Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor

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• 作者：Ruth Pettengell ; Peter Bias ; Udo Mueller ; Nicole Lang
• 刊名：Supportive Care in Cancer
• 出版年：2016
• 出版时间：June 2016
• 年：2016
• 卷：24
• 期：6
• 页码：2677-2684
• 全文大小：362 KB
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  Nursing
  Nursing Management and Research
  Pain Medicine
  Rehabilitation Medicine
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1433-7339
• 卷排序：24

文摘

The recombinant human granulocyte colony-stimulating factor (G-CSF) known as filgrastim (Tevagrastim®, Ratiograstim®, Biograstim®) in Europe (approved in 2008) and tbo-filgrastim (Granix®) in the USA (approved in 2012; Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel) is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This article presents pooled clinical data for tbo-filgrastim compared with Neupogen® (Amgen, Thousand Oaks, CA, USA) as well as tbo-filgrastim post-marketing safety data. The safety and efficacy of tbo-filgrastim were evaluated in three phase III studies in 677 patients receiving myelosuppressive chemotherapy and study drug (348 patients with breast cancer, 237 with lung cancer, 92 with non-Hodgkin lymphoma). In each study, the efficacy of tbo-filgrastim was similar to that of Neupogen. Overall, 633 (93.5 %) patients receiving the study drug experienced 6093 treatment-emergent adverse events (AEs), most of which were related to chemotherapy. Adverse events related to the study drug (tbo-filgrastim or Neupogen) were experienced by 185 (27.3 %) patients; 19 (2.8 %) had severe drug-related AEs, 5 (0.7 %) had drug-related serious AEs, and 6 (0.9 %) discontinued the study due to drug-related AEs. Overall, the most common drug-related AEs were bone pain (7.1 %), myalgia (4.0 %), and asthenia (4.4 %). The post-marketing safety profile of tbo-filgrastim was consistent with that observed during the clinical studies. The availability of tbo-filgrastim, a G-CSF with safety and efficacy comparable to those of Neupogen, provides physicians with an alternative treatment option for supportive care of patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.KeywordsNeutropeniaDrug toxicityGranulocyte colony-stimulating factorFilgrastimAdverse drug eventSafety