Pathological assessment of gastrointestinal biopsies from patients with idelalisib-associated diarrhea and colitis.
Future Oncol. 2018 Mar 23;:
Authors: Yeung CC, Hockenbery DM, Westerhoff M, Coutre SE, Sedlak RH, Dubowy RL, Munugalavadla V, Taylor K, Bosch F
Abstract
AIM: 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 9 clinical trials.
METHODS: 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.
RESULTS: 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.
CONCLUSION: This study revealed evidence of T-cell dysregulation and a substantial infectious component in association with IDELA-related diarrhea/colitis.
PMID: 29569483 [PubMed - as supplied by publisher]
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