| アブストラクト | Docetaxel is a microtubule inhibitor indicated for the treatment of multiple cancers as a single agent or in combination with other antineoplastics. The U.S. Food and Drug Administration (FDA) conducted a postmarketing review of fatal neutropenic enterocolitis cases reported with docetaxel using the FDA Adverse Event Reporting System (FAERS) and literature to determine whether the drug was a potential cause. We searched FAERS and the literature for reports of fatal neutropenic enterocolitis with docetaxel-based treatment reported between 14 May 1996 and 13 March 2017. We characterized the clinical course and severity of neutropenic enterocolitis and utilized the World Health Organization-Uppsala Monitoring Centre rubric to assess drug causality. We identified 41 fatal cases of neutropenic enterocolitis with docetaxel from FAERS and the literature. The median time to onset of neutropenic enterocolitis from last docetaxel dose was seven days (range 2-13 days), and median time to death was nine days (range 3-23 days). The cause of death in 83% (34/41) of patients was neutropenic enterocolitis. We determined the drug-event association as probable in seven cases. Neutropenic enterocolitis with docetaxel monotherapy occurred in six cases; however, in 85% (35/41) of cases, neutropenic enterocolitis occurred when docetaxel was used in combination with other cytotoxic chemotherapy. In some cases, neutropenic enterocolitis occurred despite use of granulocyte colony-stimulating factors. Neutropenic enterocolitis is a severe and potentially fatal complication of docetaxel-based treatment, especially when combined with other antineoplastic treatments known to cause neutropenia. Practitioners should be aware of this safety risk to promptly recognize and manage patients. |
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| ジャーナル名 | Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners |
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| 投稿日 | 2019/10/9 |
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| 投稿者 | Singh, Pritpal; Nayernama, Afrouz; Christopher Jones, S; Amiri Kordestani, Laleh; Fedenko, Katherine; Prowell, Tatiana; Bersoff-Matcha, Susan J |
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| 組織名 | Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center;for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver;Spring, MD, USA.;Division of Oncology Products, Office of Hematology and Oncology Products, Center |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31594460/ |
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