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Abstract: SA-PO627

Tumor Lysis Syndrome Linked to Anticancer Agents: An Analysis Using the FDA Adverse Event Reporting System

Session Information

  • Pharmacology
    October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

  • 1700 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

Authors

  • Sanagawa, Akimasa, Nagoya City University Hospital, Nagoya, Aichi, Japan
  • Hotta, Yuji, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Aichi, Japan
  • Kondo, Masahiro, Nagoya City University Hospital, Nagoya, Aichi, Japan
  • Ryohei, Nishikawa, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Aichi, Japan
  • Tohkin, Masahiro, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Aichi, Japan
  • Kimura, Kazunori, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Aichi, Japan
Background

Tumor lysis syndrome (TLS) is an oncologic emergency that can lead to severe renal impairment, cardiac arrhythmias, seizures, and death. We used the Food and Drug Administration Adverse Reporting System (FAERS) database to identify associations between anticancer agents and TLS.

Methods

Reports of TLS were retrieved from the FAERS database. Reporting odds ratios (RORs) were used to estimate associations between TLS and old and new anticancer agents or their combinations.

Results

We identified 1,615 TLS cases from among 4,330,807 case reports from the first quarter of 2004 through the first quarter of 2014. Statistically significant risk signals were detected for 56 of 64 anticancer agents. Bortezomib (BOR), a drug used for multiple myeloma (MM), had a high ROR and large number of TLS events relative to that of molecular-targeted drugs (161 TLS events, ROR = 28.89, 95% CI: 24.53-34.02). However, MM is a disease considered low-risk for TLS. We analyzed regimens containing novel MM drugs (e.g., BOR, lenalidomide, and thalidomide). Of those drugs, TLS was more frequently reported for BOR-containing treatments than for other MM treatments (Fig. 1).

Conclusion

Although the risk of TLS is generally considered low for MM patients, careful evaluation of TLS risk is recommended for those receiving BOR-containing therapy.

Fig. 1 Estimates of TLS risk in MM chemotherapy regimens. Chemotherapy drug combinations are in blue cells. Values listed are for the TLS risk of column-defined combinations relative to that of row-defined combinations. For RORs in the opposing direction, reciprocals of the listed values must be used. ROR values > 1 favor the column-defined combinations. Light blue and gray cells indicate statistical significance. Ranges represent 95% confidence intervals.

Funding

  • Government Support - Non-U.S.