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NCI CANCERLIT® Search: Therapy of Gastric Cancer - September 2001

Last Modified: November 1, 2001

Table of Contents

CancerMail from the National Cancer Institute

1
UI - 21236548
AU - Sun CF; Hsieh YY; Ngan KW; Wang WT
TI - Search for immunomodulatory effects of blood transfusion in gastric cancer patients: flow cytometry of Th1/Th2 cells in peripheral blood.
SO - Ann Clin Lab Sci 2001 Apr;31(2):171-8

AD - Department of Clinical Pathology, Chang Gung Memorial Hospital, Lin-Kou Medical Center, Tao-Yuan, Taiwan.
Allogeneic transfusion seems to drive the immune system toward a Th2 response and away from a Th1 response, providing a hypothetical mechanism for transfusion-induced immunomodulation. By means of an intracytoplasmic cytokine detection technique with flow cytometry, it is possible to measure Th1 and Th2 cells derived from peripheral blood mononuclear cells. This study evaluated the presence of transfusion-induced immunomodulation in 11 gastric cancer patients after gastrectomy with perioperative blood transfusion, compared to 11 gastric cancer patients who were treated by gastrectomy without transfusion. Lymphocytes subsets, including CD4 T cells, CD8 T cells, CD4/CD8 Ratio, CD2(+) T cells, CD3(+) T cells, and CD19(+) B cells, were measured in these patients, as well as variables that might suggest transfusion-induced immunomodulation, such as duration of antibiotic use, duration of hospital stay, and total hospital charges. This study also measured changes in the Th1/Th2 ratio. Th1 and Th2 lymphocytes were characterized by measuring intracellular expression of cytokines with flow cytometry. Cells were stimulated with phorbol myristate acetate and ionomycin in the presence of brefeldin-A. The results showed no significant differences in lymphocyte subsets, Th1/Th2 ratio, total hospital charges, or duration of antibiotic utilization between the groups of transfused and non-transfused gastric cancer patients after gastrectomy. The only significant difference was a longer hospital stay for transfused patients (mean 20.5 da) compared to non-transfused patients (mean 16.2 da). The anticipated finding of a Th2 response after blood transfusion was not observed. A larger group of patients may be needed to document such an effect, since many confounding variables affect the morbidity and outcome of surgery in these patients.

2
UI - 21399420
AU - Kalmar K; Cseke L; Zambo K; Horvath OP
TI - Comparison of quality of life and nutritional parameters after total gastrectomy and a new type of pouch construction with simple Roux-en-Y reconstruction: preliminary results of a prospective, randomized, controlled study.
SO - Dig Dis Sci 2001 Aug;46(8):1791-6

AD - First Department of Surgery, University Medical School of Pecs, Hungary.
The aim of the study was to introduce a new type of gastric substitute, the aboral pouch, after total gastrectomy and to compare nutritional, motility, and quality of life parameters of patients with an aboral pouch to those undergoing simple Roux-en-Y reconstruction in a prospective, randomized, and controlled trial. To date 40 patients have entered the study. In 22 of them the aboral pouch was created; the remaining 18 patients with simple Roux-en-Y reconstruction served as the control group. Laboratory measurements, passage studies, lipid and carbohydrate absorption tests, and quality of life interviews were carried out as follow-up examinations. Preliminary results suggest that the aboral pouch has some advantages over simple Roux-en-Y reconstruction. Serum immunoglobulin M level and the quality of life estimated by the gastrointestinal quality of life index, yielded significantly better results in the pouch group.

3
UI - 21416725
AU - Kitano S; Inomata M; Yasuda K; Shiraishi N; Adachi Y
TI - [Gastric cancer]
SO - Gan To Kagaku Ryoho 2001 Aug;28(8):1071-6

AD - Dept. of Surgery I, Oita Medical University, Idaigaoka 1-1, Hasama-cho, Oita-gun, Oita 879-5593, Japan.
With the development of related instruments and techniques, laparoscopic surgery has come to be applied to treatment of gastrointestinal malignancies as a minimally invasive surgery. For early gastric cancers with negligible risk of lymph node metastasis, endoscopic mucosal resection (EMR), laparoscopic wedge resection (LWR), and laparoscopic intragastric mucosal resection (IGMR) have been performed. For those with fairly sizable risk of lymph node metastasis, laparoscopy-assisted distal gastrectomy (LADG) is applied. Our studies have suggest that LADG is more useful than open distal gastrectomy in the management of patients with gastric cancer from the viewpoints of curability, minimal invasiveness, and quality of life of patients.

4
UI - 21255262
AU - Rembacken B; Fujii T; Kondo H
TI - The recognition and endoscopic treatment of early gastric and colonic cancer.
SO - Best Pract Res Clin Gastroenterol 2001 Apr;15(2):317-36

AD - Department of Gastroenterology, Centre for Digestive Diseases, The General Infirmary at Leeds, Great George Street, Leeds, LS16 8LT, UK.
As the prognosis of both gastric and colonic cancer remains poor, the challenge is to detect lesions at an early and treatable stage. The benefit of early detection is not only improved survival, but also that patients may be treated with endoscopic mucosal resection, a low-cost, low-morbidity and low-mortality alternative to surgery. In spite of the increasing use of endoscopy in the West, we are not detecting as many early cancers as in Japan. This chapter will discuss the possible reasons for this discrepancy and give a practical guide to 'Japanese endoscopy techniques'. Finally, we have compiled a comprehensive review of the indications, techniques and complications of endoscopic mucosal resection. Throughout the chapter, controversies have been highlighted to give an insight into the limits of our knowledge and stimulate future research. Copyright 2001 Harcourt Publishers Ltd.

5
UI - 21227802
AU - Goh PM; Khan AZ; So JB; Lomanto D; Cheah WK; Muthiah R; Gandhi A
TI - Early experience with laparoscopic radical gastrectomy for advanced gastric cancer.
SO - Surg Laparosc Endosc Percutan Tech 2001 Apr;11(2):83-7

AD - Minimally Invasive Surgical Center, Department of Surgery, National University Hospital, Singapore. surgohmy@nus.edu.sg
Use of the laparoscopic approach for the management of gastric cancer is still in the developmental phase. The authors present their experience with laparoscopic radical gastrectomy for advanced gastric cancer. Between September 1997 and August 1999, four laparoscopic gastrectomies for gastric carcinoma were performed on two male and two female patients (mean age, 61.5 years). One D2 total radical gastrectomy and three D2 subtotal distal gastrectomies were performed, using a totally laparoscopic approach. Mean operative time was 210 minutes. There were no intraoperative complications. All four patients recovered uneventfully from surgery and began oral feeding on the third postoperative day. Median postoperative stay was 7 days (range, 6-9). All patients were alive 8 months to 3 years after the operation, with no cancer recurrences. This series shows that laparoscopic radical gastrectomy for moderately advanced cancers can produce good results in terms of safety and oncologic adequacy.

6
UI - 21353430
AU - Shigeoka Y; Ito K; Otsu T
TI - [Therapeutic outline for gastric lymphoma]
SO - Nippon Naika Gakkai Zasshi 2001 Jun 10;90(6):1003-9

7
UI - 21410614
AU - Macdonald JS; Smalley SR; Benedetti J; Hundahl SA; Estes NC; Stemmermann GN; Haller DG; Ajani JA; Gunderson LL; Jessup JM; Martenson JA
TI - Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction.
SO - N Engl J Med 2001 Sep 6;345(10):725-30

AD - St Vincent's Comprehensive Cancer Center, New York, USA.
BACKGROUND: Surgical resection of adenocarcinoma of the stomach is curative in less than 40 percent of cases. We investigated the effect of surgery plus postoperative (adjuvant) chemoradiotherapy on the survival of patients with resectable adenocarcinoma of the stomach or gastroesophageal junction. METHODS: A total of 556 patients with resected adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to surgery plus postoperative chemoradiotherapy or surgery alone. The adjuvant treatment consisted of 425 mg of fluorouracil per square meter of body-surface area per day, plus 20 mg of leucovorin per square meter per day, for five days, followed by 4500 cGy of radiation at 180 cGy per day, given five days per week for five weeks, with modified doses of fluorouracil and leucovorin on the first four and the last three days of radiotherapy. One month after the completion of radiotherapy, two five-day cycles of fluorouracil (425 mg per square meter per day) plus leucovorin (20 mg per square meter per day) were given one month apart. RESULTS: The median overall survival in the surgery-only group was 27 months, as compared with 36 months in the chemoradiotherapy group; the hazard ratio for death was 1.35 (95 percent confidence interval, 1.09 to 1.66; P=0.005). The hazard ratio for relapse was 1.52 (95 percent confidence interval, 1.23 to 1.86; P<0.001). Three patients (1 percent) died from toxic effects of the chemoradiotherapy; grade 3 toxic effects occurred in 41 percent of the patients in the chemoradiotherapy group, and grade 4 toxic effects occurred in 32 percent. CONCLUSIONS: Postoperative chemoradiotherapy should be considered for all patients at high risk for recurrence of adenocarcinoma of the stomach or gastroesophageal junction who have undergone curative resection.

8
UI - 21410083
AU - Cerea K; Romano F; Bravo AF; Motta V; Uggeri F; Brivio F; Fumagalli LA; Uggeri F
TI - Phase IB study on prevention of surgery-induced immunodeficiency with preoperative administration of low-dose subcutaneous interleukin-2 in gastric cancer patients.
SO - J Surg Oncol 2001 Sep;78(1):32-7

AD - 1(st) General Surgery Department, II University of Milano-Bicocca, San Gerardo Hospital-Monza (Milano), Italy.
BACKGROUND AND OBJECTIVES: Low count of total and T helper lymphocytes predicts a poor prognosis in cancer patients and surgical trauma can worsen cancer-related immunodeficiency. Aim of this phase IB study is to verify toxicity and biological effects of interleukin-2 (IL-2) at 9 million IU/day subcutaneously (sc.) administered one, two or three preoperative days in patients with gastric cancer undergoing radical surgery. METHODS: Absolute value of total and T-helper (CD4) lymphocytes were measured at baseline and at 7th, 14th, and 50th postoperative days in 12 gastric cancer patients, who preoperatively received IL-2 at 9 million IU/day sc. as follows: group A (4 pts) 1-day; group B (4 pts) 2-days; group C (4 pts) 3-days administration. T and total lymphocytes count were recorded and retrospectively analyzed in a historical control-group of 22 consecutive patients, age and stage-matched. RESULTS: Toxicity consisted of fever grade I. In group A (1 day) T helper lymphocytes count decreased at 7th and at 14th postoperative day; in group B (2 days) and group C (3 days) no decrease of neither total nor T helper lymphocyte count occurred postoperatively, whereas in the historical group these parameters decreased significantly postoperatively and recovered only at 50th day. CONCLUSIONS: Two- and three-day schedules of sc. IL-2 preoperative administration at 9 million IU/daily prevented postoperative lymphocytopenia, whereas one-day administration did not. Since the IL-2 dose was so tolerable, that it could be given safely as outpatient, based on the previous results on survival observed in colorectal cancer patients with 3-days schedule we suggest that a 3-day schedule of Interleukin-2 as outpatient preoperative treatment seems advisable for further studies in gastric cancer patients. Copyright 2001 Wiley-Liss, Inc.

9
UI - 20581953
AU - Jiang XH; Wong BC; Yuen ST; Jiang SH; Cho CH; Lai KC; Lin MC; Kung HF; Lam SK; Chun-Yu Wong B
TI - Arsenic trioxide induces apoptosis in human gastric cancer cells through up-regulation of p53 and activation of caspase-3.
SO - Int J Cancer 2001 Jan 15;91(2):173-9

AD - Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong.
Arsenic trioxide (As(2)O(3)) can induce clinical remission in patients suffering from acute promyelocytic leukemia, through induction of apoptosis and activation of caspases. We investigated the potential use of As(2)O(3) in human gastric cancer and its possible mechanisms. Human gastric cancer cell lines AGS and MKN-28 were treated with various concentrations (0.1 to 100 microM) of As(2)O(3) for 24 to 72 hr. Apoptosis was determined by acridine orange staining, flow cytometry and DNA fragmentation. Protein levels of p53, p21(waf1/cip1), c-myc, bcl-2 and bax were detected by Western blotting. Effects of As(2)O(3) on caspase-3 protease activity, its protein concentration and cleavage of poly(ADP)-ribose polymerase (PARP) were also studied. As(2)O(3) inhibited cell growth and induced apoptosis in both cell lines, though AGS cells were more sensitive. As(2)O(3) induced apoptosis in AGS cells in a concentration- and time-dependent manner. Treatment resulted in a marked increase in p53 protein levels as early as 4 hr. Co-incubation with p53 anti-sense oligo-nucleotide suppressed As(2)O(3)-induced intracellular p53 over-expression and apoptosis. As(2)O(3) increased the activity of caspase-3, with appearance of its 17 kDa peptide fragment, and cleavage of PARP, with appearance of the 85 kDa cleavage product, both in parallel with the induction of apoptosis. Both the tripeptide caspase inhibitor zVAD-fmk and the specific caspase-3 inhibitor DEVD-fmk partially suppressed As(2)O(3)-induced caspase-3 activation and apoptosis. As(2)O(3) inhibits cell growth and induces apoptosis in gastric cancer cells, involving p53 over-expression and activation of caspase-3. The potential use of this compound in the treatment of gastric cancer is worth further investigation. Copyright 2001 Wiley-Liss, Inc.

10
UI - 20181099
AU - Elias D
TI - Reflections and proposals for the standardization of lymphadenectomy for gastric carcinoma.
SO - Eur J Surg Oncol 2000 Feb;26(1):6-10

AD - Department of Surgical Oncology, Institut Gustave Roussy, Comprehensive Cancer Center, Villejuif, France. elias@igr.fr
In this paper, I consider: the value of various histological procedures; the feasibility and reproducibility of lymphadenectomies according to the Japanese Research Society for Gastric Cancer; the minimal number of lymph nodes (LNs) which should be resected for each type of lymphadenectomy; and the best way to present the results concerning the LN status. A reproducible lymphadenectomy is proposed for simplified anatomical level I (anterior plane, along the gastric curves) and level II (intermediate plane, along the gastric arteries), without spleno-pancreatectomy for the majority of cases. The LN status must be based on the total number of involved nodes, as recommended by the 1997 UICC classification. These simple, reproducible guidelines offer a basis for the standardization of procedures used for the treatment and classification of gastric carcinomas.

11
UI - 20468694
AU - Bozzetti F
TI - Re: reflections and proposals for the standardization of lymphadenectomy for gastric cancer.
SO - Eur J Surg Oncol 2000 Aug;26(5):522-3

12
UI - 21416113
AU - McCulloch P
TI - Gastric cancer.
SO - Surg Oncol 2000 Jul;9(1):1-3

13
UI - 21416115
AU - Steele RJ; Lane DP
TI - Gene therapy for gastric cancer: problems and prospects.
SO - Surg Oncol 2000 Jul;9(1):13-6

AD - Department of Surgery and Molecular Oncology, University of Dundee, Scotland, UK.

14
UI - 21416116
AU - Sano T; Katai H; Sasako M; Maruyama K
TI - The management of early gastric cancer.
SO - Surg Oncol 2000 Jul;9(1):17-22

AD - Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.

15
UI - 21416118
AU - Sasako M; Katai H; Sano T; Maruyama K
TI - Management of complications after gastrectomy with extended lymphadenectomy.
SO - Surg Oncol 2000 Jul;9(1):31-4

AD - Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.

16
UI - 21416119
AU - Stein HJ; Feith M; Siewert JR
TI - Cancer of the esophagogastric junction.
SO - Surg Oncol 2000 Jul;9(1):35-41

AD - Chirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen, Munich, Germany. stein@nt1.chir.med.tu-muenchen.de
In the Western world, there has been an alarming rise in the incidence and prevalence of adenocarcinoma arising at the esophagogastric junction during recent decades. Epidemiological, clinical and pathological data support a sub-classification of adenocarcinomas arising in the vicinity of the esophagogastric junction (AEG) into adenocarcinoma of the distal esophagus (Type I), true carcinoma of the cardia (Type II) and subcardial carcinoma (Type III). While most, if not all, adenocarcinomas of the distal esophagus arise from areas with specialized intestinal metaplasia, which develop as a consequence of chronic gastroesophageal reflux, the etiology and pathogenesis of true carcinoma of the gastric cardia and subcardial gastric cancer is not clear at present. Although a subgroup of true carcinomas of the gastric cardia may also develop within short segments of intestinal metaplasia at the esophagogastric junction, a causal relation between these tumors and gastroesophageal reflux has been difficult to establish. Irrespective of the etiology, a complete removal of the primary tumor and its lymphatic drainage has to be the primary goal of any surgical approach to adenocarcinoma of the esophagogastric junction. Our experience in the management of more than 1000 such patients during the past 18 years suggests that an individualized therapeutic strategy oriented by tumor type and stage results in survival rates superior to those reported with a more indiscriminate approach. This individualized strategy prescribes a transmediastinal esophagectomy with lymphadenectomy in the lower posterior mediastinum and along the celiac axis for Type I tumors, extended total gastrectomy with transhiatal resection of the distal esophagus and D2 lymphadenectomy for Type II and Type III tumors, a limited resection of the esophagogastric junction and distal esophagus with interposition of a pedicled jejunal segment for uT1N0 tumors, and neoadjuvant chemotherapy followed by resection for uT3/T4 tumors. Extensive preoperative staging is essential to allow correct selection of the appropriate therapeutic strategy using this tailored approach.

17
UI - 99399905
AU - Saidi F; Keshoofy M; Abbassi-Dezfuli A; Ahamadi ZH; Shadmehr MB
TI - A new approach to the palliation of advanced proximal gastric cancer.
SO - J Am Coll Surg 1999 Sep;189(3):259-68

AD - Department of Surgery, Modarress Hospital, and The National Research Institute of Tuberculosis and Lung Diseases, Beheshti University of Medical Sciences, Tehran, Iran.
BACKGROUND: The operative mortality and morbidity rates of palliative total gastrectomy can be high, and survival is not extended. The quality of a foreshortened life is often marred by distressing postprandial symptoms and relentless weight loss. These problems can be attributed to the conventional manner of reconstruction after total gastrectomy, with small-bowel gastric reservoirs restricting the amount of caloric intake. Large-bowel gastric reservoirs have greater capacity and empty well if positioned upright within the chest for proper emptying. The scope of a combined palliative total gastrectomy, esophagectomy, and colon pull-through must be kept within the limits of patient tolerance. STUDY DESIGN: A palliative total gastrectomy was performed in 70 patients with incurably advanced cancers of the proximal and middle third of the stomach (TNM stages: II, 4%; III, 26%; and IV, 70%) using the large-bowel as a gastric substitute. The trauma of reconstruction by colon pull-through was lowered by avoiding thoracotomy and by positioning the colon within the lumen of the deepithelialized esophagus. Proximal cervical esophagocolostomy, distal duodenocolostomy, and colocolostomy reestablished gastrointestinal continuity. Follow-up focused on subjective gastrointestinal symptoms and nutritional maintenance. RESULTS: The operative mortality rate was 10%, postoperative complications were not inordinately high, and autopsy findings showed no defects in the technique of reconstruction. The normal esophageal mucosa was readily cored out through the neck and the abdomen, and the remaining esophageal muscular tunnel accommodated the pulled-through segment of colon. Quantitative assessment of postoperative quality of life proved impractical, but none of 58 longterm survivors (mean of 17.1 months for combined TNM stages II, III, and IV) suffered from disabling symptoms or pronounced weight loss. The quality of life, but not its length, appeared distinctly improved. CONCLUSIONS: The frequently encountered problems of abdominal distress and weight loss after palliative total gastrectomy can be averted by safely positioning a colonic gastric substitute within the lumen of the normal esophagus from which the mucosal lining has been extracted.

18
UI - 21189923
AU - Di Lorenzo N; Coscarella G; Lirosi F; Gaspari A
TI - Palliation of proximal gastric cancer.
SO - J Am Coll Surg 2001 Apr;192(4):552-3

19
UI - 21333672
AU - Nakane Y; Yamanaka H; Hioki K
TI - [Pre- and postoperative nutritional management for gastric cancer patients]
SO - Nippon Rinsho 2001 May;59 Suppl 5():497-500

AD - Second Department of Surgery, Kansai Medical University.

20
UI - 21333673
AU - Kawaguchi Y; Kamiyama Y
TI - [Parenteral and enteral nutrition in the inoperable gastric cancer]
SO - Nippon Rinsho 2001 May;59 Suppl 5():501-3

AD - First Department of Surgery, Kansai Medical University.

21
UI - 21369494
AU - Heideman DA; Snijders PJ; Craanen ME; Bloemena E; Meijer CJ; Meuwissen SG; van Beusechem VW; Pinedo HM; Curiel DT; Haisma HJ; Gerritsen WR
TI - Selective gene delivery toward gastric and esophageal adenocarcinoma cells via EpCAM-targeted adenoviral vectors.
SO - Cancer Gene Ther 2001 May;8(5):342-51

AD - Department of Gastroenterology, University Hospital Vrije Universiteit, Amsterdam. dam.heideman@avzu.nl
Application of recombinant adenoviral vectors for cancer gene therapy is currently limited due to lack of specificity for tumor cells. For gastric and esophageal adenocarcinoma, we present here that the relative abundant expression of the primary adenovirus receptor, coxsackie/adenovirus receptor (CAR), on normal epithelium compared to carcinoma favors the transduction of the epithelium. As such, to achieve specific transduction of cancer cells, targeting approaches are required that ablate the binding of the virus to CAR and redirect the virus to tumor-specific receptors. By immunohistochemistry and reverse transcriptase polymerase chain reaction assays, we demonstrate a marked difference in expression of the human epithelial cell adhesion molecule (EpCAM) between normal and (pre)malignant lesions of the stomach and esophagus. Based on this, we explored the feasibility of using EpCAM to achieve gastric and esophageal adenocarcinoma selective gene transfer. Adenoviral vectors redirected to EpCAM using bispecific antibodies against the adenovirus fiber-knob protein and EpCAM specifically infected gastric and esophageal cancer cell lines. Using primary human cells, an improved ratio of tumor transduction over normal epithelium transduction was accomplished by the EpCAM-targeted vectors. This study thus indicates that EpCAM-targeted adenoviral vectors may be useful for gastric and esophageal cancer-specific gene therapy in patients.

22
UI - 21384858
AU - Chan AO; Wong BC; Lam SK
TI - Gastric cancer: past, present and future.
SO - Can J Gastroenterol 2001 Jul;15(7):469-74

AD - Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Pokfulam Road, Hong Kong, ROC.
Gastric cancer remains a major cause of cancer mortality in the world. However, in the past 10 decades, the view of gastric cancer has been changing. This includes the unexplained decline in the incidence of the cancer, the proximal shift of the cancer in the stomach, the identification of Helicobacter pylori as an etiological agent, rapid development in molecular tumour biology, new treatment modalities and the adoption of mass screening for prevention. This article reviews the changing views of gastric cancer and the latest developments.

23
UI - 21387135
AU - Guilhot F
TI - [Anti-tyrosine kinase: the beginning of molecular therapies of cancer and initial results]
SO - Bull Cancer 2001 Jul;88(7):659-60

AD - Service d'oncologie hematologique et de therapie cellulaire, CHU La Miletrie, 86021 Poitiers. f.guilhot@chu-poitiers.fr

24
UI - 21419032
AU - Ravaud A; Borner M; Schellens JH; Geoffrois L; Schoffski BP; Kroon K; Wanders J; Hanauske AR; Fumoleau P; EORTC-ECSG
TI - UFT and leucovorin in first-line chemotherapy for patients with metastatic gastric cancer. An Early Clinical Studies Group (ECSG)/European Organization for Research Treatment of Cancer (EORTC) phase II trial.
SO - Eur J Cancer 2001 Sep;37(13):1642-7

AD - ECSG/EORTC, Institut Bergonie, Bordeaux, France. ravaud@bergonie.org
A phase II study was performed to evaluate 1-(2-tetrahydrofuryl)-5-fluorouracil and uracil (UFT) and leucovorin as first-line chemotherapy in European patients with advanced gastric cancer. From 38 patients, 25 were evaluable for response and 36 for toxicity. Patients received UFT at 300 mg/m(2)/day for 28 days, every 35 days and leucovorin at 90 mg/day on an identical schedule. Overall response rate was 10.5% (95% confidence interval (CI): 3.7-22.5%) in intent-to-treat analysis and 16% (95% CI: 5.7-33%) in evaluable patients. Grade 3-4 common toxicity criteria (CTC) toxicities were diarrhoea (28%; 10/36), nausea (11%; 4/36), vomiting (8%; 3/36) and asthenia (11%; 4/36). 23 patients in 44% (42/96) of the courses had to skip days of treatment due to toxicity or to non-compliance. In conclusion, UFT+leucovorin has a definitive, but low, efficacy in advanced gastric cancer patients. Toxicities were mainly gastrointestinal and treatment needs to be withheld if grade 2 diarrhoea occurs.

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