5PSQ-066 The other side of immunotherapy: safety and toxicity management in clinical practice

Background Nivolumab and Pembrolizumab are monoclonal antibodies that block the programmed-cell-death-ligand (PD-L1) and its receptor (PD-1) respectively, inhibiting the immune checkpoint. They have demonstrated their efficacy and safety in the treatment of different solid tumours. Purpose To evaluate the incidence of adverse events (AE) associated with immune checkpoint inhibitors and to analyse the management of the toxicity. Material and methods Descriptive and retrospective study which included every patient treated with Nivolumab or Pembrolizumab between April 2015 and September 2018 in a third-level hospital. Demographics and clinical variables were collected from the electronic medical records: sex, age, type of tumour, number of cycles, causes of treatment suspension, AE and its severity, as well the need for referral to other specialist, pharmacological treatment or hospitalisation for its handling. Results We included 71 patients (74.6% males), 60.6% were treated with Nivolumab and 39.4% with Pembrolizumab. Average age was 67.6 years (SD 10.3) and the median number of cycles was eight (1–70). The most frequent types of tumours were non-small-cell lung cancer (63.0%), bladder cancer (15.1%) and renal cancer (8.2%). 74.7% of patients presented >1 AE, all immunomediated: 79.1% with Nivolumab (8.9% grade 3) and 71.4% with Pembrolizumab (22.5% grade 3). The most common AE in both groups were asthaenia (53.5% with Nivolumab and 32.1% with Pembrolizumab), skin toxicity (37.2% and 25% respectively) and diarrhoea (14% and 21.4% respectively). Immune-mediated toxicity was the cause of permanent treatment suspension in 15.1% of patients (45.5% hepatitis and 18.2% pneumonitis). Referral to other specialists was necessary in 20.9% of patients treated with Nivolumab and 25% with Pembrolizumab. 32.6% of patients with Nivolumab and 39.3% with Pembrolizumab required pharmacological management. Also, 7% of cases required hospitalisation to control AE due to Nivolumab and 25% due to Pembrolizumab. Conclusion All treatment-related AE are immune-mediated. Despite being less frequent, there are certain AE which, due to their clinical relevance, led to the permanent suspension of treatment. The incidence of grade 3 EA was higher in patients treated with Pembrolizumab, as well as hospitalisation required. The role of a multidisciplinary team is essential in handling possible related EA, achieving an adequate treatment optimisation. References and/or acknowledgements https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481296/ No conflict of interest.