In several studies a single dose of 32 mg was compared to an ondansentron (OND) administration schedule of every 6 h, yielding no differences in overall efficacy. The aim of this randomized comparative study was to identify differences of these two schedules on an hour-to-hour control of nausea and vomiting, during the first 24 h in patients receiving cisplatin (CDDP)-based chemotherapy. One hundred ten patients were randomly assigned to two groups (A and B); all received combination chemotherapy with CDDP at a dose of 100 mg/m2. OND was administered as follows: group A: 8 mg, 30 min before the infusion of CDDP, and repeated every 6 h after the first dose (totally 4 doses) in the first 24 h, and group B: 32 mg before CDDP, as a loading dose and this was the total dose for the first 24 h. No overall difference was noticed during the first 24 h, as well as the next 3 days from the infusion of CDDP in the intensity of vomits, vomits without gastric content (retches), and nausea. In a more detailed monitoring of the distribution of emetic episodes during the first 24 h, there were important differences between these two antiemetic schedules: for group A an increased vomiting with or without gastric content between midnight and 6 p.m. was observed, and for group B between 6 p.m. and midnight (vomits with p 0.03, and without gastric content p 0.02). Preloading with the total 24-hour dose of OND 32 mg exhibits a more potent antiemetic activity during the initial 18 h, becoming weaker over the last 5 h of the first day, whereas the every-6-hour schedule leaves periods of poor emesis control between dosing intervals.
The levels of soluble interleukin-2 receptors (sIL-2R) were measured in the serum of 52 patients with advanced colorectal carcinoma and compared to CEA and CA 19-9 levels. Twenty-five normal, age and sex-matched individuals served as controls. Seventy-five per cent of the patients had increased mean serum levels of sIL-2R (1539 +/- 155 U/ml), while normal controls had mean levels of 555 +/- 31 U/ml (p < 0.001). The relationship with hepatic or lymph nodal metastases showed no statistically significant difference (p = 0.34 and p = 0.47, respectively). Serum sIL-2R levels showed a linear correlation with CEA (p < 0.05). Patients with lower pretreatment sIL-2R levels (less than 1.200 U/ml) had a longer survival than patients with higher initial levels (more than 1.200 U/ml) (p = 0.0049). In conclusion, the present work shows that the serum levels of sIL-2R: a) are elevated in patients with advanced colorectal cancer, b) have no relationship with the type of metastases, c) correlate with serum CEA and d) have a prognostic value for survival.
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