Background Nivolumab is a human immunoglobulin G4 monoclonal antibody, which binds to the programmed death-1 receptor and blocks its interaction with PD-L1 and PD-L2. It is approved for melanoma, renal, urhotelial, non-small cell lung cancer (NSCLC) and other types of cancer.

Purpose To evaluate the effectiveness and safety of patients treated with nivolumab in our hospital.

Material and methods Retrospective observational study of all patients treated with nivolumab from February 2016 to June 2017. Data collected from clinical history: age, sex, diagnosis, Eastern Cooperative Oncology Group (ECOG) performance status score, treatment duration, number of cycles, prior lines of treatment, progression-free survival (PFS), overall survival (OS) (obtained by the Kaplan–Meier method and defined as the time elapsed from the start of the treatment until the patient died, excluding those patients who had not died at the end of the study), percentage of patients continuing treatment at study time, and percentage of deaths and adverse effects.

Results Forty patients (71% males) were included in the study.

Treatment-related adverse effects of any grade were reported in 26 (63%) patients. The most common were asthaenia grade 1–2 (24%), pruritus and dermatological reactions grade 1–2 (14.6%), and myalgia or arthralgia grade 1 (9.7%). Other side reactions were also important: two patients had hepatitis grade 1–2, one patient presented neumonitis grade 2 and one patient neurotoxicity grade 2. No patient required hospitalisation, however, one patient discontinued treatment for renal toxicity. Grade 3–4 reactions were not detected.

Conclusion The effectiveness in terms of PFS and OS was more reduced than clinical essays, although we should consider that there were patients with ECOG ≥2.

In most cases, nivolumab was safe and well tolerated.

To evaluate efficacy and long-term safety, a longer monitoring period is required.

No conflict of interest