Pathological assessment of gastrointestinal biopsies from patients with idelalisib-associated diarrhea and colitis

Idelalisib (IDELA) treatment is associated with diarrhea/colitis (incidence of ∼15% grade ≥3). We performed a retrospective analysis of gastrointestinal biopsies from 29 patients treated with IDELA across nine clinical trials. A central core laboratory performed histopathologic review, immunohistoch...

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Bibliographic Details
Published in:Future oncology (London, England) England), 2018-09, Vol.14 (22), p.2265-2277
Main Authors: Yeung, Cecilia CS, Hockenbery, David M, Westerhoff, Maria, Coutre, Steven E, Sedlak, Ruth H, Dubowy, Ronald L, Munugalavadla, Veerendra, Taylor, Kerry, Bosch, Francesc
Format: Article
Language:English
Subjects:
Abdomen
Aged
Aged, 80 and over
Antineoplastic Agents - adverse effects
Biopsy
Clinical trials
colitis
Colitis - chemically induced
Colitis - drug therapy
Colitis - pathology
Colitis - virology
Colon
Colon - pathology
Colon - virology
Cytomegalovirus
Cytomegalovirus Infections - pathology
Diarrhea
Diarrhea - chemically induced
Diarrhea - drug therapy
Diarrhea - pathology
Female
Fever
Homeostasis
Humans
Idelalisib
Immunohistochemistry - methods
Inflammatory bowel disease
Kinases
Leukemia
Lymphocytes
Lymphoma
Male
Middle Aged
Pain
Pathology
Patients
Polymerase Chain Reaction
Purines - adverse effects
Quinazolinones - adverse effects
Rectum - pathology
Rectum - virology
Studies
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Description
Summary:Idelalisib (IDELA) treatment is associated with diarrhea/colitis (incidence of ∼15% grade ≥3). We performed a retrospective analysis of gastrointestinal biopsies from 29 patients treated with IDELA across nine clinical trials. A central core laboratory performed histopathologic review, immunohistochemistry, and droplet digital PCR viral studies. These results were correlated with tissue immune profiling data and morphologic features per modified Geboes score. Out of 29 eligible patients with abdominal pain or diarrhea, 24 (82.8%) had reported adverse event terms of diarrhea and/or colitis. Infectious pathogens were detected in 9/29 samples. Most biopsies presented with mixed/inflammatory infiltrates and contained increased numbers of FOXP3 cells versus normal controls. This study revealed evidence of T-cell dysregulation and a substantial infectious component in association with IDELA-related diarrhea/colitis.
ISSN:1479-6694
1744-8301
DOI:10.2217/fon-2017-0528