrico é de grande importância quando lidando com câncer gástrico. OBJETIVO: Verificar se a linfadenectomia com estações linfonodais separadas aumenta o número da dissecção de linfonodos e estabelecer comparação entre o TNM 2002 e o JGCA 1998, avaliando o status dos linfonodos (N). MÉTODOS: Foi realizada análise retrospectiva de pacientes que foram submetidos à gastrectomia curativa e dissecções do tipo D2 para adenocarcinomas, entre 2004 e 2006. Entre janeiro de 2004 e junho de 2005 (grupo 1), a linfadenectomia foi realizada em flape único com gastrectomia e somente o sistema TNM foi utilizado. Após junho de 2005 (grupo 2), o cirurgião realizou a dissecção de estações linfonodais, permitindo o uso dos sistemas TNM e JGCA. Os aspectos estudados e analisados foram idade, classificação de Borrmann, grau histológico, invasão venosa ou linfática, profundidade da invasão, citologia peritoneal e tipo de gastrectomia. Foram analisados o número de linfonodos dissecados, o número de linfonodos positivos e o entendimento entre os sistemas de estadiamento. O teste do Chi-quadrado e teste-t foram utilizados para realizar a análise estatística. RESULTADOS: Foram realizadas 145 gastrectomias, sendo 76 no grupo 1 e 69 no grupo 2. A idade média referente ao grupo 1 foi de 61 anos e de 59 no grupo 2 (P=0,12). Em ambos os grupos 80% dos tumores eram avançados. Invasão venosa e linfática e citologia peritonial positiva foram mais freqüentes no grupo 1, 65.6% vs 35.3% (P=0,001) e 13.9% vs 3.1% (P=0,03), respectivamente. A classificação de Borrmann, grau histológico, classificação de Lauren e tipo de gastrectomia não foram diferentes entre os grupos. No grupo 1, a média de linfonodos foi de 32.7 e no grupo 2 de 37.35 (P=0,09). O índice de linfonodos positivos nos grupos 1 e 2 foi de 72.2% e 53%, respectivamente (P=0,02). A análise de migração do status de linfonodos (N) foi realizada no grupo 2 (69 pacientes) em concordância com o TNM e JGCA em 50 pacientes (72.5%). Ao utilizar o sistema JGCA, ocorreram modificações em 19 pacientes (27.5%), com aumento de estadiamento em 13 (18.8%) e diminuição em 6 (8.7%). CONCLUSÃO: Neste estudo, foi verificada tendência ao aumento do número de linfonodos quando o cirugião realizou, ele mesmo, a dissecção das estações linfonodais. O sistema JGCA modificou o estadiamento linfonodal quando comparado ao sistema TNM em 30% de todos os casos.