ABSTRACT
Patients with advanced colorectal cancer were randomized to receive either fluorouracil (5-FU) 370 mg/m2 IV days 1 to 5 followed by weekly applications of 5-FU 600 mg/m2 or the same doses of 5-FU preceded by folinic acid 200 mg/m2. Because of toxicity, the weekly 5-FU dose in the combination treatment schedule was reduced to 500 mg/m2 in the course of the study. As of November 1990, 135 patients entered the study; 71 have received combination therapy, and 64 monotherapy. Sixty-three and 59 patients, respectively, are included in the present interim analysis. The two groups are well matched for age, performance status, site of disease, number of metastatic sites, and biochemical parameters. Treatment results are evaluable in 118 patients. Thirty percent receiving combination treatment and 20% receiving monotherapy achieved a complete or partial remission. There is no survival time difference between the groups. However, time to progression is superior in the combination treatment group (median 26 weeks compared with 13 weeks). The main toxicity was diarrhea during the weekly therapy. This was especially true for patients receiving combination treatment before the reduction of 5-FU dosage. In contrast to only four of 56 patients with monotherapy, 14 of 39 with the combination treatment at the initial dosage had severe diarrhea with two treatment-related deaths in this latter group. By reduction of 5-FU dosage during the weekly therapy severe diarrhea could be clearly reduced with only one of 18 patients suffering from diarrhea of World Health Organization grade 3. Other toxicity was usually mild. In conclusion, a prolongation of time to progression could be achieved by combination treatment of folinic acid and 5-FU, which was well tolerated when the weekly dose of 5-FU did not exceed 500 mg/m2.
Subject(s)
Colorectal Neoplasms/drug therapy , Fluorouracil/therapeutic use , Leucovorin/therapeutic use , Colorectal Neoplasms/mortality , Drug Administration Schedule , Female , Humans , Liver Neoplasms/secondary , Male , Middle Aged , Survival AnalysisABSTRACT
In 200 patients with upper abdominal complaints biopsy material was taken by fiberoptic endoscopy for histologic evaluation. Histology was normal in both the gastric fractions from fundus and antrum and from the duodenal mucosa in 53 cases. 36 Patients showed the histologic picture of duodenitis with leucocytic infiltrates of the villous stroma in the vicinity of erosions or ulcerations. In 28 cases duodenitis was found without such mucosal lesions, accompanying coexistent gastritis. This is, however, not a constant finding in patients with gastritis of either histologic type in either gastric region: 82 cases from all age groups had gastritis without accompanying duodenitis. In contrast to a good deal of the literature reports about duodenitis being a disease entity, we could not find but one case of isolated duodenitis without gastritis and/or duodenal mucosal lesions. Furthermore, there is no specific clinical symptomatology.
Subject(s)
Duodenal Diseases/pathology , Duodenal Diseases/complications , Duodenal Diseases/diagnosis , Enteritis/complications , Enteritis/diagnosis , Enteritis/pathology , Gastritis/complications , Gastritis/diagnosis , Gastritis/pathology , HumansABSTRACT
In an open controlled multicenter study the effectiveness of various dose levels of (+)-Cyanidanol-3 (Catergen) in patients suffering from chronic liver disease and treated over a period of 6 months is assessed. Subjective symptoms as fatigue, nausea, loss of appetite, vomiting and pruritus are positively influenced at all dose levels. A statistically significant fall of the transaminases SGOT, SGPT and gamma--GT however occurs only at a dosage of 6 tablets per day (3000 mg per day) of (+)-Cyanidanol-3, which cannot be demonstrated at a dose level of 3 X 1 tablet per day. Between the dosage of 2 X 3 or 3 X 2 tablets per day is no significant difference. Side effects due to therapy could not be observed.
