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Management of adverse events associated with idelalisib treatment: expert panel opinion.

Publication ,  Journal Article
Coutré, SE; Barrientos, JC; Brown, JR; de Vos, S; Furman, RR; Keating, MJ; Li, D; O'Brien, SM; Pagel, JM; Poleski, MH; Sharman, JP; Yao, N-S ...
Published in: Leuk Lymphoma
2015

Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe diarrhea or colitis, hepatotoxicity, pneumonitis and intestinal perforation. An expert panel was convened to review the pathology of these treatment-emergent adverse events (TEAEs) to propose key management tools for patients receiving idelalisib therapy. This article provides an overview of idelalisib TEAEs reported in clinical trials, and a summary of the panel's recommendations for identification and management of idelalisib treatment-emergent diarrhea or colitis as well as a discussion of transaminitis and pneumonitis. For idelalisib-related diarrhea or colitis (including unresolved grade 2 and grade ≥ 3), after exclusion of infectious causes, the panel recommends individualized treatment with budesonide or oral or intravenous steroid therapy.

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Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

2015

Volume

56

Issue

10

Start / End Page

2779 / 2786

Location

United States

Related Subject Headings

  • Treatment Outcome
  • TOR Serine-Threonine Kinases
  • Signal Transduction
  • Quinazolinones
  • Purines
  • Proto-Oncogene Proteins c-akt
  • Phosphoinositide-3 Kinase Inhibitors
  • Phosphatidylinositol 3-Kinases
  • Immunology
  • Humans
 

Citation

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Chicago
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Coutré, S. E., Barrientos, J. C., Brown, J. R., de Vos, S., Furman, R. R., Keating, M. J., … Zelenetz, A. D. (2015). Management of adverse events associated with idelalisib treatment: expert panel opinion. Leuk Lymphoma, 56(10), 2779–2786. https://doi.org/10.3109/10428194.2015.1022770
Coutré, Steven E., Jacqueline C. Barrientos, Jennifer R. Brown, Sven de Vos, Richard R. Furman, Michael J. Keating, Daniel Li, et al. “Management of adverse events associated with idelalisib treatment: expert panel opinion.Leuk Lymphoma 56, no. 10 (2015): 2779–86. https://doi.org/10.3109/10428194.2015.1022770.
Coutré SE, Barrientos JC, Brown JR, de Vos S, Furman RR, Keating MJ, et al. Management of adverse events associated with idelalisib treatment: expert panel opinion. Leuk Lymphoma. 2015;56(10):2779–86.
Coutré, Steven E., et al. “Management of adverse events associated with idelalisib treatment: expert panel opinion.Leuk Lymphoma, vol. 56, no. 10, 2015, pp. 2779–86. Pubmed, doi:10.3109/10428194.2015.1022770.
Coutré SE, Barrientos JC, Brown JR, de Vos S, Furman RR, Keating MJ, Li D, O’Brien SM, Pagel JM, Poleski MH, Sharman JP, Yao N-S, Zelenetz AD. Management of adverse events associated with idelalisib treatment: expert panel opinion. Leuk Lymphoma. 2015;56(10):2779–2786.

Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

2015

Volume

56

Issue

10

Start / End Page

2779 / 2786

Location

United States

Related Subject Headings

  • Treatment Outcome
  • TOR Serine-Threonine Kinases
  • Signal Transduction
  • Quinazolinones
  • Purines
  • Proto-Oncogene Proteins c-akt
  • Phosphoinositide-3 Kinase Inhibitors
  • Phosphatidylinositol 3-Kinases
  • Immunology
  • Humans