High-tech homecare infusion therapies

Dramatic changes in health care delivery have created an increased reliance on ambulatory care. Adults and children increasingly are receiving infusions of intravascular medication or fluid in the home for a wide array of conditions. Several therapies have been adapted to the home, including chemotherapy, BRMs, TPN, blood components, anti-infectives, analgesics, inotropic agents, and investigational drugs. High-technology therapy in the home mandates safe and reliable vascular access to maximize positive outcomes, independence, and self-care; minimize costs and disruption of daily activities and work schedules; and enhance client and family adjustments and satisfaction. Currently, the four main VADs for vascular access are central venous catheters (CVCs), peripherally inserted central catheters (PICCs, implantable infusion ports, and external or implantable ambulatory infusion pumps.     

Continuous infusion of chemotherapy: focus on 5-fluorouracil and fluorodeoxyuridine

Continuous infusion of chemotherapy is one of the developments to try to improve the treatment of metastatic cancer. There is a sound theoretical rationale to deliver cytotoxic drugs as a continuous infusion. Furthermore, the development of reliable venous access devices and portable infusion pumps enables patients to be treated in an ambulatory setting. This review focuses on the continuous infusion of the most frequently used drugs: 5-fluorouracil (5-FU) and fluorodeoxyuridine (FUDR). An overview is given of both preclinical studies and studies in humans. Continuous infusion of 5-FU and FUDR has proven to be feasible in all studies. However, the results (response rate and especially survival) are rather disappointing. So far, continuous infusion of cytostatic drugs can still be considered as an experimental procedure. Whether protracted, intermittent of circadian modulated continuous infusion is the optimal treatment schedule has still to be proven in future studies. Furthermore, studies are needed to demonstrate whether dose intensity for most tumours is important for treatment outcome. Also, studies are needed to investigate quality of life and economic issues.     

Cervical meningoceles and myelocystoceles: a unifying hypothesis

We initiated a pilot study of adjuvant hepatic arterial infusion chemotherapy (AHAIC) using 5-fluorouracil (5-FU) and leucovorin. Hepatic arterial infusion ports were placed in 15 consecutive patients undergoing curative resection of colorectal liver metastases. The chemotherapy regimen consisted of a weekly infusion of 5-FU (12 mg m 2 per day) and leucovorin (200 mg m 2 per day) for 12 months. The mean follow-up was 22 months (range 3-62 months, SD 21-37 months). There were no clinical or biological complications related to chemotherapy, except for sharp epigastric burns in four patients immediately after 5-FU infusions. Catheter irreversible occlusions led to early cessation of the treatment in three patients. Four of the 15 evaluable patients developed recurrent disease. The site of relapse was the liver in two patients and extra-hepatic sites in the two remaining patients. Three of these four patients died of their recurrent disease. These results suggest that 5-FU and leucovorin can be combined for AHAIC in a long duration regimen with a very low rate of side-effects. This protocol could be safely employed in a prospective randomized study in combination with 5-FU systemic infusions.     

Circadian chemotherapy in cancer patients

Continuous infusion of 5-FU at night was performed for four patients: three had liver metastasis (one with gastric cancer and two with rectal cancer) and one had local recurrence of rectal cancer. The chemotherapy schedule was 400 mg/m2/day 5-FU intraarterial or intravenous infusion from 6:00 p.m. to 6:00 a.m. for five days repeated every 3 weeks. There were one complete response, two partial responses and one with no change. It is expected that the chemotherapy of 5-FU at night will result in a high efficacy and lower toxicity.     

Comparison of costs for infusion versus bolus chemotherapy administration--Part two. Use of charges versus reimbursement for cost basis

BACKGROUND: The costs of infusion versus bolus administration of chemotherapy has been a point of controversy as has been the method of quantitating the cost. The present study analyzes the reimbursement for chemotherapy administration by infusion compared with bolus delivery based on reimbursement and relates this to cost based on projected charges and actual charges in a private practice setting. METHODS: Actual reimbursement records were retrieved for selected patients receiving infusion or bolus administration of specific chemotherapy regimens for three tumors: colon carcinoma, breast carcinoma, and lymphoma. All services were included except for radiology and hospitalization. Medicare reimbursement represented 90% of the treatment cycles analyzed. RESULTS: Actual reimbursement per month for each infusion regimen was as follows: colon carcinoma, $528 (5-fluorouracil [5-FU]); breast carcinoma, $621 (doxorubicin and cyclophosphamide [AC]) and $685 (cyclophosphamide, methotrexate, and fluorouracil [CMF]); and lymphoma, $603 (cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP]). Actual reimbursement per month for a bolus regimen was colon carcinoma, $393 (5-FU + leucovorin); breast carcinoma, $991 (AC) or $453 (CMF); and lymphoma, $749 (CHOP). Actual reimbursement represents 21-36% of actual charges. Projected charges based on the model system are generally less than the actual charges. CONCLUSIONS: The cost of chemotherapy as defined by reimbursement are substantially less than actual charges and are also less than projected costs based on charges. Data comparing bolus versus infusion reimbursement costs for colon carcinoma, breast carcinoma, and lymphoma indicate that differences between reimbursement for bolus and infusion administration are not substantial.     

Modulation of 5-fluorouracil with methotrexate and low-dose N-(phosphonacetyl)-L-aspartate in patients with advanced colorectal cancer. Results of a phase II study

Methotrexate (MTX) and N-phosphonacetyl-L-aspartate acid (PALA) have been shown to modulate the cytotoxic effects of 5-fluorouracil (5-FU). A phase II study was initiated to evaluate the feasibility, toxicity and efficacy of PALA/MTX and 5-FU in patients with metastatic colorectal cancer. 26 patients received PALA 250 mg/m2 as an intravenous 15-min infusion plus MTX 200 mg/m2 as a 30-min intravenous (i.v.) infusion on day 1 and 5-FU 600 mg/m2 as i.v. push on day 2. Cycles were repeated every 14 days and the 5-FU dose was escalated in the individual patient in steps of 100 mg/m2 for the third, fifth and seventh cycle in the absence of toxicity. 7 patients had received prior 5-FU-based chemotherapy while 19 patients were chemotherapy naive. Objective responses occurred in 23% of patients (1 CR, 5 PR of which 2 were pretreated), no change in 13 patients (50%) and tumour progression (6 patients) or toxic death (one patient) in 27%. Responses lasted for a median of 7 months (range 6-9), the median time to progression was 4 months and median survival 13 months. Toxicity was mainly gastrointestinal with diarrhoea and mucositis, and severe or life threatening in only 3 patients. In 3 patients an increase in serum glucose levels occurred while being treated with PALA/MTX and 5-FU. 2 patients with insulin-dependent diabetes had a 33% increase in insulin requirement and 1 patient with dietary-controlled diabetes died due to a ketoacidotic coma. PALA/MTX/5-FU in this dose and schedule is active in patients with colorectal cancer. Hyperglycaemia may be a potential side-effect of PALA-containing regimens especially in patients with diabetes. Careful monitoring of serum glucose levels in these patients is indicated.     

Trials and tribulations of vascular surgical benchmarking

The purpose of this study was to review the efficacy of a protracted venous infusion of 5-fluorouracil (PVI 5-FU)-based chemotherapy in advanced small bowel adenocarcinoma. Data on all patients with small bowel malignancy who were seen at a single institution over a 5-year period were retrieved from the gastrointestinal unit and hospital databases, and these cases were reviewed. Eight patients with advanced small bowel adenocarcinoma received PVI 5FU-based chemotherapy. The overall response rate in assessable patients was 37.5% (3/8). The median overall survival was 13 months (range 1-28), and progression-free survival was 7.8 months (range 0-15). Overall, the treatment was well tolerated and symptomatic benefit was seen. In conclusion, PVI 5-FU has activity in this disease. This should be assessed either as a single agent or as part of a combination regimen such as epirubicin/cisplatin/PVI FU (ECF) in a multicentre randomized study.     

A new complication of chemotherapy administered via permanent indwelling central venous catheter

BACKGROUND: The use of permanent intravenous access devices for chemotherapy administration has become a common practice in clinical oncology. Therefore, awareness of potential complications is important. The authors previously reported the use of high dose 5-fluorouracil (5-FU) (2600 mg/m2) and leucovorin (500 mg/m2) as a weekly 24-hour infusion for patients with colorectal carcinoma. In this report, a new complication of permanent indwelling catheters with high dose 5-fluorouracil (2600 mg/m2) and leucovorin (500 mg/m2) as a weekly 24-hour infusion for colorectal carcinoma is described. METHODS: Twenty-two patients in the previous Phase II trial on weekly high dose 5-FU and leucovorin were included in this study. All patients had either a single-lumen Port-o-cath (Pharmacia Deltec, St. Paul, MN) or Hickman catheter (Travenol Laboratories, Deerfield, IL). Occluded catheters were explanted, and the material found in their lumen was analyzed using infrared spectroscopy. RESULTS: Eleven of 22 patients had catheter blockage, and calcium carbonate formation (Calcite 100%) was identified within these catheters. CONCLUSION: Calcite formation causing catheter occlusion is a new and important complication resulting from using intravenous access devices for chemotherapy administration. Oncologists should be alerted to this phenomenon when high dose 5-FU and leucovorin are administered for 24 hours by continuous infusion using a single-port port-o-cath.     

An analysis of the reliability of 2 types of enteral nutrition pumps

The main advantages of infusion pumps are their enhanced accuracy and safety in providing enteral nutrition. We proposed to observe pumps reliability in connection with a variety of factors such as the type of pump used, the administration rate and the energy density of the diets used. An experimental design was prepared with two types of enteral nutrition pumps-VP, volumetric pump, and PP, peristaltic pump. The clinical simulation was done by connecting the enteral nutrition equipment to a graduated dosing system, making hourly measurements of the volume infused. The Reliability Index (RI) used was the ratio between the volume infused by the pump and the regulated dose (Vi/Do). Five volumetric pumps (FLEXIFLO COMPANION) and five peristaltic pumps (FLEXIFLO II) were selected at random from a single commercial outlet. Each was used for twenty-three hours, without interruption, to infuse five types of diet with different energy densities (D1:2 Kcal/ml, D2: 1.5 Kcal/ml, D3: 1.25 Kcal/ml, D4: diet with fibre, and D5: reconstituted powder diet) at three different flow rates (40, 80 and 120 ml/h), to provide fifteen experimental conditions with each pump. Reliability was maintained for both types of pump within the margin of error claimed by the manufacturer (+/- 10%) except in the first hour of infusion (RI = 71.4%). Comparison of the overall RI between the two pump types revealed significant differences, with an RI below the reference range for the VP only during hour 23 (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Evaluation of enzyme-linked immunosorbent assay for the diagnosis of Helicobacter pylori infection in children from different age groups with and without duodenal ulcer

BACKGROUND: Myocardial ischemia induced by 5-fluorouracil (5-FU) is a relatively rare, but potentially serious, occurrence. Some case reports have indicated that recurrent ischemia may be prevented if 5-FU is resumed after pretreatment with antianginal therapy. METHODS: A 54-year old woman was diagnosed with stage IIA squamous cell carcinoma of the anus. Treatment with concurrent radiation and chemotherapy (mitomycin-C and 5-FU) was initiated with curative intent. RESULTS: The patient had no evidence of underlying coronary artery disease based on history, physical examination or ECG. Approximately 48 h after initiation of 5-FU infusion the patient developed anginal pain associated with ECG changes compatible with ischemia. After resolution of ischemia and ruling out of myocardial infarction, coronary arteriography demonstrated normal coronary arteries. In an attempt to prevent myocardial ischemia, calcium channel blocker and nitrate therapy was started, but anginal pain with ECG change recurred when 5-FU was resumed. This necessitated selection of an alternative chemotherapy regimen. CONCLUSIONS: Even in the presence of normal coronary arteries, antianginal therapy may not preclude the occurrence of potentially serious 5-FU induced myocardial ischemia. For patients who experience 5-FU-induced myocardial ischemia, development of alternative chemotherapy regimens should be considered.     

Multivariate analyses of the hominid ulna from Klasies River mouth

BACKGROUND: The combination of 5-fluorouracil (5-FU) and cisplatin has shown great activity in many different types of tumour with an in vitro synergistic effect between 5-FU and cisplatin. A phase II study of 5-FU plus cisplatin was performed in 25 previously untreated patients with inoperable locally advanced or metastatic biliary tract carcinoma. PATIENTS AND METHODS: Twenty-five patients, 10 of them men and 15 women with a median age of 58, were entered into the study. The chemotherapy regimen consisted of 5-FU: 1 g/m2/day in continuous intravenous (i.v.) infusion for five consecutive days, and cisplatin: 100 mg/m2/day on day 2 in a one-hour infusion with standard hyperhydration. Twenty-two patients had metastatic tumours and three had locally advanced disease. RESULTS: Of the 25 patients entered into the study, 24 were evaluable for response and 25 for toxicity. Nausea and vomiting was the main toxic side effect in 19 patients. Severe, WHO grade 3-4 thrombocytopenia or neutropenia were observed in three and seven patients, respectively. There were no toxic deaths. Of 25 patients, six had partial remissions (overall response 24%, 95% confidence interval 7%-41%). For three patients, tumour reduction permitted local radiotherapy and one of these patients with initially advanced disease is still alive six years after the beginning of treatment. CONCLUSIONS: This study, one of the largest phase II trials performed in this disease, shows interesting activity of the combination of 5-FU and cisplatin in advanced biliary tract carcinoma.     

Bone mass in middle-aged osteoporotic men and their relatives: familial effect

Combination chemotherapy with continuous infusion 5-FU, 350 mg/m2/day and low-dose CDDP between 5 to 10 mg/body/day (day 1-5) was evaluated in 46 patients with unresectable gastric (34), colorectal (10) and biliary tract (2) carcinoma. This regimen was repeated for 4 weeks. The overall response rate was 45.7% (21/46), but the resectable rate was only 10.9% (5/46). Toxic response (> grade 2) was 22% (10/46). After chemotherapy, the patients preserved good performance status and quality of life. Median survival time was about 11 months, and there was no significant difference between CR or PR cases and NC one. Survival time of patients correlated not to the reduction rate of tumor but to conditions of hosts (e.g., performance status, quality of life). These results suggested that this therapy is an effective palliative chemotherapy for patients with unresectable gastrointestinal carcinoma.     

Anticancer activity and toxicity of S-1, an oral combination of tegafur and two biochemical modulators, compared with continuous i.v. infusion of 5-fluorouracil

S-1 is an oral combined form of 1 M tegafur [a prodrug of 5-fluorouracil (5-FU)], 0.4 M 5-chloro-2,4-dihydroxypyridine (a reversible inhibitor of dihydropyrimidine dehydrogenase) and 1 M potassium oxonate (an inhibitor of orotate phosphoribosyltransferase). S-1 has been shown to exert a potent antitumor effect with low gastrointestinal toxicity in experimental tumor models. We have therefore compared the antitumor effect of oral S-1 with that of continuous infusion of 5-FU in rats bearing transplants of human and murine tumors. Almost complete inhibition of the tumor growth was obtained on 7 day schedules in Yoshida sarcoma-bearing rats by consecutive administration of 30 mg/kg/day of oral S-1 and 40 mg/kg/day infusion of 5-FU. However, a significant difference between the incidence of toxicities of S-1 and 5-FU, including body weight loss and diarrhea, was noted. The rats given the 5-FU infusion had marked weight loss and severe diarrhea, while those given oral S-1 had neither. Although about 50% inhibition of the tumor growth was attained with 15 mg/kg/day of oral S-1 and 30 mg/kg/day infusion of 5-FU in nude rats with xenografted human colon cancer (KM12C), the rate of body weight loss in the 5-FU-treated group was distinctly higher than in the S-1-treated group. The ratio of the 5-fluoronucleotide concentrations in gastrointestinal tissue to that in the tumor was lower in the S-1-treated rats than in the 5-FU-treated rats. In conclusion, the results suggest that oral S-1 might be more effective in the treatment of cancer patients than continuous infusion of 5-FU, from the standpoint of antitumor potency and toxicity.     

Concurrent radiotherapy and chemotherapy with protracted continuous infusion of 5-fluorouracil in inoperable esophageal squamous cell carcinoma

PURPOSE: The feasibility of a concurrent chemoradiotherapeutic protocol for patients with inoperable esophageal squamous cell carcinoma was tested. METHODS AND MATERIALS: Concurrent chemoradiotherapy using protracted low-dose continuous infusions of five-fluorouracil (5-FU; 250-300 mg/m2/24 h) and standard external beam irradiation was given to 28 patients with inoperable esophageal squamous cell carcinoma between November 1991 and June 1993. RESULTS: For 25 patients receiving a total dose of > or = 60 Gy and concurrent 5-FU infusion for more than 5 weeks, the complete response rate was 52%. Local progression-free rate in this chemoradiotherapy group was significantly higher than the historical controls treated by radiotherapy alone (p < 0.05). A multivariate analysis revealed the treatment scheme (concomitant chemoradiotherapy vs. radiotherapy alone) to be a significant factor in local control (p < 0.01). Swallowing pain (39%), anorexia (39%), and nausea (32%) were the most frequent early reactions. Serious late radiation complications have not been observed. CONCLUSION: The concurrent chemoradiotherapy using protracted low-dose continuous infusion of 5-FU and standard radiotherapy is an effective and safe method to obtain a local control in inoperable esophageal squamous cell carcinoma.     

Long-term complete response in two cases of liver metastases from rectal and gastric cancer treated with intra-arterial infusion chemotherapy of leucovorin and 5-fluorouracil

Intra-arterial infusion chemotherapy combined with leucovorin (LV) and 5-fluorouracil (5-FU) was performed in two patients with multiple metastases from rectal and gastric cancer. In each patient LV 45 mg was infused as a bolus just before and after 5-FU 1,000 mg/4 hrs administration. Thereafter 5-FU dose was decreased gradually. This regimen was principally repeated weekly on an outpatient basis. In both patients PR was detectable 3 and 4 months after the beginning of chemotherapy, and CR was obtained in 21 and 6 months, respectively. Neither patient showed any signs of recurrence and are in good health 35 and 30 months after initiation of chemotherapy. These findings suggest that our protocol has an excellent anti-tumor effect and improves the QOL in some patients for a long time.     

Demonstration of hepatic steatosis by computerized tomography in patients receiving 5-fluorouracil-based therapy for advanced colorectal cancer

The frequency and severity of fatty infiltration of the liver in patients receiving 5-fluorouracil (5-FU) and folinic acid has not been documented systematically. Its development can result in difficulty assessing disease progression, and treatment may be altered inappropriately. Twenty-seven patients with colon cancer and liver metastases receiving 5-FU and folinic acid were studied with computerized tomography (CT) before treatment and after six or 12 cycles of chemotherapy. Forty-seven per cent of patients developed hepatic steatosis during treatment. There was no correlation between development of hepatic steatosis and the dose of chemotherapy or the liver function tests. Hepatic steatosis occurs commonly in patients receiving 5-FU and folinic acid and can be severe. Its development can make hepatic metastases difficult to assess and if its benign nature is not appreciated treatment may be inappropriately altered.     

Combination chemotherapy of continuous infusion 5-fluorouracil and daily low-dose cisplatin in advanced gastrointestinal and lung adenocarcinoma

Continuous intravenous infusion (c.v.i.) of 5-fluorouracil (5-FU) plus daily low-dose cisplatin (CDDP) was evaluated in 45 patients with advanced and recurrent unresected colorectal, lung, gastric and pancreatic adenocarcinoma. 5-FU was given at a dose of 320 mg/m2/day, c.v.i. for 4 weeks, and CDDP between 3.5 to 7 mg/m2/day, infused for one hour five times a week for 4 weeks. Patients received 1 to 3 cycles of treatment (average 1.5 cycle). Pancreatic cancer cases needed longer treatment periods (2.25 cycles). The response rate of colorectal cancer cases was 57.7% (15/26), pancreas cancer 40%, gastric cancer 62.5%, and lung cancer 66.7%. The overall response rate was 57.8%. No severe side effects occurred in any of these cases. These data indicate that this combination 5-FU + daily low-dose CDDP chemotherapy is effective in the treatment of advanced gastrointestinal and lung adenocarcinoma.     

Disturbance of continuous, pump administration of cardiovascular drugs by hydrostatic pressure

Administration of highly concentrated, highly potent, and therefore highly dangerous drugs with syringe pumps is common in modern anaesthesia as well as in intensive care and emergency medicine. Because of their exact flow rates down to < 1 ml/h, these pumps are predestined for delivery of drugs with short half-lives, such as catecholamines and vasodilators. But intravenous application of drugs with syringe pumps is not without problems. While it is well known that syringes not fixed correctly into the pump can empty themselves by the influence of gravity, it seems not to be known that hydrostatic pressure can influence the flow rate of a correctly connected system even during continuous infusion. In this situation a change of height of the syringe pump in relation to the patient's position can have tremendous effects on hemodynamics due to unintended acceleration or deceleration of the flow rate. This case report demonstrates that the elevation of a connected epinephrine pump while moving a cardiac surgery patient after ACB operation from the operation table into his bed led to critical increases of heart rate, blood pressure and left atrial pressure. In order to quantify the problem we repeated the situation experimentally. It could be demonstrated that the elevation of the syringe pump by 80-100 cm delivers an additional bolus of 4-5 drops as the central venous catheter outlet. Lowering the pump consecutively leads to the opposite effect. In the case reported, the accidentally administered bolus of epinephrine was 12-15 micrograms (we use a concentration of 60 micrograms/ml epinephrine for continuous infusion with syringe pumps). From this accidental observation the following conclusion can be drawn: The change of height, in relation to the patient's position, of a running syringe pump during continuous infusion of highly concentrated cardiovascular drugs may cause considerable, even life-threatening hemodynamic disorders. Even in a closed infusion system (syringe-extension-central venous catheter), hydrostatic pressure influences infusion rate. Elevation of the pump leads to unintended bolus administration, and lowering of the pump is followed by an interruption of the infusion. In the knowledge of this phenomenon, unexpected hemodynamic reactions during transport of critically ill patients cannot always be interpreted as a result of inadequate anesthesia or volume load, but may be a consequence of incorrect handling of the syringe pumps as described in this report.     

Evaluation of intra-arterial infusion chemotherapy for advanced gastric cancer

We evaluated the therapeutic efficacy of intraarterial infusion chemotherapy in advanced gastric cancer, its side effect and patient prognosis, in comparison with systemic infusion. Of 125 cases of advanced gastric cancer, 41 cases received intraarterial chemotherapy (A group) and the rest were given systemic infusion (S group). Protocols of chemotherapy were 5-FU + MTX in 49 cases, 5-FU + cisplatin in 62, and 5-FU + MMC in 14. Location of the disease was the peritoneum in 69 cases, nodes in 59, liver in 38, and other sites, 33. The response rate of A group was significantly higher than that of S group, at 31% and 13% respectively. Although 41% of cases showed side effects (> or = grade 2), there was no significant difference between the 2 groups. The median survival period and 1-year survival rate were 8.4 months and 35%, respectively, and there was no significant difference between the 2 groups. In cases with liver metastasis, the prognosis of A group was better than that of S group. The results suggest that intra-arterial infusion chemotherapy is an effective treatment for liver metastasis from gastric cancer.     

High expression of thymidylate synthase is associated with the drug resistance of gastric carcinoma to high dose 5-fluorouracil-based systemic chemotherapy

BACKGROUND: In the past 4 years, the weekly 24-hour infusion of high dose 5-fluorouracil (5-FU) and leucovorin in the treatment of patients with advanced gastric carcinoma has been prospectively studied at the authors' institution. This has enabled them to explore the possibility that the level of expression of thymidylate synthase (TS), the target enzyme of 5-FU, is related to the drug sensitivity of gastric carcinoma to 5-FU-based chemotherapy. METHODS: To be eligible for this study, patients were required to have received high dose 5-FU and leucovorin chemotherapy (weekly 24-hour infusions of 5-FU, 2,600 mg/m2, and leucovorin, 300 mg/m2) and to have had adequate prechemotherapy gastric carcinoma tissues for immunohistochemical study. TS106 monoclonal antibody was used to detect the expression of TS. A visual scoring system, which ranged from 0 to 3+, was adopted by 2 independent pathologists to semiquantitate the intensity of TS expression. RESULTS: Between 1993 and 1996, a total of 30 patients, 18 men and 12 women, with a median age of 61.5 years, were enrolled. Of these patients, 16 (53.3%) and 14 (46.7%) had high and low expression of TS, respectively. Two of the 16 patients (12.5%) with high expression of TS and 13 of the 14 patients (92.9%) with low expression of TS responded to chemotherapy (P < 0.001, chi-square test). The median overall survival was 10 months for patients with low TS expression and 4 months for patients with high TS expression (P < 0.01, log rank test). CONCLUSIONS: The data from this study suggest that the expression of TS, as determined by immunohistochemistry, is a relatively reliable indicator of whether 5-FU should be used in the treatment of patients with gastric carcinoma.