CP-065 Effectiveness and safety of nivolumab in non-small cell lung cancer

• Published in: European journal of hospital pharmacy. Science and practice 2017-03, Vol.24 (Suppl 1), p.A29-A29
• Main Authors: Pineiro, L Villaverde, Santamaria, A Iglesias, Garcia, VM López
• Format: Article
• Language: English
• Subjects: Cancer therapies; Clinical trials; Conflicts of interest; Drug prices; Genotype & phenotype; Health insurance; Immunotherapy; Lung cancer; Monoclonal antibodies; Patient satisfaction; Pharmacy; Targeted cancer therapy; Tumors
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2017-000640.64

Background Immunotherapy is a new approach for cancer treatment that improves the capacity of the immune system to acknowledge and delete tumours. Nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, has demonstrated improved survival over docetaxel in previously treated advanced squamous and non-squamous non-small cell lung cancer (NSCLC). Purpose To evaluate the effectiveness and safety of nivolumab in patients with NSCLC. Material and methods This was a retrospective observational study of all patients with advanced squamous and non-squamous NSCLC treated with nivolumab from September 2015 to September 2016. Data collected: age, histology, ECOG performance status (PS), previous treatments in the advanced setting, mean number of cycles administered, progression and death dates, and adverse events. Disease status was assessed by the Response Evaluation Criteria in Solid Tumours (RECIST). Results 14 patients were included (85.71% were men). Mean age was 62.3 years (50-74); 78.57% had non-squamous histology; ECOG PS was 0 (35.72%) and 1 (64.28%). All patients had progressed during or after platinum based chemotherapy. Mean number of cycles administered was 8.07 (1-26) and mean treatment duration was 113 days (14-364). Nivolumab dose was 3 mg/kg every 2 weeks. 6 patients (42.87%) are still receiving treatment. Causes of treatment suspension in the remaining patients were disease progression (21.42%), death (28.57%) and clinical worsening (7.14%). Median progression free survival (PFS) was 98 days. The most common adverse events were: asthenia (42.85%), decreased appetite (14.28%), vomiting (7.14%), cough (7.14%), fever (7.14%) and immune related diarrhoea that required corticosteroid therapy (7.14%). Conclusion Median PFS in our study was similar to the results of the CheckMate 017 and 057 trials. It will be necessary to increase the sample size to confirm these results. It is important to note that conventional RECIST criteria might underestimate the benefit of immunotherapy agents, so it may be convenient to use immune related response criteria that permit treatment beyond initial progression per RECIST to prevent premature cessation of treatment and to increase the effectiveness of those agents in clinical practice. Nivolumab was safe and well tolerated, and its safety profile was similar to that described in both clinical trials. References and/or acknowledgements CheckMate 017 and CheckMate 057 trials No conflict of interest