Accuracy of surgeons for predicting radiological sarcopenia in colorectal cancer surgery.

BACKGROUND: This study explored the performance of surgeons for predicting radiological sarcopenia as accessed by psoas cross-sectional area in patients with colorectal cancer (CRC). METHODS: A cross-sectional study was carried out and a diagnostic accuracy strategy was applied using the radiologist team assessment as gold standard. RESULTS: Cohort analysis of 45 consecutive patients found that 31.1% had sarcopenia. Correlation of Total Psoas Index between radiologists and surgeons was very strong for the Junior and strong for the Senior surgeon, with a strong correlation between the surgeons. By the simplistic criterion, agreement between radiologists and surgeons was substantial for both the Junior and Senior surgeons, with a moderate level between the surgeons. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of Junior surgeon were 92.9%, 83.9%, 72.2%, 96.3%, and 86.7%, respectively. The corresponding results for the Senior surgeon were 78.6%, 90.3%, 78.6%, 90.3%, and 86.7%, respectively. We found no major differences on agreement levels and performance of surgeons using the composite criterion. CONCLUSIONS: Surgeons seem to be accurate for identifying radiological sarcopenia in patients with CRC. The simplistic criterion should be preferred since a composite criterion adds complexity without increasing accuracy or agreement levels.

Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER).

OBJECTIVE: To evaluate the non-inferiority and safety of simple hysterectomy in early stage (<2 cm) cervical cancer. METHODS: This proof-of-concept randomized phase II non-inferiority trial was performed between May 2015 and April 2018 in three oncological centers in Northeast Brazil. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IA2-IB1 cervical cancer and tumors ≤2 cm were treated with either simple or modified radical hysterectomy (Querleu-Morrow type B2). Intention-to-treat analysis was carried out. The primary endpoint was 3-year disease-free survival and secondary endpoints were overall survival, operative outcomes, adjuvant therapy, and patient's health-related quality of life (QoL). RESULTS: A total of 40 patients underwent either simple hysterectomy (n=20) or modified radical hysterectomy (n=20). All patients except three underwent open procedures (n=37/40, 92.5%). At a median follow-up of 52.1 months (IQR 43.9-60.1), 3-year disease-free survival was 95% (95% CI 68% to 99%) after simple hysterectomy and 100% (95% CI 100% to 100%) after modified radical hysterectomy (log-rank p=0.30). The corresponding 5-year overall survival rates were 90% (95% CI 64% to 97%) and 91% (95% CI 50% to 98%), respectively (log-rank p=0.46). The operative time was shorter after simple hysterectomy than after modified radical hysterectomy (150 min (IQR 137.5-180) vs 199.5 min (IQR 140-230); p=0.003), with a trend towards a longer time for vesical catheterization removal (1 day (IQR 1-1) vs 1 day (IQR 1-2); p=0.043). There was no post-operative mortality and the rates of post-operative complications were not statistically different between arms (15% and 25%; p=0.69). QoL questionnaires were received from only 17 patients (42.5%), with no major differences observed over time between the surgical arms. CONCLUSIONS: Simple hysterectomy is safe and potentially non-inferior to the radical surgery in patients with early-stage cervical cancer ≤2 cm. TRIAL REGISTRATION NUMBER: NCT02613286.

A phase 2 trial of short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS) for advanced ovarian cancer.

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.

A phase 2 trial of short-course Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) at interval cytoreductive surgery (iCRS) for advanced ovarian cancer / Quimioterapia Intraperitoneal Hipertérmica (HIPEC) de curta duração ao tempo da cirurgia citorredutora de intervalo (iCRS) para câncer de ovário avançado: ensaio clínico de fase 2

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.

Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer.

INTRODUCTION: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. METHODS: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. RESULTS: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. CONCLUSIONS: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

Can HIPEC be used against platinum-resistance and for inducing sensitivity to PARP inhibitors in ovarian cancer?

Hyperthermic intraperitoneal chemotherapy (HIPEC) has emerged as a main comprehensive treatment of epithelial ovarian cancer (EOC). Despite much criticism to this approach, HIPEC has shown cost-effective benefits in both progression-free survival and overall survival for high tumor burden with no important impairment on patient-reported quality of life. On the other hand, the landscape of EOC treatment is changing rapidly and poly (ADP-ribose) polymerase inhibitors (PARPi) currently play an important role in the management of EOC based on recent trials. At this point, an important question to be scrutinized is what to expect from up-front HIPEC in the era of amazing benefits by the PARPi. Herein, we discuss the promising role of combining PARPi and HIPEC in the management of advanced EOC.

Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer / Avaliação da qualidade de vida em ensaio clínico de fase 2 envolvendo quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração no momento da citorredução de intervalo em pacientes com câncer de ovário de grande volume tumoral

ABSTRACT Introduction: to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. Methods: a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. Results: fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. Conclusions: we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

RESUMO Objetivo: avaliar o impacto da quimioterapia intraperitoneal hipertérmica (HIPEC) de curta duração (i.e.: 30 minutos) na qualidade de vida (QoL) relacionada à saúde (HRQoL) no contexto de ensaio clínico terapêutico piloto; NCT02249013. Métodos: avaliou-se o desfecho secundário predeterminado de HRQoL em ensaio clínico de fase 2 de segurança e eficácia, aberto, multicêntrico, de braço único, utilizando-se o questionário European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30, versão 3.0). As pacientes foram solicitadas a responder o questionário de HRQoL antes do tratamento, após a HIPEC, e ao fim do tratamento interdisciplinar. As variações da HRQoL ao longo do tempo foram avaliadas pelas medianas dos escores de cada domínio e analisadas pelo teste de Friedman, considerando-se nível de significância estatística bicaudal de 5%. Resultados: quinze pacientes com câncer de ovário de grande volume tumoral foram recrutadas do sistema de saúde pública (i.e.: SUS) entre fevereiro de 2015 e julho 2019. Um questionário basal e pelo menos um questionário de acompanhamento foram coletados de todas as pacientes. Não se observou diferença significativa ao longo do tempo na HRQoL em nenhum dos domínios ou sintomas estudados (p> 0,05). O comprometimento transitório da HRQoL imediatamente após a HIPEC de curta duração tendeu a retornar à linha de base ao final do tratamento multimodal. Conclusões: não se observou impacto significativo da HIPEC de curta duração sobre a HRQoL no contexto deste protocolo de tratamento interdisciplinar.

Cirurgia citorredutora e quimioterapia intraperitoneal hipertérmica no tratamento primário dos tumores epiteliais de ovário: projeto terapêutico piloto para pacientes do SUS/PE / Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy for treatment of epithelial ovarian cancer: a therapeutic pilot study for patients from SUS/PE

Contexto: O câncer ovariano representa a mais letal das neoplasias ginecológicas. Dada a predileção pela via peritoneal na disseminação desta neoplasia maligna (i.e.: carcinomatose peritoneal), a utilização de quimioterapia intraperitoneal hipertérmica (i.e.: HIPEC ­ hyperthermic intraperitoneal chemotherapy; sigla mantida em inglês) representa promissora opção de tratamento para seu manejo multidisciplinar. Assim, a adoção de um protocolo simplificado de HIPEC poderia incrementar os resultados de seu tratamento às custas de reduzida morbimortalidade. Objetivos: Avaliar a eficácia e a segurança de um protocolo de HIPEC para tratamento do câncer epitelial avançado de ovário em pacientes da rede pública de saúde ­ SUS, em Pernambuco. Métodos: Estudo transversal (análise interina) de dados oriundos de ensaio clínico prospectivo fase II, de braço único e aberta, ainda em curso. O protocolo em estudo envolve o tratamento multidisciplinar do câncer de ovário com quimioterapia sistêmica perioperatória (i.e.: neoadjuvante e adjuvante) associado à citorredução ciurgica com HIPEC. O protocolo de HIPEC utilizou o dispositivo Performer HT (RanD S.r.l., Medolla ­ MO, Itália) e envolveu o uso de cisplatina (25mg/m²/L) perfundida em solução glicosada de diálise peritoneal por 30 minutos, sob temperatura de 41 a 43°C. O estudo foi aprovado pela CONEP (CAAE: 04016212.5.0000.5201) e registrado no ClinicalTrial.gov (NCT02249013). Recebeu financiamento do Decit/SCTIE/MS ­ CNPq/FACEPE/SES-PE (APQ:0187-4.01/13) e do FAPE/IMIP. Resultados: Entre março de 2015 e junho de 2017 foram realizados nove procedimentos de HIPEC em nove pacientes portadoras de neoplasia epitelial de ovário em estádio FIGO IIIB (n=1) ou IIIC (n=8), dos sub-tipos histológicos endometrióide (n=1) e seroso (n=7) e misto (n=1), e com idade mediana foi de 43 (Min ­ Max: 19 ­ 63) anos. O valor mediano do marcador tumoral CA125 antes do início do tratamento foi de 692U/mL (Min ­ Max: 223,7 ­ 6550), o qual foi reduzido para 35,78U/mL (Min ­ Max: 18,5 ­ 374,6) após tratamento sistêmico com 3 (Min ­ Max: 2 ­ 4) ciclos de quimioterapia neoadjuvante baseada em platina, o que resultou em PCI (i.e.: índice de disseminação peritoneal) de 9 (Min ­ Max: 3 ­ 18) ao tempo do procedimento de HIPEC, realizado após 29 dias (Min ­ Max: 26 ­ 43) do último ciclo de quimioterapia pré-operatória. Oito procedimentos de citorredução associada à HIPEC resultaram em citorredução macroscópica completa, isto às custas de ressecção colônica em três pacientes ­ exenteração pélvica posterior (n=2) e colectomia parcial (n=1). O com tempo cirúrgico mediano foi de 395 minutos (Min ­ Max: 235­760), com tempo mediano de internamento hospitalar de 4 dias (Min ­ Max: 3 ­ 10). Todos os pacientes deixaram a UTI na manhã seguinte aos procedimentos, ao passo que 91% das morbidades compreenderam complicações menores grau I e II, de acordo com a classificação de Clavien-Dindo. Segundo a Common Terminology Criteria for Adverse Events ­ Versão 4 (CTCAE v4.03), as complicações mais comuns foram vômitos G1/G2 (n=2) e anemia G3 (n=2). Apenas uma paciente requereu re-operação ao quarto dia de pós-operatório devido hemorragia intraperitoneal sem foco de sangramento específico (complicação grau IIIB) e não houve registro de óbitos ou complicações tardias relacionadas aos procedimentos. O tempo mediano para reinício do tratamento sistêmico foi de 37 dias (Min ­ Max: 33 ­ 50) e todas as pacientes completaram tratamento sistêmico previsto no protocolo do estudo (i.e.: 6 ciclos de quimioterapia). Conclusões: Este protocolo de tratamento multidisciplinar parece ser factível e seus dados preliminares apontam para curto tempo de internação e baixa morbidade. Este é um ensaio clínico pioneiro no Brasil e também o primeiro a usar o dispositivo Performer HT

Context: Ovarian cancer is the main lethal gynecologic malignance. Due to its predilection for peritoneal route of spreading (i.e.: peritoneal carcinomatosis), the use of HIPEC-Hyperthermic Intraperitoneal Chemotherapy emerged as a promising treatment option for the comprehensive management of this malignancy. Thus, the adoption of a simplified protocol of HIPEC could increase the results of treatment with reduced morbidity and mortality. Objectives: To evaluate the efficacy and safety of a HIPEC protocol for treatment of advanced epithelial ovarian cancer patients from the Public Health System ­ SUS in Pernambuco. Methods: A cross-sectional study (interim analysis) was carried out on the women enrolled in our ongoing single-arm, open label, phase 2 clinical trial. The study involved the multidisciplinary treatment with perioperative systemic chemotherapy associated cytoreductive surgery (CRS) plus HIPEC. The HIPEC protocol used Performer HT device (RAND Srl, Medolla - MO, Italy) and involved the use of cisplatin (25mg/m²/L) perfused into dextrose peritoneal dialysis for 30 minutes under temperature of 41-43°C. The study was approved by CONEP (CAAE: 04016212.5.0000.5201) and recorded in ClinicalTrial.gov (NCT02249013). It received funding from Decit/SCTIE/MS - CNPq/FACEPE/SES-PE (APQ: 0187-4.01/13) and FAPE/IMIP. Results: From March 2015 to August 2016, nine patients with stage IIIB (n=1) or IIIC (n=8) epithelial ovarian carcinoma were enrolled into our trial, with sub-types endometrioid (n=1), serous (n=7) or mixed (n=1) adenocarcinoma, and median (range) age of 43 years (range: 19 ­ 63). The median preoperative serum CA125 levels at diagnosis was 692U/mL (range: 223.7­6550), which was reduced to 35.78U/mL (Min ­ Max: 18,5 ­ 374,6) after a median of 3 (range: 2 ­ 4) cycles of neoadjuvant chemotherapy, and peritoneal cancer index scores (PCI) of 9 (range: 3 ­ 18) at the time of CRS/HIPEC, developed after 29 days (range: 26 ­ 43) from the last neoadjuvant course of chemotherapy. Eight procedures resulted in no visible disease, and three patients required bowel resection as rectosigmoidectomy (n=2) or partial colectomy (n=1). Median operation time was 395 minutes (range: 235 ­ 760), with a length of hospital stay of 4 days (range: 3­10). All patients left the ICU on the morning after the procedure, whereas about 91% of postoperative complications were minor grade I and II complications, according to the Clavien­Dindo classification. The most common morbidities were minor G1/G2 vomiting (n=2) and G3 anemia (n=2), according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) classification version 4.0. Only one patient experienced reoperation at the fourth postoperative day because of G3 postoperative hemorrhage, but no deaths or long-term complications were recorded. Time to re-starts systemic chemotherapy (i.e.: adjuvant chemotherapy) was 37 days (range: 33 ­ 50) and all patients completed the systemic treatment protocol (i.e.: 6 cycles of chemotherapy). Conclusions: Our comprehensive multimodal protocol seems to be feasible and safe, with low rates of complications and a short length of hospital stay in this preliminary report. This is a pioneering clinical trial in Brazil and also the very first to use the Performer HT device

Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) has been considered a promising treatment option for advanced or recurrent ovarian cancer, but there is no clear evidence based on randomized controlled trials to advocate this approach as a standard therapy. In this study, we aim to present the early outcomes and insights after an interim analysis of a pioneering clinical trial in Brazil. METHODS: This study was a cross-sectional analysis of early data from our ongoing clinical trial - an open-label, double-center, single-arm trial on the safety and efficacy of using HIPEC for advanced ovarian cancer (ClinicalTrials.gov: NCT02249013). A fast-track recovery strategy was also applied to improve patient outcomes. RESULTS: Nine patients with stage IIIB (n=1) or IIIC (n=8) epithelial malignancies were enrolled until February 2017. The median (range) serum CA125 level at diagnosis was 692 (223.7-6550) U/mL. The median number of preoperative cycles of intravenous (i.v.) chemotherapy was 3 (2-4), resulting in peritoneal cancer index scores of 9 (3-18) at the time of HIPEC. Time of restarting i.v. chemotherapy was 37 (33-50) days with all patients completing 6 cycles as planned. The median operation time was 395 (235-760) minutes, the length of hospital stay was 4 (3-10) days, and all the patients left the ICU on the morning after the procedure. Two patients experienced no postoperative complications, whereas 91% of the complications were minor G1/G2 events. Preliminary assessment also suggested no impairment of the patient's quality of life. CONCLUSION: Our comprehensive protocol might represent a promising all-in-one approach for advanced ovarian cancer. The patient recruitment for this trial is ongoing.

A proposal of Brazilian Society of Surgical Oncology (BSSO/SBCO) for standardizing cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) procedures in Brazil: pseudomixoma peritonei, appendiceal tumors and malignant peritoneal mesothelioma

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.

A proposal of Brazilian Society of Surgical Oncology (BSSO/SBCO) for standardizing cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) procedures in Brazil: pseudomixoma peritonei, appendiceal tumors and malignant peritoneal mesothelioma / Proposta de padronização da Sociedade Brasileira de Cirurgia Oncológica (BSSO/SBCO) para procedimentos de citorredução cirúrgica (CRS) e quimioterapia intraperitoneal hipertérmica (HIPEC) no Brasil: pseudomixoma peritoneal, tumores do apêndice cecal e mesotelioma peritoneal maligno

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.

Exploring flow rate selection in HIPEC procedures / Explorando parâmetros de fluxo em procedimentos de HIPEC

ABSTRACT Cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) has emerged as a main comprehensive treatment of peritoneal malignancies. However, current data on the literature are very heterogeneous in terms of its technical particularities, which require some efforts to standardization of practices. In these setting, we present some early data from a pioneering clinical trial in Brazil (ClinicalTrials.gov Identifier: NCT02249013) to explore the dynamic relationships between flow rates and temperature parameters in the first cases of our study, which may help in selecting better technical parameters during HIPEC procedures.

RESUMO Cirurgia citorredutora avançada e quimioterapia intraperitoneal hipertérmica (i.e.: HIPEC, sigla em inglês) têm se consagrado como promissora abordagem terapêutica multidisciplinar para neoplasias malignas peritoneais. Contudo, dados da literatura corrente são muito heterogêneos em torno de muitos de seus aspectos técnicos, o que demanda algum esforço na busca por padronizações do procedimento. Neste sentido, são apresentados dados de um ensaio clínico pioneiro no Brasil (ClinicalTrials.gov Identifier: NCT02249013), relacionando parâmetros dinâmicos de taxas de fluxo e temperaturas de perfusão nos primeiros casos do estudo, o que pode ajudar na seleção de melhores parâmetros técnicos para procedimentos de HIPEC.

Exploring flow rate selection in HIPEC procedures.

Cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) has emerged as a main comprehensive treatment of peritoneal malignancies. However, current data on the literature are very heterogeneous in terms of its technical particularities, which require some efforts to standardization of practices. In these setting, we present some early data from a pioneering clinical trial in Brazil (ClinicalTrials.gov Identifier: NCT02249013) to explore the dynamic relationships between flow rates and temperature parameters in the first cases of our study, which may help in selecting better technical parameters during HIPEC procedures.

PREVALENCE OF INCIDENTAL GALLBLADDER CANCER IN A TERTIARY-CARE HOSPITAL FROM PERNAMBUCO, BRAZIL.

BACKGROUND: Gallbladder cancer is sometimes incidentally uncovered following cholecystectomy for gallstones diseases. The supposed highly variable prevalence of incidental gallbladder cancer through our country is unknown. OBJECTIVE: To explore the prevalence of incidental gallbladder cancer in our tertiary-care hospital. METHODS: A cross-sectional study was carried out on patients who consecutively underwent cholecystectomy due to gallstones disease at Faculdade Pernambucana de Saúde, Instituto de Medicina Integral Professor Fernando Figueira - FPS/IMIP, from January, 2007 to December, 2010. Data on incidental gallbladder cancer patients were explored for prevalence estimation and description of our experience with the management of this malignancy. RESULTS: Our analysis involved 2018 patients with a marked predominance of women (n=1.697; 84.1%) over men (n=321; 15.9%). The 3-year prevalence estimate of 0.34% was recorded for incidental gallbladder cancer in our sample. Regarding tumor staging, there were 1 T1a, 1 T1b, and 5 T2 adenocarcinoma tumors. Laparoscopic cholecystectomy alone was performed for the T1a tumor, and additional radical surgery was performed in five others. One patient presented metastatic disease at the time of repeat surgery. The final pathology revealed residual/additional disease in all T2 tumors after radical surgery whereas the T1b patient underwent a salvage Whipple's procedure due to a secondary distal cholangiocarcinoma. The patient with T1a tumor is alive after 3-year follow-up but all of the others died because of disease recurrence/progression up to 12 months. CONCLUSION: This study confirms the poor prognosis of Gallbladder cancer even when incidentally diagnosed following cholecystectomy and supposes a 3-year prevalence estimate of 0.34% for incidental gallbladder cancer in our Center from Pernambuco State, Brazil.

A PHASE II TRIAL EXPLORING THE EXTENSIVE INTRA-OPERATIVE PERITONEAL LAVAGE (EIPL) AS A PROPHYLACTIC STRATEGY FOR PERITONEAL RECURRENCE IN LOCALLY ADVANCED GASTRIC CANCER: reporting postoperative morbidity and mortality after early closure.

BACKGROUND: The Extensive Intraoperative Peritoneal Lavage (EIPL) has been proposed as a practical prophylactic strategy to decrease the risk of peritoneal metastasis in gastric cancer. OBJECTIVE: To explore the safety and efficacy of the EIPL in our locally advanced gastric cancer patients. METHODS: This study is an open-label, double-center, single-arm phase II clinical trial developed at two tertiary hospitals from Recife (Pernambuco, Brazil). RESULTS: The study protocol was prematurely closed due to slow accrual after only 16 patients had been recruited to participate. Eight of them were excluded of the protocol study during the laparotomy, whereas four cases were also excluded from the per-protocol analysis. Two patients had died in hospital before 30 days and six were alive with no evidence of cancer relapses after a follow-up ranging from five to 14,2 months (median of 10.6 months). In the intention-to-treat analysis, three of eight patients suffered of gastrointestinal leakages and two of them had died. On a per-protocol basis, two of four patients presented this type of postoperative complication and one of them had died. All deaths occurred as a somewhat consequence of gastrointestinal leakages. CONCLUSION: We could not make any conclusion about the safety and efficacy of the EIPL, but the possibility of this approach might increase the rate of gastrointestinal leakage is highlighted.