Bolus injection (2-4 min) versus short-term (10-20 min) infusion of 5-fluorouracil in patients with advanced colorectal cancer: a prospective randomised trial. Nordic Gastrointestinal Tumour Adjuvant Therapy Group.

The use of bolus 5-fluorouracil (5-FU) as a short-term infusion over 10-30 min is increasing at the cost of a push injection, mainly due to practical advantages. Since even a short prolongation of the administration time results in lower 5-FU peak and area under the curve (AUC) levels, there might be a risk of decreased efficacy. The aim of this study was to compare a rapid intravenous (i.v.) 5-FU injection and a short-term 5-FU infusion with respect to objective responses and toxicity in patients with advanced colorectal cancer. 203 patients with measurable advanced colorectal cancer were randomised to bolus 5-FU either as an injection for 2-4 min or as a short-term infusion lasting 10-20 min. In both groups, the 5-FU dose was 500 mg/m2 and leucovorin 60 mg/m2 was given 40 min after the start of 5-FU. Treatment was given on two successive days every other week until progression. Objective tumour regression was seen in 27/100 (27%) in the injection group and in 13/103 (13%) in the infusion group (P = 0.02). Severe toxicity was rare and did not differ significantly between the groups. Progression-free survival tended to be longer in the injection group (P = 0.07), but overall survival did not differ between the groups. Bolus 5-FU should be administered as a rapid i.v. injection rather than as a short-term infusion, since the former rate of administration results in a higher response rate without being significantly more toxic.

Effect of prophylactic systemic administration of cephalothin in colorectal surgery.

The effect of standardized prophylactic treatment with systemically administered cephalothin (Keflin) was studied in a series of 120 consecutive patients in whom elective colorectal surgery was planned. The patients were divided by random selection into one treatment group and one control group. The same mechanical cleansing with cathartics and tap water enemas was performed in both groups. The patients in the treatment group received intravenously 2 g cephalothin 2 hours prior to the operation, 2 g during the operation and then 2 g every 6th hour during 4 days. 14 cases were excluded for various reasons. In 19 cases only minor operations were performed, such as laparotomy with or without simultaneous colostomy. The overall frequency of infections was 17.5% in the treatment group and 53.1% in the control group. In the 87 cases undergoing major operations, infections were registered in 17.4% of the treated patients and 58.5% of the control patients. The difference is highly significant (p less than 0.001) in both cases. Escherichia coli was present in about 70% of the infections, often together with other aerobic or anaerobic organisms.

Lansoprazole versus omeprazole in active duodenal ulcer. A double-blind, randomized, comparative study.

BACKGROUND: Lansoprazole is a new substituted benzimidazole that inhibits the H+,K(+)-adenosine triphosphatase in the parietal cell and, like the first developed proton pump inhibitor omeprazole, gives a strong inhibition of gastric acid output. METHODS: In this double-blind randomized comparative study patients with active duodenal ulcers were treated with either 30 mg lansoprazole or 20 mg omeprazole in the morning. All demographic data in the two treatment groups were comparable. RESULTS: A total of 279 patients entered the study. There was no difference in healing rates between the groups either after 2 weeks (86.2% for lansoprazole and 82.1% for omeprazole) or after 4 weeks (97.1% and 96.2%). No patient ceased treatment owing to side effects. CONCLUSIONS: Both lansoprazole and omeprazole generate very high healing rates and good symptom relief in active duodenal ulcer. Side effects are few and mild.

Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer.

BACKGROUND: In certain patients with pancreatic and biliary cancer, chemotherapy may relieve tumour-related symptoms, improve quality of life and possibly prolong survival. The extent of these improvements is not completely known in spite of the extensive use of this treatment modality. The aim of this study was to estimate any gain in the quantity and quality of life produced by chemotherapy in patients with pancreatic and biliary cancer. PATIENTS AND METHODS: Between January 1991 and February 1995, 90 eligible patients with pancreatic or biliary cancer were randomized to either chemotherapy in addition to best supportive care or to best supportive care. Chemotherapy was allowed in the latter group if the supportive measures did not lead to palliation. Chemotherapy was either sequential 5-fluorouracil/leucovorin combined with etoposide (FELv) or, in elderly and poor performance patients, the same regimen without etoposide (FLv). Quality of life was evaluated with the EORTC-QLQ-C30 instrument. RESULTS: Mean scale scores in the QLQ-C30 improved more often/deteriorated less frequently in the chemotherapy group than in the best supportive care group. More patients in the chemotherapy group (36%, 17/49) had an improved or prolonged high quality of life for a minimum period of 4 months compared to those in the best supportive care group (10%, 4/41, P < 0.01). Overall survival was significantly longer in the chemotherapy group (median 6 vs. 2.5 months, P < 0.01). Also, the quality-adjusted survival time was longer for patients randomized to chemotherapy (median 4 vs. 1 months, P < 0.01). The effects were seen both in pancreatic and biliary cancer. CONCLUSIONS: The results show that chemotherapy can add to both quantity and quality of life in advanced pancreatic and biliary cancer. The number of patients who benefit from treatment is, however, still limited; for this reason careful selection before, and close monitoring during, treatment are necessary.

Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer.

BACKGROUND: The extent to which chemotherapy may relieve tumour-related symptoms, improve quality of life and prolong survival in patients with gastric cancer is not known in spite of the extensive use of this treatment modality. The aim of this study was to estimate any gain in the quantity and quality of life produced by chemotherapy in these patients. PATIENTS AND METHODS: Between January 1991 and February 1995, 61 patients with gastric cancer were randomized to either chemotherapy in addition to best supportive care or to best supportive care. Chemotherapy was allowed in the latter group if the supportive measures did not lead to palliation. Chemotherapy was the ELF-regimen consisting of 5-fluorouracil, leucovorin and etoposide, or, in elderly patients with poor performance, a 5-fluorouracil/leucovorin regimen (FLv). Quality of life was evaluated with the EORTC-QLQ-C30 instrument. RESULTS: More patients in the chemotherapy group (45%, 14/31) had an improved or prolonged high quality of life for a minimum period of 4 months compared to those in the best supportive care group (20%, 6/30, P < 0.05). A similar difference was seen in the treating physician's evaluation of whether the patient was subjectively improved or continued to do well for at least 4 months (17/31, 55% versus 6/30, 20%, P < 0.01). Overall survival was longer in the chemotherapy group (median 8 vs. 5 months) although the difference was not statistically significant (P = 0.12). After corrections for imbalances in pretreatment characteristics, chemotherapy treatment was, however, associated with a survival benefit (P = 0.003). Also, the quality-adjusted survival time and time to disease progression were longer for patients randomized to chemotherapy (median 5 vs. 2 months, P = 0.03). CONCLUSIONS: The results show that chemotherapy can add to both quantity and quality of life in advanced gastric cancer. The number of patients who benefit from treatment is, however, still rather limited.