Nivolumab, an immune checkpoint inhibitor, is now a standard treatment for previously treated advanced non-small cell lung cancer. We aimed to evaluate the real-world efficacy and safety of nivolumab in a non-selective population and identify clinical characteristics that influence efficacy.
One hundred and forty-two patients with previously treated advanced non-small cell lung cancer who were administered nivolumab at Keio University and affiliated hospitals (in Japan) between January and July 2016 were enrolled. Treatment responses and adverse events were retrospectively reviewed and clinical characteristics associated with nivolumab responses were evaluated using univariate and stratified analyses and the Cochran-Mantel-Haenszel test.
The objective response rate was 17.0%, while the proportion of patients with adverse events of any grade was 45.0%. Clinical characteristics such as age, sex, Eastern Cooperative Oncology Group performance status, histological type, presence or absence of central nervous system metastases, smoking status, and the number of previous lines of treatment, were not related to efficacy. However, EGFR/ALK mutation status was inversely associated with treatment response (P < 0.05). Prior radiotherapy also exhibited a positive association with treatment response (P = 0.012). Although no significant difference was observed between current/ex-smokers and non-smokers (P = > 0.05), a subgroup analysis revealed smoking status in pack-years to be significantly higher in responders than non-responders (P < 0.05). Nivolumab is effective and safe regardless of age or the number of previous lines of treatment.
The objective response rate and adverse event profiles were comparable to those observed in previous clinical trials. An EGFR/ALK mutation-negative status and prior radiotherapy are key clinical characteristics that are statistically associated with a positive treatment response. Our findings may aid in the efficient immunotherapeutic management of advanced non-small cell lung cancer.
We will add other measurements of the treatment activity such as progression-free survival by the congress.
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All authors have declared no conflicts of interest.