In 2016, nivolumab could be prescribed according to French registration in stage IIIB/IV NSCLC after disease progression with prior platinum-based chemotherapy and TKI therapy for patients with EGFR mutation. The Observatory of Drugs, Medical Devices and Therapeutic Innovations (OMEDIT), a network from the Health Ministry has evaluated the use, current practices and medico-economic approach in the Bretagne and Pays de la Loire areas.
All consenting adult patients with stage IIIB/IV NSCLC who initiated nivolumab (3 mg/kg every 2 weeks) in 2016 were included. Minimum follow-up for survival was 12 months. Sex, age, mutation profile, toxicities, Clinic Benefit (CB: pts with complete/partial response/stable disease as the best response), progression-free survival (PFS) and overall survival (OS) have been studied for ECOG PS 0-1 pts (according to registration).
377 pts with squamous (113 pts), non-squamous (197) and undifferentiated (67) NSCLC have been included. The median number of courses was 8 (1-54). 140 pts (37%) had 1 to 4 courses, 67 pts (18%) 5 to 8 courses and 170 pts (45%) more than 8. 247 pts were treated in 2nd line, 98 in 3rd line. All lines combined, CB was experienced by 212 pts (56%). For these pts, median course was 17 (1-54), mPFS and mOS were 4.6 months and 15.0 months, respectively. No difference on survival has been noticed according to histology, treatment line, age (cut-off 70 y), grade III/IV toxicity. However, mPFS and mOS were lower in ECOG PS ≥ 2 pts than in PS0-1 pts: 2.4 months vs 4.6 m (p < 0.01) for PFS and 3.7 m vs 15.0 m (p < 0.001) for OS. 20% of pts presented grade III/IV toxicities. These pts presented a better CB (74% vs 56%, p = 0.002). In 2016-2017, this treatment, for pts initiated in 2016 only, cost 15.8 million euros (drug, hospitalisation and transportation). 86% of these costs were dedicated to pts who experienced CB.
In a real-life setting, survival outcomes and toxicities with nivolumab in advanced NSCLC are comparable to literature data. ECOG PS ≥ 2 pts presented shorter survival than PS0-1 pts. Interestingly, 86% of the cost incurred for these treatments was to pts with CB. Updated data will be shown at the meeting.
Clinical trial identification
Legal entity responsible for the study
Cancer Observatory, OMEDIT B and PL.
Has not received any funding.
R. Corre: Board, invitation Congress: BMS. J-Y. Douillard: CMO: ESMO. O. Molinier: Expert advice: BMS. All other authors have declared no conflicts of interest.