179P - Nivolumab monotherapy in patients with previously treated advanced non-small cell lung cancer (NSCLC) in routine clinical practice in a Spanish center

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Immunotherapy
Non-Small Cell Lung Cancer
Presenter Xabier Mielgo
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors X. Mielgo1, P. Toro2, L. Ruiz-Giménez1, C. Olier1, M. Pérez2, A. Rosero1, J.C. Cámara1, S. Hernando1, A. Hurtado1, C. Jara1
  • 1Oncology Unit, HUFA Hospital Universitario Fundacion Alcorcon, 28922 - Alcorcon/ES
  • 2Pharmacy Unit, HUFA Hospital Universitario Fundacion Alcorcon, 28922 - Alcorcon/ES



Nivolumab, a PD-1 blocking monoclonal antibody, shown survival advantage in patients with NSCLC whose disease progressed during or after platinum-based chemotherapy in 2 phase 3 studies. It obtained American and European approval, but it is pending approval by the Spanish agency, so there is little evidence of its use out of clinical trial. This is one of the first reports of use of Nivolumab in routine clinical practice.


This is a retrospective review of patients with advanced NSCLC treated with Nivolumab monotherapy (3 mg/kg/2week) via compassionate use in our center, in routine clinical practice. There were retrospectively analyzed clinicopathological features and clinical outcomes.


11 patients treated with Nivolumab were reviewed. 90% were men. Mean age: 65 year (range: 40–78). Majority of patients were heavily pretreated: 18% received Nivolumab in 2nd line and 82% in 3rd line onwards (28% in 5th and 6th line). Median number of received cycles was 6.9. 73% were adenocarcinoma and 27% squamous histology. 18% had received prior thoracic radiotherapy (RT). Disease control rate was 72%. Radiologic response: 50% stable disease (SD), 37% partial response (PR), 13% progression disease (PD). 4 patients (36.3%) had initial pseudoprogression and later tumor burden reduction. 1 patient with central nervous system (CNS) progression who was no treated with RT achieved CR in CNS. 1 EGFR mutant patient was treated with PR. Median time to response: 14.2 weeks. Little severe toxicity occurred: only 1 patient had grade 3 pneumonitis and only this patient discontinued Nivolumab for toxicity. Toxicity: dysnea G1 9%; asthenia G1 45%, G2 9%; skin G1 18%; onycodystrophy G1 9%; uveitis G1 9%; endocrinopathies G1 27%; anorexia G1 18%; arthralgia G1 36%. 1 patient with HCV chronic infection had good tolerance and no hepatic toxicity.


Nivolumab monotherapy produced encouraging response rates with good tolerance and little toxicity in patients treated in routine clinical practice, using wider selection criteria than clinical trials. Nivolumab shown activity in CNS, in a patient with EGFR mutation and good tolerance in spite of HCV chronic infection.

Clinical trial identification

Legal entity responsible for the study

Hospital Universitario Fundación Alcorcón


Hospital Universitario Fundación Alcorcón


All authors have declared no conflicts of interest.