Comparative study of the clinical efficacy of two dosing regimens of flutamide.

PURPOSE: We performed a randomized trial to compare the efficacy and toxicity of a new dose of flutamide (500 mg QD) with the currently recommended dose (250 mg q8h) in the treatment of advanced prostate cancer. The primary endpoints were percent of patients having normalization of prostate specific antigen (PSA), time to normalization, and percent change from baseline. Secondary endpoints were quality of life and toxicity. PATIENTS: Altogether, 440 men aged 46 to 94 years (mean 71 years) with confirmed stage M(1) disease, documented PSA rise >0.2 ng/mL, ECOG status 0 to 2, no second neoplasm, no liver function tests > or = 1.5-fold normal values, and no previous treatment for metastatic disease were entered in the trial. RESULTS: The PSA normalized by week 12 in 71% of the patients receiving 500-mg dose and 75% of those receiving the standard dose. The percent change in PSA was 89% and 96%, respectively. The treatment groups were not significantly different with respect to the incidence of adverse events: 71% v 68% in the 500-mg and 250-mg arms, respectively (P = 0.337). CONCLUSIONS: When combined with castration, 500 mg of flutamide appears to be equally effective in lowering serum PSA and is not significantly more toxic than conventional dosing. The use of 500 mg QD instead of the standard 250 mg q8h would result in a cost savings of 30%.

Characterization of maternal influence on teratogenicity: an assessment of developmental toxicity studies for the herbicide cyanazine.

The contribution of maternal toxicity to the teratogenic effects of the herbicide cyanazine has been assessed to determine whether it may be a hazard to development. Eye defects such as anophthalmia and microphthalmia were observed in rat fetuses and pups. Maternal toxicity was determined from body weight data and clinical signs. Two approaches were used. First, the timing of maternal toxicity was correlated with the specific period of gestation during which the observed fetal defect was most likely to have occurred. Second, individual dams, as well as mean values for each group, were evaluated. The data at the individual level, i.e., in dams with affected litters, did not support conclusions based on the group means. Instead, it is suggested that the developmental effects were not a direct result of maternal toxicity of cyanazine. Data from a rabbit developmental toxicity study supported the findings from the Fischer 344 rat studies. The strategy employed may thus enable direct toxicity to the fetus to be distinguished from developmental toxicity arising as a secondary consequence of maternal toxicity.

Assessment of ductus arteriosus shunt in preterm infants supported by mechanical ventilation: effect of interatrial shunting.

We studied 51 preterm infants (< 1500 gm) with serial color Doppler echocardiography to determine the impact of incompetence of the foramen ovale on the hemodynamic implications of shunting through a patent ductus arteriosus. Doppler and two-dimensional echocardiographic measures included left atrial/aortic root ratio, right (RVSV) and left ventricular stroke volumes (LVSV), and outputs to determine relative ventricular outputs (RVSV/LVSV) and to calculate the pulmonary/systemic flow ratio (Qp/Qs), the diameter of the color flow Doppler mapping of interatrial and ductal shunts, pulsed Doppler pattern, and velocity of those shunts. The dominant direction of shunting at the ductal and atrial levels was left to right. In studies with minimal atrial shunting, there was a weak but significant correlation between RVSV/LVSV (1/(Qp/Qs)) and the left atrial/aortic root ratio, LVSV, and output index, but there was a close correlation with the diameter of the color flow Doppler of the shunt within the ductus (r = -0.8). With this diameter used as a constant, increasing color flow Doppler diameter of atrial shunt significantly reduced LVSV and increased RVSV/LVSV (1/(Qp/QS)). In infants with large ductal and atrial shunts, right ventricular output was often greater than left ventricular output. We conclude that atrial shunting has a significant impact on the hemodynamic implications of ductal shunting in many very preterm infants. This renders use of the relative ventricular outputs to calculate Qp/Qs inaccurate as a single measure of shunt size in patent ductus arteriosus. If the shunt is predominantly left to right, the most accurate assessment is provided by color flow ductal shunt diameter.

Alternate lunch patterns in high schools. III. Food acceptability.

Food acceptability was assessed in forty-eight high schools using alternate methods of menu planning for school lunches. The free-choice pattern resulted in a significant reduction of total plate waste, particularly in the vegetable and salad categories. Girls consistently wasted more food than did boys, regardless of menu pattern. Overall plate waste was 7 and 13 per cent of food service for boys and girls, respectively. The data suggest that a free-choice lunch may be effective in reducing plate waste, particularly for poorly consumed menu items.

Alternate lunch patterns in high schools. I. Labor requirements and meal costs.

Meal costs were compared in forty-eight high schools as a function of the lunch pattern. The patterns evaluated were: Type A "offer vs. serve," traditional Type A, four food groups (Basic 4), and free choice. Participation in school lunch increased with free choice, resulting in a reduction in labor and total meal costs. Sixteen per cent of foodservice work involved administration, 37 per cent preparation, 16 per cent service, 25 per cent clean-up, and 6 per cent other, which did not vary with the menu pattern.