Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II).

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.

Association of Hospital Costs With Complications Following Total Gastrectomy for Gastric Adenocarcinoma.

IMPORTANCE: Postoperative complications are associated with increased hospital costs following major surgery, but the mechanism by which they increase cost and the categories of care that drive this increase are poorly described. OBJECTIVE: To describe the association of postoperative complications with hospital costs following total gastrectomy for gastric adenocarcinoma. DESIGN, SETTING, AND PARTICIPANTS: This retrospective analysis of a prospectively collected gastric cancer surgery database at a single National Cancer Institute-designated comprehensive cancer center included all patients undergoing curative-intent total gastrectomy for gastric adenocarcinoma between January 2009 and December 2012 and was conducted in 2015 and 2016. MAIN OUTCOMES AND MEASURES: Ninety-day normalized postoperative costs. Hospital accounting system costs were normalized to reflect Medicare reimbursement levels using the ratio of hospital costs to Medicare reimbursement and categorized into major cost categories. Differences between costs in Medicare proportional dollars (MP $) can be interpreted as the amount that would be reimbursed to an average hospital by Medicare if it paid differentially based on types and extent of postoperative complications. RESULTS: In total, 120 patients underwent curative-intent total gastrectomy for stage I through III gastric adenocarcinoma between 2009 and 2012. Of these, 79 patients (65.8%) were men, and the median (interquartile range) age was 64 (52-70) years. The 51 patients (42.5%) who underwent an uncomplicated total gastrectomy had a mean (SD) normalized cost of MP $12 330 (MP $2500), predominantly owing to the cost of surgical care (mean [SD] cost, MP $6830 [MP $1600]). The 34 patients (28.3%) who had a major complication had a mean (SD) normalized cost of MP $37 700 (MP $28 090). Surgical care was more expensive in these patients (mean [SD] cost, MP $8970 [MP $2750]) but was a smaller contributor to total cost (24%) owing to increased costs from room and board (mean [SD] cost, MP $11 940 [MP $8820]), consultations (mean [SD] cost, MP $3530 [MP $2410]), and intensive care unit care (mean [SD] cost, MP $7770 [MP $14 310]). CONCLUSIONS AND RELEVANCE: Major complications were associated with tripled normalized costs following curative-intent total gastrectomy. Most of the excess costs were related to the treatment of complications. Interventions that decrease the number or severity of postoperative complications could result in substantial cost savings.

Cost-utility analysis of the newly recommended adjuvant chemotherapy for resectable gastric cancer patients in the 2011 Chinese National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Gastric Cancer.

BACKGROUND: Postoperative adjuvant chemotherapy with capecitabine and oxaliplatin was first recommended for resectable gastric cancer patients in the 2011 Chinese National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Gastric Cancer, but the economic influence of this therapy in China is unknown. OBJECTIVE: The aim of the present study was to determine the cost-effectiveness of adjuvant chemotherapy with capecitabine and oxaliplatin after a gastrectomy with extended (D2) lymph-node dissection, compared with a D2 gastrectomy alone, for patients with stage II-IIIB gastric cancer. METHODS: On the basis of data from the CLASSIC trial, a Markov model was created to determine economic and clinical data for patients in the chemotherapy and surgery group (CSG) and the surgery-only group (SOG). The costs, presented in 2010 US dollars and estimated from the perspective of the Chinese health-care system, were obtained from the published literature and the local health system. The utilities were based on published literature. Costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICER) were estimated. A lifetime horizon and a 3 % annual discount rate were used. One-way and probabilistic sensitivity analyses were performed. RESULTS: For the base case, the CSG compared with SOG would increase LYs and QALYs in a 3-, 5-, 10- or 30-year time horizon (except the QALYs at 3 or 5 years). In the short run (such as in 3 or 5 years), the medical costs would increase owing to adjuvant chemotherapy of capecitabine plus oxaliplatin after D2 gastrectomy, but in the long run the costs would decline. The ICERs suggested that the SOG was dominant at 3 or 5 years and the CSG was dominant at 10 or 30 years. The one-way sensitivity analysis showed that the utility of disease-free survival for 1-10 years for the SOG and the cost of oxaliplatin were the most influential parameters. The probabilistic sensitivity analysis predicted a 98.6 % likelihood that the ICER for the CSG would be less than US$13,527/QALY (three times the per capita gross domestic product of China). CONCLUSION: For patients in China with resectable disease, our results suggest that adjuvant chemotherapy with capecitabine plus oxaliplatin after a D2 gastrectomy is cost-saving and dominant in the long run on the basis of a current clinical trial, compared with treatment with a D2 gastrectomy alone.

[Improvement of the efficiency of the treatment of gastric cancer by the standardization of the treatment plan].

Standardized treatment plan for gastric cancer was established in our department by which surgeons and nurses understood the treatment schedules of each gastric cancer patient as the common knowledge, and the cooperation of surgeons and nurses could be improved. Furthermore, the modality decreased the length of hospital stay from 35 +/- 15 days to 24 +/- 8 days, which indicated that the number of patients per one bed for one year increased from 10 to 15, and the efficiency of the treatment of gastric cancer patients 50% by our system.

[A new model for economic studies of therapies exemplified by postoperative parenteral nutrition]. / Ein neues Modell zur Wirtschaftlichkeitsuntersuchung von Therapien am Beispiel der postoperativen parenteralen Ernährung.

In this economic evaluation we compared the costs of a new therapeutic system (two-chamber bag) in total parenteral nutrition (TPN) with the comparative standard therapeutic systems (multiple-bottle system in intensive care patients followed by a combination solution (glass bottles) on the ward). In the model, standard treatment algorithms of a 10-day course TPN for patients after major gastric surgery were specified for both application systems, the two-chamber bag and the comparative system. Based on the standard treatment pattern, the resource utilisation (manpower services, medical needs, material) was assessed. In a base case analysis the types and amounts of resources were valued using salaries, prices and tariffs to assess the costs. The costs per day and per case of the therapeutic systems were compared. Sensitivity analyses were carried out to validate the cost-estimates. The total costs per patient of the two-chamber bag amounted to DM 2324.41, which was substantially less than the DM 2728.99 cost of the comparative system. The average daily costs for the two-chamber bag system were 12% to 23% lower than for the comparative system. The results were shown to be valid for the whole range of tested parameters. This model makes it possible to obtain an economic evaluation of various therapeutic modalities without undertaking a prospective randomized study with the attendant high time and cost requirements.