Background Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks interaction with its PD-L1 and PD-L2. This binding releases PD-1 pathway-mediated immune responses against tumour cells. Nivolumab has demonstrated efficacy in non-small-cell lung cancer (NSCLC), renal cancer, and head and neck cancer in monotherapy. Also, in metastatic melanoma in monotherapy or combined with ipilimumab. The toxicity grade was classified by Common Terminology Criteria for Adverse Effects v.4 (CTCAE): grade 1- mild, grade 2- moderate, grade 3- severe, grade 4- life-threatening consequences and grade 5- death related to AE. Its most common adverse effects (AE) (≥10%) at a dose of 3 mg/kg iv in monotherapy described in clinical trial phases II and III were asthaenia (in 34% of patients), rash (19%), pruritus (14%), diarrhoea (13%) nausea (13%) and anorexia (10%). Ninety per cent were mild or moderate (G1–2) and 10% were severe (G≥3).

Purpose With the aim of assessing the safety of nivolumab (3 mg/kg iv) in the clinical practice and compare it with clinical trials’ results, a transversal analysis was conducted on patients treated with nivolumab in a university hospital from June 2016 to March 2017.

Material and methods Our study included 13 patients (92% males) of whom 62% had a NSCLC diagnosis (43% squamous ethyology, 57% adenocarcinoma), 15% renal cancer and 23% metastatic head and neck cancer. Treatments were discontinued in seven (53%) of those patients following disease progression or patient’s death, but none of them because of toxicity.

Results Most frequent AEs (≥10%) were: hyperglycaemia (36%), anaemia (14%), arthromyalgias (14%) and asthaenia (11%), and the less frequent were: nausea (7%), hypertriglyceridaemia (7%), pruritus (4%), anorexia (4%) and hepatic toxicity with high transaminases levels (4%). According to CTCAE, 39% of AE were grade 1, 32% grade 2% and 29% grade ≥3. Eight severe AE were described as follows hyperglycemia (four), hypertriglyceridaemia (two), asthaenia (one) and arthromyalgia (one).

Conclusion In our clinical practice we had found hyperglycaemia as the most common AE compared with asthaenia in clinical trials. The proportion of grade ≥3 was higher than in clinical trials (29% vs 10%, respectively).

References and/or Acknowledgements Thanks to all my co-workers for carrying out this study with me.

No conflict of interest