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Sanagawa A, Hotta Y, Kataoka T, et al. Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System. Cancer Med. 2018;7(6):2269-2279doi: 10.1002/cam4.1429.
Sanagawa, A., Hotta, Y., Kataoka, T., Maeda, Y., Kondo, M., Kawade, Y., Ogawa, Y., Nishikawa, R., Tohkin, M., & Kimura, K. (2018). Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System. Cancer medicine, 7(6), 2269-2279. https://doi.org/10.1002/cam4.1429
Sanagawa, Akimasa, et al. "Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System." Cancer medicine vol. 7,6 (2018): 2269-2279. doi: https://doi.org/10.1002/cam4.1429
Sanagawa A, Hotta Y, Kataoka T, Maeda Y, Kondo M, Kawade Y, Ogawa Y, Nishikawa R, Tohkin M, Kimura K. Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System. Cancer Med. 2018 Jun;7(6):2269-2279. doi: 10.1002/cam4.1429. Epub 2018 Apr 16. PMID: 29663729; PMCID: PMC6010750.
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Cancer Med. 2018 Jun;7(6):2269-2279. doi: 10.1002/cam4.1429. Epub 2018 Apr 16.

Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System.

Cancer medicine

Akimasa Sanagawa, Yuji Hotta, Tomoya Kataoka, Yasuhiro Maeda, Masahiro Kondo, Yoshihiro Kawade, Yoshihiro Ogawa, Ryohei Nishikawa, Masahiro Tohkin, Kazunori Kimura

Affiliations

  1. Department of Pharmacy, Nagoya City University Hospital, Nagoya, Japan.
  2. Department of Hospital Pharmacy, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan.
  3. Department of Clinical Pharmaceutics, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
  4. Department of Regulatory Science, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan.

PMID: 29663729 PMCID: PMC6010750 DOI: 10.1002/cam4.1429

Abstract

We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular-targeted drugs). We focused on molecular-targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab-containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology.

© 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Keywords: Cancer chemotherapy; FDA Adverse Event Reporting System; data mining; hepatitis B virus; signal detection

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