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e-Poster Display Session

45P - Immune-related adverse events: Spectrum and clinical features in the real world


09 Dec 2020


e-Poster Display Session


Supportive Care and Symptom Management

Tumour Site


Iolanda Vieira


Annals of Oncology (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391


I. Vieira, S. Pinelas, C. Gaspar, J. Dinis, J. Oliveira

Author affiliations

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E, Porto/PT

Abstract 45P


Immune checkpoint inhibitors (ICI) have shown benefits in the treatment of several types of tumours. However, their safety profile outside clinical trials requires better characterization. This study aims to assess, with real world data, the frequency and clinical features of immune-related adverse effects (irAE) in patients with solid tumours treated with ICI in a large comprehensive cancer center.


Retrospective unicentric study including all patients with solid tumours treated with ICI between March 2014 and December 2019. IrAE were assessed clinically and graded based on Common Terminology Criteria for Adverse Events v4.0. Progression-free survival (PFS) and overall survival (OS) were estimated using Kaplan-Meier method, compared by Log-rank test; time-dependent Cox regression was performed for multivariate analysis. A p<0.05 was considered statistically significant.


We identified 359 patients, all with advanced or metastatic cancers; primary tumours were lung cancer (n=157; 43.7%), melanoma (n=133; 37.0%), renal cell carcinoma (n=27; 7.5%), head and neck carcinoma (n=20; 5.6%), urothelial carcinoma (n=12; 3.3%) and others (n=10; 2.8%). ICI used were pembrolizumab (n=170; 47.4%), nivolumab (n=135; 37.6%), ipilimumab (n=31; 8.6%), atezolizumab (n=18; 5.0%) and others (n=5; 1.4%). IrAE occurred in 100 patients (27.9%), being most frequently cutaneous (n=47; 13.1%), endocrine (n=37; 10.3%) and gastrointestinal (n=23; 6.4%). Thirty-four patients (9.5%) presented irAE grade ≥3; 27 (7.5%) discontinued ICI and 5 (1.4%) died due to toxicity. Both median PFS and OS were longer in patients who developed irAE (3 vs. 13 months, p<0.001 and 24 vs. 11 months, p<0.001, respectively). In multivariate analysis, the occurrence of irAE was a prognostic factor independent of treatment duration (HR 2.13, CI 95%: 1.50 – 3.02, p<0.001).


In our population, ICI were globally well tolerated across different tumour types, presenting a lower irAE rate than previously reported. The occurrence of irAE appear to be associated with more favourable outcome when managed properly, but can also lead to clinically significant consequences, including toxic death, which highlights the importance of monitoring toxicity in these patients.

Legal entity responsible for the study

The authors.


Has not received any funding.


All authors have declared no conflicts of interest.

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