Life-threatening dermatologic adverse events in oncology

Alyx C. Rosen, Yevgeniy Balagula, Dennis W. Raisch, Vishvas Garg, Beatrice Nardone, Nicole Larsen, Jennifer Sorrell, Dennis P. West, Milan J. Anadkat, Mario E. Lacouture

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95% confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions.

Original languageEnglish (US)
Pages (from-to)225-234
Number of pages10
JournalAnti-Cancer Drugs
Volume25
Issue number2
DOIs
StatePublished - 2014
Externally publishedYes

Fingerprint

Stevens-Johnson Syndrome
United States Food and Drug Administration
Pharmaceutical Preparations
Lomustine
Procarbazine
Chlorambucil
Pharmacovigilance
Busulfan
PubMed
Antineoplastic Agents
Clinical Trials
Confidence Intervals
Safety
Skin

Keywords

  • adverse drug event
  • chemotherapy
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Cancer Research
  • Oncology

Cite this

Rosen, A. C., Balagula, Y., Raisch, D. W., Garg, V., Nardone, B., Larsen, N., ... Lacouture, M. E. (2014). Life-threatening dermatologic adverse events in oncology. Anti-Cancer Drugs, 25(2), 225-234. https://doi.org/10.1097/CAD.0000000000000032

Life-threatening dermatologic adverse events in oncology. / Rosen, Alyx C.; Balagula, Yevgeniy; Raisch, Dennis W.; Garg, Vishvas; Nardone, Beatrice; Larsen, Nicole; Sorrell, Jennifer; West, Dennis P.; Anadkat, Milan J.; Lacouture, Mario E.

In: Anti-Cancer Drugs, Vol. 25, No. 2, 2014, p. 225-234.

Research output: Contribution to journalArticle

Rosen, AC, Balagula, Y, Raisch, DW, Garg, V, Nardone, B, Larsen, N, Sorrell, J, West, DP, Anadkat, MJ & Lacouture, ME 2014, 'Life-threatening dermatologic adverse events in oncology', Anti-Cancer Drugs, vol. 25, no. 2, pp. 225-234. https://doi.org/10.1097/CAD.0000000000000032
Rosen, Alyx C. ; Balagula, Yevgeniy ; Raisch, Dennis W. ; Garg, Vishvas ; Nardone, Beatrice ; Larsen, Nicole ; Sorrell, Jennifer ; West, Dennis P. ; Anadkat, Milan J. ; Lacouture, Mario E. / Life-threatening dermatologic adverse events in oncology. In: Anti-Cancer Drugs. 2014 ; Vol. 25, No. 2. pp. 225-234.
@article{0609552cc2074f6eb33aad6fb6338456,
title = "Life-threatening dermatologic adverse events in oncology",
abstract = "The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95{\%} confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions.",
keywords = "adverse drug event, chemotherapy, Stevens-Johnson syndrome, toxic epidermal necrolysis",
author = "Rosen, {Alyx C.} and Yevgeniy Balagula and Raisch, {Dennis W.} and Vishvas Garg and Beatrice Nardone and Nicole Larsen and Jennifer Sorrell and West, {Dennis P.} and Anadkat, {Milan J.} and Lacouture, {Mario E.}",
year = "2014",
doi = "10.1097/CAD.0000000000000032",
language = "English (US)",
volume = "25",
pages = "225--234",
journal = "Anti-Cancer Drugs",
issn = "0959-4973",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Life-threatening dermatologic adverse events in oncology

AU - Rosen, Alyx C.

AU - Balagula, Yevgeniy

AU - Raisch, Dennis W.

AU - Garg, Vishvas

AU - Nardone, Beatrice

AU - Larsen, Nicole

AU - Sorrell, Jennifer

AU - West, Dennis P.

AU - Anadkat, Milan J.

AU - Lacouture, Mario E.

PY - 2014

Y1 - 2014

N2 - The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95% confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions.

AB - The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95% confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions.

KW - adverse drug event

KW - chemotherapy

KW - Stevens-Johnson syndrome

KW - toxic epidermal necrolysis

UR - http://www.scopus.com/inward/record.url?scp=84891872634&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84891872634&partnerID=8YFLogxK

U2 - 10.1097/CAD.0000000000000032

DO - 10.1097/CAD.0000000000000032

M3 - Article

C2 - 24108082

AN - SCOPUS:84891872634

VL - 25

SP - 225

EP - 234

JO - Anti-Cancer Drugs

JF - Anti-Cancer Drugs

SN - 0959-4973

IS - 2

ER -