Abstract 990P
Background
Immunotherapy is already a revolution in oncology. Moreover, combined immunotherapy has shown very good results in some cancers. New kind of immune-related adverse events (irAEs) have been related with immunotherapy due to the stimulation of immune system and some of them concerning endocrine system (endocrine irAEs) can be severe with significant clinical consequences.
Methods
A systematic review with detailed search in PubMed, Medline and Clinical trials.gov (from 1/2015 to 12/2020) followed by a meta-nalysis were performed for this study. Adult patients with solid tumors who received combined immunotherapy approved by EMA or FDA were included in this study. Endocrine irAEs of all grades were collected from the relevant clinical studies.
Results
Twenty-six clinical trials in total were included. Particularly, in 21 studies with 3269 patients who received Ipilimumab + Nivolumab, the incidence of hypophysitis was 6% (95%Cl: 4-10%), with mild symptoms and of adrenal insufficiency was 2% (95% CI: 1-3). Although heterogeneity was high, incidence of hypothyroidism was 15% (95% CI: 13-18%) and of hyperthyroidism 14% (95% CI: 11-18%). Additionally, in 5 studies with 862 patients who received Durvalumab + Tremelimumab, the incidence of hypophysitis was very low 1% (95% CI: 0-2%) but was almost always severe grade 3/4. The same observation was for adrenal insufficiency, which concerned the 2% (95% CI: 1-5%) of patients. The most common endocrine irAE was hypothyroidism 10% (95% CI: 8-13%). The percentage of hyperthyroidism was 4% (95% CI: 1-17%), but only 2 clinical trials had data regarding this AE.
Conclusions
Combined immunotherapy is a promising treatment in oncology. This study provides more data regarding endocrine irAEs in patients who received combined immunotherapy. The most common irAEs was thyroid dysfunction or hypophisitis instead of adrenal insufficiency. Oncologists should be aware about these endocrine irAEs of immunotherapy because early diagnosis of them can be very important for cancer patients’ prognosis and quality of life.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Computational Medicine and Bioinformatics University of Thessaly, Greece.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.