Fluorouracil-alone versus high-dose folinic acid and fluorouracil in advanced colorectal cancer: a randomized trial of the Italian Oncology Group for Clinical Research (GOIRC).

One hundred eighty-one patients with measurable recurrent or metastatic colorectal cancer, who had not received prior chemotherapy, were randomized in a prospective controlled trial to receive 5-fluorouracil (5FU), 13.5 mg/kg, for five days (arm A) or high-dose folinic acid [Cyanamid-Lederle, Italy] (FA), 200 mg/m2, for five days and 5FU, 400 mg/m2 for five days (arm B). The treatments were repeated every four weeks. One hundred fifty-five patients were evaluable for response. The two arms were balanced for all potential prognostic factors studied. The response rate (CR+PR) was 18% in the 5FU arm and 16% in the 5FU plus FA arm. Median duration of response was 56 weeks for 5FU alone and 42 weeks for the combination (p = 0.48). Median time to failure (TTF) was 20 weeks for arm A and 21 for arm B (p = 0.62). Median survival was 62 weeks on the 5FU arm and 53 weeks on the FA plus 5FU arm (p = 0.14). Dose intensity (DI) delivered was the same in both arms. Diarrhea and mucositis were the most frequent adverse reactions in arm B; 20% of the patients in arm A and 38% of those in arm B experienced diarrhea (p = 0.008). Mucositis occurred in 34% of patients in arm A and 42% in arm B (p = 0.04). In general nausea and vomiting were moderate. Hematological toxicity was more severe in patients treated with 5FU alone: 31% in arm A and 14% in arm B developed leukopenia (p = 0.015). In the combination arm one patient died due to gastrointestinal and hematological toxicity after the seventh cycle. This study indicates that, in advanced colorectal cancer, the combination of high-dose FA and 5FU is not superior to 5FU alone when utilized at standard high-dose intensity.     

The effect of naloxone on the preoperative gastric volume and pH

The effect of 4 mg oral naloxone on preoperative gastric volume and pH of gastric aspirate was studied in a double-blind, randomized study. Twenty patients received 10 ml of naloxone (4 mg) mixed with 10 ml of orange juice, and 20 patients received 10 ml of isotonic saline mixed with 10 ml of orange juice, 2 h before surgery. Gastric content was obtained immediately after intubation of the trachea. No significant difference in gastric volume and pH of gastric aspirate was found between the two groups. It is concluded that naloxone does not affect gastric emptying and gastric acid secretion to a degree great enough to protect against aspiration of gastric contents into the lungs.     

Seroprevalence of anti-HTLV I/II and anti-HIV-1 antibodies in a sample population in the Marche Region,Italy

A total of 1292 sera, provided by different USLs (Local Health Centers) in the Marche Region (Italy), was tested by ELISA and Western Blot for the detection of anti-HTLV I/II ad HIV-1 antibodies. It was decided not to follow any particular criterion when collecting the sera, so no protocol of admission was established in advance. Of the 1292 sera tested, 12 were found antibody positive to HTLV I/II, 18 to HIV-1 and 4 to both viruses. Of the seropositives, for HTLV I/II and HIV-1, respectively, 2 and 3 were prisoners; 2 and 4 were IVDAs, 3 and 7 were hematological patients, 3 and 2 were hospitalized subjects (not for hematological disorders), and 2 and 2 were positives belonging to a healthy population group. These data suggest that the viruses may also be spreading among groups other than the high-risk ones (homosexuals, IVDAs, prisoners, blood-transfusion recipients, promiscuous heterosexuals).     

Lipid and insulin concentrations in obese postmenopausal women: separate effects of energy restriction and weight loss.

The separate effects of energy restriction and weight loss on serum lipids were studied in 24 postmenopausal moderately obese women before and after weight loss of greater than 10 kg to normal weight. Fasting serum triglycerides (TGs), total cholesterol (TC), high-density-lipoprotein (HDL) and low-density-lipoprotein (LDL) cholesterol, and insulin were measured at the end of four 10-d in-hospital phases, two before and two after weight loss: phase I, stable weight; phase II, 3350 kJ/d(800 kcal/d), followed by outpatient weight loss; phase III, 3350 kJ/d (800 kcal/d); and phase IV, stable weight. Diet composition and exercise were constant the entire study. Energy-restriction effect was determined by comparing average values in stable-weight phases (I and IV) with low-energy phases (II and III); weight-loss effect was determined by comparing values in obese phases (I and II) with reduced-weight phases (III and IV). Energy restriction lowered TG, TC, LDL cholesterol, the LDL-HDL cholesterol ratio, and insulin and raised HDL cholesterol (all P less than 0.05). Weight loss lowered TG, TC, LDL cholesterol, and insulin (all P less than 0.01) but did not change HDL cholesterol or the LDL-HDL cholesterol ratio. The results suggest that reduction to a weight-steady nonobese state significantly lowers TG, TC, and LDL cholesterol but does not improve HDL cholesterol or the LDL-HDL cholesterol ratio.