Abstract 3732
Background
Colitis is one of the major immune-related adverse events (irAEs) to immunotherapy that leads to significant morbidity and discontinuation of treatment. Despite being a frequent irAE, clinical presentation, endoscopic and pathological features, and management of colitis in patients (pts) treated with combination IPI+PD1 and PD1 monotherapy are not well- defined.
Methods
Pts with locally advanced or metastatic melanoma who received combination IPI+PD1 or PD1 monotherapy and developed clinically significant colitis (requiring systemic corticosteroids) were identified retrospectively from 2 academic centers. Clinical data were collected on all pts; endoscopic and histopathologic data were examined on a subset.
Results
112 patients were identified who developed significant colitis between May 2013 and October 2018; 73 treated with IPI+PD1 and 33 treated with PD1 monotherapy. Six pts were excluded from the analysis that received ipilimumab alone (3 pts) or received treatment (3 pts) on clinical trials (blinded). Endoscopic and histopathologic data were available on 63 pts. Combination therapy induced colitis was earlier onset (8.8 weeks vs 44.6 weeks, p < 0.0001) and more severe (Grade 3/4; 66% vs 31%, p = 0.0014) than with monotherapy. Infliximab and immunosuppressive agents beyond corticosteroids were required in most pts with combination therapy (54% vs 30% with monotherapy, p = 0.02). Five pts (3 combination, 2 monotherapy) underwent colectomy due to complicated steroid refractory disease (3/5 were infliximab refractory). There were no colitis related deaths. The presence of moderate to severe, diffuse inflammation was more common on combination therapy than monotherapy (51% vs 33%, p = 0.36). A chronic inflammatory infiltrate was more common on histopathology with combination colitis compared to monotherapy (46% vs 20%, p = 0.12).
Conclusions
Clinically significant colitis due to immunotherapy varies in presentation, response to immunosuppression and endoscopic/histologic features. IPI+PD1 colitis has an earlier onset, is more severe yet resistant to corticosteroids than PD1 induced colitis.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M.S. Carlino: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Advisory / Consultancy: Amgen; Advisory / Consultancy: Novartis; Advisory / Consultancy: Roche; Advisory / Consultancy: Pierre Fabre. R.A. Scolyer: Advisory / Consultancy: Merck Sharp & Dohme; Advisory / Consultancy: Novartis; Advisory / Consultancy: Myriad; Advisory / Consultancy: NeraCare. G.V. Long: Advisory / Consultancy: Aduro; Advisory / Consultancy: BMS; Advisory / Consultancy: MERCK MSD; Advisory / Consultancy: Mass-Array; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Roche. A.M. Menzies: Advisory / Consultancy: BMS; Advisory / Consultancy: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: Pierre Fabre. All other authors have declared no conflicts of interest.
Resources from the same session
2344 - Lung Cancer in Europe: strengthening policy responses to address unmet needs
Presenter: Mary Bussell
Session: Poster Display session 3
Resources:
Abstract
1359 - Curative treatment timelines for breast, colorectal, lung and prostate cancer: Implications for medical leave coverage
Presenter: Selina Wong
Session: Poster Display session 3
Resources:
Abstract
4433 - Acute Diagnostic Oncology Clinic: A Unique Primary Care-Oncology Service
Presenter: Abhijit Gill
Session: Poster Display session 3
Resources:
Abstract
3506 - THE NEW MUTATIONAL MODEL IN ONCOLOGY. What changes in welfare, clinical practice, research, and regulatory procedures
Presenter: Nicola Normanno
Session: Poster Display session 3
Resources:
Abstract
3350 - Selection of a set of quality indicators (QI) for oncological clinical pathway
Presenter: Aude Fourcade
Session: Poster Display session 3
Resources:
Abstract
4400 - Sustainable drug prices at market launch: policy proposals and their empirical evidence
Presenter: Nora Fanzen
Session: Poster Display session 3
Resources:
Abstract
4118 - Impact of financial considerations on French physicians’ prescription choices for advanced non-small cell lung cancer (NSCLC)
Presenter: Nathalie Olympios
Session: Poster Display session 3
Resources:
Abstract
1340 - The direct medical cost of breast cancer in a Belgian hospital
Presenter: Hannan Lemhouer
Session: Poster Display session 3
Resources:
Abstract
1863 - Does the healthcare system approaches cancer patients for using private services during diagnostic process?
Presenter: Karolina Osowiecka
Session: Poster Display session 3
Resources:
Abstract
2637 - Measuring financial toxicity of cancer in the Italian health care system: initial results of the patient reported outcome for Fighting Financial Toxicity of cancer project (proFFiT).
Presenter: Silvia Riva
Session: Poster Display session 3
Resources:
Abstract