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5PSQ-011 Toxicity of immunotherapy treatment in clinical practice
  1. B Rodriguez De Castro,
  2. C Rodriguez Lage
  1. HM Hospitales, Pharmacy, Leon, Spain


Background and Importance Immunotherapy has broken new ground in the treatment of oncological disease. However, it is not exempt from Adverse Events (AE).

Aim and Objectives To analyse and describe the toxicity profile of immunotherapy in clinical practice.

Material and Methods Multicentre descriptive observational retrospective study of patients who initiated immunotherapy treatment (June 2018 to June 2023). Clinical data were obtained from the computerised clinical histories (Doctoris®) and the eOncology® database. The following variables were collected: demographic data (sex and age), smoking status, comorbidities, history of autoimmune disease, oncological diagnosis and stage, treatment line, treatment regimen used, number of administered cycles, and toxicity assessed according to the CTCAE v5 (Common Terminology Criteria for Adverse Events) criteria of the NCI (National Cancer Institute).

Results During the study period, 40 patients (65% male) initiated immunotherapy treatment, median age 67 years [39–87]. 35% were active smokers and 47% were former smokers. The most frequent comorbidities were hypertension 47%, dyslipidaemia 42%, diabetes mellitus 27%, and psychiatric illness 17%. Two patients had an autoimmune disease.

57.5% lung cancer; 12.5% renal cancer; 12.5% melanoma; 10% bladder urothelial cancer; 2.5% gastric cancer; 2.5% hepatic cancer, and 2.5% pancreatic cancer. 63% in first-line immunotherapy treatment, 27% second-line, 10% third-line.

20 patients (50%) experienced at least one immune-mediated AE, mostly of grade 2 (moderate,48%), followed by grade 1 (mild,35%), and grade 3 or higher (severe and very severe,12.5%). Corticosteroids were used in 63%.

In 80% of patients treated with nivolumab, toxicity was observed (20% of which were severe), compared to 50% for durvalumab (non-severe), 50% avelumab (non-severe), 35% pembrolizumab (10% severe), and 16% atezolizumab (non-severe).

Digestive AEs were the most frequent (29.6%), followed by cutaneous AEs (22.2%), musculoskeletal (arthralgia, weakness) (18.5%), and pulmonary AEs (14.8%).

Conclusion and Relevance Immunotherapy is becoming a first-line treatment for several tumours.

Our real-world clinical experience shows that immunotherapy has been reasonably well tolerated, with most immune-mediated AEs being moderate or mild.

Corticosteroids were the most widely used drugs to treat this type of toxicity.

Severe immune-mediated reactions have required hospitalisation and discontinuation of treatment.

A larger sample size and an extended study period are needed to confirm the correlation between treatment response and toxicity.

Conflict of Interest No conflict of interest.

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