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Hyperthermic intraperitoneal chemotherapy combined with systemic chemotherapy for gastric cancer peritoneal carcinomatosis: A protocol for systematic review and meta-analysis of randomized controlled trials.

ABSTRACT: BACKGROUND:The prognosis of gastric cancer peritoneal carcinomatosis (GCPC) remains poor despite recent advances in systemic chemotherapy (SC) with an average survival less than 6 months. Current evidence supporting the utility of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with SC for GCPC is limited. We plan to provide a systematic review and meta-analysis of randomized controlled trials to evaluate the comparative effects and safety of HIPEC combined with SC in the management of GCPC. METHODS:Randomized controlled trials evaluating HIPEC combined with SC versus SC as first-line treatment for GCPC will be searched in MEDLINE, EMBASE, Web of Science, the Cochrane Library, ClinicalTrials.gov, and Google Scholar, from database inception to April 30, 2020. Data on study design, participant characteristics, intervention details, and outcomes will be extracted. Primary outcomes to be assessed are: median progression-free survival; secondary outcomes are: median survival time, 1- year survival rate, 2-year survival rate, objective response rate, and adverse events. Meta-analysis will be performed using RevMan V.5.3 statistical software. Data will be combined with a random effect model. Study quality will be assessed using the Cochrane Risk of Bias Tool. Heterogeneity will be assessed, and if necessary, a subgroup analysis will be performed to explore the source of heterogeneity. RESULTS:The results will provide useful information about the effectiveness and safety of HIPEC combined with systemic chemotherapy regimens in patients with gastric cancer peritoneal carcinomatosis. CONCLUSION:The findings of the study will be disseminated through peer-reviewed journal. THE REGISTRATION NUMBER:INPLASY202050006. DOI NUMBER:10.37766/inplasy2020.5.0006.

SUBMITTER: Lu Y

PROVIDER: S-EPMC7337564 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Hyperthermic intraperitoneal chemotherapy combined with systemic chemotherapy for gastric cancer peritoneal carcinomatosis: A protocol for systematic review and meta-analysis of randomized controlled trials.

Lu Yidan Y Jin Zheng Z Zheng Song S Bai Yurong Y Sun Yangcheng Y

Medicine 20200701 27

<h4>Background</h4>The prognosis of gastric cancer peritoneal carcinomatosis (GCPC) remains poor despite recent advances in systemic chemotherapy (SC) with an average survival less than 6 months. Current evidence supporting the utility of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with SC for GCPC is limited. We plan to provide a systematic review and meta-analysis of randomized controlled trials to evaluate the comparative effects and safety of HIPEC combined with SC in the mana ...[more]

PMID: 32629710

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Project description:BackgroundGastric cancer patients with peritoneal carcinomatosis (PC) have a poor prognosis, with a median overall survival of 10 months when treated with systemic chemotherapy only. Cohort studies showed that cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) might improve the prognosis for gastric cancer patients with limited PC. Besides generating trial data on clinical effectiveness, it is crucial to timely collect information on economic aspects to guide the reimbursement decision-making process. No previous data have been published on the cost(-effectiveness) of CRS/HIPEC in this group of patients. Therefore, we performed an early model-based cost-effectiveness analysis of CRS/HIPEC for gastric cancer patients with limited PC in the Dutch setting.MethodsWe constructed a two-state (alive-dead) Markov transition model to evaluate costs and clinical outcomes from a Dutch healthcare perspective. Clinical outcomes, transition probabilities and utilities were derived from literature and verified by clinical experts in the field. Costs were measured using two available representative cohorts (2010-2017): one 'systemic chemotherapy only' cohort and one 'CRS/HIPEC' cohort (n = 10 each). Incremental cost-utility ratios (ICURs) were expressed as Euros per quality-adjusted life-year (QALY). We performed probabilistic and deterministic sensitivity, scenario, and value-of-information analyses using a willingness-to-pay (WTP) threshold of €80,000/QALY, which reflects the Dutch norm for severe diseases.ResultsIn the base-case analysis, CRS/HIPEC yielded more QALYs (increment of 0.68) and more costs (increment of €34,706) compared with systemic chemotherapy only, resulting in an ICUR of €50,990/QALY. The probability that CRS/HIPEC was cost effective compared with systemic chemotherapy alone was 64%. To reduce uncertainty, the expected value of perfect information amounted to €4,021,468. The scenario analyses did not alter the results and showed that treatment costs, lifetime health-related quality of life and overall survival had the largest influence on the model.ConclusionsThe presented early cost-effectiveness analysis suggests that adding CRS/HIPEC to systemic chemotherapy for gastric cancer patients with limited PC has a good chance of being cost-effectiveness compared with systemic chemotherapy alone when using a WTP of €80,000/QALY. However, there is substantial uncertainty in view of the current available data on effectiveness. Results from the ongoing phase III PERISCOPE II trial are therefore crucial for further decisions on treatment policy and its cost-effectiveness.

Project description:BackgroundBioelectric impedance analysis (BIA)-measured body composition and nutritional status have been used as prognostic indicators in various cancer cohorts. This study investigated whether BIA could provide information on prognosis in peritoneal carcinomatosis patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).MethodsWe retrospectively analyzed the data of 99 patients with preoperative BIA data among those who underwent CRS and HIPEC. The association between BIA-derived parameters and intraoperative peritoneal cancer index (PCI) score was assessed. Predictive analysis for the occurrence of postoperative morbidities including major complications (Clavien-Dindo classification 3-4) and re-admission within 30 days after surgery as well as 1 year mortality was also performed.ResultsBIA-derived mineral (r = 0.224, p = 0.027), fat (r = - 0.202, p = 0.048), and total body water (TBW)/fat-free mass (FFM) (r = - 0.280, p = 0.005) showed significant associations with intraoperative PCI score. Lower TBW/FFM was an independent predictor of major postoperative complications (OR 0.047, 95% CI 0.003-0.749, p = 0.031) and re-admission (OR 0.094, 95% CI 0.014-0.657, p = 0.017) within 30 days after surgery. Higher fat mass was also independently associated with a higher risk of major postoperative complications (OR 1.120, 95% CI 1.006-1.248, p = 0.039) and re-admission (OR 1.123, 95% CI 1.024-1.230, p = 0.013). Intraoperative PCI score > 20 (OR 4.489, 95% CI 1.191-16.917, p = 0.027) and re-admission within 30 days after surgery (OR 5.269, 95% CI 1.288-21.547, p = 0.021) independently predicted postoperative 1-year mortality.ConclusionsWe demonstrate that preoperative BIA-derived TBW/FFM and fat mass were significantly correlated with metastatic extent, assessed by PCI score, in patients with peritoneal carcinomatosis. In addition, BIA-derived TBW/FFM and fat mass showed independent predictability for postoperative 30-day major complications and re-admission in patients undergoing CRS and HIPEC. Our findings suggest that assessment of BIA may improve discrete risk stratification in patients who are planned to receive CRS and HIPEC.

Project description:BACKGROUND:There is no currently available treatment for peritoneal metastasis of gastric cancer. This phase II study aimed to evaluate the efficacy and safety of neoadjuvant systemic chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) combined with cytoreductive surgery (CRS) for the treatment of these patients. METHODS:Neoadjuvant chemotherapy comprised two cycles of HIPEC and four cycles of S-1 plus paclitaxel. HIPEC was administered intraperitoneally with paclitaxel (75?mg/m2). For systemic chemotherapy, paclitaxel was administered intravenously(150?mg/m2) on day 1, and S-1 was administered orally(80?mg/m2/day)on days 1-14 of a 3-week?cycle. Another two cycles of HIPEC and four cycles of S-1 plus paclitaxel were administered after second diagnostic staging laparoscopy or CRS. The primary endpoints were treatment efficiency and safety; the secondary endpoint was 3-year overall survival (OS). RESULTS:A total of 40 patients were enrolled and 38 patients have been analyzed. Of these, 18 (47.4%) patients received neoadjuvant systemic chemotherapy, HIPEC and CRS (conversion therapy group), while 20 patients received only chemotherapy and HIPEC (palliative chemotherapy group). Median OS was markedly improved in the conversion therapy group (21.1?months, 95% confidence interval [CI] 16.7-25.6?months) in comparison with the palliative chemotherapy group(10.8?months, 95%CI 7.3-14.2?months, p?=?0.002). After neoadjuvant systemic chemotherapy and HIPEC, a second laparoscopic exploration was performed, and the prognosis of patients with low peritoneal cancer index (PCI) (PCI?<?6) was significantly better than that of patients with high PCI (PCI???6)(20.1 vs.11.3?months, p?=?0.006). CONCLUSION:Neoadjuvant systemic chemotherapy and HIPEC combined with CRS is safe and feasible, and could potentially improve the prognosis of gastric cancer patients with limited peritoneal metastasis. However, further clinical trials are still warranted. TRIAL REGISTRATION:This study has been registered with ClinicalTrials.gov as NCT02549911 . Trial registration date: 15/09/2015.

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Hyperthermic intraperitoneal chemotherapy combined with systemic chemotherapy for gastric cancer peritoneal carcinomatosis: A protocol for systematic review and meta-analysis of randomized controlled trials.

Publications

Hyperthermic intraperitoneal chemotherapy combined with systemic chemotherapy for gastric cancer peritoneal carcinomatosis: A protocol for systematic review and meta-analysis of randomized controlled trials.

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