Anticancer Agent-Induced Life-Threatening Skin Toxicities: A Database Study of Spontaneous Reporting Data

Ryota Tanaka1,2,3, Kan Yonemori4, Akihiro Hirakawa5

  • 1Divisions of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.

The Oncologist
|September 27, 2018
PubMed

Insights

Anticancer drugs are linked to Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), but with a lower death risk and longer onset time than other drugs. Continuous monitoring is crucial for patients on anticancer agents.

Area of Science:

  • Pharmacovigilance
  • Dermatology
  • Oncology

Background:

  • Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe adverse drug reactions affecting skin and mucous membranes.
  • The association between anticancer agents and SJS/TEN is not fully understood, necessitating further investigation.

Purpose of the Study:

  • To analyze the characteristics and outcomes of SJS/TEN cases induced by anticancer agents in the Japanese population.
  • To compare the risk of mortality, time to onset, and delayed onset of SJS/TEN between anticancer drugs and other medications.

Main Methods:

  • Analysis of a spontaneous reporting database containing 9,738 SJS/TEN events.
  • Identification of 485 events (5%) attributed to anticancer agents.
  • Application of multivariate logistic and Cox regression analyses to compare outcomes.

Main Results:

  • Anticancer agent-induced SJS/TEN accounted for 5% of all cases, with an 11% fatality rate.
  • Patients on anticancer drugs had a significantly lower risk of death (HR=0.592) and a longer median time to SJS/TEN onset (18 vs. 11 days).
  • A higher proportion of anticancer drug-related SJS/TEN cases (15%) occurred later than 70 days after drug initiation compared to other drugs (7%).

Conclusions:

  • Anticancer agents are associated with SJS/TEN, but these reactions appear to have a better prognosis regarding mortality and onset timing compared to those induced by other drugs.
  • Vigilance and continuous monitoring for SJS/TEN are essential for patients undergoing anticancer therapy due to the potential for delayed onset.

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