DI-090 Compassionate use of nivolumab in non-small cell lung cancer

Abstract

BackgroundPatients diagnosed with stage 4 non-small cell lung cancer (NSCLC) have poor survival (median 9–12 months). A platinum based regimen is generally preferred, usually with limited results. Secondline therapies have not shown long lasting responses. Nivolumab is an anti-programmed cell death 1 (PD-1) monoclonal antibody that works as a checkpoint inhibitor by improving the immune response. It is administered every 14 days in a 3 mg/kg dose. Nivolumab is the first drug that has demonstrated superior response versus docetaxel, the standard treatment for disease progression.PurposeTo evaluate survival rates and tolerability of nivolumab in NSCLC.Material and methodsA retrospective observational study was carried out from June 2015 to September 2016. Electronic medical records were reviewed and analysed using SPSS Statistics programme. Variables collected were age, sex, stage, Eastern Cooperative Oncology Group (ECOG) performance status score, subtype of NSCLC, sites of metastasis, previous lines of treatment, adverse events, progression free survival (PFS) and overall survival (OS).Results22 stage 4 patients were included (14 men, 8 women) with a median age of 64 years (51–82). ECOG0: 1 patient, ECOG1: 16 patients, ECOG2: 5 patients. Histology: 15 patients adenocarcinoma, 5 squamous cell carcinoma and 2 unknown. The most frequent metastatic sites were: liver (6), kidney (6), peritoneum (5), bone (5) and nervous system (4). Nivolumab was mostly used as a fourthline therapy (2nd–6th). Firstline was a platinum based therapy (with pemetrexed, gemcitabine or vinorelbine) in 18 patients, erlotinib in 2, and 2 patients had monotherapy with paclitaxel and gemcitabine. Docetaxel was most frequent secondline treatment. Median PFS was 1.8 months (95% CI 0.53–3.06) and median OS was 5.9 months (95% CI 0.24–11.56; 40.9% censored). The most common adverse effect was asthenia in 12 patients, followed by shortness of breath in 7. Related to immune mediated events, 2 patients had thyroid dysfunction. Grade 3–4 reactions were not detected.ConclusionThe PFS and OS results were worse than in a pivotal study (squamous cell indication, only 23% of our cases). Nevertheless, we had a small number of patients with ECOG2 (23%), and 77% used nivolumab as thirdline or more treatment, where the evidence is limited. Nivolumab was well tolerated and there was no need for treatment discontinuation.No conflict of interest