Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group.

In a prospective phase III multicenter trial, 213 patients with advanced measurable or nonmeasurable gastric cancer were randomized to receive methotrexate (MTX), fluorouracil (5-FU), and Adriamycin (doxorubicin; Farmitalia Carlo Erba, Milan, Italy) (FAMTX) or 5-FU, Adriamycin, and mitomycin (FAM). The results show a significantly superior response rate (41% v 9% [P less than .0001]), and survival (median, 42 weeks v 29 weeks [P = .004]) for FAMTX. There was a cumulative thrombocytopenia in FAM and not in FAMTX. The FAMTX protocol should be the reference treatment in future clinical trials that seek to improve the therapeutic outcome in advanced gastric cancer.

[Long iliac artery occlusions: Feasibility, short- and mid-term outcome]. / Perkutane Therapie langstreckiger Beckenarterienverschlüsse: Technische Durchführbarkeit, kurz- und mittelfristige Ergebnisse.

PURPOSE: It was the aim of the following study to determine the feasibility of the recanalization of long occlusions in iliac arteries and to establish its patency rate. MATERIAL AND METHODS: We retrospectively evaluated the data of 23 patients (15 male and 8 female) with occlusions of the iliac arteries with a mean length of 12 cm (range: 9-15 cm). The occlusions were situated either in the common iliac artery (CIA) (n = 3), in the external iliac artery (EIA) (n = 12) or in both CIA and EIA (n = 7). In one patient three vessels, the common femoral artery included, were involved. The recanalization procedure was performed with wire and catheter from retrograde and, in case of a failure, from antegrade in a cross-over technique. RESULTS: Recanalization succeeded in all patients. Technical success defined as residual stenosis < 30 % was seen in 20 of 23 patients. Early reocclusions were seen in four patients, in three of whom, the stent dilatation had been incomplete. Late reocclusions were observed in three patients, one of whom had already had early reocclusion. The reason was stent breakage in one, stent dehiscence in the second and restenosis in the third patient. All of the patients with reocclusion either early or late, had received covered stents. In four patients restenosis developed within 30 months: It was successfully treated by ballon dilatation or stent. Embolism during the recanalization procedure was observed in six patients. Embolism was observed on the ipsilateral side in five, and on the contralateral side in one patient. In each patient who had experienced embolism, balloon dilatation had been performed before stent implantation. CONCLUSION: 1) There is some evidence that the recanalization of long iliac artery occlusions is feasible. 2) The main reason for early and late reocclusions is either rest stenosis or restenosis. 3) Covered stents should only be used in selected cases. 4) Primary stenting is the treatment of choice in order to prevent embolism.

A modified sclerosing needle for the sclerotherapy of upper gastrointestinal bleeding.

A modified instrument that permits simultaneous endoscopic irrigation and sclerotherapy of a bleeding site in the gastrointestinal tract under direct visualisation is presented. To date, the system has been used in 12 patients. Five cases of grade III esophageal varices have been treated and in three cases of acute bleeding, definitive arrest of the bleeding was achieved. In seven cases of acute upper gastrointestinal hemorrhage presenting with gastric ulcer (n = 2 Forrest-Ia and n = 2 Forrest-Ib) and duodenal ulcer (n = 3 Forrest-Ib) bleeding was successfully stopped. The system is easy to handle, reliable in clinical practice, can be employed anywhere and the instrument is inexpensive.

[A contribution to the rate of side-effects of hepatotropic contrast media. A clinical comparative study of iodoxamate (Endomirabil) and ioglycamid (Bilivistan) (author's transl)]. / Beitrag zur Nebenwirkungsrate hepatotroper Kontrastmittel. Klinische Vergleichsuntersuchung von Iodoxamat (Endomirabil) und Ioglycamid (Bilivistan)

The new substance Iodoxamate (Endomirabil) is a hepatotropic contrast medium. In a clinical comparative study, the contrast of the biliary ducts and gall bladder is equivalent compared with Ioglycamid (Bilivistan). Assuming equal conditions of injection and in conformity with animal experimental studies, the rate of side effects of Iodoxamate is distinctly lower than that of the referring substance Iolgycamid (Bilivistan).

Right atrial silicone catheters as angioaccess for hemodialysis with special emphasis to their complications.

Right atrial silicone catheters (RASCs) serve as temporary angioaccess in hemodialysis (HD) patients. In a retrospective study of the years 1989 to 1996 we analyzed catheter-related complications, and tried to define patients at special risk for complications. We compared our results with published data on RASCs and percutaneous catheters. In 73 patients older than 64 (mean age 76) years with severe comorbidity 109 single lumen RASCs, type Demers, were implanted. Fifty-five similar catheters implanted in 44 younger patients (mean age 53) with a comparable severe comorbidity were used as controls. In the older patients the mean indwelling time was 157 (1-995) days, median 98 days, in the younger patients 135 (1-623) days, median 61 days. Early complications that led to RASC removal within one week after implantation were kinking, formation of a narrow loop, perforation, infected hematoma, and immediate clotting. Reasons for removal of the RASC after a longer period were infection, occlusion, and dislocation. In the old age group a great proportion (40%) of patients died with functioning RASC. In the literature RASCs are superior to percutaneous (Shaldon) catheters as temporary angioaccess for HD with respect to both better longevity and fewer complications such as venous stenoses or occlusions or infections. This is in accordance with our experience. However RASCs have complications, especially in the high risk groups of diabetics and patients with malignancies.

[Genetics of Crohn disease: study of the HLA association in 169 patients]. / Zur Genetik des Morbus Crohn: Untersuchung der HLA-Assoziation bei 169 Patienten.

Histocompatibility (HLA) antigen phenotypes have been studied in 169 patients with Crohn's disease. The following results could bei shown: HLA-Aw33, -B45 and -Cw3 showed a positive association and HLA-A26, -DR3 and -DRw8 a negative association with Crohn's disease compared to healthy controls. However, when the p-values were corrected by multiplying them by the number of determined antigens per gen-locus, the differences were not significant. Patients with a late onset of the disease (greater than 25 years) showed a statistical significant negative association with HLA-DR3. Numerous studies revealed no significant association between Crohn's disease and HLA-antigens except Smolen et al. (HLA-B12). The significant association of Crohn's disease and HLA-B12 reported by Smolen et al. could be caused by an increased frequency of HLA-B45 as we found in our patients.

Sequential methotrexate and 5-fluorouracil (FU) vs. FU alone in metastatic colorectal cancer. Results of a randomized multicenter trial. The Association of Medical Oncology (AIO) of the German Cancer Society.

Methotrexate (MTX) modulates 5-fluorouracil (FU) in several in vitro and in vivo experimental systems. Results of phase II studies have suggested improved response rates for the sequential application of MTX and FU in colorectal cancer. In a prospective randomized multicenter study we compared sequential MTX (300 mg/m2) and FU (900 mg/m2) using a seven-hour time interval and leucovorin rescue with FU (450 mg/m2/d for five days) in patients with previously untreated metastatic colorectal cancer. Of 172 patients randomized 159 were eligible for survival analysis and 153 for toxicity and response evaluation. Complete or partial response has been seen in 25.3% of patients receiving sequential MTX and FU and in 17.6% of those receiving FU alone (p = 0.11). There have been two long-term survivors, apparently cured by MTX/FU. Overall toxicity was more pronounced with FU alone, but sequential MTX/FU caused four toxic deaths. Median survival and survival rates at one and two years were not significantly different. It is concluded that this schedule of sequential MTX and FU is no more effective than a dose-intensive treatment with FU alone in metastatic colorectal cancer.

[Fluorouracil as monotherapy or combined with folinic acid in the treatment of metastasizing colorectal carcinoma]. / Fluorouracil als Monotherapie oder in Kombination mit Folinsäure in der Behandlung des metastasierten kolorektalen Karzinoms.

In a prospective randomized multicentre trial 139 patients with metastatic colorectal carcinoma (70 men, 69 women; age 35-81 years) were given palliative treatment with fluorouracil (400 mg/m2 daily for 5 days) alone or combined with folic acid (100 mg/m2 before each dose of fluorouracil). Both groups were comparable in respect of age, sex, Karnofsky index and number of localisations of metastases. The criterion for starting the treatment was progression of the malignancy or clinical symptoms caused by the tumour. Resulting remission rates (fluorouracil monotherapy vs combination with folic acid) were: complete or partial remission, 9 vs 16%; arrest of tumour growth, 20 vs 60%; progression 71 vs 24%. Peripheral side effects, such as stomatitis and diarrhoea, were similarly frequent with the two treatment regimens and reasonably tolerable. Median survival time for the fluorouracil monotherapy was 7.24 months from onset of treatment, and 9.1 months from the time that any metastases were diagnosed. The combination treatment with folic acid achieved a significantly longer median survival time (P less than 0.0001), 14.98 months from treatment onset and 16.3 months from metastasis diagnosis. The higher rate of response and the significantly prolonged survival time signify an improvement of the therapeutic profile of fluorouracil by addition of folic acid in the palliative therapy of colorectal carcinomas.