Open AccessAnticancer Agent‐Induced Life‐Threatening Skin Toxicities: A Database Study of Spontaneous Reporting Data
Author(s) -
Tanaka Ryota,
Yonemori Kan,
Hirakawa Akihiro,
Kinoshita Fumie,
Kobayashi Yumiko,
Yamazaki Naoya,
Fujimoto Manabu,
Tamura Kenji,
Fujiwara Yasuhiro
Publication year - 2019
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2017-0511
Subject(s) - medicine , toxic epidermal necrolysis , adverse effect , hazard ratio , population , proportional hazards model , pharmacovigilance , database , pharmacology , oncology , dermatology , confidence interval , environmental health , computer science
Stevens‐Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially life‐threatening cutaneous and mucosal adverse reactions to drugs. Nevertheless, the connection to anticancer agents remains unclear. To provide insight into the association of such adverse reactions with anticancer agents, we analyzed the profile of anticancer agent‐induced SJS and TEN in the Japanese population. Of the 9,738 SJS/TEN events recorded in a database of spontaneous reporting data, 485 (5%, further categorized as SJS, 384 events, 79%; TEN, 101 events, 21%) were identified as anticancer agent‐induced, and 53 of these (11%) were fatal. Multivariate logistic regression analyses indicated that, compared with patients using other drugs, those using anticancer drugs had lower incident risk of death (hazard ratio [HR], 0.592; p = .0006), longer median time to onset of SJS/TEN (18 vs. 11 days; p < .0001; multivariate Cox regression: HR, 0.66; p < .0001), and a higher likelihood of developing SJS/TEN later than 70 days after initiation of the suspected causal agent (15% vs. 7%; p < .0001), highlighting the need for vigilance and continuous monitoring for SJS/TEN in patients treated with anticancer agents. Implications for Practice Life‐threatening skin toxicities induced by anti‐cancer agents indicated significantly lower incident risk of death and longer time to onset of symptoms than for those induced by other drugs.