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1.
Acta Obstet Gynecol Scand ; 103(7): 1302-1310, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38532280

RESUMO

INTRODUCTION: Serum levels of procalcitonin and C-reactive protein (CRP) have been used to predict anastomotic leakage after colorectal surgery, but information is scarce in advanced ovarian cancer (AOC) surgery with bowel resection. This study aimed to assess the predictive value of procalcitonin and CRP in detecting anastomotic leakage after AOC surgery with bowel resection. The study also aimed to determine the optimal postoperative reference values and the best day for evaluating these markers. MATERIAL AND METHODS: This prospective, observational and multicentric trial included 92 patients with AOC undergoing debulking surgery with bowel resection between 2017 and 2020 in 10 reference hospitals in Spain. Procalcitonin and CRP levels were measured at baseline and on postoperative days 1-6. Receiver operating characteristic analysis was performed to evaluate the predictive value of procalcitonin and CRP at each postoperative day. Sensitivity, specificity, positive and negative predictive values were calculated. RESULTS: Anastomotic leakage was detected in six patients (6.5%). Procalcitonin and CRP values were consistently higher in patients with anastomotic leakage at all postoperative days. The maximum area under the curve (AUC) for procalcitonin was observed at postoperative day 1 (AUC = 0.823) with a cutoff value of 3.8 ng/mL (83.3% sensitivity, 81.3% specificity). For CRP, the maximum AUC was found at postoperative day 3 (AUC = 0.833) with a cutoff level of 30.5 mg/dL (100% sensitivity, 80.4% specificity). CONCLUSIONS: Procalcitonin and C-reactive protein are potential biomarkers for early detection of anastomotic leakage after ovarian cancer surgery with bowel resection. Further prospective studies with a larger sample size are needed to confirm these findings.


Assuntos
Fístula Anastomótica , Proteína C-Reativa , Neoplasias Ovarianas , Pró-Calcitonina , Humanos , Feminino , Fístula Anastomótica/sangue , Fístula Anastomótica/diagnóstico , Proteína C-Reativa/análise , Proteína C-Reativa/metabolismo , Neoplasias Ovarianas/cirurgia , Neoplasias Ovarianas/sangue , Estudos Prospectivos , Pessoa de Meia-Idade , Pró-Calcitonina/sangue , Idoso , Valor Preditivo dos Testes , Biomarcadores/sangue , Adulto , Espanha , Biomarcadores Tumorais/sangue , Procedimentos Cirúrgicos de Citorredução/efeitos adversos
2.
World J Surg ; 48(2): 466-473, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38310307

RESUMO

INTRODUCTION: The recurrence of acute diverticulitis (AD) of the colon is frequent and leads to hospital readmissions and the need for elective surgery in selected cases. It is important to individualize risk factors and develop predictive tools for their identification. MATERIALS AND METHODS: This prospective observational study included 368 patients who were diagnosed with AD between 2016 and 2021 in a tertiary general university hospital during their first episode and who had a good response to antibiotic, percutaneous, or peritoneal lavage treatment. Univariate and multivariate Cox regression analyses of the variables associated with recurrence were performed. Subsequently, a predictive risk score was developed and validated through survival studies. RESULTS: After a median follow-up of 50 months, there were 71 (19.3%) cases of recurrence out of a total of 368 patients. The mean time of recurrence was 15 months, and 73.3% of cases of recurrence occurred before 2 years of follow-up. Recurrence was independently associated with presentation with colonic perforation in the antimesenteric location (HR 3.67 95% CI [1.59-8.4]) and a CRP level greater than 100 mg/dl (HR 1.69 95% CI [1.04-2.77). A score with 5 variables was created that differentiated two risk groups: intermediate risk (0-3 points), with 19% recurrence and high risk (more than 3 points), with 42% recurrence. CONCLUSIONS: The risk of recurrence after the first episode of diverticulitis can be estimated using predictive scores. The detection of high-risk patients facilitates the individualization of follow-up and treatment.


Assuntos
Doença Diverticular do Colo , Diverticulite , Humanos , Doença Diverticular do Colo/complicações , Doença Diverticular do Colo/cirurgia , Recidiva , Diverticulite/complicações , Fatores de Risco , Estudos Prospectivos , Estudos Retrospectivos
3.
J Pers Med ; 13(12)2023 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-38138863

RESUMO

BACKGROUND: Ovarian cancer is the gynaecological malignancy with the highest mortality and diagnosis often occurs in its advanced stages. Standard treatment in these cases is based on complete cytoreductive surgery with adjuvant intravenous chemotherapy. Other types of treatment are being evaluated to improve the prognosis of these patients, including intraperitoneal chemotherapy and antiangiogenic therapy. These may improve survival or time to relapse in addition to intravenous chemotherapy. OBJECTIVE: The aim of this meta-analysis is to determine whether treatment with intravenous chemotherapy remains the gold standard, or whether the addition of intraperitoneal chemotherapy has a benefit in overall survival (OS) and disease-free interval (DFS). MATERIALS AND METHODS: A literature search was carried out in Pubmed and Cochrane, selecting clinical studies and systematic reviews published in the last 10 years. Statistical analysis was performed using the hazard ratio measure in the RevMan tool. RESULTS: Intraperitoneal chemotherapy shows a benefit in OS and DFS compared with standard intravenous chemotherapy. The significant differences in OS (HR: 0.81 CI 95% 0.74-0.88) and in DFS (HR: 0.81 CI 95% 0.75-0.87) are statistically significant (p < 0.00001). There were no clinical differences in toxicity and side-effects. CONCLUSION: Intraperitoneal chemotherapy is an option that improves OS and DFS without significant toxicity regarding the use of intravenous chemotherapy alone. However, prospective studies are needed to determine the optimal dose and treatment regimen that will maintain the benefits while minimising side effects and toxicity and the profile of patients who will benefit most from this treatment.

4.
J Pers Med ; 13(11)2023 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-38003855

RESUMO

Background: Cytoreductive surgery (CRS) is a complex procedure with a high incidence of perioperative complications. Elevated lactacidaemia levels have been associated with complications and perioperative morbidity and mortality. This study aims to analyse the intraoperative variables of patients undergoing CRS and their relationship with lactacidaemia levels. Methods: This retrospective, observational study included 51 patients with peritoneal carcinomatosis who underwent CRS between 2014 and 2016 at the Abdomino-Pelvic Oncological Surgery Reference Unit (URCOAP) of the General University Hospital of Castellón (HGUCS). The main variable of interest was the level of lactic acid at the end of surgery. Intraoperative variables, including preoperative haemoglobin, duration of surgery, intraoperative bleeding, fluid therapy administered, administration of blood products, and intraoperative peritoneal cancer index (PCI), were analysed. Results: Positive correlations were found between lactic acid levels and PCI, duration of intervention, fluid therapy, intraoperative bleeding, and transfusion of blood products. Additionally, a negative correlation was observed between haemoglobin levels and lactic acid levels. Notably, the strongest correlations were found with operative PCI (ρ = 0.532; p-value < 0.001) and duration of surgery (ρ = 0.518; p-value < 0.001). Conclusions: PCI and duration of surgery are decisive variables in determining the prognosis of patients undergoing debulking surgery. This study suggests that, for each minute of surgery, lactic acid levels increase by 0.005 mmol/L, and for each unit increase in PCI, lactic acid levels increase by 0.060 mmol/L.

5.
Cancers (Basel) ; 15(17)2023 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-37686547

RESUMO

INTRODUCTION: Epithelial ovarian cancer (EOC) is primarily confined to the peritoneal cavity. When primary complete surgery is not possible, neoadjuvant chemotherapy (NACT) is provided; however, the peritoneum-plasma barrier hinders the drug effect. The intraperitoneal administration of chemotherapy could eliminate residual microscopic peritoneal tumor cells and increase this effect by hyperthermia. Intraperitoneal hyperthermic chemotherapy (HIPEC) after interval cytoreductive surgery could improve outcomes in terms of disease-free survival (DFS) and overall survival (OS). MATERIALS AND METHODS: A multicenter, retrospective observational study of advanced EOC patients who underwent interval cytoreductive surgery alone (CRSnoH) or interval cytoreductive surgery plus HIPEC (CRSH) was carried out in Spain between 07/2012 and 12/2021. A total of 515 patients were selected. Progression-free survival (PFS) and OS analyses were performed. The series of patients who underwent CRSH or CRSnoH was balanced regarding the risk factors using a statistical analysis technique called propensity score matching. RESULTS: A total of 170 patients were included in each subgroup. The complete surgery rate was similar in both groups (79.4% vs. 84.7%). The median PFS times were 16 and 13 months in the CRSH and CRSnoH groups, respectively (Hazard ratio (HR) 0.74; 95% CI, 0.58-0.94; p = 0.031). The median OS times were 56 and 50 months in the CRSH and CRSnoH groups, respectively (HR, 0.88; 95% CI, 0.64-1.20; p = 0.44). There was no increase in complications in the CRSH group. CONCLUSION: The addition of HIPEC after interval cytoreductive surgery is safe and increases DFS in advanced EOC patients.

6.
Cancers (Basel) ; 15(13)2023 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-37444580

RESUMO

Background: The second cytoreductive surgery performed for a patient who has recurrent ovarian cancer remains controversial. Our study analyzes overall survival (OS) and disease-free survival (DFS) for cytoreductive surgery in addition to chemotherapy in recurrent ovarian cancer instead of chemotherapy alone. Methods: A meta-analysis was conducted using PubMed and the Cochrane database of systematic reviews to select randomized controlled studies. In total, three randomized studies were used, employing a total of 1249 patients. Results: The results of our meta-analysis of these randomized controlled trials identified significant differences in OS (HR = 0.83, IC 95% 0.70-0.99, p < 0.04) and DFS (HR = 0.63, IC 95% 0.55-0.72, p < 0.000001). A subgroup analysis comparing complete cytoreductive surgery and surgery with residual tumor achieved better results for both OS (HR = 0.65, IC 95% 0.49-0.86, p = 0.002) and DFS (HR = 0.67, IC 95% 0.53-0.82, p = 0.0008), with statistical significance. Conclusions: A complete secondary cytoreductive surgery (SCS) in recurrent ovarian cancer (ROC) demonstrates an improvement in the OS and DFS, and this benefit is most evident in cases where complete cytoreductive surgery is achieved. The challenge is the correct patient selection for secondary cytoreductive surgery to improve the results of this approach.

7.
J Pers Med ; 13(2)2023 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-36836494

RESUMO

OBJECTIVE: The use of hyperthermic intraperitoneal chemotherapy (HIPEC) as a treatment for epithelial ovarian cancer remains controversial. Our study aims to analyze the overall survival and disease-free survival for the use of HIPEC as a treatment for advanced epithelial ovarian cancer after neoadjuvant chemotherapy. METHODS: A systematic review and meta-analysis was carried out using PubMed, Cochrane, Web of Science, and ClinicalTrials.gov. A total of six studies were used, comprising a total of 674 patients. RESULTS: The results of our meta-analysis of all studies analyzed together (observational and randomized controlled trials (RCT)) did not achieve significant results. Contrary to the OS (HR = 0.56, 95% IC = 0.33-0.95, p = 0.03) and DFS (HR = 0.61, 95% IC = 0.43-0.86, p < 0.01) of the RCT analyzed separately, a clear impact on survival was suggested. The subgroup analysis showed that studies making use of higher temperatures (≥42 °C) for a shorter period of time (≤60 min) achieved better results for both OS and DFS, as well as the use of cisplatin as the form of chemotherapy in HIPEC. Moreover, the use of HIPEC did not increase high-grade complications. CONCLUSIONS: The addition of HIPEC to cytoreductive surgery demonstrates an improvement in OS and DFS for patients with epithelial ovarian cancer in advanced stages, without an increase in the number of complications. The use of cisplatin as chemotherapy in HIPEC obtained better results.

8.
Front Immunol ; 14: 1111344, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36817483

RESUMO

Introduction: High-grade serous ovarian cancer (HGSOC) is the second most frequent gynecological malignancy but the most lethal, partially due to the spread of the disease through the peritoneal cavity. Recent evidence has shown that, apart from their role in immune defense through phagocytosis and degranulation, neutrophils are able to participate in cancer progression through the release of neutrophil extracellular traps (NETs) in a process called NETosis. NETs are composed of DNA, histones, calprotectin, myeloperoxidase (MPO) and elastase and the NETosis process has been proposed as a pre-requisite for the establishment of omental metastases in early stages of HGSOC. Nevertheless, its role in advanced stages remains to be elucidated. Therefore, our principal aim is to characterize a NETosis biomarker profile in biofluids from patients with advanced HGSOC and control women. Methods: Specifically, five biomarkers of NETosis (cell-free DNA (cfDNA), nucleosomes, citrullinated histone 3 (citH3), calprotectin and MPO) were quantified in plasma and peritoneal fluid (PF) samples from patients (n=45) and control women (n=40). Results: Our results showed that HGSOC patients presented a higher concentration of cfDNA, citH3 and calprotectin in plasma and of all five NETosis biomarkers in PF than control women. Moreover, these biomarkers showed a strong ability to differentiate the two clinical groups. Interestingly, neoadjuvant treatment (NT) seemed to reduce NETosis biomarkers mainly systemically (plasma) compared to the tumor environment (PF). Discussion: In conclusion, NETosis biomarkers are present in the tumor environment of patients with advanced HGSOC, which might contribute to the progression of the disease. Besides, plasma cfDNA and calprotectin could represent minimally invasive surrogate biomarkers for HGSOC. Finally, NT modifies NETosis biomarkers levels mainly at the systemic level.


Assuntos
Ácidos Nucleicos Livres , Armadilhas Extracelulares , Neoplasias Ovarianas , Humanos , Feminino , Neutrófilos , Histonas , Biomarcadores
9.
Appl Environ Microbiol ; 88(19): e0129722, 2022 10 11.
Artigo em Inglês | MEDLINE | ID: mdl-36102660

RESUMO

After the outbreak of COVID-19, additional protocols have been established to prevent the transmission of the SARS-CoV-2 from the patient to the health personnel and vice versa in health care settings. However, in the case of emergency surgeries, it is not always possible to ensure that the patient is not infected with SARS-CoV-2, assuming a potential source of transmission of the virus to health personnel. This work aimed to evaluate the presence of the SARS-CoV-2 and quantify the viral load in indoor air samples collected inside operating rooms, where emergency and scheduled operations take place. Samples were collected for 3 weeks inside two operating rooms for 24 h at 38 L/min in quartz filters. RNA was extracted from the filters and analyzed using RT-qPCR targeting SARS-CoV-2 genes E, N1 and N2 regions. SARS-CoV-2 RNA was detected in 11.3% of aerosol samples collected in operating rooms, despite with low concentrations (not detected at 13.5 cg/m3 and 10.5 cg/m3 in the scheduled and emergency operating rooms, respectively). Potential sources of airborne SARS-CoV-2 could be aerosolization of the virus during aerosol-generating procedures and in open surgery from patients that might have been recently infected with the virus, despite presenting a negative COVID-19 test. Another source could be related to health care workers unknowingly infected with the virus and exhaling SARS-CoV-2 virions into the air. These results highlight the importance of reinforcing preventive measures against COVID-19 in operating rooms, such as the correct use of protective equipment, screening programs for health care workers, and information campaigns. IMPORTANCE Operating rooms are critical environments in which asepsis must be ensured. The COVID-19 pandemic entailed the implementation of additional preventative measures in health care settings, including operating theaters. Although one of the measures is to operate only COVID-19 free patients, this measure cannot be always implemented, especially in emergency interventions. Therefore, a surveillance campaign was conducted during 3 weeks in two operating rooms to assess the level of SARS-CoV-2 genetic material detected in operating theaters with the aim to assess the risk of COVID-19 transmission during operating procedures. SARS-CoV-2 genetic material was detected in 11% of aerosol samples collected in operating rooms, despite with low concentrations. Plausible SARS-CoV-2 sources have been discussed, including patients and health care personnel infected with the virus. These results highlight the importance of reinforcing preventive measures against COVID-19 in operating rooms, such as the correct use of protective equipment, screening programs for health care workers and information campaigns.


Assuntos
COVID-19 , SARS-CoV-2 , COVID-19/prevenção & controle , Carga Genética , Humanos , Salas Cirúrgicas , Pandemias/prevenção & controle , Quartzo , RNA Viral/genética , Aerossóis e Gotículas Respiratórios , SARS-CoV-2/genética
10.
J Pers Med ; 12(7)2022 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-35887578

RESUMO

OBJECTIVE: Fertility-sparing surgery (FSS) is the treatment of choice for patients with early cervical cancer (ECC) and fertility desire, but survival rates compared to radical hysterectomy (RH) have been scarcely reported. The aim of this study was to analyse the oncological outcomes of FSS compared to a balanced group of standard RH. METHODS: A retrospective multicentre study of ECC patients who underwent FSS or RH was carried out in 12 tertiary hospitals in Spain between January 2005 and January 2019. The experimental group included patients who underwent a simple and radical trachelectomy, and the control group included patients who underwent RH. Optimal 1:1 propensity score (PS) matching analysis was performed to balance the series. RESULTS: The study included 222 patients with ECC; 111 (50%) were treated with FSS, and 111 (50%) were treated with RH. After PS matching, a total of 38 patients in the FSS group and 38 patients in the RH group were analysed. In both groups, the overall survival (HR 2.5; CI 0.89, 7.41) and recurrence rates (28.9% in the FSS group vs. 13.2% in RH group) were similar. The rate of disease-free survival at 5 years was 68.99% in the FSS group and 88.01% in the RH group (difference of -19.02 percentage points; 95% CI -32.08 to -5.96 for noninferiority). In the univariate analysis, only tumour size reached statistical significance. CONCLUSION: FSS offers excellent disease-free and overall survival in women with ECC with fertility desire and is not inferior compared to RH.

11.
J Clin Med ; 11(3)2022 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-35159927

RESUMO

To compare the diagnostic performance of routine CT (rCT), CT enterography (CTE) and intraoperative quantification of PCI to surgical and pathological reference standards in patients with advanced ovarian cancer, a retrospective study of 122 patients who underwent cytoreduction surgery for ovarian peritoneal carcinomatosis was conducted. Radiological, surgical, and pathological PCIs were obtained from the corresponding reports, and the latter two were considered reference standards. The radiological techniques used were rCT: 64 MDCT (32 × 1 mm) (100 mL iopromide 370 i.v., 800 mL water p.o.), and CTE: 64 MDCT (64 × 0.5 mm) (130 mL iopromide 370 i.v., 1800 mL mannitol solution p.o., 20 mg buscopan i.v.). Data were grouped by imaging technique and analyzed using total PCI and stratified by tumor burden (low-PCI < 10, high-PCI > 20). Agreement, diagnostic performance and degree of cytoreduction were evaluated. Disappointing results for rCT and CTE were obtained when using a surgical referent, but better diagnostic performance and concordance (0.86 vs. 0.78 vs. 0.62, p < 0.05) was observed when using a pathological referent-surgical PCI overestimates and overstaged patients. PCI is underestimated by rCT rather than CTE. For high-PCI, the ROC curve was mediocre for CTE and useless for rCT, as it failed to identify any cases. For low-PCI, the ROC was excellent (86% CTE vs. 75% rCT). In four cases with low-PCI as determined by rCT, cytoreduction was suboptimal. CTE has a better diagnostic performance than rCT in quantifying PCI in patients with advanced ovarian cancer, suggesting that CTE should be used as the initial technique. Surgical-PCI could be considered as an imperfect standard reference.

12.
J Pers Med ; 11(11)2021 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-34834404

RESUMO

OBJECTIVE: Surgical societies of different specialties have lately demonstrated a growing concern regarding the potential risk of SARS-CoV-2 transmission during surgery, mainly via aerosols carrying SARS-CoV-2 particles during laparoscopy smoke evacuation. Since there is not sufficient scientific evidence to rule out this hypothesis, our study aimed to evaluate the prevalence of the appearance of SARS-CoV-2 genetic material in the in-filter membrane of the smoke filter systems, used in laparoscopic surgery, in a tertiary referral hospital during the peak phases of the pandemic. METHODS: During the highest incidence of the pandemic outbreak, 180 laparoscopic smoke evacuation systems were collected from laparoscopies performed between April 2020 and May 2021 in University General Hospital of Castellón. As part of the safety protocol established as a result of the pandemic, an oropharyngeal reverse-transcription polymerase chain reaction (RT-PCR) was performed before surgery. We performed RT-qPCR tests for the detection and quantification of SARS-CoV-2 genetic material in the in-filter membranes extracted from the smoke evacuation systems. RESULTS: We found two RT-qPCR positive in-filters from a sample of 128 patients with SARS-CoV-2-negative results in their oropharyngeal RT-qPCR, i.e., 1.6% (95% CI: 0.5-5.5%). From this estimation, the predictive posterior probabilities of finding n cases of negative oropharyngeal COVID-19 patients with positive filters increases with the increasing number of surgeries performed. CONCLUSIONS: This cross-sectional study provides evidence suggesting that airborne transmission of SARS-CoV-2 particles from smoke evacuation of aerosols carrying viral particles during laparoscopy should not be ruled out.

13.
J Pers Med ; 11(11)2021 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-34834467

RESUMO

BACKGROUND: Ovarian cancer has a low incidence, but high mortality due to a habitual diagnosis in advanced cancer stages. Currently, used biomarkers have good sensitivity, but low specificity. AIM: To determine the usefulness of the biomarkers and algorithms used up to now in the screening, diagnosis, response to treatments and identification of recurrence in patients with ovarian masses. METHODOLOGY: Systematic search of publications in English in the Medline-PubMed database with the terms: "biomarkers", "tumour", "tumour biomarkers", "marker", "tumour marker", "ovarian cancer", "ovarian", "Neoplasms", "cancer", CA-125 Antigen; Human Epididymis-specific Protein E4; Risk of Malignancy Index (RMI); Risk of Ovarian Malignancy Algorithm (ROMA); Ovarian Neoplasms. Original articles, clinical trials, reviews, systematic reviews and meta-analyses, published between January 2000 and November 2020, were selected to determine the usefulness (among others) of CA 125 and HE4 antigen in ovarian cancer. RESULTS: Finally, 39 transcendental publications were selected to write this article to determine the usefulness of tumour markers and algorithms in ovarian cancer. CONCLUSIONS: The usefulness of the tumour markers antigen CA125 and antigen HE4 individually or as a basis for decision-making algorithms has low specificity; however, there is little evidence that confirms their usefulness as markers in ovarian cancer screening.

15.
J Clin Med ; 10(12)2021 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-34207720

RESUMO

OBJECTIVE: Peritoneal carcinomatosis is a disease's presentation in the advanced stages of many gynecologic tumours. The distribution and volume of the disease are the main factors in achieving complete debulking. Diagnostic laparoscopy is a technique to allow evaluation of the disease. This study's objective is to compare two laparoscopic scores (Fagotti's index and Sugarbaker's peritoneal cancer index (PCI)) and assess the diagnostic accuracy to select patients for neoadjuvant treatment and reduce unnecessary laparotomies. METHODS: A non-randomised retrospective cohort study was conducted in patients with peritoneal carcinomatosis (ovarian and endometrial origin) who underwent laparoscopy and subsequent laparotomy. We evaluated the scores' ability to predict incomplete surgery and whether they were related to the patients' prognosis. RESULTS: We included 34 patients, of which 23.5% received neoadjuvant chemotherapy. The rate of complete cytoreductive surgery was 79.4% (n = 27 patients). The highest sensitivity was obtained with a PCI value greater than 20. It was the best parameter to determine incomplete debulking. Survival curves were analysed according to the "cut off" established for each score, and statically significant differences were found using PCI with respect to Fagotti's Index. However, these differences were not found with Fagotti's score. CONCLUSION: The best diagnostic method to classify patients with peritoneal cancer is the PCI. It could be adapted to each surgical team because it allows identifying the "cut off point", which depends on incomplete surgery rate.

16.
Gynecol Oncol ; 161(3): 681-686, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33795131

RESUMO

OBJECTIVE: Despite radical surgery and chemotherapy, most patients with ovarian cancer die due to disease progression. M-Trap is an implantable medical device designed to capture peritoneal disseminated tumor cells with the aim to focalize the disease. This trial analyzed the safety and performance of the device. METHODS: This first-in-human prospective, multi-center, non-blinded, single-arm study enrolled 23 women with high-grade serous advanced ovarian cancer. After primary or interval debulking surgery, 3 M-Trap devices were placed in the peritoneum of the abdominal cavity. 18-months post-implantation or at disease progression, devices were initially removed by laparoscopy. The primary safety endpoint was freedom from device and procedure-related major adverse events (MAEs) through 6-months post-implantation compared to an historical control. The primary performance endpoint was histopathologic evidence of tumor cells capture. RESULTS: Only one major adverse event was attributable to the device. 18 women were free of device and procedure related MAEs (78.3%). However, the primary safety endpoint was not achieved (p = 0.131), primarily attributable to the greater surgical complexity of the M-Trap patient population. 62% of recurrent patients demonstrated tumor cell capture in at least one device with a minimal tumor cell infiltration. No other long-term device-related adverse events were reported. The secondary performance endpoint demonstrated a lack of disease focalization. CONCLUSIONS: The M-Trap technology failed to meet its primary safety objective, although when adjusted for surgical complexity, the study approved it. Likewise, the devices did not demonstrate the anticipated benefits in terms of tumor cell capture and disease focalization in recurrent ovarian cancer.


Assuntos
Carcinoma Epitelial do Ovário/cirurgia , Procedimentos Cirúrgicos de Citorredução/instrumentação , Recidiva Local de Neoplasia/cirurgia , Neoplasias Ovarianas/cirurgia , Neoplasias Peritoneais/cirurgia , Adulto , Idoso , Carcinoma Epitelial do Ovário/secundário , Feminino , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Recidiva Local de Neoplasia/patologia , Neoplasias Ovarianas/patologia , Neoplasias Peritoneais/secundário , Estudos Prospectivos , Espanha , Resultado do Tratamento
17.
Sci Rep ; 11(1): 8111, 2021 04 14.
Artigo em Inglês | MEDLINE | ID: mdl-33854085

RESUMO

The standard treatment for advanced ovarian cancer (AOC) is cytoreduction surgery and adjuvant chemotherapy. Tumor volume after surgery is a major prognostic factor for these patients. The ability to perform complete cytoreduction depends on the extent of disease and the skills of the surgical team. Several predictive models have been proposed to evaluate the possibility of performing complete cytoreductive surgery (CCS). External validation of the prognostic value of three predictive models (Fagotti index and the R3 and R4 models) for predicting suboptimal cytoreductive surgery (SCS) in AOC was performed in this study. The scores of the 3 models were evaluated in one hundred and three consecutive patients diagnosed with AOC treated in a tertiary hospital were evaluated. Clinicopathological features were collected prospectively and analyzed retrospectively. The performance of the three models was evaluated, and calibration and discrimination were analyzed. The calibration of the Fagotti, R3 and R4 models showed odds ratios of obtaining SCSs of 1.5, 2.4 and 2.4, respectively, indicating good calibration. The discrimination of the Fagotti, R3 and R4 models showed an area under the ROC curve of 83%, 70% and 81%, respectively. The negative predictive values of the three models were higher than the positive predictive values for SCS. The three models were able to predict suboptimal cytoreductive surgery for advanced ovarian cancer, but they were more reliable for predicting CCS. The R4 model discriminated better because it includes the laparotomic evaluation of the peritoneal carcinomatosis index.


Assuntos
Neoplasias Ovarianas/cirurgia , Idoso , Área Sob a Curva , Procedimentos Cirúrgicos de Citorredução , Análise Discriminante , Feminino , Humanos , Laparoscopia , Modelos Logísticos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Razão de Chances , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/patologia , Valor Preditivo dos Testes , Prognóstico , Curva ROC , Estudos Retrospectivos , Centros de Atenção Terciária
18.
Med Ultrason ; 23(2): 168-175, 2021 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-33626112

RESUMO

AIMS: To compare the diagnostic performance of two ultrasound-based diagnostic systems for the classification of benign or malignant adnexal masses, the three-step strategy and the predictive logistic regression model LR2, both proposed by the International Ovarian Tumour Analysis (IOTA) Group. MATERIAL AND METHODS: Prospective observational study at a single centre that included patients diagnosed with a persistent adnexal mass by transvaginal ultrasound over a period of two years. They were evaluated by a non-expert sonographer by applying the three-step diagnostic strategy and the LR2 predictive model to classify the masses as benign or malignant. Patients were treated surgically or followed up for at least one year, taking as the standard reference for benignity or malignancy the histological diagnosis of the lesion or ultrasound changes suggestive of malignancy during the follow-up period. Sensitivity, specificity, positive and negative likelihood ratios and overall accuracy of both systems was calculated and compared. RESULTS: One hundred patients were included, with a mean age of 50.6 years (range 18-87). Surgery was performed on 62 (62%) patients and 38 (38%) were managed expectantly. Eighty-three (83%) lesions were benign and 17 (17%) were malignant. The IOTA three-step strategy presented sensitivity of 94.1% (95%CI, 86.7-98.3%) and specificity 97.6% (95%CI, 94.8-99%). The LR2 logistic regression model showed sensitivity 94.1% (95%CI, 73-98.9%) and specificity 81.9% (95%CI 72.3-88.7%). Comparison of the two systems showed a statistically significant dif-ference in specificity in favour of the three-step strategy. CONCLUSIONS: The IOTA three-step strategy, in addition to being sim-ple to use in clinical practice, has a high diagnostic accuracy for the classification of benignity and malignancy of the adnexal masses, overtaking that of other predictive models such as the LR2 logistic regression model.


Assuntos
Doenças dos Anexos , Neoplasias Ovarianas , Doenças dos Anexos/diagnóstico por imagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Diagnóstico Diferencial , Feminino , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Neoplasias Ovarianas/diagnóstico por imagem , Ultrassonografia , Adulto Jovem
19.
Cancer Manag Res ; 13: 13-23, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33442290

RESUMO

BACKGROUND: Advanced ovarian cancer (AOC) requires an aggressive surgery with large visceral resections in order to achieve an optimal or complete cytoreduction and increase the patient's survival. However, the surgical aggressiveness in the treatment of AOC is not exempt from major complications, such as the gastrointestinal fistula (GIF), which stands out among others due to its high morbidity and mortality. METHODS: We evaluated the clinicopathological features in patients with AOC and their association with GI. Data for 107 patients with AOC who underwent primary debulking surgery were analyzed retrospectively. Clinicopathological features, including demographic, surgical procedures and follow-up data, were analyzed in relation to GIF. RESULTS: GIF was present in 11% of patients in the study, 5 (4.5%) and 7 (6.4%) of colorectal and small bowel origin, respectively. GIF was significantly associated with peritoneal cancer index (PCI) >20, more than 2 visceral resections, and multiple digestive resections. Overall and disease-free survival were also associated with GIF. Multivariate analysis identified partial bowel obstruction and operative bleeding as independent prognostic factors for survival. The presence of GIF is positively associated with poor prognosis in patients with AOC. CONCLUSION: Given the importance of successful cytoreductive surgery in AOC, the assessment of the amount of tumor and the aggressiveness of the surgery to avoid the occurrence of GIF become a priority in patients with AOC.

20.
J Gynecol Oncol ; 32(1): e4, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33185045

RESUMO

OBJECTIVE: The prognostic impact of surgical paraaortic staging remains unclear in patients with locally advanced cervical cancer (LACC). The objective of our study was to evaluate the results of the surgical technique of preoperative aortic lymphadenectomy in LACC related to tumor burden and disease spread to assess its influence on survival. METHODS: Data of 1,072 patients with cervical cancer were taken from 11 Spanish hospitals (Spain-Gynecologic Oncology Group [GOG] working group). Complete aortic lymphadenectomy surgery (CALS) was considered when the lymph nodes (LNs) were excised up to the left renal vein. The extent of the disease was performed evaluating the LNs by calculating the geometric means and quantifying the log odds between positive LNs and negative LNs. The Kaplan-Meier method was used to estimate the survival distribution. A Cox proportional hazards model was used to account for the influence of multiple variables. RESULTS: A total of 394 patients were included. Pathological analysis revealed positive aortic LNs in 119 patients (30%). LODDS cut-off value of -2 was established as a prognostic indicator. CALS and LODDS <-2 were associated with better disease free survival and overall survival than suboptimal aortic lymphadenectomy surgery and LODDS ≥-2. In a multivariate model analysis, CALS is revealed as an independent prognostic factor in LACC. CONCLUSION: When performing preoperative surgical staging in LACC, it is not advisable to take simple samples from the regional nodes. Radical dissection of the aortic and pelvic regions offers a more reliable staging of the LNs and has a favorable influence on survival.


Assuntos
Neoplasias do Colo do Útero , Feminino , Humanos , Excisão de Linfonodo , Linfonodos/patologia , Linfonodos/cirurgia , Metástase Linfática , Estadiamento de Neoplasias , Prognóstico , Estudos Retrospectivos , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/cirurgia
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