Pharmacokinetics (PK) of bendamustine in pediatric patients with relapsed/refractory acute leukemia.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9547-9547
Author(s):  
Mona Darwish ◽  
Gail C. Megason ◽  
Mary Bond ◽  
Edward Hellriegel ◽  
Philmore Robertson ◽  
...  
Keyword(s):  
Acute Leukemia ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Pediatric Patients ◽  
Systemic Exposure ◽  
The Body ◽  
Adult Patients ◽  
Concentration Data ◽  
Pharmaceutical Industries

9547 Background: The PK profile of bendamustine in adult patients is well characterized. The objective of this analysis was to describe the pediatric PK profile of bendamustine relative to the adult PK profile and correlate the systemic exposure of bendamustine to efficacy and safety parameters. Methods: Samples were obtained after a single dose from patients aged 1-19 years with relapsed/refractory acute leukemia who were enrolled in an open-label, nonrandomized study of bendamustine (90–120 mg/m2, infused over 60 minutes). Samples were obtained prior to bendamustine infusion and preselected time points through 24 hours after start of infusion on day 1. Population PK modeling was performed using plasma concentration data from these patients. PK data from adults were used for comparison. Results: Systemic exposure of pediatric patients to bendamustine was similar to that obtained previously in adult patients. Mean Cmax was 6806 ng/mL and mean AUC0-24 was 8240 ng*hr/mL in pediatric patients, compared with a mean Cmax of 5746 ng/mL and AUC0-24 of 7121 ng*hr/mL in adults. Similarity in exposure despite the large range of body surface area across the pediatric and adult populations confirms appropriateness of the body surface area–based dosing scheme. In pediatric patients, age, race, sex, or disease state had no statistically significant effect on systemic exposure to bendamustine. No changes in systemic exposure to bendamustine in the presence of a CYP1A2 inhibitor/inducer were observed. Differences in PK were not observed in pediatric patients with mild renal impairment as compared with patients with normal renal function. Exposure in 2 pediatric patients with moderate hepatic dysfunction appeared to be higher. No clear exposure-response relationship was observed. Infection was the only adverse event for which the probability of occurrence increased with increase in exposure to bendamustine. Conclusions: The PK profile of bendamustine in pediatric patients was similar to the known PK profile in adults, demonstrating that exposures reflective of the therapeutic range in adults were attained following administration of 120 mg/m2 to pediatric patients. Support: Teva Pharmaceutical Industries Ltd., Frazer, PA.

The use of Body Surface Index as a Better Clinical Health indicators Compare to Body Mass Index and Body Surface Area for Clinical Application

2018 ◽  
pp. 131-136
Author(s):  
Shirazu I. ◽  
Theophilus. A. Sackey ◽  
Elvis K. Tiburu ◽  
Mensah Y. B. ◽  
Forson A.
Keyword(s):  
Surface Area ◽  
Body Surface Area ◽  
Clinical Application ◽  
Body Surface ◽  
Body Height ◽  
Health Indicators ◽  
The Body ◽  
Body Parameters ◽  
The Relationship ◽  
Individual Body

The relationship between body height and body weight has been described by using various terms. Notable among them is the body mass index, body surface area, body shape index and body surface index. In clinical setting the first descriptive parameter is the BMI scale, which provides information about whether an individual body weight is proportionate to the body height. Since the development of BMI, two other body parameters have been developed in an attempt to determine the relationship between body height and weight. These are the body surface area (BSA) and body surface index (BSI). Generally, these body parameters are described as clinical health indicators that described how healthy an individual body response to the other internal organs. The aim of the study is to discuss the use of BSI as a better clinical health indicator for preclinical assessment of body-organ/tissue relationship. Hence organ health condition as against other body composition. In addition the study is `also to determine the best body parameter the best predict other parameters for clinical application. The model parameters are presented as; modeled height and weight; modelled BSI and BSA, BSI and BMI and modeled BSA and BMI. The models are presented as clinical application software for comfortable working process and designed as GUI and CAD for use in clinical application.

scholarly journals Evaluation of body-surface-area adjusted dosing of high-dose methotrexate by population pharmacokinetics in a large cohort of cancer patients

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Usman Arshad ◽  
Max Taubert ◽  
Tamina Seeger-Nukpezah ◽  
Sami Ullah ◽  
Kirsten C. Spindeldreier ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Large Cohort ◽  
Therapeutic Drug ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Concentration Data ◽  
Dose Methotrexate

Abstract Background The aim of this study was to identify sources of variability including patient gender and body surface area (BSA) in pharmacokinetic (PK) exposure for high-dose methotrexate (MTX) continuous infusion in a large cohort of patients with hematological and solid malignancies. Methods We conducted a retrospective PK analysis of MTX plasma concentration data from hematological/oncological patients treated at the University Hospital of Cologne between 2005 and 2018. Nonlinear mixed effects modeling was performed. Covariate data on patient demographics and clinical chemistry parameters was incorporated to assess relationships with PK parameters. Simulations were conducted to compare exposure and probability of target attainment (PTA) under BSA adjusted, flat and stratified dosing regimens. Results Plasma concentration over time data (2182 measurements) from therapeutic drug monitoring from 229 patients was available. PK of MTX were best described by a three-compartment model. Values for clearance (CL) of 4.33 [2.95–5.92] L h− 1 and central volume of distribution of 4.29 [1.81–7.33] L were estimated. An inter-occasion variability of 23.1% (coefficient of variation) and an inter-individual variability of 29.7% were associated to CL, which was 16 [7–25] % lower in women. Serum creatinine, patient age, sex and BSA were significantly related to CL of MTX. Simulations suggested that differences in PTA between flat and BSA-based dosing were marginal, with stratified dosing performing best overall. Conclusion A dosing scheme with doses stratified across BSA quartiles is suggested to optimize target exposure attainment. Influence of patient sex on CL of MTX is present but small in magnitude.

scholarly journals Nuclear medicine in the pediatric field

2021 ◽  
pp. 36-65
Author(s):  
Barone Sebastiano ◽  
Pagliuso Serena
Keyword(s):  
Nuclear Medicine ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
European Association ◽  
Pediatric Patients ◽  
Target Organ ◽  
Organ Weight ◽  
Reference Levels ◽  
Medical Examinations

The work presented describes the main ways of preparing radiopharmaceuticals and carrying out nuclear-medical examinations in pediatric patients. Through the differences in the execution of the tests, the importance of dosimetry is revealed, i.e. the diagnostic reference levels, in which the percentage of activity that must be administered to the child on the basis of that introduced in the adult is indicated. Through a study performed on pediatric patients, subjected to nuclear-medical investigations, the validity of the LDRs is reported according to the scheme in tab. 6 (EANM-EUROPEAN ASSOCIATION OF NUCLEAR MEDICINE). Through a study conducted in pediatric patients, subjected to medical - nuclear investigations, the importance of the dose is noted in order to obtain greater benefits in the patient and high quality images for diagnostic purposes. By carrying out pediatric-radiopharmaceutical calculations, it is possible to reproduce the aforementioned, ie an optimization of the dose. Using body surface area Child's body surface area (m2) _______________________________ = 0.53g: 1.8 g = 29% - 2.9 mCi Adult's body surface area (m2) Using organ weight Target organ weight of child (g) = 93 g: 310g = 30% - 3.0 mCi Target organ weight of adult (g)

Correlation between the Minimal Cross-Sectional Area of the Nasal Cavity and Body Surface Area: Preliminary Results in Normal Patients

2002 ◽  
Vol 16 (4) ◽  
pp. 209-213 ◽  
Author(s):  
Martin Jurlina ◽  
Ranko Mladina ◽  
Krsto Dawidowsky ◽  
Davor Ivanković ◽  
Zeljko Bumber ◽  
...  
Keyword(s):  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Anterior Part ◽  
Inferior Turbinate ◽  
Objective Evaluation ◽  
Cross Sectional Area ◽  
The Body ◽  
Sectional Area ◽  
Cross Sectional

Nasal symptoms often are inconsistent with rhinoscopic findings. However, the proper diagnosis and treatment of nasal pathology requires an objective evaluation of the narrow segments of the anterior part of the nasal cavities (minimal cross-sectional area [MCSA]). The problem is that the value of MCSA is not a unique parameter for the entire population, but rather it is a distinctive value for particular subject (or smaller groups of subjects). Consequently, there is a need for MCSA values to be standardized in a simple way that facilitates the comparison of results and the selection of our treatment regimens. We examined a group of 157 healthy subjects with normal nasal function. A statistically significant correlation was found between the body surface area and MCSA at the level of the nasal isthmus and the head of the inferior turbinate. The age of subjects was not found a statistically significant predictor for the value of MCSA. The results show that the expected value of MCSA can be calculated for every subject based on anthropometric data of height and weight.

Estimation of body surface area of extremely obese human subjects

1960 ◽  
Vol 15 (5) ◽  
pp. 781-784 ◽  
Author(s):  
Garrett R. Tucker ◽  
James K. Alexander
Keyword(s):  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Human Subjects ◽  
Total Body Surface Area ◽  
The Body ◽  
Du Bois ◽  
Linear Formula ◽  
Total Body ◽  
Obese Human

The body surface areas of one normal and four extremely obese human subjects have been estimated by three methods: a) direct measurement by a method similar to that which Du Bois described; b) calculation from the Du Bois height-weight formula; and c) calculation from the Du Bois linear formula. The values for the total body surface area of the obese subjects calculated from the height-weight formula varied up to 11% below those that were directly measured. The values for the total body surface area obtained with the linear formula ranged between 13% and 20% above the direct measurements, this being almost entirely due to discrepancies in the trunk and in the thigh estimations. It has been concluded that estimation of the body surface area oxf extremely obese subjects by the Du Bois height-weight formula is satisfactory when considered in relation to the accuracy of the physiologic measurements with which it is generally used. Because of the unusual body form the Du Bois linear formula has been found unsatisfactory for this group. Submitted on March 1, 1960

5-flourouracil (5FU) shortage: Clinical implications and costs in a single month.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 663-663 ◽  
Author(s):  
Shweta Gupta ◽  
Prantesh Jain ◽  
Saurabh Gupta ◽  
Barbara Yim ◽  
Michael Russell Mullane
Keyword(s):  
Colon Cancer ◽  
Adverse Effects ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Wholesale Price ◽  
Progression Free Survival ◽  
The Body ◽  
Colon Cancers ◽  
Number Of Cycles

663 Background: Capecitabine (XELODA) is an orally active fluoropyrimidine that is absorbed intact through the gastrointestinal tract and converted in to 5FU. Standard chemotherapy for advanced colon cancers includes infusional 5FU with leucovorin in combination of oxaliplatin (FOLFOX) or irinotecan (FOLFIRI). With the national shortage of 5FU we had to switch our FOLFOX and FOLFIRI regimens to XELOX or XELIRI. Although in trials the xeloda regimens were non-inferior, the PFS (progression free survival) and OS (overall survival), survival curves tailed behind the infusional 5FU regimens. Methods: At our institution over one month period from August 18th 2011 to September 18th 2011, all patients who were switched from 5FU to xeloda due to national shortage were identified. All charts were retrospectively reviewed identifying patients with colon cancer. Patients with other cancer histologies, were excluded. The charts were reviewed for number of cycles, clinical toxicity, admission to hospital. Results: A total of 90 patients were switched form 5FU to xeloda. 51 had colon cancer. Out of which, 6 (11.7%) patients had the drug discontinued due to toxicity and 4 out of the 6 required hospitalization due to adverse effects of xeloda, mainly diarrhea and vomiting. 80% of these had left sided colon cancer and 50% each received oxaliplatin and irinotecan respectively. The total number of hospitalization days was 20. The average wholesale price (AWP) of one cycle of xeloda for body surface area range from 1.5m2 to 2m2 ranges from 2605.68$ to 3474.24$ for every 3 week cycle. In comparison the corresponding AWP for 2 cycles of 5FU over a month is 51.81$ to 69.08$. This would become a net higher price of 2553.87$ to 3405.16$ for BSA of 1.5 to 2m2 per month for the switch to xeloda. There were 51 patients who received xeloda at least one cycle which costed about 151,954.50$ if we average the body surface area. Additionally there were 20 admission days costing about 50,000$, making the net costs of switching to xeloda more than 200,000$ in a single month. Conclusions: Although xeloda is non-inferior to 5FU and can be a substitute, left sided colon cancers tend to do have more adverse effects. Additionally Xeloda is associated with higher administration costs.

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