The influence of body weight, height, age and sex on plasma cholinesterase activity (ChE) in 650 males and 437 females with ChE-1 phenotype U (genotype ChEuChEu or ChEuChEs) or UA (genotype ChEuChEa) was studied in a multiple regression model. ChE was not influenced by age (p > 0.01), but, like other liver synthesized plasma enzymes, highly (p < 0.001) influenced by body weight and height. In a logarithmic scale ChE followed a linear model (R = 0.535, p < 0.001) with randomly distributed residuals, InChE = 3.286-0.308 x ChE-1 phenotype-0.104 x sex + 0.00765 x weight - 0.00723 x height (U = 1, UA = 2; male = 1, female = 2; kg; cm). A simplified model based on body-mass index (BMI = weight divided by squared height, kg/m2), InCHE = 2.016-0.308 x ChE-1 phenotype - 0.091 x sex + 0.0230 x BMI, showed the same goodness-of-fit (R = 0.533). In a non-logarithmic scale both multiple regression models failed to fit cases with high ChE activity. A model for a 'standardized' plasma ChE in which the effects of ChE-1 phenotype, sex, body weight and height are eliminated, is proposed to compare ChE in unmatched population groups when using this enzyme activity as a biomarker in environmental or occupational medicine.
Inter-individual variations of plasma cholinesterase were analysed in 193 apparently healthy volunteers (122 males, 71 females) with no known occupational exposure to cholinesterase inhibitors. Multiple regression analysis and analysis of variance showed statistically significant effects on the individual plasma cholinesterase activity by body weight, height, sex, and ChE-1 phenotype (but not by age or electrophoretic phenotype). Varying body weight explained one-fourth of the observed biological variance (s2total). The intra-individual variations during an 8-month period varied substantially from one individual to another (3% to 41% of the subject's mean activity); a repeated-measures analysis of variance showed a within-person variance (s2intra) = 5% of s2total. Intra-individual variation was uninfluenced by the variables that influence the inter-individual variance. A model for a 'standardized' plasma cholinesterase in which the combined effects of the four significant variables, ChE-1 phenotype, sex, body weight, and height are eliminated, is proposed for comparisons of plasma cholinesterase activities in unmatched population groups, e.g. within environmental or occupational medicine.
Developmental, morphogenetic, and reproductive effects of four polycyclic non-isoprenoid juvenoids (fenoxycarb, pyriproxyfen, CGA45128, and PH030) were compared in nymphal German cockroaches, Blattella germanica (L.). A pronounced dose-dependent response was exhibited with all juvenoids. Ecdysial failure was induced at 100 and 10 μg by fenoxycarb, CGA45128 and PH030, while pyriproxyfen did not cause this effect at any dose tested. All juvenoids induced significant developmental delays (at doses of 100, 10 and 1 μg/insect) and caused high levels of morphogenetic wing twisting, with PH030 being significantly more active than the other compounds. Twisted-wing adultoids were capable of reproducing unless they had been treated at 100 or 10 μg; PH030 was the only compound causing reproductive inhibition at the lower 1 μg dose. Wing twisting was not an absolute indicator of reproductive inhibition, as most slightly affected adultoids were capable of producing progeny when mated with normal adults. The implications of this latter finding to German cockroach population management with juvenoids is discussed.
Background: The need for granulocyte-colony stimulating factor (G-CSF) support during dose-dense (DD) paclitaxel (T) after doxorubicin and cyclophosphamide (AC) is unclear. Given that G-CSF is not devoid of adverse effects, and adds significant costs to treatment, we are examining the feasibility and safety of avoiding G-CSF during dose dense T. Methods: This is a single center, single-arm, phase II, two stage study. The primary aim is to evaluate the rate of T treatment completion within 7 weeks (from D1 of cycle 1 to D1 of cycle 4 of T) omitting Pegfilgrastim using pre-specified safety rules. Secondary aims include: characterization of the utilization of Pegfilgrastim using pre-specified safety rules in patients receiving dose dense T; evaluation of the safety of omitting routine Pegfilgrastim support in patients receiving dose dense T; evaluation of total cost ($ United States) of omitting routine Pegfilgrastim use during dose dense T. As a secondary aim we will evaluate the safety of simplifying the pre-medication regimen used for the T portion of the regimen (withholding corticosteroids in cycle 3 and 4 if no evidence of allergic reactions in cycle 1 and 2). A Simon Optimal design was selected with an overall one-side type I error of 10% and 90% power to detect the difference between unacceptable T completion rate (75%) and desirable completion rate (85%). In the first stage, 51 evaluable patients will be enrolled. If during the first stage, at any point, a total of 12 or more patients do not complete treatment within 7 weeks the trial will be closed permanently. Among the 51 patients enrolled after the first stage, if at least 40 patients complete treatment without dose delay, accrual will continue to the second stage where an additional 74 evaluable patients will be enrolled. If there are at least 100 among the 125 evaluable patients completing treatment without dose delay, the regimen will be considered worthy of further study. If during the second stage, at any point, a total of 26 patients do not complete treatment within 7 weeks the trial will be closed permanently and the study intervention will not be of clinical interest. If the true treatment completion rate is 75%, the chance the regimen is declared ineffective is 91% (exact alpha = 0.094) and if the true treatment completion rate is 85% the chance that the regimen is falsely declared ineffective is 10% (exact power = 0.899). The estimated accrual rate is 6-8 patients/month. Accrual started in April 2016. Clinical trial information: NCT02698891. Citation Format: Barroso-Sousa R, Vaz-Luis I, Guo H, Barry WT, Brackett AM, Brock VA, Roche KA, Kasparian E, Winer EP, Lin NU. Feasibility and safety of avoiding granulocyte colony-stimulating factor prophylaxis during the paclitaxel portion of dose dense doxorubicin-cyclophosphamide and paclitaxel regimen [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT1-01-09.
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