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1.
PLoS One ; 16(12): e0260255, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34879081

RESUMO

PURPOSE: To identify patient and hospital characteristics associated with extended surgical cytoreduction in the treatment of ovarian cancer. METHODS: A retrospective analysis using the National Inpatient Sample (NIS) database identified women hospitalized for surgery to remove an ovarian malignancy between 2013 and 2017. Extended cytoreduction (ECR) was defined as surgery involving the bowel, liver, diaphragm, bladder, stomach, or spleen. Chi-square and logistic regression were used to analyze patient and hospital demographics related to ECR, and trends were assessed using the Cochran-Armitage test. RESULTS: Of the estimated 79,400 patients undergoing ovarian cancer surgery, 22% received ECR. Decreased adjusted odds of ECR were found in patients with lower Elixhauser Comorbidity Index (ECI) scores (OR 0.61, p<0.001 for ECI 2, versus ECI≥3) or residence outside the top income quartile (OR 0.71, p<0.001 for Q1, versus Q4), and increased odds were seen at hospitals with high ovarian cancer surgical volume (OR 1.25, p<0.001, versus low volume). From 2013 to 2017, there was a decrease in the proportion of cases with extended procedures (19% to 15%, p<0.001). There were significant decreases in the proportion of cases with small bowel, colon, and rectosigmoid resections (p<0.001). Patients who underwent ECR were more likely treated at a high surgical volume hospital (37% vs 31%, p<0.001) over the study period. For their hospital admission, patients who underwent ECR had increased mortality (1.6% vs. 0.5%, p<0.001), length of stay (9.6 days vs. 5.2 days, p<0.001), and mean cost ($32,132 vs. $17,363, p<0.001). CONCLUSIONS: Likelihood of ECR was associated with increased medical comorbidity complexity, higher income, and undergoing the procedure at high surgical volume hospitals. The proportion of ovarian cancer cases with ECR has decreased from 2013-17, with more cases performed at high surgical volume hospitals.


Assuntos
Procedimentos Cirúrgicos de Citorredução/tendências , Neoplasias Ovarianas/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos de Citorredução/economia , Feminino , Hospitais com Alto Volume de Atendimentos , Humanos , Tempo de Internação , Modelos Logísticos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Estudos Retrospectivos , Resultado do Tratamento
2.
Gynecol Oncol ; 161(1): 56-62, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33536126

RESUMO

OBJECTIVE: To determine if laparoscopy is a cost-effective way to assess disease resectability in patients with newly diagnosed advanced ovarian cancer. METHODS: A cost-effectiveness analysis from a health care payer perspective was performed comparing two strategies: (1) a standard evaluation strategy, where a conventional approach to treatment planning was used to assign patients to either primary cytoreduction (PCS) or neoadjuvant chemotherapy with interval cytoreduction (NACT), and (2) a laparoscopy strategy, where patients considered candidates for PCS would undergo laparoscopy to triage between PCS or NACT based on the laparoscopy-predicted likelihood of complete gross resection. A microsimulation model was developed that included diagnostic work-up, surgical and adjuvant treatment, perioperative complications, and progression-free survival (PFS). Model parameters were derived from the literature and our published data. Effectiveness was defined in quality-adjusted PFS years. Results were tested with deterministic and probabilistic sensitivity analysis (PSA). The willingness-to-pay (WTP) threshold was set at $50,000 per year of quality-adjusted PFS. RESULTS: The laparoscopy strategy led to additional costs (average additional cost $7034) but was also more effective (average 4.1 months of additional quality-adjusted PFS). The incremental cost-effectiveness ratio (ICER) of laparoscopy was $20,376 per additional year of quality-adjusted PFS. The laparoscopy strategy remained cost-effective even as the cost added by laparoscopy increased. The benefit of laparoscopy was influenced by mitigation of serious complications and their associated costs. The laparoscopy strategy was cost-effective across a range of WTP thresholds. CONCLUSIONS: Performing laparoscopy is a cost-effective way to improve primary treatment planning for patients with untreated advanced ovarian cancer.


Assuntos
Laparoscopia/economia , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/cirurgia , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Humanos , Laparoscopia/métodos , Modelos Econômicos , Modelos Estatísticos , Neoplasias Ovarianas/economia , Estados Unidos
3.
Eur J Surg Oncol ; 47(4): 828-833, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32972815

RESUMO

BACKGROUND: Cost-effective cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for treatment of patients with peritoneal malignancy remains an ongoing financial challenge for healthcare systems, hospitals and patients. This study aims to describe the detailed in-hospital costs of CRS and HIPEC compared with an Australian Activity Based Funding (ABF) system, and to evaluate how the learning curve, disease entities and surgical outcomes influence in-hospital costs. METHODS: A retrospective descriptive costing review of all CRS and HIPEC cases undertaken at a large public tertiary referral hospital in Sydney, Australia from April 2017 to June 2019. In-hospital cost variables included staff, critical care, diagnosis, operating theatre, and other costs. Univariate and multivariate analyses were conducted to investigate the differences between actual cost and the provision of funding, and potential factors associated with these costs. RESULTS: Of the 118 CRS and HIPEC procedures included in the analyses, the median total cost was AU$130,804 (IQR: 105,744 to 153,972). Provision of funding via the ABF system was approximately one-third of the total CRS and HIPEC costs (p < 0.001). Surgical staff proficiency seems to reduce the total CRS and HIPEC costs. Surgical time, length of intensive care unit and hospital stay are the main predictors of total CRS and HIPEC costs. CONCLUSION: Delivery of CRS and HIPEC is expensive with high variability. A standard ABF system grossly underestimates the specific CRS and HIPEC funding required with supplementation essential to sustaining this complex highly specialised service.


Assuntos
Procedimentos Cirúrgicos de Citorredução/economia , Custos Hospitalares/estatística & dados numéricos , Hospitais Públicos/economia , Quimioterapia Intraperitoneal Hipertérmica/economia , Neoplasias Peritoneais/economia , Neoplasias Peritoneais/terapia , Idoso , Austrália , Competência Clínica , Custos e Análise de Custo , Cuidados Críticos/economia , Técnicas e Procedimentos Diagnósticos/economia , Feminino , Financiamento Governamental/métodos , Pessoal de Saúde/economia , Humanos , Curva de Aprendizado , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Salas Cirúrgicas/economia , Duração da Cirurgia , Neoplasias Peritoneais/diagnóstico , Estudos Retrospectivos
4.
Eur J Surg Oncol ; 46(4 Pt A): 607-612, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31982207

RESUMO

INTRODUCTION: This study aimed to evaluate the costs of CRS and HIPEC and treatment of the related postoperative complications in the public healthcare system. We also aimed to identify the risk factors that increase the cost of CRS and HIPEC. MATERIALS AND METHODS: We retrospectively evaluated 80 patients who underwent CRS and HIPEC between February 2016 and November 2018 in the Department of Surgery, University Hospital of Olomouc, Czech Republic. Intraoperative factors and postoperative complications were assessed. The treatment cost included the surgery, hospital stay, intensive care unit (ICU) admission, pharmaceutical charges including medication, hospital supplies, pathology, imaging, and allied healthcare services. RESULTS: The postoperative morbidity rate was 50%, and the mortality rate was 2.5%. The mean length of hospitalisation and ICU admission was 15.44 ± 8.43 and 6.15 ± 4.12 for all 80 patients and 10.73 ± 2.93 and 3.73 ± 1.32, respectively, for 40 patients without complications, and 20.15 ± 13.93 and 8.58 ± 6.92, respectively, for 40 patients with complications. The total treatment cost reached €606,358, but the total reimbursement was €262,931; thus, the CRS and HIPEC profit margin was €-343,427. Multivariate analysis showed that blood loss ≥1.000 ml (p = 0.03) and grade I-V Clavien-Dindo complications (p < 0.001) were independently associated with increased costs. CONCLUSION: The Czech public health insurance system does not fully compensate for the costs of CRS and HIPEC. Hospital losses remain the main limiting factor for further improving these procedures. Furthermore, treatment costs increase with increasing severity of postoperative complications.


Assuntos
Procedimentos Cirúrgicos de Citorredução/economia , Financiamento Governamental , Hipertermia Induzida/economia , Reembolso de Seguro de Saúde/estatística & dados numéricos , Seguro Saúde , Neoplasias Peritoneais/terapia , Complicações Pós-Operatórias/economia , Adulto , Idoso , Neoplasias do Apêndice/patologia , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Neoplasias Colorretais/patologia , Custos e Análise de Custo , República Tcheca/epidemiologia , Diagnóstico por Imagem/economia , Equipamentos e Provisões Hospitalares/economia , Feminino , Financiamento da Assistência à Saúde , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva/economia , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Neoplasias Ovarianas/patologia , Neoplasias Peritoneais/secundário , Assistência Farmacêutica/economia , Complicações Pós-Operatórias/epidemiologia
5.
J Natl Cancer Inst ; 112(10): 1063-1066, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31854444

RESUMO

The effect of the Dependent Coverage Expansion (DCE) under the Affordable Care Act (ACA) on receipt of colorectal cancer treatment has yet to be determined. We identified newly diagnosed DCE-eligible (aged 19-25 years, n = 1924) and DCE-ineligible (aged 27-34 years, n = 8313) colorectal cancer patients from the National Cancer Database from 2007 to 2013. All statistical tests were two-sided. Post-ACA, there was a statistically significant increase in early-stage diagnosis among DCE-eligible (15 percentage point increase, confidence interval = 9.8, 20.2; P < .001), but not DCE-ineligible (P = .09), patients. DCE-eligible patients resected for IIB-IIIC colorectal cancer were more likely to receive timely adjuvant chemotherapy (hazard ratio = 1.34, 95% confidence interval = 1.05 to 1.71; 7.0 days' decrease in restricted mean time from surgery to chemotherapy, P = .01), with no differences in DCE-ineligible patients (hazard ratio = 1.10, 95% confidence interval = 0.98 to 1.24; 2.1 days' decrease, P = .41) post-ACA. Our findings highlight the role of the ACA in improving access to potentially lifesaving cancer care, including a shift to early-stage diagnosis and more timely receipt of adjuvant chemotherapy.


Assuntos
Neoplasias Colorretais/economia , Neoplasias Colorretais/terapia , Patient Protection and Affordable Care Act/estatística & dados numéricos , Adulto , Quimioterapia Adjuvante/economia , Quimioterapia Adjuvante/estatística & dados numéricos , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/estatística & dados numéricos , Detecção Precoce de Câncer/economia , Detecção Precoce de Câncer/estatística & dados numéricos , Feminino , Humanos , Masculino , Modelos de Riscos Proporcionais , Estados Unidos/epidemiologia , Adulto Jovem
6.
J Surg Oncol ; 120(3): 397-406, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31236957

RESUMO

BACKGROUND AND OBJECTIVE: Financial hardship occurring as a result of cancer treatment has been termed financial toxicity and is an established side effect of the cancer treatment. We investigated the risk of financial toxicity among patients undergoing surgery for gastrointestinal cancers. METHODS: All uninsured and privately insured patients who underwent surgery for a gastrointestinal cancer were identified from the National Inpatient Sample. Publicly available government data were used estimate income, food expenditure, and average maximum out-of-pocket expenditure. Risk of financial toxicity was defined as health expenditure ≥ 40% of postsubsistence income. RESULTS: Among the 78 545 patients in the analytic cohort, 73 305 individuals had private insurance while 5240 patients were uninsured. Overall median hospital charges were $58 651 (IQR: $37 912-$95 379). Approximately 90% of uninsured and 10% of privately insured patients were at risk of financial toxicity. At the subpopulation level, patients in the lowest income quartile, undergoing emergency surgery, black or hispanic individuals, and those undergoing surgery for esophageal or colon cancer were more likely to experience catastrophic costs following surgery (P < .001). CONCLUSION: Approximately 9 in 10 uninsured and 1 in 10 privately insured patients with cancer were at risk of financial toxicity after the surgery. Targeted interventions are needed to provide financial protection to patients undergoing the cancer treatment.


Assuntos
Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos do Sistema Digestório/economia , Neoplasias Gastrointestinais/economia , Neoplasias Gastrointestinais/cirurgia , Adolescente , Adulto , Idoso , Estudos de Coortes , Feminino , Financiamento Pessoal/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Custos Hospitalares/estatística & dados numéricos , Humanos , Pacientes Internados , Seguro Saúde/estatística & dados numéricos , Masculino , Pessoas sem Cobertura de Seguro de Saúde/estatística & dados numéricos , Pessoa de Meia-Idade , Estados Unidos , Adulto Jovem
7.
J Clin Oncol ; 37(23): 2041-2050, 2019 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-31251694

RESUMO

PURPOSE: In the randomized open-label phase III OVHIPEC trial, the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improved recurrence-free and overall survival in patients with stage III ovarian cancer. We studied the cost effectiveness of the addition of HIPEC to interval CRS in patients with ovarian cancer. PATIENTS AND METHODS: We constructed a Markov health-state transition model to measure costs and clinical outcomes. Transition probabilities were derived from the OVHIPEC trial by fitting survival distributions. Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY), was calculated from a Dutch societal perspective, with a time horizon of 10 years. Univariable and probabilistic sensitivity analyses were conducted to evaluate the decision uncertainty. RESULTS: Total health care costs were €70,046 (95% credibility interval [CrI], €64,016 to €76,661) for interval CRS compared with €85,791 (95% CrI, €78,766 to €93,935) for interval CRS plus HIPEC. The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group. The ICER amounted to €28,299/QALY. In univariable sensitivity analysis, the utility of recurrence-free survival and the number of days in the hospital affected the calculated ICER most. CONCLUSION: On the basis of the trial data, treatment with interval CRS and HIPEC in patients with stage III ovarian cancer was accompanied by a substantial gain in QALYs. The ICER is below the willingness-to-pay threshold in the Netherlands, indicating interval CRS and HIPEC is cost effective for this patient population. These results lend additional support for reimbursing the costs of treating these patients with interval CRS and HIPEC in countries with comparable health care systems.


Assuntos
Procedimentos Cirúrgicos de Citorredução/economia , Neoplasias Ovarianas/economia , Neoplasias Ovarianas/cirurgia , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Humanos , Estadiamento de Neoplasias , Neoplasias Ovarianas/mortalidade , Neoplasias Ovarianas/patologia , Análise de Sobrevida
8.
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
9.
Am J Obstet Gynecol ; 221(2): 136.e1-136.e9, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30965052

RESUMO

BACKGROUND: Communicating healthcare costs to patients is an important component of delivering high-quality value-based care, yet cost data are lacking. This is especially relevant for ovarian cancer, where no clinical consensus on optimal first-line treatment exists. OBJECTIVE: The objective of this study was to generate cost estimates of different primary management strategies in ovarian cancer. STUDY DESIGN: All women who underwent treatment for ovarian cancer from 2006-2015 were identified from the MarketScan database (n=12,761) in this observational cohort study. Total and out-of-pocket costs were calculated with the use of all claims within 8 months from initial treatment and normalized to 2017 US dollars. The generalized linear model method was used to assess cost by strategy. RESULTS: Among patients who underwent neoadjuvant chemotherapy and those who underwent primary debulking, mean adjusted total costs were $113,660 and $107,153 (P<.001) and mean out-of-pocket costs were $2519 and $2977 (P<.001), respectively. Total costs for patients who had intravenous standard, intravenous dose-dense, and intraperitoneal/intravenous chemotherapy were $105,047, $115,099, and $121,761 (P<.001); and out-of-pocket costs were $2838, $3405, and $2888 (P<.001), respectively. Total costs for regimens that included bevacizumab were higher than those without it ($171,468 vs $104,482; P<.001); out-of-pocket costs were $3127 vs $2898 (P<.001). Among patients who did not receive bevacizumab, 25% paid ≥$3875, and 10% paid ≥$6265. For patients who received bevacizumab, 25% paid ≥$4480, and 10% paid ≥$6635. Among patients enrolled in high-deductible health plans, median out-of-pocket costs were $4196, with 25% paying ≥$6680 and 10% paying ≥$9751. CONCLUSION: Costs vary across different treatment strategies, and patients bear a significant out-of-pocket burden, especially those enrolled in high-deductible health plans.


Assuntos
Custos de Cuidados de Saúde/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Neoplasias Ovarianas/economia , Idoso , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Bevacizumab/economia , Bevacizumab/uso terapêutico , Quimioterapia Adjuvante/economia , Estudos de Coortes , Procedimentos Cirúrgicos de Citorredução/economia , Dedutíveis e Cosseguros/economia , Feminino , Humanos , Modelos Lineares , Pessoa de Meia-Idade , Terapia Neoadjuvante/economia , Neoplasias Ovarianas/epidemiologia , Neoplasias Ovarianas/terapia , Estudos Retrospectivos , Estados Unidos/epidemiologia
10.
Gynecol Oncol ; 153(2): 376-380, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30718126

RESUMO

OBJECTIVES: A recent randomized controlled trial demonstrated an overall survival benefit to the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to neoadjuvant chemotherapy (NACT) for stage III epithelial ovarian cancer (EOC). The objective of the current study was to quantify the cost-effectiveness of HIPEC in this setting. METHODS: A decision analytic cost-effectiveness model was designed from a payer perspective to compare 2 surgical management strategies for EOC: (1) interval cytoreductive surgery (ICS); (2) ICS + HIPEC. Overall survival and ostomy rates with HIPEC were modeled from published studies. We assumed that 25% of each arm would later undergo secondary cytoreductive surgery, with the ICS arm eligible for HIPEC at that time. Costs were obtained from Medicare data, published studies, and the financial department of an academic hospital. Quality of life was not different between the arms; we assigned utilities based on a prior time-trade off study of ovarian cancer treatment. A Monte Carlo probabilistic sensitivity analysis was performed in the base case; primary outcome was the incremental cost-effectiveness ratio (ICER), expressed in 2017 US Dollars/quality-adjusted life years (QALYs). RESULTS: ICS was the least costly strategy at $78,849, compared to ICS + HIPEC at $79,954. ICS + HIPEC was more effective than ICS (2.9 QALYs versus 2.45 QALYs for ICS). ICS + HIPEC was highly cost-effective, with an ICER of $2436/QALY compared to ICS. In one-way sensitivity analyses, probability of ostomy reversal and use of HIPEC at secondary cytoreduction did not substantially impact the cost-effectiveness of ICS + HIPEC. CONCLUSION: ICS + HIPEC constitutes cost-effective management of stage III EOC when NACT is performed.


Assuntos
Carcinoma Epitelial do Ovário/terapia , Hipertermia Induzida/economia , Carcinoma Epitelial do Ovário/tratamento farmacológico , Carcinoma Epitelial do Ovário/economia , Carcinoma Epitelial do Ovário/cirurgia , Quimioterapia Adjuvante , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/métodos , Técnicas de Apoio para a Decisão , Feminino , Humanos , Hipertermia Induzida/métodos , Terapia Neoadjuvante , Estadiamento de Neoplasias , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos
11.
BMC Cancer ; 19(1): 58, 2019 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-30642296

RESUMO

BACKGROUND: The most important goal for survival benefit of advanced stage ovarian cancer is to surgically remove all visible tumour, because complete cytoreductive surgery (CCS) has been shown to be associated with prolonged survival. In a remarkable number of women, CCS is very challenging. Especially in women with many small metastases on the peritoneum and intestinal surface, conventional CCS with electrosurgery is not able to be "complete" in removing safely all visible tumour. In this randomized controlled trail (RCT) we investigate whether the use of the PlasmaJet Surgical Device increases the rate of CCS, and whether this indeed leads to a longer progression free and overall survival. The main research question is: does the use of the PlasmaJet Surgical Device in surgery for advanced stage ovarian cancer result in an increased number of complete cytoreductive surgeries when compared with conventional surgical techniques. Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, Quality of Life, disease-free survival, overall survival, percentage colostomy, cost-effectiveness. METHODS: The study design is a multicentre single-blinded superiority RCT in two university and nine non-university hospitals in The Netherlands. Three hundred and thirty women undergoing cytoreductive surgery for advanced stage ovarian carcinoma (FIGO Stage IIIB-IV) will be randomized into two arms: use of the PlasmaJet (intervention group) versus the use of standard surgical instruments combined with electrocoagulation (control group). The primary outcome is the rate of complete cytoreductive surgery in both groups. Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, Quality of Life, disease-free survival, overall survival, percentage colostomy, cost-effectiveness. Quality of life will be evaluated using validated questionnaires at baseline, at 1 and 6 months after surgery and at 1, 2, 3 and 4 years after surgery. DISCUSSION: We hypothesize the additional value of the use of the PlasmaJet in CCS for advanced stage epithelial ovarian cancer. More knowledge about efficacy, side effects, recurrence rates, cost effectiveness and pathology findings after using the PlasmaJet Device is advocated. This RCT may aid in this void. TRIAL REGISTRATION: Dutch Trial Register NTR6624 . Registered 18 August 2017. Medical Ethical Committee approval number: NL62035.078.17 (Medical Ethical Committee Erasmus Medical Centre Rotterdam).


Assuntos
Procedimentos Cirúrgicos de Citorredução , Neoplasias Ovarianas/patologia , Neoplasias Ovarianas/cirurgia , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Humanos , Metástase Neoplásica , Estadiamento de Neoplasias , Países Baixos , Neoplasias Ovarianas/mortalidade , Qualidade de Vida , Resultado do Tratamento
12.
Ann Surg Oncol ; 26(4): 1110-1117, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30690682

RESUMO

BACKGROUND: Cost-effectiveness evaluations of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of peritoneal carcinomatosis (PC) from metastatic colorectal cancer (mCRC) in the United States are lacking. METHODS: The authors developed a Markov model to evaluate the cost-effectiveness of CRS/HIPEC compared with systemic chemotherapy for isolated PC from mCRC from a societal perspective in the United States. The systemic treatment regimens consisted of FOLFOX, FOLFIRI, bevacizumab, cetuximab, and pantitumumab. The model inputs including costs, probabilities, survival, progression, and utilities were taken from the literature. The cycle length for the model was 2 weeks, and the time horizon was 7 years. A discount rate of 3% was applied. The model was tested for internal and external validation, and robustness was established with univariate sensitivity and probabilistic sensitivity analyses (PSA). The primary outcomes were total costs, quality-adjusted life-years (QALYs), life-years (LYs), and incremental cost-effectiveness ratio (ICER). A willingness-to-pay (WTP) threshold of $100,000 per QALY was assumed. RESULTS: The ICER for treatment with CRS/HIPEC compared with systemic chemotherapy was $91,034 per QALY gained ($74,098 per LY gained). The univariate sensitivity analysis showed that the total costs for treatment with CRS/HIPEC had the largest effect on the calculated ICER. The CRS/HIPEC treatment was a cost-effective strategy during the majority of simulations in the PSA. The average ICER for 100,000 simulations in the PSA was $70,807 per QALY gained. The likelihood of CRS/HIPEC being a cost-effective strategy at the WTP threshold was 87%. CONCLUSIONS: The CRS/HIPEC procedure is a cost-effective treatment for isolated PC from mCRC in the United States.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/economia , Quimioterapia do Câncer por Perfusão Regional/economia , Neoplasias Colorretais/economia , Procedimentos Cirúrgicos de Citorredução/economia , Hipertermia Induzida/economia , Neoplasias Peritoneais/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimioterapia do Câncer por Perfusão Regional/métodos , Neoplasias Colorretais/patologia , Neoplasias Colorretais/terapia , Terapia Combinada , Procedimentos Cirúrgicos de Citorredução/métodos , Humanos , Hipertermia Induzida/métodos , Cadeias de Markov , Metanálise como Assunto , Neoplasias Peritoneais/secundário , Neoplasias Peritoneais/terapia , Prognóstico , Taxa de Sobrevida
14.
Gynecol Oncol ; 151(1): 117-123, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30100053

RESUMO

OBJECTIVE: Enhanced recovery pathways have been shown to reduce length of stay without increasing readmission or complications in numerous areas of surgery. Uptake of gynecologic oncology ERAS guidelines has been limited. We describe the effect of ERAS guideline implementation in gynecologic oncology on length of stay, patient outcomes, and economic impact for a province-wide single-payer system. METHODS: We compared pre- and post-guideline implementation outcomes in consecutive staging and debulking patients at two centers that provide the majority of surgical gynecologic oncology care in Alberta, Canada between March 2016 and April 2017. Clinical outcomes and compliance were obtained using the ERAS Interactive Audit System. Patients were followed until 30 days after discharge. Negative binomial regression was employed to adjust for patient characteristics. RESULTS: We assessed 152 pre-ERAS and 367 post-ERAS implementation patients. Mean compliance with ERAS care elements increased from 56% to 77.0% after implementation (p < 0.0001). Median length of stay for all surgeries decreased from 4.0 days to 3.0 days post-ERAS (p < 0.0001), which translated to an adjusted LOS decrease of 31.4% (95% CI = [21.7% - 39.9%], p < 0.0001). In medium/high complexity surgery median LOS was reduced by 2.0 days (p = 0.0005). Complications prior to discharge decreased from 53.3% to 36.2% post-ERAS (p = 0.0003). There was no significant difference in readmission (p = 0.6159), complications up to 30 days (p = 0.6274), or mortality (p = 0.3618) between the cohorts. The net cost savings per patient was $956 (95%CI: $162 to $1636). CONCLUSIONS: Systematic implementation of ERAS gynecologic oncology guidelines across a healthcare system improves patient outcomes and saves resources.


Assuntos
Neoplasias dos Genitais Femininos/cirurgia , Fidelidade a Diretrizes/estatística & dados numéricos , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Assistência Perioperatória/normas , Complicações Pós-Operatórias/epidemiologia , Idoso , Redução de Custos , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Neoplasias dos Genitais Femininos/economia , Procedimentos Cirúrgicos em Ginecologia/economia , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Auditoria Médica , Pessoa de Meia-Idade , Alta do Paciente/estatística & dados numéricos , Readmissão do Paciente/economia , Readmissão do Paciente/estatística & dados numéricos , Assistência Perioperatória/economia , Assistência Perioperatória/métodos , Guias de Prática Clínica como Assunto , Avaliação de Programas e Projetos de Saúde
16.
Eur Urol ; 74(6): 693-696, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30037529

RESUMO

Cytoreductive radical prostatectomy (CRP) may offer a survival advantage, according to several retrospective analyses. However, few data are available regarding the morbidity of radical prostatectomy in the metastatic setting. We addressed intra- and postoperative complications of CRP relative to radical prostatectomy for nonmetastatic prostate cancer (nmRP). Within the National Inpatient Sample database (2008-2013), we identified patients who underwent CRP versus nmRP. Propensity score matching to reduce the effect of inherent differences between CRP and nmRP patients, multivariable logistic regression models, Poisson regression models, and linear regression models were used. Of 76 378 patients, 1.2% (n=953) underwent CRP. CRP resulted in higher rates of overall (odds ratio [OR]: 1.34, p=0.01), intraoperative (OR: 2.61, p=0.005), and miscellaneous surgical complications (OR: 1.69, p=0.02). Moreover, CRP was associated with longer stay (OR: 1.07, p=0.01) and higher total hospital charges ($810 more per surgery, p=0.0004). Intra- and postoperative complications associated with CRP are higher than those of nmRP. Similarly, an increase in total hospital charges is associated with CRP. Nonetheless, CRP complication profile validates its safety and feasibility. PATIENT SUMMARY: In this population-based study, we recorded higher intra- and postoperative complications rates for CRP versus nmRP. Nonetheless, CRP complication rates appear manageable but require explicit discussion at counseling.


Assuntos
Procedimentos Cirúrgicos de Citorredução/métodos , Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Idoso , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/mortalidade , Bases de Dados Factuais , Preços Hospitalares , Custos Hospitalares , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Prostatectomia/efeitos adversos , Prostatectomia/economia , Prostatectomia/mortalidade , Neoplasias da Próstata/economia , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/patologia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
17.
Ann Surg Oncol ; 25(8): 2340-2346, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29948417

RESUMO

BACKGROUND: Peritoneal carcinomatosis from colorectal cancer is a stage 4 disease for which palliative chemotherapy has traditionally been considered the mainstay of treatment. Since the development of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) by Sugarbaker, this combined method treatment has resulted in improved survival outcomes with acceptable morbidity for selected patients with peritoneal carcinomatosis. This study examined the cost effectiveness of CRS and HIPEC compared with palliative chemotherapy for patients with peritoneal carcinomatosis from colorectal cancer within the context of the Singaporean health care system. METHODS: A retrospective review of patients with peritoneal carcinomatosis from histologically proven colorectal cancer treated at the National Cancer Centre Singapore (NCCS) was conducted. RESULTS: The average cost of CRS and HIPEC per patient was S$83,680.26, and the median overall survival period was 47 months. The calculated cost per life year attained for a patient who underwent CRS and HIPEC was S$21,365.19 per life year. In comparison, the average cost of palliative chemotherapy was S$44,478.87, with a median overall survival of 9 months, and the calculated cost per life year attained for a patient in this treatment group was S$59,305.16 per life year. CONCLUSION: The findings show that CRS and HIPEC results in prolonged survival for selected patients with colorectal peritoneal carcinomatosis and a lower cost per life year attained than for the traditionally used palliative chemotherapy. It should logically be the preferred treatment of choice for selected patients with colorectal peritoneal metastasis.


Assuntos
Quimioterapia do Câncer por Perfusão Regional/economia , Neoplasias Colorretais/economia , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Hipertermia Induzida/economia , Recidiva Local de Neoplasia/economia , Neoplasias Peritoneais/economia , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Colorretais/patologia , Neoplasias Colorretais/terapia , Terapia Combinada , Gerenciamento Clínico , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/terapia , Neoplasias Peritoneais/patologia , Neoplasias Peritoneais/terapia , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida
18.
Int J Gynecol Cancer ; 28(6): 1077-1084, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29683880

RESUMO

OBJECTIVES: Neoadjuvant chemotherapy (NACT) versus primary debulking surgery (PDS) for advanced epithelial ovarian cancer (AEOC) remains controversial in the United States. Generalizability of existing trial results has been criticized because of less aggressive debulking procedures than commonly used in the United States. As a result, economic evaluations using input data from these trials may not accurately reflect costs and outcomes associated with more aggressive primary surgery. Using data from an ongoing trial performing aggressive debulking, we investigated the cost-effectiveness and cost-utility of NACT versus PDS for AEOC. METHODS: A decision tree model was constructed to estimate differences in short-term outcomes and costs for a hypothetical cohort of 15,000 AEOC patients (US annual incidence of AEOC) treated with NACT versus PDS over a 1-year time horizon from a Medicare payer perspective. Outcomes included costs per cancer-related death averted, life-years and quality-adjusted life-years (QALYs) gained. Base-case probabilities, costs, and utilities were based on the Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasms trial. Base-case analyses assumed equivalent survival; threshold analysis estimated the maximum survival difference that would result in NACT being cost-effective at $50,000/QALY and $100,000/QALY willingness-to-pay thresholds. Probabilistic sensitivity analysis was used to characterize model uncertainty. RESULTS: Compared with PDS, NACT was associated with $142 million in cost savings, 1098 fewer cancer-related deaths, and 1355 life-years and 1715 QALYs gained, making it the dominant treatment strategy for all outcomes. In sensitivity analysis, NACT remained dominant in 99.3% of simulations. Neoadjuvant chemotherapy remained cost-effective at $50,000/QALY and $100,000/QALY willingness-to-pay thresholds if survival differences were less than 2.7 and 1.4 months, respectively. CONCLUSIONS: In the short term, NACT is cost-saving with improved outcomes. However, if PDS provides a longer-term survival advantage, it may be cost-effective. Research is needed on the role of patient preferences in tradeoffs between survival and quality of life.


Assuntos
Carcinoma Epitelial do Ovário/economia , Carcinoma Epitelial do Ovário/terapia , Carcinoma Epitelial do Ovário/tratamento farmacológico , Carcinoma Epitelial do Ovário/cirurgia , Quimioterapia Adjuvante/economia , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Procedimentos Cirúrgicos de Citorredução/métodos , Árvores de Decisões , Feminino , Custos de Cuidados de Saúde , Humanos , Terapia Neoadjuvante/economia , Qualidade de Vida , Resultado do Tratamento , Estados Unidos
19.
Eur J Surg Oncol ; 44(7): 983-990, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29530346

RESUMO

BACKGROUND: The aim was to compare health-related quality-of-life (HRQOL) and cost-effectiveness between cytoreductive surgery with intraperitoneal chemotherapy (CRS + IPC) and systemic chemotherapy for patients with colorectal peritoneal metastases. METHODS: Patients included in the Swedish Peritoneal Trial comparing CRS + IPC and systemic chemotherapy completed the EORTC QLQ-C30 and SF-36 questionnaires at baseline, 2, 4, 6, 12, 18, and 24 months. HRQOL at 24 months was the primary endpoint. EORTC sum score, SF-36 physical and mental component scores at 24 months were calculated and compared for each arm and then referenced against general population values. Two quality-adjusted life-year (QALY) indices were applied (EORTC-8D and SF-6D) and an incremental cost-effectiveness ratio (ICER) per QALY gained was calculated. A projected life-time ICER per QALY gained was calculated using predicted survival according to Swedish population statistics. RESULTS: No statistical differences in HRQOL between the arms were noted at 24 months. Descriptively, survivors in the surgery arm had higher summary scores than the general population at 24 months, whereas survivors in the chemotherapy arm had lower scores. The projected life-time QALY benefit was 3.8 QALYs in favor of the surgery arm (p=0.06) with an ICER per QALY gained at 310,000 SEK (EORTC-8D) or 362,000 SEK (SF-6D) corresponding to 26,700-31,200 GBP. CONCLUSION: The HRQOL in patients with colorectal peritoneal metastases undergoing CRS + IPC appear similar to those receiving systemic chemotherapy. Two-year survivors in the CRS + IPC arm have comparable HRQOL to a general population reference. The treatment is cost-effective according to NICE guidelines.


Assuntos
Antineoplásicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma/terapia , Neoplasias Colorretais/terapia , Procedimentos Cirúrgicos de Citorredução/métodos , Fluoruracila/administração & dosagem , Hipertermia Induzida/métodos , Neoplasias Peritoneais/terapia , Qualidade de Vida , Idoso , Antineoplásicos/economia , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Carcinoma/fisiopatologia , Carcinoma/psicologia , Carcinoma/secundário , Neoplasias Colorretais/patologia , Neoplasias Colorretais/fisiopatologia , Neoplasias Colorretais/psicologia , Análise Custo-Benefício , Procedimentos Cirúrgicos de Citorredução/economia , Feminino , Fluoruracila/economia , Nível de Saúde , Humanos , Hipertermia Induzida/economia , Infusões Parenterais , Masculino , Pessoa de Meia-Idade , Compostos Organoplatínicos/administração & dosagem , Compostos Organoplatínicos/economia , Oxaliplatina , Neoplasias Peritoneais/fisiopatologia , Neoplasias Peritoneais/psicologia , Neoplasias Peritoneais/secundário , Anos de Vida Ajustados por Qualidade de Vida
20.
Medicine (Baltimore) ; 97(10): e0042, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29517660

RESUMO

Complications after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) result in impaired short- and long-term outcomes. However, financial consequences of complications after CRS and HIPEC in a European health care setting are unknown. This study aims to assess the consequences of complications on hospital costs after CRS and HIPEC.In this prospective observational cohort study, patients with colorectal peritoneal metastases treated with CRS and HIPEC were included. Financial information was collected according to the Dutch manual for costs analyses. Costs were compared between patients without complications (NC), minor complications (MC), or severe complications (SC), according to the Clavien-Dindo classification.One hundred and sixty-one patients were included, of whom 42% experienced NC, 27% MC and 31% SC. Mean hospital costs were &OV0556;9.406 ±â€Š2.235 in NC patients, &OV0556;12.471 ±â€Š3.893 in MC patients, and &OV0556;29.409 ±â€Š22.340 in SC patients. The 31% of patients with severe complications accounted for 56% of all hospital costs. Hospital admission costs in SC patients were 320% higher compared to NC patients. Costs of complications were estimated to be 43% of all admission costs.Severe postoperative complications have major influence on costs after CRS and HIPEC and result in a threefold increase of hospital costs in affected patients. This finding stresses the need for adequate risk assessment of developing severe complications after CRS and HIPEC.


Assuntos
Neoplasias Colorretais/terapia , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Custos Hospitalares/estatística & dados numéricos , Hipertermia Induzida/efeitos adversos , Neoplasias Peritoneais/terapia , Complicações Pós-Operatórias/economia , Adulto , Idoso , Estudos de Coortes , Neoplasias Colorretais/patologia , Procedimentos Cirúrgicos de Citorredução/economia , Feminino , Humanos , Hipertermia Induzida/economia , Masculino , Pessoa de Meia-Idade , Países Baixos , Neoplasias Peritoneais/secundário , Estudos Prospectivos
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