Evaluation of reported bone pain in patients (pts) receiving chemotherapy in pegfilgrastim clinical trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9621-9621 ◽  
Author(s):  
J. Sierra ◽  
R. Harms ◽  
M. Mo ◽  
C. L. Vogel

9621 Background: Bone pain is the most commonly reported treatment-related adverse event (AE) associated with colony-stimulating growth factors. Some authors have suggested that pegfilgrastim-induced bone pain is unpredictable and refractory to analgesics (Kirshner 2007), though that impression may not be uniformly accepted. To better characterize this adverse event we evaluated bone pain across pegfilgrastim clinical trials. Methods: Completed Amgen-sponsored trials that both incorporated pegfilgrastim 6mg administered 24 hours after chemotherapy and utilized MedDRA library coding of AEs were examined. Included were 2 studies comparing pegfilgrastim with placebo (Vogel 2005, Hecht 2007) and 2 studies comparing pegfilgrastim with filgrastim (Sierra 2008, Lopez 2004). The incidence of bone pain was determined by treatment (pegfilgrastim, filgrastim, or placebo), chemotherapy (taxane-containing or not), cycle, severity, age, and body surface area (BSA). Analysis and recoding of studies with preferred AEs coded to nonMedDRA dictionaries is ongoing. Results: 1310 pts (filgrastim=67, pegfilgrastim=665, placebo=578) were analyzed. In studies comparing pegfilgrastim (n=74) and filgrastim (n==7) in pts with AML and NHL, 52% were female, and the mean (SD) age was 50 (15.1) years. Similar proportions (CI) of pts reported bone pain (24.3% [16.1, 35.7] vs 25.4% [15.5, 37.5], respectively), and grade 3/4 bone pain was reported in 3% [0.3, 9] versus 0% [-, -] of pts, respectively. Studies comparing pegfilgrastim (n=591) and placebo (n=578) pts in breast and colorectal cancer are below ( Table ). Conclusions: Bone pain of any grade was commonly reported in all 3 groups (pegfilgrastim, filgrastim, and placebo) and was marginally higher in pts receiving pegfilgrastim compared with placebo. Bone pain was most common in cycle 1. Severe bone pain was infrequently reported. Bone pain was similar in pts receiving pegfilgrastim and filgrastim. Chemotherapy (eg, taxanes) may also contribute to bone pain. [Table: see text] [Table: see text]

PEDIATRICS ◽  
1967 ◽  
Vol 39 (2) ◽  
pp. 252-257
Author(s):  
Mary L. Voorhess

There is increase in the daily urinary excretion of dopamine (DA), norepinephrine (NE), epinephrine (E), and 3-methoxy-4-hydroxymandelic acid (VMA) with age. The mean output in micrograms per 24 hours for various age groups is as follows: birth to 1 year-DA 60.9 (± 24.3), NE 10.6 (± 3.4), E 1.3 (± 1.2), VMA 569 (± 309); 1 through 5 years—DA 124.1 (± 40.7), NE (18.8 ± 7.0), E 3.2 (± 2.7), VMA 1348 (± 433); 6 through 15 years—DA 169.3 (± 72.6), NE 37.4 (± 16.6), E 4.8 (± 2.4), VMA 2373 (± 698); over 15 years—DA 249.1 (± 74.9), NE 50.7 (± 15.7), E 7.1 (± 3.3), VMA 3192 (± 699). The studies suggest that the daily output of these compounds in the various age groups is similar when related to body surface area after infancy.


1999 ◽  
Vol 19 (2_suppl) ◽  
pp. 176-178 ◽  
Author(s):  
Dae Joong Kim ◽  
Woo-Heon Kang ◽  
Hae Young Kim ◽  
Bang Hoon Lee ◽  
Bum Kim ◽  
...  

Methods and Patients We evaluated gastric emptying time (GET) with a technetium (Tc) 99m-sulfur colloid gastric emptying scan in 11 patients on continuous ambulatory peritoneal dialysis (CAPO) (6 males, 5 females) and in 14 controls. We investigated the effect of dialysate dwell on GET by studying the subjects twice: once without dialysate in the abdomen (drained) and once with 2 L of dialysate in the abdomen (full). We also investigated the relationship between body surface area (BSA) and delayed gastric emptying. Results (1) The mean gastric emptying rate in 120 minutes in patients on CAPO when drained (67.8% ± 13.4%) was not different from that in controls (65.4% ± 8.6%). (2) The mean gastric emptying rate in 120 minutes in patients on CAPO when full was significantly slower than that when drained (55.6% ± 14.6% versus 67.8% ± 13.4%, p < 0.05). In four of the 11 patients (36.4%), gastric emptying was extremely delayed from normal to abnormal range when full. (3) The BSA of patients who had extremely delayed GET from normal to abnormal range was smaller than that of patients who had minimal delayed or unchanged GET when full (1.5 ± 0.11 m2 versus 1.74 ± 0.22 m2). Conclusion This study showed that patients on CAPO had normal gastric emptying when drained, and that gastric emptying was delayed by dialysate dwell, especially in patients who has less than 1.5 m2 of body surface area. Therefore, we suggest that, based on adequacy, intermittent nocturnal peritoneal dialysis or a small volume of dialysate be considered for patients with small body surface area.


2017 ◽  
Vol 44 (5) ◽  
pp. 691-692 ◽  
Author(s):  
Joseph F. Merola ◽  
Alice B. Gottlieb

At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), we presented the case for quantitatively assessing the extent of both psoriasis and psoriatic arthritis in the clinical setting, with a particular focus on the validation and expanded novel use of the PGAxBSA (static physician’s global assessment × body surface area of involvement) in the era of targeted metrics. Herein, we summarize our presentation.


2021 ◽  
Author(s):  
Hyangkyoung Kim ◽  
Tae-Won Kwon ◽  
Eol Choi ◽  
Seonjeong Jeong ◽  
Hong-Kyu Kim ◽  
...  

Abstract Objective: Diameter is currently the only screening and diagnostic criterion for asymptomatic aneurysms. Therefore, aortic and lower-extremity arterial diameter has diagnostic, therapeutic, and prognostic importance. We aimed to determine aortic and lower-extremity arterial reference diameters in a general population and compare them according to age, sex, and other characteristics.Methods: We evaluated consecutive 3,692 patients who underwent computed tomography as part of a general health checkup from 2015–2019 in a single tertiary center. Aortic and lower-extremity arterial diameters and the most important factor related to arterial diameters were evaluated.Results: The mean diameter of the abdominal aorta was 17.490 ± 2.110 mm, while that of the common iliac artery was 10.851 ± 1.689 mm. The mean diameter of the abdominal aorta was 18.377 ± 1.766 mm in men and 15.884 ± 1.694 mm in women. Significant intersex differences were observed for all mean diameters and lengths. Multilinear regression analysis showed that age, sex, and body surface area impacted mean diameters of all measured sites except aorta and common iliac artery length. Between male and female patients matched for body surface area, there were significant intersex differences for all measured sites, except for common iliac artery length.Conclusions: The mean diameter of the abdominal aorta in this healthy cohort was 17.490 ± 2.110 mm overall, 18.377 ± 1.766 mm in men, and 15.884 ± 1.694 mm in women. Arterial diameter increased with male sex, older age, and increased body surface area, and aortic diameters were larger in men than in women with the same body surface area.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Binalfew Tsehay ◽  
Dessalegn Shitie ◽  
Abebe Afenigus ◽  
Mustofa Essa

Abstract Background Assessment of spleen size is an important part of the clinical skills of medical students and physicians. Many diseases can affect the size of the aforementioned organ, ranging from infective processes to malignant disorders. However, to detect changes, prior knowledge of the actual normal size of these viscera is required in the population being studied. Establishing a customized chart and curve for a specific population of the same sociodemographic characteristics enables a better interpretation of sonographic assessments. Methods A hospital-based cross-sectional study design was conducted among 403 children in primary and referral hospitals of the east and west Gojjam zone. Data were collected using a structured questionnaire, physical examination, and ultrasound. The collected data were entered into Epi Data version 3.1 and exports to SPSS version 24 for analysis. Descriptive data were analyzed using descriptive statistics. A Pearson product-moment correlation was run to determine the relationship between age, anthropometric measurements of children, and ultrasound measurements of the spleen. Reference intervals were established using non-parametric reference limits (2.5th -97.5th ) and (5th – 97th ) percentiles by MedCalc software version 20.0.3. Results Four hundred three children aged from 7 to 15 years were included in this study. The mean sonographic longitudinal (length), anteroposterior(depth) and transverse (width) dimension of the spleen was, (8.24 ± 1.26 cm), (3.98 ± 0.57 cm), and (4.26 ± 0.59 cm) respectively. The mean volume of the spleen was 75.04 ± 23.92 cm3. The height and body surface area of children were best correlated with sonographic dimensions of the spleen. Reference intervals were established using height, age, and body surface area specific for clinically practical dimensions of the spleen. Conclusions According to this study, the children are considered as having enlarged longitudinal dimension of the spleen(splenomegaly) if he or she has a size above 97.5th percentile based on their respective height.


PEDIATRICS ◽  
1993 ◽  
Vol 91 (2) ◽  
pp. 344-349 ◽  
Author(s):  
Elizabeth C. Powell ◽  
Robert R. Tanz

To identify the incidence, type, and severity of burns associated with microwave oven (MW) use and to compare MW-associated burns with those associated with use of conventional stoves, we conducted a review of a national data base. Data were obtained from the US Consumer Product Safety Commission Injury Information Clearinghouse for 1986 through 1990 concerning burn injuries to children (0 to 19 years). There were an estimated 5160 burns associated with MW use. The mean age was 7.6 years (median, 6 years); 25% of burns were to children younger than 36 months old. Fifty-eight percent involved females. Most MW burns were scalds (95%); 16% of these scalds were from exploding eggs or other food. No MW burn involved a body surface area greater than 25% and no patient required hospital admission. Microwave oven burns were compared with stove burns. There were an estimated 41198 stove-associated burns to children. The mean age was 5.8 years; the median was 3 years. Forty-five percent of burns were to children younger than 36 months old; 55% were to males. Most stove burns (74%) were thermal; 7% involved a body surface area greater than 25%. Five percent of children with stove burns required hospital admission. We conclude that (1) burns to children associated with MW use are less frequent and less severe than stove burns; (2) MW burns predominantly affect females; and (3) burn prevention efforts should emphasize the hazards of stoves, which vastly exceed those of MWs.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3969-3969
Author(s):  
Wasil Jastaniah ◽  
Mohammed Aseeri

Abstract Abstract: Standardizing Body Surface Area (BSA) determination is essential for avoiding variation in chemotherapy dosage calculations. In this study we compared variation in BSA calculation using weight and height by the Mosteller formula with weight alone using recently adapted table at the Princess Norah Oncology Center (PNOC). Methods: Cross-sectional study of pediatric oncology patients presenting to the pediatric oncology clinic at PNOC over a week period of time. Results: One hundred consecutive pediatric oncology patients presented to the clinic. The mean BSA calculated by the Mosteller formula was 0.83m2 (Standard Deviation = 0.24) and the mean BSA determined by the table (based on weight alone) was 0.82m2 (Standard Deviation = 0.25). The mean variation in dosing between the two methods was 1.64% (Standard Deviation = 3.4). Only 13 out of 100 patients (13%) had equal dosing using both methods and 21 out of 100 patients (21%) had dosing variation greater than 5%. When comparing both methods, using paired t-test, the difference was statistically significant (t(99) = 3.99 and P &lt; 0.001). Conclusion: Significant differences in BSA-based chemotherapy dosing exist in our center. The Mosteller method should remain the standard until prospective studies are performed to determine the significance of this dosing variability on toxicity and survival outcome.


Sign in / Sign up

Export Citation Format

Share Document