| Автор | Jolson, Heidi M. |
| Автор | Bosco, Lynn |
| Автор | Bufton, Marilyn G. |
| Автор | Gerstman, B. Burt |
| Автор | Rinsler, Stephan S. |
| Автор | Williams, Eliot |
| Автор | Flynn, Bridget |
| Автор | Simmons, William D. |
| Автор | Stadel, Bruce V. |
| Автор | Faich, Gerald A. |
| Автор | Peck, Carl |
| Дата выпуска | 1992 |
| dc.description | Background: Cerebellar toxicity is a severe, therapy-limiting adverse reaction of cytarabine given in high doses. The Food and Drug Administration received a report of an increased frequency of cerebellar toxicity at the University of Wisconsin Hospital and Clinics after a switch from the product (Cytosar-U) manufactured by The Upjohn Co., Kalamazoo, Mich., to the generic form made by Quad Pharmaceuticals, Inc., Indianapolis, Ind. Purpose: To compare the incidence of cerebellar toxicity in Quad-treated patients with Upjohn-treated patients, a record-based cohort study was conducted at the University of Wisconsin Hospital and Clinics between January 1986 and August 1989. Methods: The incidence of cerebellar toxicity was studied in 63 leukemia patients according to the manufacturer of the product received (34 Upjohn only, 25 Quad only, and four both manufacturers). The relative risk of cerebellar toxicity was adjusted for other known risk factors. Results: Patients in the manufacturer-defined treatment groups did not differ significantly with respect to age, sex, type of leukemia, disease stage, calculated creatinine clearance, presence of abnormal liver function tests, or total dose received. The crude relative risk of cerebellar toxicity comparing the Quad product with the Upjohn product was 5.0 (95% confidence interval = 1.8–13.7). Adjustment for potential confounders did not alter the association. Other risk factors for cerebellar toxicity, independent of manufacturer, were age greater than 50 years, type of leukemia, disease stage, total dose greater than or equal to 20 g/m, abnormal pretreatment liver function, and reduced creatinine clearance. Conclusion: This study found a significantly higher incidence of cerebellar toxicity with high-dose cytarabine manufactured by Quad Pharmaceuticals when compared with the incidence of cerebellar toxicity with the Upjohn product. Further research at independent institutions would be necessary to allow generalization of this finding. In addition, our findings suggest that a dose reduction in high-dose cytarabine therapy may be indicated for patients with reduced glomerular filtration rates. [J Natl Cancer Inst 84: 500–505, 1992] |
| Формат | application.pdf |
| Издатель | Oxford University Press |
| Копирайт | © Oxford University Press |
| Тема | Articles |
| Название | Clustering of Adverse Drug Events: Analysis of Risk Factors for Cerebellar Toxicity With High-Dose Cytarabine |
| Тип | research-article |
| Electronic ISSN | 1460-2105 |
| Print ISSN | 0027-8874 |
| Журнал | JNCI: Journal of the National Cancer Institute |
| Том | 84 |
| Первая страница | 500 |
| Последняя страница | 505 |
| Аффилиация | Jolson Heidi M.; Center for Drug Evalution and Research, Food and Drug Administration |
| Аффилиация | Bosco Lynn; Center for Drug Evalution and Research, Food and Drug Administration |
| Аффилиация | Bufton Marilyn G.; The University of Wisconsin Hospital and Clinics |
| Аффилиация | Gerstman B. Burt; Department of Health Science, San Jose State University |
| Аффилиация | Rinsler Stephan S.; Center for Drug Evalution and Research, Food and Drug Administration |
| Аффилиация | Williams Eliot; Department of Health Science, San Jose State University |
| Аффилиация | Flynn Bridget; The University of Wisconsin Hospital and Clinics |
| Аффилиация | Simmons William D.; The University of Wisconsin Hospital and Clinics |
| Аффилиация | Stadel Bruce V.; Center for Drug Evalution and Research, Food and Drug Administration |
| Аффилиация | Faich Gerald A.; Center for Drug Evalution and Research, Food and Drug Administration |
| Аффилиация | Peck Carl; Center for Drug Evalution and Research, Food and Drug Administration |
| Выпуск | 7 |
