Concomitant use of corticosteroids (CS) during immune checkpoint inhibitors (ICI) therapy are not recommended, but their real impact on ICI efficacy remains unknown. The aim of this study was to assess the impact of CS on ICI outcomes in NSCLC pts.
Baseline CS intake and dose, patient characteristics and outcome were retrospectively collected in patients treated with PD1/PDL1 inhibitors from Nov. 2012 to Mar. 2017 in our Institute. Primary endopoints were overall survival (OS) and disease control rate (DCR: complete response + partial response + stable disease) and secondary endpoint was progression free survival (PFS).
We enrolled 244 pts. Median age was 63 years (30-85), 158 (65%) were males, 212 (87%) smokers, 196 (80%) PS 0-1; 155 (64%) had non-squamous cells carcinoma. The median of prior lines was 1 (0-11). KRASmut and EGFRmut was present in 62 (25%) and 14 (6%) of NSCLC, 3 (1%) were ALK+, 64 (26%) PDL1 + (cut-off 1% of tumor cells), 24 (10%) PD-L1- and 156 (64%) PD-L1 unknown. In the whole population, the overall response rate (ORR) was 20% and DCR 50%. Median OS and PFS were 9 months (m) [6-12] and 2m [2-3], respectively. The median follow-up was 10m [7-12]. Sixty-six patients (27%) received CS at baseline. Main reasons for taking CS were dyspnea (48%) and brain metastasis (15%). The median dose of daily prednisone was 16.25 mg [5;32.75] and >20mg in 19 (29%). CS dose >20mg was an independent factor for poor OS [HR 1,013, 95% CI 1,006; 1,02, p 20mg, the median OS was 3m [2-12] vs. 10m [7-15] for 20mg was 1m [1-4] vs. 3m [2-4] for < 20mg (p = 0.002). CS > 20mg was also significantly associated with progressive disease (p = 0.011).
Baseline daily prednisone intake of at least 20mg is associated with poor outcomes in advanced NSCLC treated with ICI. Further prospective studies are awaited for validating the real impact of CS in ICI efficacy.
Clinical trial identification
Legal entity responsible for the study
Dr Benjamin Besse
Institut Gustave Roussy
D. Planchard: AstraZeneca Boehringer Ingelheim BMS Lilly MSD Pfizer Roche Novartis Chugai. J-C. Soria: AstraZeneca, Astex, Clovis, GSK, Gammamabs, Lilly, MSD, Mission Therapeutics, Merus, Pfizer, Pharmamar Pierre Fabre, Roche-Genentech, Sanofi, Servier, Symphogen, Takeda. All other authors have declared no conflicts of interest.