Nivolumab treatment in advanced non-small cell lung cancer (aNSCLC): A French nationwide retrospective cohort (UNIVOC Study)

Abstract

Background: Nivolumab demonstrated superior overall survival (OS) in clinical trials compared to docetaxel in patients previously treated for squamous (Sq) and non-squamous (NSq) aNSCLC. The objective was to describe in French real-world setting the characteristics and outcomes of patients treated with nivolumab for aNSCLC according to histology. Methods: Based on the National hospitals database (PMSI), we performed a retrospective cohort of all NSCLC patients (ICD code: C34∗) initiating nivolumab in 2015-2016 and followed until Dec 2017. Information on patients' baseline characteristics (demographics, comorbidities, treatment history) was retrieved for Sq and NSq patients, and time to treatment discontinuation (TTD) with nivolumab and OS were estimated with Kaplan-Meier methodology. Results: The overall cohort included 10,452 patients. Among them, a majority (N=5805; 56%) presented NSq histology. Compared to Sq patients (N=4647), NSq patients were younger (61.9 vs. 66.1 years; p<0.001) and less frequently men (64.3% vs 79.3%; p<0.001). They had less comorbidities such as hypertension (15.8% vs 23.0%; p<0.001), diabetes (6.7% vs 11.7%; p<0.001) and COPD (8.8% vs 18.1%; p<0.001). Cerebral metastases were more frequent in the NSq population (22.9% vs 10.1%; p<0.001). Median time from NSCLC diagnosis to nivolumab initiation was longer in NSq patients (14.2 vs 10.5 months; p<0.001), as well as median time from first systemic treatment to nivolumab initiation (12.0 vs 8.9 months; p<0.001). Nivolumab TTD was comparable across histologies with a median treatment duration of 2.8 months (p=0.556). Proportion of NSq and Sq patients treated were 27.8% vs 25.7% (p<0.001) at 6-month and 14.6% vs 12.1% (p<0.001) at 1-year, respectively. Median OS was higher in NSq patients (12.6 vs 10.6 months; p=0.004). NSq and Sq patients OS rates were 51.1% vs 45.7% (p<0.001) at 1-year and 29.3% vs 24.6% (p<0.001) at 2-year, respectively. Conclusions: This analysis of a large nationwide retrospective cohort assessed patients' characteristics and outcomes associated with nivolumab treatment in clinical practice in France. In both histologies, results suggest similar TTD and OS in real life setting as those observed in phase III trials.